Although cure rates with DAAs top 97%, less than two-thirds of patients receive treatment

Palo Alto, CA - Less than two-thirds of insured patients with viremic hepatitis C virus infection received treatment with direct-acting antivirals from 2014 to 2021, with a sharp decline in diagnoses and treatment reported during the COVID-19 pandemic. “We believe that DAA treatment for HCV can improve patient clinical outcomes and survival, and that it is very safe and well-tolerated,” Mindie H. Nguyen, MD, MAS, AGAF, FAASLD, professor of medicine in the department of gastroenterology, hepatology and liver transplant at Stanford Medicine, told Healio. “However, I observed in my practice that there are still many barriers to the patient — from linkage to care or connection to a clinician who treats HCV to insurance authorization and approval of medications.”  In a retrospective cohort study published in JAMA Network Open, Nguyen and colleagues aimed to characterize patients in the U.S. with HCV using the deidentified Optum Clinformatics Data Mart Database and determine treatment rates in the DAA era (2014-2021). “Such data can inform patients, patient advocacy, clinicians and policy makers on what or how much gap we still have to encourage further efforts to fill these care gaps,” Nguyen said. Among 133,348 identified patients (mean age, 59.7 years; 59.7% men; 56.1% white), 26.8% had HCV RNA data and, of those, 53.1% had positive HCV RNA. Overall, 65.2% of patients with positive HCV RNA results received treatment with DAAs and 97.3% achieved sustained virologic response. Adjusted analysis showed a 0.5 times greater treatment rate in 2018 vs. 2014 (adjusted prevalence ratio = 1.5; 95% CI, 1.42-1.59), which then declined after 2018 from 64.8% to 61.2%. The treatment rate decreased to less than 60% between April 2020 to March 2021. Additionally, during the COVID-19 pandemic, only 496 patients with viremic HCV were identified. Researchers noted this was a “sizeable decrease” compared with those identified between April 2019 and March 2020 (n = 2,761) and between April 2018 and March 2019 (n = 3,258). Patients who received care from a gastroenterologist or infectious disease specialist with an advanced care practitioner were 65% more likely to received treatment with DAAs compared with those who received care from a primary care practitioner (adjusted OR = 1.64; 95% CI, 1.38-1.95). Further, patients with decompensated cirrhosis and/or hepatocellular carcinoma were 30% less likely to receive treatment vs. patients without cirrhosis (aOR = 0.69; 95% CI, 0.54-0.9). “In this nationwide U.S. study of insured HCV patients conducted between 2014 and 2021, we found suboptimal treatment rates for patients with viremic HCV infection, especially since the beginning of the COVID-19 pandemic,” researchers wrote. “We found a high cure rate of approximately 97% among patients treated with DAAs, regardless of what kind of clinician provided care. However, less than two-thirds of all patients with viremic HCV received DAA treatment.” According to Nguyen, patients with positive HCV RNA tests, especially those with advanced disease such as liver cancer and decompensated cirrhosis, should be considered for treatment and referred to clinicians who are familiar with the management of these patients. “All adult patients should be screened for HCV,” she said. “Clinicians and hospital and care systems should set up reminder system to facilitate this.”

For more information: https://tinyurl.com/se2teuyw

England Set to Eliminate Hepatitis C Before 2030 Goal

London, UK - The English National Health Service (NHS) is on track to eliminate hepatitis C virus (HCV) as a public health concern nearly five years ahead of the 2030 deadline set by the World Health Organization (WHO) thanks to direct-acting antivirals (DAAs). The WHO defines elimination of hep C as “as a 90% reduction in new chronic infections and a 65% reduction in mortality compared with the 2015 baseline.” The DAAs, for which the NHS paid almost £1 billion ($1.049 billion) in a deal with pharmaceutical companies Gilead Sciences, Merck & Co. and AbbVie, have been distributed to thousands of patients and have reduced the number of deaths from hepatitis C, liver disease and liver cancer by 35%. About 70,000 people have been cured of hepatitis C, which has reduced the number of people in need of liver transplants, according to an NHS news release. What’s more, within the last six years, requests for liver transplants have decreased by about two thirds. Annual registrations for a liver transplant in those with hepatitis C and related diseases fell from 140 per year to less than 50 per year in 2020. The NHS also credits its success to a screening program launched in September that has diagnosed 80,000 people with hepatitis C and started them on treatment for the virus. All of which means the NHS is poised to eliminate hepatitis C in 2025. “These figures demonstrate the ability of the NHS to use its commercial capabilities and purchasing power to tackle population health challenges benefiting tens of thousands of people,” said John Stewart, national director for specialized commissioning at NHS England, in the NHS news release. Hepatitis C is transmitted when the blood of a person with HCV passes into the blood of an uninfected person by, for example, sharing needles and other paraphernalia used to inject drugs. Direct-acting antivirals can cure more than 95% of people with hep C. When left untreated, HCV can lead to liver cancer, liver failure and death. The NHS recommends that patients get screened regularly to ensure early detection and treatment of the virus.

For more information: https://tinyurl.com/4uzttmtj

Study looks at discontinuation of prescribed opioids and risk of overdose

Vancouver, BC - The overdose crisis in North America has prompted system-level efforts to restrict opioid prescribing for chronic pain. However, little is known about how discontinuing or tapering prescribed opioids for chronic pain shapes overdose risk, including possible differential effects among people with and without concurrent opioid use disorder (OUD). Researchers here examined associations between discontinuation and tapering of prescribed opioids and risk of overdose among people on long-term opioid therapy for pain, stratified by diagnosed OUD and prescribed opioid agonist therapy (OAT) status. For this retrospective cohort study, they used a 20% random sample of residents in the provincial health insurance client roster in British Columbia (BC), Canada, contained in the BC Provincial Overdose Cohort. The study sample included persons aged 14 to 74 years on long-term opioid therapy for pain (≥90 days with ≥90% of days on therapy) between October 2014 and June 2018 (n = 14,037). At baseline, 7,256 (51.7%) persons were female, the median age was 55 years (quartile 1–3: 47–63), 227 (1.6%) persons had been diagnosed with OUD (in the past 3 years) and recently (i.e., in the past 90 days) been prescribed OAT, and 483 (3.4%) had been diagnosed with OUD but not recently prescribed OAT. The median follow-up duration per person was 3.7 years (quartile 1–3: 2.6–4.0). Marginal structural Cox regression with inverse probability of treatment weighting (IPTW) was used to estimate the effect of prescribed opioid treatment for pain status (discontinuation versus tapered therapy versus continued therapy [reference]) on risk of overdose (fatal or nonfatal), stratified by the following groups: people without diagnosed OUD, people with diagnosed OUD receiving OAT, and people with diagnosed OUD not receiving OAT. In marginal structural models with IPTW adjusted for a range of demographic, prescription, comorbidity, and social-structural exposures, discontinuing opioids (i.e., ≥7-day gap[s] in therapy) was associated with increased overdose risk among people without OUD (adjusted hazard ratio [AHR] = 1.44; 95% confidence interval [CI] 1.12, 1.83; p = 0.004), people with OUD not receiving OAT (AHR = 3.18; 95% CI 1.87, 5.40; p < 0.001), and people with OUD receiving OAT (AHR = 2.52; 95% CI 1.68, 3.78; p < 0.001). Opioid tapering (i.e., ≥2 sequential decreases of ≥5% in average daily morphine milligram equivalents) was associated with decreased overdose risk among people with OUD not receiving OAT (AHR = 0.31; 95% CI 0.14, 0.67; p = 0.003). The main study limitations are that the outcome measure did not capture overdose events that did not result in a healthcare encounter or death, medication dispensation may not reflect medication adherence, residual confounding may have influenced findings, and findings may not be generalizable to persons on opioid therapy in other settings. The researchers concluded that discontinuing prescribed opioids was associated with increased overdose risk, particularly among people with OUD. Prescribed opioid tapering was associated with reduced overdose risk among people with OUD not receiving OAT. They added that these findings highlight the need to avoid abrupt discontinuation of opioids for pain. As well, enhanced guidance is needed to support prescribers in implementing opioid therapy tapering strategies with consideration of OUD and OAT status. Published: December 1, 2022 in PLOS journal.

For more information: https://doi.org/10.1371/journal.pmed.1004123

WHO recommends new name for monkeypox disease

Geneva, Switzerland - Following a series of consultations with global experts, WHO will begin using a new preferred term “mpox” as a synonym for monkeypox. Both names will be used simultaneously for one year while “monkeypox” is phased out. When the outbreak of monkeypox expanded earlier this year, racist and stigmatizing language online, in other settings and in some communities was observed and reported to WHO. In several meetings, public and private, a number of individuals and countries raised concerns and asked WHO to propose a way forward to change the name. Assigning names to new and, very exceptionally, to existing diseases is the responsibility of WHO under the International Classification of Diseases (ICD) and the WHO Family of International Health Related Classifications through a consultative process which includes WHO Member States.  WHO, in accordance with the ICD update process, held consultations to gather views from a range of experts, as well as countries and the general public, who were invited to submit suggestions for new names. Based on these consultations, and further discussions with WHO’s Director-General Dr Tedros Adhanom Ghebreyesus, WHO recommends the following: Adoption of the new synonym mpox in English for the disease. Mpox will become a preferred term, replacing monkeypox, after a transition period of one year. This serves to mitigate the concerns raised by experts about confusion caused by a name change in the midst of a global outbreak. It also gives time to complete the ICD update process and to update WHO publications.   The synonym mpox will be included in the ICD-10 online in the coming days. It will be a part of the official 2023 release of ICD-11, which is the current global standard for health data, clinical documentation and statistical aggregation. The term “monkeypox” will remain a searchable term in ICD, to match historic information. Considerations for the recommendations included rationale, scientific appropriateness, extent of current usage, pronounceability, usability in different languages, absence of geographical or zoological references, and the ease of retrieval of historical scientific information. Usually, the ICD updating process can take up to several years. In this case, the process was accelerated, though following the standard steps. Various advisory bodies were heard during the consultation process, including experts from the medical and scientific and classification and statistics advisory committees which constituted of representatives from government authorities of 45 different countries.  The issue of the use of the new name in different languages was extensively discussed.  The preferred term mpox can be used in other languages. If additional naming issues arise, these will be addressed via the same mechanism. Translations are usually discussed in formal collaboration with relevant government authorities and the related scientific societies.  WHO will adopt the term mpox in its communications, and encourages others to follow these recommendations, to minimize any ongoing negative impact of the current name and from adoption of the new name.

For more information: https://tinyurl.com/2b2eeu2k

Feds announce over $15 million to support Canadians living with an addiction or who use substances

Ottawa, ON - Many people are impacted by addiction, and the overdose crisis and illicit toxic drug supply continue to impact individuals, families and communities across our country. Raising awareness on addiction, reducing stigma related to substance use and providing a range of supports for people living with addiction and problematic substance use has never been more important. During National Addictions Awareness Week (NAAW), the Honourable Carolyn Bennett, Minister of Mental Health and Addictions and Associate Minister of Health, announced over $15 million in federal funding for 24 projects across Canada through Health Canada's Substance Use and Addictions Program These projects will significantly help improve health outcomes for people who are at risk of experiencing substance-related harms and overdose by scaling up prevention, harm reduction and treatment efforts, including access to safer supply programs. The funding announced today will allow innovative community-led projects to serve the many communities and people who need them. However, more needs to be done to support people who use substances, including those who struggle with addiction. We will continue to work with all levels of government, partners, Indigenous communities, stakeholders, people with lived and living experience of addiction, and organizations in communities across the country to save lives and improve health outcomes for all Canadians. The initiatives announced stretch across the continuum of care (prevention, harm reduction, treatment), and vary from community-based service delivery projects like drug checking, to national initiatives, like the YMCA's Youth Opioids Awareness Program, aimed at increasing knowledge of opioid use, addressing stigma and promoting healthy lifestyles through physical activity for youth in Toronto, Vancouver and rural communities in Newfoundland and Labrador.  Since 2017, through SUAP, the Government of Canada has supported over 300 projects across the country to respond to current drug and substance use issues in Canada.  Budget 2022 proposes to provide $100 million over three years to support harm reduction, treatment, and prevention at the community level.  This builds on the $116 million provided in Budget 2021 and $66 million in the 2020 Fall Economic Statement for the Substance Use and Addictions Program.

For more information: https://tinyurl.com/mrx2y7jt

Outreach key to success of HCV elimination program

Washington, DC -  An expert panel of physicians, researchers and scientific advisers called upon The Liver Meeting attendees to support a proposed national HCV elimination program in the US. “We don’t get to use the word ‘eliminate’ all that often with a disease that is taking thousands or tens of thousands or, worldwide, hundreds of thousands of lives every year,” Francis S. Collins, MD, PhD, former director of NIH and acting science adviser for President Joe Biden, said. “But we have that opportunity with hepatitis C.” “For many, the prospect of a national program is a beacon of hope that follows decades of lives lost to a preventable — and now curable — disease," Adrienne Simmons, PharmD, MS, said. Collins outlined the current state of HCV infection in the United States, citing recent data from the CDC that show significant increases in new, acute cases of HCV in young adults and IV drug users. “Around 2.4 million people are living with HCV in the United States, 40% of whom are unaware of their infection despite the fact that routine and broad screening has been recommended for everybody over 18,” Collins said. “Our goal is to try to do something to change this, because we now have highly effective oral agents that don’t just treat the disease, they cure it 95% to 97% of the time.” Despite the widespread availability of testing and curative therapy, Collins explained that a substantial gap exists between diagnosing and treating the disease, driven largely by a lack of awareness, a “clunky” two-step diagnostic process and the expense of treatment, which can reach nearly $90,000 per patient for direct-acting antivirals.  “Let’s be clear,” he said. “You’re dealing with hard-to-reach populations that are underserved, uninsured, people who are in tough times, justice-involved populations, and anything you put in the way as a barrier is going to make this worse.” He continued, “If we are a country that cares about all its people, a country with a lot of resources, and a country that’s able to think about cost and benefit, this ought to be a case where we can jointly put together a plan — a national plan — to eliminate this disease.” Rachael Fleurence, PhD, MSc, serving in the White House Office of Science Technology Policy, detailed the renewed focus of the national plan, following discussions with federal agencies, patient and advocacy groups, manufacturers, insurers and state leaders.  “A large component and a large focus will be working on diagnostic test development, but also accelerating and bringing into the U.S. tests that are currently available outside of the U.S.,” Fleurence said. “These include point-of-care RNA diagnostic tests, as well as core antigen laboratory tests.” The program also would implement a national subscription model that would make DAAs available to Medicaid beneficiaries, justice-involved populations, uninsured individuals, and American Indian and Alaskan natives who are receiving care through the Indian Health Service. It also involves working with commercial insurers to potentially offer copay assistance for Medicare beneficiaries and decrease barriers to access. Further, a public health information effort will entail “substantially expanding screening strategies, especially for high-risk populations,” Fleurence said, as well as increasing the number of providers that can screen and treat HCV with telemedicine, ensuring the right incentives are set in place for providers, increasing the linkage of care and the number of community health workers, and supporting vaccine research and development, as well preventive services. Fleurence noted that the next steps for this program include obtaining funding to support the NIH Radx program to accelerate diagnostic testing and supporting pilot trials conducted by the CDC, the Health Resources and Services Administration, the Substance Abuse and Mental Health Services Administration and Indian Health Service. Although Collins praised the creation of this program, which he called “one of the more exciting, positive developments of the last 20 years,” he acknowledged that still more needs to be done.

For more information: https://tinyurl.com/48fh94ec

CDC updates clinical guidance on prescribing opioids for pain

Atlanta, GA - The CDC has released updated and expanded clinical practice guidance on prescribing opioids to patients with short- and long-term pain. The guidance, which was first proposed in February, replaces the agency’s 2016 recommendations. The CDC has released updated clinical practice guidance on prescribing opioid treatment for pain, including categories such as acute pain and subacute pain. Source: Adobe Stock.  “Patients with pain should receive compassionate, safe and effective pain care. We want clinicians and patients to have the information they need to weigh the benefits of different approaches to pain care, with the goal of helping people reduce their pain and improve their quality of life,” Christopher M. Jones, PharmD, DrPH, MPH, acting director of CDC’s National Center for Injury Prevention and Control, said in a press release. According to CDC data, of more than 91,000 drug overdose deaths that occurred in the U.S. in 2020, 74.8% (n = 68,630) involved an opioid. About 10,000 of these deaths were attributed to prescription opioids. The updated guidance includes 12 recommendations that address whether to initiate opioid therapy for pain, selecting opioids and dosages, determining the duration of treatment and assessing the risks and benefits.  In a telebriefing, Jones touched down on several key differences between the 2016 and 2022 guidance that reflect “the expanded scope of the available scientific evidence.” “While the 2016 guideline focused almost exclusively on chronic pain, the guideline released today also includes recommendations for treating acute and subacute pain,” he said. Jones said it was particularly important that the guidance addressed these categories of pains, citing previous research that has shown opioid therapy is initiated during the subacute pain timeframe. The guidance was also expanded from a focus on clinicians in a primary care setting to a broader range of providers and specialties, and it contains new information on both tapering opioid treatment and the use of nonopioid medications and treatments for pain. “We’ve also expanded the evidence base around the use of opioid pain medications and other pain treatments in certain groups, like older adults and pregnant people, and in people with conditions posing special risks, such as those with a history of substance use disorder,” Jones said. He added that the updated guidance also specifies which recommendations apply to patients being considered for opioid therapy, “versus those who have been receiving opioids as part of ongoing care.” Responding to media comments, Jones discussed the CDC’s efforts to ensure the appropriate use of the updated guidance, particularly since the 2016 guidance was “mis-implemented” by clinicians, putting patients at risk. According to a paper published by CDC researchers in 2019, many clinicians inappropriately applied the 2016 guidance to patients receiving cancer treatment, those experiencing acute sickle cell crises or post-surgical pain, and those receiving medication-assisted treatment for opioid use disorder. In addition, many clinicians abruptly discontinued or de-escalated opioid doses, which Jones said could cause “very real harms,” including mental health crises, suicidal ideation or behavior and psychological distress. Abrupt discontinuation or de-escalation could also lead some patients to seek out opioids through illicit markets “in order to stave off withdrawal or to supplement if they are at too low of a dose,” he said. Jones stated that the CDC will look out for practices and policies that are inconsistent with the updated guidance and use them as an “educational opportunity.” “We’ll be monitoring and engaging with clinical partners in patient organizations to also raise awareness for where those circumstances may occur,” he said.

For more information: https://tinyurl.com/4y84p545

Adults with hepatitis C at increased risk for developing active TB

Atlanta, GA - People with hepatitis C, either treated or untreated, had an increased risk for developing active tuberculosis, according to data published in Clinical Infectious Diseases. “Both hepatitis C and tuberculosis (TB) are among the leading infectious causes of morbidity and mortality globally, and there is a substantial overlap in population groups affected by these two infectious diseases,” Davit Baliashvili, a PhD graduate student in the department of epidemiology at the Emory University Rollins School of Public Health, told Healio.  “Furthermore, hepatitis C virus (HCV) can suppress immune pathways involved in the control of TB infection. However, whether hepatitis C is a risk factor for active TB is not well established due to a limited number of large-scale population-based studies,” Baliashvili said. Because of this, Baliashvili and colleagues sought to evaluate the association between hepatitis C and the development of active TB in a large population-based cohort study involving more than 1.8 million adults from the eastern European country of Georgia. According to the study, they assessed patients tested for HCV antibodies between January 2015 and September 2020 and followed these patients longitudinally for the development of newly diagnosed active TB.  In total, 1,828,808 adults were included in the study, among whom active TB was diagnosed in 3,163 (0.17%) after a median of 6 months of follow-up. According to the study, the incidence rate per 100,000 person-years was 296 among people with untreated HCV infection, 109 among those with treated HCV infection and 65 among HCV-negative individuals.  Additionally, a multivariable analysis revealed that both untreated (adjusted HR=2.9; 95% CI: 2.4-3.4) and treated (aHR=1.6; 95% CI: 1.4-2) HCV infections were associated with a higher risk for active TB when compared with HCV-negative persons. According to Baliashvili, these findings suggest that integrating TB diagnostic and prevention services into the hepatitis C programs might be beneficial and should be considered because he believes people with hepatitis C could benefit from screening for active TB disease and treatment for latent TB infection to identify TB early or prevent it from developing altogether.  “Our results support including people with hepatitis C among priority populations who would benefit from regular screening for TB,” Baliashvili said. “In addition, our study again highlights the importance of timely hepatitis C treatment, which might provide collateral benefit by decreasing the risk of TB, in addition to being highly effective against the hepatitis C itself. Together, these findings underscore a patient-centered, integrated approach to care to ensure the best outcomes for two leading global pandemics — TB and hepatitis C.”

For more information: https://tinyurl.com/bdeusbjm

Injection drug users with HCV history at risk for additional infections

Atlanta, GA - An outbreak study based in West Virginia showed that people who inject drugs and have had hepatitis C are at risk for additional complications of injection drug use, including HIV hepatitis A and hepatitis B infection. “CDC previously documented that hepatitis C virus infection preceded HIV infection in an outbreak of HIV among people who inject drugs in Massachusetts from 2015-2018 at a median of 45 months, or more than 3 1/2 years prior to HIV infection,” Danae Bixler, MD, MPH, medical officer in CDC’s Division of Viral Hepatitis, told Healio. She said that she and her colleagues were also aware of a large HCV outbreak preceding the HIV outbreak in Scott County, Indiana, among people who inject drugs in 2015. She said that in some cases, the HCV outbreak led the HIV outbreak by 5 years. “We wanted to know if, similarly, hepatitis C infection preceded the more recent HIV outbreak among persons who inject drugs (PWID) in West Virginia as part of a larger study of access to services among HIV cases,” she said, adding that they also wanted to assess coinfections with HBV and HAV to better understand the natural history of viral hepatitis and HIV infection among persons who inject drugs. Bixler and colleagues performed a cross-match using data from the West Virginia Electronic Disease Surveillance System and the enhanced HIV/AIDS Reporting System to identify outbreak cases with a laboratory test indicating current or past HCV, HBV or HAV infection.  According to the study, outbreak cases were defined as confirmed HIV diagnoses on or after Jan. 1, 2019, among PWID who lived in Kanawha County at the time of HIV diagnosis. They were included in the study if they had at least one health care encounter at Charleston Area Medical Center or at West Virginia Health Right during the year before HIV diagnosis through June 18, 2021.  In total, 65 (97%) of 67 HIV cases met inclusion criteria. According to the study, most cases were seropositive for HCV infection (n = 61; 94%) with detectable HCV RNA levels (n = 55; 85%).  Of the 61 people diagnosed with past or current HCV infection, this diagnosis preceded HIV diagnosis for 50 (82%), with a median interval of 46 months (interquartile range [IQR] = 29-71), whereas three (5%) had HCV infection diagnosed 4 to 12 months after HIV diagnosis and eight (13%) had an HCV diagnosis simultaneously or within 1 week after HIV diagnosis. A history of HAV (n = 11; 17%) or HBV (n = 10; 15%) infection was also detected exclusively among persons seropositive for HCV.  According to the study, HAV diagnosis preceded HIV diagnosis in all cases by a median of 22 months (IQR = 15-31), whereas HBV infection was detected before or on the date of HIV diagnosis for seven (70%) cases. Among these cases, the median time from detection of HBV infection to HIV was 30 months (IQR = 2-67).  The researchers said only 22 (34%) people had received at least one dose of HBV vaccine, including two people with a history of HBV infection. As many as 27 (42%) of these people may have been HBV susceptible, including 19 (29%) with serologic markers indicating susceptibility with record of vaccination, as well as an another eight (12%) who had no HBV test results or immunization records.  “People who inject drugs and have ever had HCV infection are at risk for further complications of injection drug use, including HIV infection and HAV and HBV infection,” Bixler said.  “To protect their individual health and prevent transmission of HIV and viral hepatitis, they should be offered medication for opioid use disorder (if they have opioid use disorder), access to syringe services programs, testing and treatment for HIV and viral hepatitis, access to pre-exposure prophylaxis to prevent HIV, and vaccination for hepatitis A and hepatitis B.”

For more information: https://tinyurl.com/yc5anskm

Transforming management of opioid use disorder with universal treatment

Atlanta, GA - According to provisional data from the Centers for Disease Control and Prevention, there were more than 107,000 drug-overdose deaths in the United States in 2021. More than 1 million people have died of drug overdoses since 1999. Most of the deaths that occurred in 2021 involved opioids — in particular, synthetic opioids such as fentanyl, which is about 100 times more potent than morphine and is often illicitly manufactured. Barriers at multiple levels (including patient, clinician, and system levels) prevent many people with opioid use disorder (OUD) from obtaining treatment. Stigma, structural challenges, and a lack of addiction-treatment infrastructure impede people’s access to and uptake of lifesaving, evidence-based medication for opioid use disorder (MOUD). Medications used for OUD include methadone, buprenorphine, and naltrexone. Distinct challenges affect uptake of each of these drugs. For example, patients can obtain methadone only from designated opioid-treatment programs, which are governed by the Controlled Substances Act and jointly regulated by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Drug Enforcement Administration. Although buprenorphine can be administered in medical office settings, providers are required to complete a registration process and obtain an X waiver to prescribe it. These and other barriers have kept a substantial portion of the need for MOUD from being met. Only a small fraction of people with OUD report having received MOUD in the past year, and data from providers confirm the existence of treatment gaps. The president’s 2022 National Drug Control Strategy (NDCS), which is spearheaded by the Office of National Drug Control Policy (where three of us work), focuses on two drivers of the overdose crisis — untreated addiction and drug trafficking — and calls for access to MOUD for any person with OUD by 2025. The Department of Health and Human Services has also released its Overdose Prevention Strategy to strengthen the administration’s efforts to increase access to substance use disorder (SUD) services. MOUD can significantly reduce the risk of overdose death; a recent study showed that people with OUD were 82% less likely to die of an overdose when they were receiving MOUD than when they were not. In addition to reducing overdose rates and use of illicit opioids as well as easing withdrawal symptoms and opioid cravings, MOUD can improve people’s quality of life, reduce the risk of HIV and hepatitis C virus (HCV) transmission, and improve treatment outcomes for people living with HIV or HCV. As public health physicians, some of us have seen firsthand the effects of MOUD on patients’ health and well-being. At the societal level, higher MOUD treatment rates could reduce costs associated with emergency department utilization and justice-system involvement among people who use drugs. Congress is currently deliberating removing barriers to MOUD, such as the X waiver. Eliminating the X waiver is necessary but insufficient to ensure universal access to MOUD. Several actions by clinicians, health care systems, and policymakers could substantially expand treatment access.

For more information: https://tinyurl.com/26jbe4aw

Opioids Tainted With Mystery Chemical Sparked Flood of Unusual Overdoses

San Francisco, CA - Last September, opioids adulterated with a mystery ingredient sparked an outbreak of drug overdoses that flooded a southern Pennsylvania hospital with 94 patients, a toxicologist reported here. Blood pressure readings approached 200/100 mm Hg in some patients, while others had extremely low heart rates, both unusual symptoms in overdoses, said Sarah Weiss, MD, of Reading Hospital in West Reading, Pennsylvania, during the American College of Emergency Physicians (ACEP) annual meeting. "For the most part, they reported some version of the same thing -- they used their typical drug and it didn't feel right," she explained. Patients were often "somnolent, weak, falling down, or feeling generally unwell." The average length of hospital stay was 3.2 days. Three patients experienced cardiac arrest in the emergency department, where one patient died. Two others died as inpatients. It's not clear why the tainted opioids spawned overdoses that produced unexpected symptoms and often didn't respond to naloxone (Narcan) or had a limited response to it. An analysis of 49 samples turned up several common heroin adulterants such as fentanyl, xylazine (an animal tranquilizer known as "tranq"), and clonidine (a sedative/anti-hypertensive). Out of the 49 samples, xylazine was found in 96%. According to news reports, it's been linked to overdoses and horrific skin wounds. "At higher doses, it knocks people fully unconscious. Instead of the semi-awake euphoria of opioids, those taking fentanyl cut with xylazine may black out and awaken hours later," according to Time magazine. Ninety percent of the samples included clonidine, which is used to treat the symptoms of opioid withdrawal. Heroin (and its metabolites) and fentanyl (and its metabolites) were each found in 86% of samples, while 43% included cocaine and its metabolites. Fourteen samples included no heroin at all. Also present in every single sample was a chemical that's still unknown, despite months of analysis. "I don't know the influence of this chemical," Weiss said. "We've had three PhD chemists trying to make [identify] this thing." In an interview with MedPage Today, Anthony Spadaro, MD, MPH, an emergency department resident physician at the Hospital of the University of Pennsylvania in Philadelphia, said that the typical signs of heroin overdose are pinpoint pupils and slow breathing, neither of which was common in the Reading outbreak. Low blood pressure is more common in overdoses than high blood pressure, he noted, and slow heart rate is not often observed. Spadaro, who attended Weiss's ACEP presentation, said the Reading outbreak is also unusual because of the number of cases and the length of recovery time. "Most people don't need to be in the hospital for 2 days after they use heroin," he said. "This highlights the need for policy-level changes, easier access to clean syringes, overdose prevention sites/safe consumption sites, fentanyl test strips, expanded access to methadone and buprenorphine, and more focus on helping and treatment than criminalization," he added. During the outbreak, Weiss said that 60 patients came in with overdoses over 3 days, and another 34 came in later. A smaller nearby hospital saw 30 patients experiencing overdoses. Average age of patients was 45.4, 84% were men, and most were Hispanic. Nearly 60% were admitted, and four were sent to the ICU and intubated. Generally, these patients had a history of opioid use. The average duration of both bradycardia and hypertension was 43 hours. About 8% had heart rates under 40 beats/minute and 62% had rates under 60 beats/minute. Bradypnea was not noted, and there were no abnormal pupils in conscious patients.

For more information: https://tinyurl.com/59rw9k3m

Role for Hepatitis C Antiviral Drugs in PTSD Management

Boston, MA - Drug treatment options for post-traumatic stress disorder (PTSD) are limited in both number and efficacy, despite a high incidence, particularly amongst military veterans. This led co-principal investigator and senior author Jaimie Gradus, Boston University School of Public Health, Massachusetts, USA, and colleagues, to undertake new research following-up on previous data describing an association between antiviral drugs used to treat hepatitis C and PTSD symptom improvement. In this new study, data from 254 patients diagnosed with both PTSD and hepatitis C between October 1999 and September 2019, at the White River Junction Veterans Affairs Medical Center, Vermont, New England, USA, were reviewed to evaluate this association further. Participants received a combination of either glecaprevir and pibrentasvir (GLE/PIB), ledipasvir and sofosbuvir, or sofosbuvir and velpatasvir. Both hepatitis C virus and PTSD symptoms were monitored at two clinical visits, which took place over an 8–12 week period. After adjusting for confounding variables such as opioid use, other hepatic diagnoses, and emergency psychiatric care, the researchers identified that those treated with a combination of GLE/PIB displayed higher levels of PTSD symptom improvement. Gradus commented that: “The level of improvement we see for GLE/PIB is impressive and over twice what we have seen for paroxetine and sertraline.” Looking towards the future, Gradus discussed the importance of and need for prospective placebo-controlled studies in patients without hepatitis C virus infection, and co-principal investigator Brian Shiner Geisel School of Medicine, Dartmouth, Massachusetts, USA, and White River Junction Veterans Affairs Medical Center, added: “We recently received funding from the Department of Defense to study GLE/PIB as a potential treatment for PTSD in a prospective randomised placebo-controlled trial.” This is important, because although existing treatments such as psychotherapy work well, Gradus reports challenges with ‘treatment drop-out’, and given that current pharmacotherapies are limited, adding to the treatment repertoire is a high priority. Whilst further research is required, this study provides hope for a potential, alternative therapeutic treatment for those living with PTSD.

For more information: https://tinyurl.com/fza2esnb

Methamphetamine use is up in rural areas

San Jose, CA - Research shows that 79% of individuals who use drugs in rural areas across the US reported using methamphetamine within the past 30 days. Among individuals in rural areas who experienced nonfatal overdose between 2018 and 2020, 22% reported using both opioids and methamphetamine, while 14% used opioids alone and 6% used methamphetamine alone. The most effective treatment for patients who misuse methamphetamine are behavioral therapies. Studies also suggest the potential for bupropion and naltrexone to serve as pharmacological treatments for methamphetamine misuse. Although health systems have bolstered efforts to address opioid misuse, research shows that methamphetamine misuse should also be prioritized in substance abuse treatment plans and harm reduction. As researchers test medicinal treatments, clinicians can employ behavioral therapies to treat patients who struggle with methamphetamine misuse. Between April 2020 and March 2021, 100,306 individuals died of an overdose in the US—marking the deadliest year for patients struggling with substance misuse. And while the opioid crisis has received ample media attention, opioids aren't the sole driver of overdoses—especially in rural communities. According to a 2022 survey published by JAMA Open Network, nonfatal overdose among patients in rural areas was greatest in those using both methamphetamine and opioids (22%). Just 6% of those who experienced nonfatal overdose had used methamphetamine alone, and 14% had used opioids alone. Those who used both drugs had the least access to treatment, and nearly four out of five participants reported using methamphetamine within the past 30 days. Research shows that the growing prevalence of methamphetamine use among rural populations mirrors the data published by the National Survey on Drug Use and Health. It also indicates individuals who use heroin are more likely to co-use with methamphetamines. Although methamphetamines are notoriously popular among individuals who use drugs in rural Oregon, the presence of methamphetamine is steadily growing eastward. As noted by JAMA, methamphetamine-related hospitalizations across the country have risen 270% between 2007–2015. In the authors’ words, the survey results “document pervasive co-use of methamphetamine and opioids associated with nonfatal overdose among people who use drugs in rural communities.” Drug treatment programs and harm-reduction efforts—especially those in rural areas—may therefore better serve patients by addressing methamphetamine misuse in addition to opioid misuse. Behavioral therapies are the current standard in treatment for methamphetamine misuse. According to an article published by the National Institute on Drug Abuse, cognitive behavioral therapy and contingency management interventions are the most effective forms of treatment. One example of a program that employs behavioral therapies is the Matrix Model. It provides patients with 16 weeks of behavioral therapy, family education, individual counseling, a 12-step program, and access to drug testing. It also encourages patients to pursue non-drug-related activities. Contingency management interventions such as Motivational Incentives for Enhancing Drug Abuse Recovery (MIEDAR) implement incentive-based methods for abstaining from cocaine and methamphetamines. Through NIDA’s National Drug Abuse Clinical Trials Network, MIEDAR has proven effective for those who use methamphetamine. In addition to therapies and contingency management interventions, potential medicinal treatments for methamphetamine misuse are on the horizon. A study published by the New England Journal of Medicine stated that the combination of bupropion (“a stimulant-like antidepressant”) and naltrexone (“an opioid-receptor antagonist”) may serve as treatment for methamphetamine misuse in the future. The study’s first stage showed that 16.5% of participants who had been treated with naltrexone-bupropion had a response, while just 3.4% of the placebo group did. These percentages dropped slightly in the second stage to 11.4% and 1.8%, respectively. The study authors defined a “response” as “valid negative urine samples obtained after only 4 to 6 weeks in each stage of the trial.”

For more information: https://tinyurl.com/48xzvwvw

 

Injection drug users with HCV history at risk for additional infections

Charleston, West Virginia - An outbreak study based in West Virginia showed that people who inject drugs and have had hepatitis C are at risk for additional complications of injection drug use, including HIV hepatitis A and hepatitis B infection. “CDC previously documented that hepatitis C virus infection preceded HIV infection in an outbreak of HIV among people who inject drugs in Massachusetts from 2015-2018 at a median of 45 months, or more than 3 1/2 years prior to HIV infection,” Danae Bixler, MD, MPH, medical officer in CDC’s Division of Viral Hepatitis, told Healio. She said that she and her colleagues were also aware of a large HCV outbreak preceding the HIV outbreak in Scott County, Indiana, among people who inject drugs in 2015. She said that in some cases, the HCV outbreak led the HIV outbreak by 5 years. “We wanted to know if, similarly, hepatitis C infection preceded the more recent HIV outbreak among persons who inject drugs (PWID) in West Virginia as part of a larger study of access to services among HIV cases,” she said, adding that they also wanted to assess coinfections with HBV and HAV to better understand the natural history of viral hepatitis and HIV infection among persons who inject drugs. Bixler and colleagues performed a cross-match using data from the West Virginia Electronic Disease Surveillance System and the enhanced HIV/AIDS Reporting System to identify outbreak cases with a laboratory test indicating current or past HCV, HBV or HAV infection.  According to the study, outbreak cases were defined as confirmed HIV diagnoses on or after Jan. 1, 2019, among PWID who lived in Kanawha County at the time of HIV diagnosis. They were included in the study if they had at least one health care encounter at Charleston Area Medical Center or at West Virginia Health Right during the year before HIV diagnosis through June 18, 2021.  In total, 65 (97%) of 67 HIV cases met inclusion criteria. According to the study, most cases were seropositive for HCV infection (n = 61; 94%) with detectable HCV RNA levels (n = 55; 85%).  Of the 61 people diagnosed with past or current HCV infection, this diagnosis preceded HIV diagnosis for 50 (82%), with a median interval of 46 months (interquartile range [IQR] = 29-71), whereas three (5%) had HCV infection diagnosed 4 to 12 months after HIV diagnosis and eight (13%) had an HCV diagnosis simultaneously or within 1 week after HIV diagnosis. A history of HAV (n = 11; 17%) or HBV (n = 10; 15%) infection was also detected exclusively among persons seropositive for HCV.  According to the study, HAV diagnosis preceded HIV diagnosis in all cases by a median of 22 months (IQR = 15-31), whereas HBV infection was detected before or on the date of HIV diagnosis for seven (70%) cases. Among these cases, the median time from detection of HBV infection to HIV was 30 months (IQR = 2-67).  The researchers said only 22 (34%) people had received at least one dose of HBV vaccine, including two people with a history of HBV infection. As many as 27 (42%) of these people may have been HBV susceptible, including 19 (29%) with serologic markers indicating susceptibility with record of vaccination, as well as an another eight (12%) who had no HBV test results or immunization records.  “People who inject drugs and have ever had HCV infection are at risk for further complications of injection drug use, including HIV infection and HAV and HBV infection,” Bixler said.  “To protect their individual health and prevent transmission of HIV and viral hepatitis, they should be offered medication for opioid use disorder (if they have opioid use disorder), access to syringe services programs, testing and treatment for HIV and viral hepatitides, access to pre-exposure prophylaxis to prevent HIV, and vaccination for hepatitis A and hepatitis B.”

 For more information: https://tinyurl.com/29m9kbxj

A low-barrier, flexible safe supply program to prevent deaths from overdose

Ottawa, ON - Safer Alternatives for Emergency Response (SAFER) is a low-barrier, flexible safe supply program that provides several medication options, including fentanyl, and is integrated with other health care and social services. Harm reduction, primary care and treatment for substance use disorders can effectively coexist. Between January 2016 and June 2021, 24 626 people died from opioid toxicity in Canada. A key driver of this ongoing public health crisis has been the infiltration of illicitly manufactured fentanyl and other dangerous adulterants into the unregulated drug supply. Although a range of educational, harm reduction and substance use disorder (SUD) treatment interventions have been implemented and expanded in response, these efforts have not been sufficient, and the number of deaths from drug poisoning continues to rise. Furthermore, a substantial proportion of people do not access conventional treatments; for instance, only a minority of patients with opioid use disorder regularly receive treatment medications. Emerging evidence also suggests that the changing drug supply has negatively affected the effectiveness of these medications, including the efficacy of buprenorphine among people using fentanyl compared with those using heroin. An additional concern is unintentional exposure to fentanyl among people who use substances such as stimulants and the emergence of other contaminants such as benzodiazepines. This reality has prompted calls for the provision of a legal and regulated source of psychoactive substances, known as “safe supply,” particularly low-barrier, flexible options that meet the diverse needs and goals of people who use drugs.  Operating in Vancouver since April 2021, Safer Alternatives for Emergency Response (SAFER) is a safe supply program that provides substitutes to the toxic drug supply in the form of medications that are prescribed off label. The program is operated by a nonprofit organization (PHS Community Services Society) in partnership with Vancouver Coastal Health and is funded through Health Canada’s Substance Use and Addiction Program. A multidisciplinary team of physicians, nurses, pharmacists, social workers and people with lived or living experience of substance use oversees the program. The approach adopted at SAFER can be viewed as an extension of the use of medications as treatment for SUDs, such as opioid agonist therapy (OAT). However, in contrast to OAT, which is often prescribed with a goal of abstinence, the primary goal of SAFER is to prevent overdose and other harms by decreasing reliance on the unpredictable, unregulated drug market. Medications provided at SAFER include those with mind- and body-altering effects that are often desired by people who use drugs but are typically accessible only via unregulated drugs and are not provided by conventional treatments such as OAT.  Eligibility for SAFER is based on ongoing use of substances and vulnerability to their associated harms. At intake, participants are assessed to determine appropriate medication options and potential need for precautions owing to medical conditions that affect tolerability of SAFER medications, factors that confer additional vulnerability (such as pregnancy or young age) and concurrent use of substances such as alcohol that require additional counselling. Although there are no absolute contraindications to participation, the program emphasizes identifying the appropriateness of the intervention, recognizing participant autonomy and facilitating connection to evidence-based treatment for SUDs when this is aligned with participant-defined goals. Enrolled participants can access medications, including opioids such as hydromorphone and fentanyl, that substitute the unregulated substances they are currently consuming. Various formulations are available, including injectable, sublingual, oral and trans-dermal formulations. A notable and novel feature of the SAFER program is that it offers fentanyl, providing a direct substitute to the primary opioid in the local unregulated drug supply, but of known potency and without dangerous adulterants. Participants can choose between a titration schedule that starts with lower doses to ensure tolerance before increasing to a higher range, or a fixed dose that is taken as needed. Given the increasing rate of overdose deaths involving stimulants in Canada, and the limited treatment options for stimulant use disorder, prescribed psychostimulants are also available, including methylphenidate and dextroamphetamine. For each medication, a unique dosage protocol is largely overseen by nursing staff, unlike OAT, which typically requires physician assessment before dosage changes. Initial doses start at a standardized level to ensure tolerance, but are then adjusted to achieve a desired effect, thereby promoting participant autonomy in decision-making around substance use. Other program features intended to improve engagement include allowing on-site use of unregulated substances, meaning that the program also functions as a supervised consumption service, and providing a de-medicalized physical space staffed by peer support workers. Unlike OAT, which is typically administered once daily and is cancelled after a few consecutive missed doses, SAFER does not have a predetermined schedule for accessing medications, which allows participants to return multiple times per day or to be absent for periods of time. In contrast with most other existing safe supply options, SAFER participants are not required to remain on OAT concurrently. By decoupling these interventions, the focus of SAFER is on harm reduction, promotion of participant autonomy and improvement of participant–provider relationships. The SAFER program is integrated with health care and social services, and participants have access to on-site primary care from providers trained in addiction medicine. It is also co-located with a low-barrier overdose prevention site where supplies such as syringes, take-home naloxone kits and drug-checking services are available.

For more information: https://www.cmaj.ca/content/194/19/E674

Simplifying the path to elimination of hepatitis C

Geneva, Switzerland - Although the number of individuals with viraemic hepatitis C virus (HCV) infection has decreased since 2015, efforts to achieve global elimination targets by 2030 are not on track. New guidance from WHO to accelerate HCV elimination was launched on June 24, 2022, centring on three areas—treatment for adolescents and children aged 3 years or older, simplified service delivery, and HCV diagnostics. The new treatment recommendations extend WHO's 2018 guidance to now include adolescents and children aged 3 years and older with chronic HCV infection and to use the same pangenotypic direct-acting antiviral regimens as for adults. This change should simplify drug procurement and promote access to treatment for children living with HCV infection—of whom there were an estimated 3·26 million globally in 2018. The new service delivery recommendations are for delivery of testing and treatment for HCV to take place at peripheral health or community-based facilities, ideally at the same time, and for such services to be integrated with existing care services (eg, primary care, harm reduction facilities, and HIV services). Testing, care, and treatment can be delivered by trained non-specialists (eg, primary care physicians or nurses). These recommendations aim to expand access to diagnosis, care, and treatment. The 2022 guidance include, for the first time, the use of point-of-care HCV RNA assays as an alternative to lab-based HCV RNA nucleic acid testing or core antigen assays to detect viraemic HCV infection, and to assess treatment response. Reflex HCV RNA viral load testing is also recommended for those with a positive HCV antibody test, as a key strategy to promote linkage to care and treatment. Efforts to simplify testing and treatment for HCV are essential if WHO's 90% diagnosis and 80% treatment coverage targets are to be achieved by 2030. However, these are not the only barriers to elimination—adequate funding and genuine political commitment and engagement are essential but, at present, sadly lacking.

For more information: https://tinyurl.com/ykwzj7te

Supervised consumption site could open within months with government approval

Windsor, ON - The Windsor-Essex County Health Unit's proposed location for a supervised consumption and treatment site, located at 101 Wyandotte St. E. (Peter Duck/CBC) Pending government approval, the supervised consumption and treatment site in Windsor could be ready to open in as soon as a few months, according to the CEO of the public health unit. The Windsor-Essex County Health Unit (WECHU) is working with Health Canada and Ontario's Ministry of Health to secure approval and funding to operate the site, Nicole Dupuis said Thursday during a media briefing. WECHU's applications are currently under review, she said. Meanwhile, the future location of the site, 101 Wyandotte St. E. in downtown Windsor, is under construction in preparation. "I can't give you an exact date, but I would hope within the next few months we would see the ability to open it," she said. The project is years in the works, and the potential opening of the site comes as the overdose crisis continues in Windsor-Essex. So far this year, there have been six public alerts issued over high numbers of overdoses and emergency room visits related to opioids. In 2021, 67 confirmed deaths from opioids were recorded in Windsor-Essex, according to Ontario Health data.

For more information: https://tinyurl.com/dtwcw39f

Virus pairing creates ‘perfect storm’ for unexplained hepatitis surge in children

Boston, MA - New research has linked the incidence of unexplained hepatitis in pediatric patients to a pair of viruses — adenovirus type F41 and adeno-associated virus 2 — as well as potential markers of genetic mutation.  From October 2021 to July 2022, the WHO reported 1,010 probable cases of severe acute hepatitis of unknown etiology across 35 countries, including the Unites States (33% of global cases) and the United Kingdom (27%). The first cases reported were an unusual cluster of nine patients aged 2 to 11 years in Alabama.  According to a report from Gutierrez Sanchez and colleagues in The New England Journal of Medicine, these initial cases were severe, with only a few days between symptom onset, ICU admission and, for some, liver transplantation. At the time, it was unclear whether adenovirus infection alone, or in combination with other factors, contributed to disease. “There have been similar incidents described in the past where patients with severe hepatitis had adenovirus in the blood but not detected in the liver biopsies,” Henry Shiau, MD, a pediatric hepatologist at the University of Alabama at Birmingham and Children’s of Alabama, said in a university press release. “It’s unclear if the biopsies missed evidence of adenovirus presence due to sampling error or if the infection could be playing an indirect role, such as triggering a dysregulated immune response.” While adenovirus type F41 is commonly found in children, it typically does not induce severe symptoms in otherwise healthy children, Elizabeth A. Fagan, MD, adjunct professor of internal medicine and pediatrics at Rush-Presbyterian-St. Luke’s Medical Center in Chicago, told Healio. “Most experts felt that wasn’t the whole story,” Fagan said. “We were struck with this group of children, both in the U.S. and in the U.K., where researchers found a vast majority had adenovirus F41, but that virus tends not to cause liver upsets very much in ordinarily healthy children. The question is: Was it just a coincidence?” Further investigation has uncovered coinfection with other viruses — specifically, adeno-associated virus 2 as well as a family of herpes viruses (e.g., HHV6). “What we currently believe is that the original adenovirus was F41,” Fagan said. “With those other two viruses, the view is that it was ‘the perfect storm’ where they help each other in making the situation worse.”  According to Fagan, an investigation that included 28 children with hepatitis in the U.K., five of whom underwent LT, detailed findings from blood, liver tissue, microscopic, genomic and genetic molecular sample studies. Their analysis ruled out the usual causes of viral hepatitis and instead revealed high levels of adeno-associated virus 2 in the blood and liver of these sick pediatric patients. Researchers also uncovered a genetic marker that was associated with an increased immune response in these children. The marker was not activated in most study participants who had hepatitis but did not test positive for adeno-associated virus 2.  “The other interesting finding is this coincided with the SARS-CoV-2 pandemic,” Fagan said. “The general view is that the SARS-CoV-2 virus is not specifically involved. Also, none of these children were vaccinated, so we cannot blame vaccine involvement either.” Fagan noted that quarantine during the pandemic initially may have had a protective effect on children. Infants are usually exposed to high levels of adenoviruses shortly after birth but sequestering during the pandemic largely prevented this. As parents became more comfortable allowing their children to interact freely with others, there was an increase in viral exposure and subsequent infection in children aged 2 to 5 years.

For more information: https://tinyurl.com/2p8jvb53

US to release 1.8 million more doses of monkeypox vaccine

Washington, DC - The United States will release an additional 1.8 million doses of monkeypox vaccine starting Monday and will make up to 50,000 doses available upon request for large LGBTQ events, health officials announced Thursday. The 1.8 million doses of the Jynneos vaccine will come from 360,000 vials, which will be available to jurisdictions that have adopted intradermal delivery of the vaccine and have used 90% or more of their current supply, White House national monkeypox response coordinator Robert Fenton said during a press briefing. “More shots in arms is how we get the outbreak under control,” Fenton said. Officials last week announced a plan to allow the vaccine to be delivered in fractional doses — five doses drawn from each one-dose vial — to extend the supply. A new HHS pilot program will allow U.S. jurisdictions to request additional doses of vaccine above their regular allotment for events drawing large LGBTQ crowds, and the CDC will offer support to prepare for the events, including help with vaccine and testing strategies, officials said. Jurisdictions hosting these events can request to receive additional vaccine doses “based on the size and nature of the event and the ability to reach attendees who are at the highest risk of monkeypox” — largely men who have sex with men, CDC Director Rochelle P. Walensky, MD, MPH, said during the briefing. “I want to emphasize that while we are offering the vaccine at these events to those at high risk, this is a two-dose vaccine series and receiving the vaccine at these events will not provide protection at the event itself,” Walensky said. She said scientists are still learning about the vaccine’s effectiveness against monkeypox in this outbreak, but that it is expected to be most effective 2 weeks after the second dose. “Although we anticipate vaccines will provide protection, temporarily avoiding or reducing behaviors that increase your risk of monkeypox exposure is important, especially between your first and second doses of vaccine,” Walensky said. She said jurisdictions requesting doses for LGBTQ events will need to address how they will approach monkeypox education and awareness and address vaccine equity. HHS will also make 50,000 doses of the treatment TPOXX available “in jurisdictions where the outbreak is most severe,” Fenton said.  HHS Secretary Xavier Becerra, who declared the outbreak a public health emergency earlier this month, said more than 1 million doses of the vaccine and more than 22,000 courses of TPOXX have been delivered in the U.S. so far. He said U.S. labs have the capacity to conduct 80,000 monkeypox tests per week. As of Wednesday, more than 39,000 cases of monkeypox had been reported globally, including more than 13,500 cases in the U.S., Walensky noted. Wyoming is the only U.S. state that has not reported a case. Walensky said 98% of U.S. cases have occurred in men. Among cases with available data, 93% have occurred among men who reported recent sexual contact with other men, nearly 35% were white, 33% were Hispanic and nearly 28% were Black, Walensky said. The median age of the patients is 35 years.

For more information: https://tinyurl.com/8cvahfzh

HCV reinfection prevalence rises among MSM as acute cases decline

London, UK - Although the annual incidence of acute hepatitis C virus has decreased over the past 10 years in Frankfurt, Germany, the prevalence of HCV genotype 4 increased in men who have sex with men, according to research. “Despite the broad availability of direct acting antivirals, ongoing transmission of HCV, as well as a persistent epidemic of HCV infections, has been especially observed in high interest groups such as HIV-positive men who have sex with men,” Christiana Graf, of the University Hospital Frankfurt department of internal medicine, said at the International Liver Congress. “While the incidence of acute hepatitis C has been observed to increase in the United States over the past decade, it seemed to decline in the European countries and is still largely unknown in many other parts of the world.” In a prospective, observational study, Graf and colleagues analyzed clinical and epidemiological parameters of 161 patients (87% HIV positive, 90% MSM) diagnosed with acute HCV between 2009 and 2019 in Frankfurt, Germany, to characterize HCV transmission among MSMs. At the time of diagnosis, NS5B population-based sequencing was used to determine HCV genotype (GT) and phylogenetics.  While HCV GT1 was most common genotype in the first 8 years of the study (58%-100%), its prevalence decreased to 30% in 2018. Conversely, the proportion of patients with HCV GT4d increased from 2013 to 2019 (0%-40%). Researchers also reported more cases of HCV GT3a in 2018 and 2019, but only individual cases of HCV GT1b/GT2 between 2009 and 2014. While HCV genotypes were equally distributed among non-MSM patients (36% GT1a, 21% GT1b or GT3a and 16% GT2), the most common among MSM patients were GT1a (82%) and GT4d (16%). Further, phylogenic analyses showed close relation of sequencing patterns in HCV GT1a and GT4d strains among MSM patients.  Comparison of HCV GT or NS5B sequences revealed HCV reinfection occurred in 15% of patients with the incidence rate for a first HCV infection among MSM patients declining between 2017 and 2019 (3.6/1,000 person-years) compared with the direct acting antiviral era (2013-2017: 6.8/1,000 person-years) and the interferon era (2008-2013: 10.1/1,000 person-years). In contrast, incidence of HCV reinfection among MSM patients increased over time (1.9/100 person-years to 2.8/100 person-years). “We observed an overall decline of acute HCV cases in Frankfurt, Germany. All classes proved to be MSM-specific, and I think that we showed that there seems to be distinct and specific transmission networks and classes among MSM,” Graf concluded. “We observed an increase in reinfection incidence. Thus, post-treatment surveillance, rapid diagnostics and prioritizing dosing is crucial in order to achieve elimination.”

For more information: https://tinyurl.com/4z6st99y

Researchers create highly accurate non-invasive test for major liver diseases

London, UK - Researchers have created a liquid biopsy test, which uses two circulating proteins, to test for major liver diseases. The test was found to be highly accurate, sensitive, and specific for both NASH and liver fibrosis. For the first time, a non-invasive test will allow for the determination of staging of both diseases without recurring to invasive liver biopsy. Non-alcoholic steato-hepatitis (NASH) is the most severe form of non-alcoholic fatty liver disease (NAFLD) and is diagnosed in approximately 60% of NAFLD patients. NASH puts people at risk of progressing to advanced liver diseases such as liver fibrosis, cirrhosis, and liver cancer. NAFLD affects approximately 52 million people in Europe and 64 million people in the US, costing $138 billion annually to the European and US healthcare systems combined. Currently, NASH can only be diagnosed with invasive liver biopsy, which is the standard of diagnosis, but is expensive and has co-morbidities and complications. There are also no reliable blood (i.e. liquid biopsy) tests for the diseases because of low sensitivity and specificity. Current blood tests are also unable to reliably predict NASH and fibrosis staging. Professor Geltrude Mingrone, from King's College London and Catholic University of Rome, Italy, looked to find a more accurate liquid biopsy test. The paper, published in the journal Gut, identified two protein biomarkers, PLIN2 and RAB14, that were used as part of an algorithm to identify people with NASH and/or liver fibrosis. The ability for these proteins to detect NASH was tested in cohorts of people with either biopsy-confirmed NASH or liver fibrosis. The algorithms, which used A.I., gave impressive results, including a sensitivity of 88–95%, a specificity of 90–100%, and an overall accuracy of 92–93% for NASH. For fibrosis, they were even better, with a sensitivity of 99–100%, specificity of 90–96%, and accuracy of 98–99%. As well as being much more accurate than all other currently available biomarkers, it is now possible to predict the stages of the diseases without invasive liver biopsy. Mingrone says that "this blood test will allow to define the real prevalence of NASH in large and small populations, including children and adolescents, avoiding the need for invasive liver biopsy. Importantly, it will also allow to monitor the efficacy of NASH treatments over time, reducing screen failures and helping generate better drugs. "These results show that the PLIN2/RAB14-based liquid biopsy can provide rapid and cost-effective testing to combat the growing epidemic of NASH and liver fibrosis. This will be an invaluable tool in diagnosing and monitoring cases of liver diseases, enabling people to receive earlier treatment. The authors also believe that the testing will allow for the improved capacity for researchers to study NASH and liver fibrosis in the general population, including disease progression, and record the effects of treatment, from lifestyle to surgical and pharmacological interventions. No NASH drug has been approved by the FDA or EMA due to the lack of an accurate, reliable, and non-invasive test. Between 65–73% of patients that currently enroll in clinical trials for NASH-related therapies are found to be ineligible for the trial due to screen failure. The test—developed in collaboration with Metadeq Corp.—is expected to significantly reduce screen failures in clinical trials and improve the chances of new life-saving drugs reaching the market.

For more information: https://tinyurl.com/4y5d7c3b

New study shows benefits of micro-dosing psilocybin

Vancouver, BC - A new study has added to the growing body of evidence that psychedelics will be useful in the treatment of mental health disorders.  The study, done at the University of British Columbia, involves the therapeutic potential of micro-dosing psilocybin, or “magic mushrooms.”  According to a news release from Quantified Citizen, the main findings are that psilocybin micro-dosing is a boon to mood and mental health and may have special importance to those over 55 years old.  Results of the study were published in nature.com The research showed those who micro-dosed psilocybin for 30 days showed greater improvements in mood, mental health, and psychomotor abilities versus those who did not micro-dose.  And there was a finding specific to individuals over the age of 55: micro-dosing was associated with greater improvements in psychomotor performance, relative to non-micro-dosers. Those improvements increased when psilocybin is stacked with lion’s mane (a type of mushroom believed to boost mental function) and niacin (vitamin B3), versus psilocybin alone.  The study followed 953 people taking regular small amounts of psilocybin and a second group of 180 people who were not micro-dosing.  Neuroscience news reports that over the 30-day study, participants completed several assessments on mood, mental health and cognition.  Those who were micro-dosing saw greater improvements in all those areas over those who were not micro-dosing.  Among micro-dosers who expressed mental health concerns, scores for depression, anxiety and stress dropped after 30 days; micro-dosers also exhibited greater increase in positive mood and larger decrease in negative mood at the 30 day mark, over those who were not micro-dosing. The research was led by UBC Okanagan’s Dr. Zach Walsh and doctoral student Joseph Rootman; this is the latest study from the Microdose.me project, which is a mobile, global micro-dosing study involving 84 countries and 19,000 participants. Interested parties can download the Quantified Citizen app to take part.  As Dr. Walsh told Neuroscience News, “Our findings of improved mood and reduced symptoms of depression, anxiety and stress add to the growing conversation about the therapeutic potential of micro-dosing.”  This is believed to be the largest longitudinal study of its type to date of micro-dosing psilocybin, and one of the few studies to engage a control group.  The study noted that there were associated improvements in psychomotor ability among stacking micro-dosers, versus those using only psilocybin. Among the cognition tests was the finger-tap test for psychomotor ability done on a smartphone, the same testing used to predict neurodegenerative disorders such as Parkinson’s Disease.  On the finger tap test, stacking psilocybin with lion’s mane (HE) and B3 proved particularly effective for older participants.  Adults over 55 who micro-dosed with psilocybin mushrooms — plus HE and B3 — showed the largest (about 40%) increases in total number of taps after about one month, relative to non-micro-dosers and those that micro-dosed psilocybin alone.  The paper states clearly, however, that although these findings might be best described as suggestive, “they nonetheless add preliminary credence to anecdotal reports of benefit from the specific combination of psilocybin, HE and B3.”

For more information: https://torontosun.com/news/national/new-study-shows-benefits-of-microdosing-psilocybin

First 2 Months of Operation at First Publicly Recognized Overdose Prevention Centers in US

New York, NY - In New York City there were 2062 overdose fatalities in 2020, the deadliest year on record for NYC and the US.1 Fentanyl and its analogs were the most common substances involved in overdose deaths in NYC, present in 77% of such deaths in 2020.1 A characteristic of fentanyl-involved overdose is rapid onset of overdose symptoms2; however, with timely administration of oxygen or naloxone, deaths can be averted. In response to unprecedented numbers of overdose deaths, on November 30, 2021, NYC implemented overdose prevention center (OPC) services at 2 syringe service programs operated by OnPoint NYC. Also known as supervised consumption sites, OPCs are health care facilities that aim to improve individual and community health, increase public safety, and reduce consequences of drug use, including overdose deaths, public drug use, and syringe litter.3,4 Operating in more than 10 countries, OPCs offer supervised, hygienic spaces in which people can use preobtained drugs and access services, onsite or by referral, to health and mental health care, drug treatment, and other social supports.3,4 While previous research documented operations at an underground US OPC,5 use of sanctioned sites has not yet been studied, to our knowledge. This study describes the first 2 months of operation and use at the first 2 publicly recognized US OPCs. Because data were collected for program evaluation and presented in aggregate, the NYC Department of Health and Mental Hygiene Institutional Review Board (IRB) determined that this quality improvement study was not human participants research and so IRB approval and informed consent were not required.  Data were collected by program staff from individuals using services at 2 OPC sites at intake and before each subsequent use of OPC services. Outcome data related to OPC visits (eg, staff interventions to mitigate overdose risk) were also recorded. Using a unique identifier, OPC participant data were then matched with data indicating uptake of additional services provided at the syringe service program. Descriptive statistics (frequencies and percentages) were calculated using SAS statistical software version 9.4 (SAS Institute). Between November 30, 2021, and January 31, 2022, 613 individuals used OPC services 5975 times across 2 sites. Most individuals identified as male (78.0%), and 55.3% identified as Hispanic, Latino, or Latina. The mean (range) age was 42.5 (18-71) years. A plurality of individuals (36.9%) reported being street homeless. Fewer than one-fifth of individuals (17.8%) were living in their own rooms or apartments. In self-reported data, the drug most commonly used across 2 sites was heroin or fentanyl (73.7%) and the most frequent route of drug administration at the OPC was injection (65.0%). Among all participants, 75.9% reported that they would have used their drugs in a public or semipublic location if OPC services had not been available. During the first 2 months of OPC operation, trained staff responded 125 times to mitigate overdose risk. In response to opioid-involved symptoms of overdose, naloxone was administered 19 times and oxygen 35 times, while respiration or blood oxygen levels were monitored 26 times. In response to stimulant-involved symptoms of overdose (also known as overamping), staff intervened 45 times to provide hydration, cooling, and de-escalation as needed. Emergency medical services responded 5 times, and participants were transported to emergency departments 3 times. No fatal overdoses occurred in OPCs or among individuals transported to hospitals. More than half of individuals using OPC services (52.5%) received additional support during their visit. This included, but was not limited to naloxone distribution, counseling, hepatitis C testing, medical care, and holistic services (eg, auricular acupuncture). This quality improvement study found that during the first 2 months of operations, services at 2 OPCs in NYC were heavily used, with early data suggesting that supervised consumption in these settings was associated with decreased overdose risk. Data also suggested that OPCs were associated with decreased prevalence of public drug use. Findings are limited by the short study period and lack of a comparison group with individuals not participating in OPC services. Additional evaluation may explore whether OPC services are associated with improved overall health outcomes for participants, as well as neighborhood-level outcomes, including public drug use, improperly discarded syringes, and drug-related crime.

For more information: https://tinyurl.com/w7msksuh

US death rate from alcoholic liver cirrhosis triples over two decades

Boca Raton, FL - Americans may have a collective drinking problem, made worse by the obesity epidemic, new research suggests. The new study found that deaths from alcoholic cirrhosis have more than tripled in 20 years. In 1999, alcoholic cirrhosis—an advanced form of alcohol-related liver disease—killed just over 6,000 Americans (a rate of 3 per 100,000). By 2019, deaths from the condition had soared to nearly 24,000 (a rate of 11 per 100,000). "The hypothesis is that people are drinking more and starting earlier in life," said lead researcher Dr. Charles Hennekens, the First Sir Richard Doll Professor & Senior Academic Adviser to the Dean at the Charles E. Schmidt College of Medicine at Florida Atlantic University in Boca Raton. But there may be other factors at work, Hennekens added, including a dramatic increase in obesity, along with more sedentary lifestyles. "That leads to fatty liver," Hennekens said. "The same kind of thing that alcohol does. My hypothesis is that the reason we're seeing more of liver disease earlier is not just that people are drinking more, but that they're eating more and exercising less, so the damage to the liver is accelerating." Obesity and lack of exercise are also at the root of the epidemic of diabetes, as well as heart disease, stroke and some cancers. "The risk factors are the same," he noted. Hennekens said that as far as drinking goes, people should limit the amount of alcohol they drink to no more than two drinks a day for men and no more than one for women. Doctors should counsel their patients that those who consume lots of alcohol have the highest death rates from both cirrhosis and heart disease, he added. Alcoholic cirrhosis accounts for one-third of all liver transplants in the United States, the study authors noted. "While the data indicate that those who have one to two drinks daily have lower risks of cardiovascular disease than nondrinkers, it is also true that the difference between drinking smaller and larger amounts of alcohol means the difference between preventing and causing premature death," Hennekens said. For the study, Hennekens and his colleagues used data from the U.S. Centers for Disease Control and Prevention to look at trends in death from alcoholic cirrhosis from 1999 to 2019. The investigators found that during those two decades there were statistically significant increases in deaths from alcoholic cirrhosis in every age group from 25 and up. The largest increase was sevenfold among those aged 24 to 35 and the steepest increase was seen among those aged 65 to 74. The report was published online recently the American Journal of Medicine.

For more information: https://tinyurl.com/2s4328eh

HCV care for people who inject drugs

New York, NY - Simplifying the hepatitis C virus treatment process is essential to improving care among vulnerable populations, particularly people who inject drugs, according to experts. “If you look globally, people who inject drugs (PWID) account for well over 60% of cases of HCV, and when you look at new cases or incident infections, that number is often over 80%, so this population is certainly a major driver of new HCV infection in the United States and in much of the Western world,” Benjamin J. Eckhardt, MD, MS, assistant professor of medicine at NYU School of Medicine and Bellevue Hospital, told Healio | Infectious Disease News. He said new HCV infections are being driven by a worsening opioid epidemic. Historically, HCV was concentrated in the baby-boom generation, with prevalence data from 2005 showing a spike among those born from 1945 to 1965, according to Eckhardt. “However, in the setting of the more recent opioid epidemic, that historic peak around the baby boomers is now becoming a more bimodal distribution,” Eckhardt said. “There is still a peak in that baby-boomer population, but there is also a definite peak among 18- to 29-year-olds or 18- to 35-year-olds, depending on which study you’re looking at. All of those are new infections and this is being driven by the worsening opioid epidemic across the United States.” When new direct-acting antiviral agents (DAAs) — now a mainstay of treatment for HCV — became available in 2014, clinicians initially focused on treating baby boomers due to the high prevalence of HCV in this population. Many of these patients, Eckhardt noted, were already engaged in health care related to aging and comorbid conditions and were perhaps not partaking in the behaviors that originally put them at risk for HCV, such as injecting drugs. However, younger patients, among whom HCV infections are currently spiking, typically do not have the same comorbidities, such as cardiovascular disease, and are generally less engaged in health care. This is especially true for young PWID, Eckhardt noted. “They oftentimes don’t have a primary care physician or are not regulars in a doctor’s office and have a little bit more of a chaotic lifestyle, potentially related to their ongoing drug use,” Eckhardt said. “Therefore, we felt that the current model of care delivery, which is scheduling a patient for a specific time at a community- or hospital-based clinic and making sure that they come to that visit or come to multiple visits before we start treatment, was not something that was going to be widely effective for this patient population. There really needed to be a paradigm shift.” To evaluate the potential benefits of a more simplified treatment strategy, Eckhardt and colleagues conducted the Seek, Test, & Rapid Treatment study — an open-label, randomized, controlled pilot study at the Lower East Side Harm Reduction Center in New York City. For the study, young, active PWID underwent HCV RNA testing before being randomly assigned to usual care or rapid treatment. In the usual care arm, Eckhardt and colleagues performed confirmatory testing at the center, and participants who were HCV RNA positive were referred to on-site HCV care coordinators, linked to community-based HCV providers and went through the typical cascade of care before initiating therapy. In the rapid treatment arm, they sent participants home with a 7-day starter pack of sofosbuvir/velpatasvir, and those participants who were confirmed to be HCV RNA positive were advised in person or via telephone 2 to 7 days later to initiate treatment. They also returned at day 7 to receive the remainder of their first month of medication. “We took this model from the HIV world where it has been demonstrated that getting people on HIV medications as soon as they’re diagnosed results in better outcomes, both in terms of getting them engaged in care but also in terms of ongoing transmission of the infection,” Eckhardt said. “If you think about it, people who are recently infected are the ones that are most likely to engage in risky behaviors and are also the most likely to then transmit their infection to other potentially uninfected individuals.” Results showed that more patients both initiated treatment and achieved SVR at 12 weeks in the rapid treatment arm than in the usual care arm. Additionally, the researchers were able to treat and cure patients more quickly in the rapid treatment arm, according to Eckhardt.

For more information: https://tinyurl.com/bdrmn4f9

Dangerous drug supply in Manitoba should be declared health emergency

Winnipeg, MB - Harm reduction advocates want the province of Manitoba to declare a public health emergency to address what they say is a drug-poisoning crisis. "The overdose crisis is spiraling out of control while our city and our province pursue a failed law enforcement approach to a public health emergency," said Thomas Linner of the Manitoba Health Coalition, a non-profit organization dedicated to the expansion of public health care. Last year, 407 Manitobans died from illicit drug overdoses, according to data from the province's chief medical examiner — more than double the historical average of 200. Linner and other community groups gathered on the steps of the Manitoba Legislature Monday morning, calling on the premier to open supervised consumption sites and establish a safe and regulated drug supply for known drug users, in order to help reduce overdose deaths. Linner said the province's approach so far has been "uniquely hostile" to harm reduction efforts. He expects the number of drug-related deaths to grow if provincial leaders don't change course. Thomas Linner of the Manitoba Health Coalition, along with other harm reduction advocates, called on the province Monday to declare a public health emergency to address an increase in overdose deaths. (CityNews) "When Justice Minister Kelvin Goertzen rejects harm reduction in favour of increased law enforcement, that sends the wrong message and hurts people on the streets who need help now," said Linner. In May, the provincial justice minister said he's not interested in asking Ottawa to exempt Manitobans from federal criminal charges for possessing small amounts of some drugs, after the federal government agreed to such a plan in British Columbia. Manitoba's provincial government has also been cool to the idea of supervised consumption sites. In a 2021 year-end interview, Premier Heather Stefanson questioned the efficacy of those sites, which can offer people with addictions a place to obtain clean needles, have street drugs checked for the presence of harmful chemicals, get tested for communicable diseases, and receive emergency medical treatment and basic medical care. The sites also typically provide access to mental health services, addictions treatment and social services, including housing. When asked again if she would be open to safe consumption sites — and if she would declare a public health emergency or consider facilitating a safe supply of drugs — Stefanson did not directly respond to those questions. "People are suffering from mental health and addiction problems that have been exacerbated ... from the COVID-19 pandemic, so certainly our thoughts and prayers are with the families," the premier said. She instead pointed to the province's rapid access to addictions medicine, or RAAM, clinics, which she said the province supports "to make sure that we get those individuals off of the addictions and can heal in the community as well." "So those are the types of supports that we're investing in — they have proven track records, very good ones, and we'll continue to make those investments."

For more information: https://tinyurl.com/26k8tnu2

HHS provides $1.5 billion to fund state opioid grant program

Washington, DC - A federal grant will provide nearly $1.5 billion to states and territories to address the nation’s opioid addiction and overdose epidemic, HHS announced in a press release.  Through the Substance Abuse and Mental Health Services Administration (SAMHSA), the HHS State Opioid Response grant program will provide formula funding to states and territories to increase access for FDA-approved medications for the treatment of opioid use disorder, as well as support for prevention, harm reduction, treatment and recovery support services. “The State Opioid Response grant program delivers crucial aid to states and territories to help address the crisis of overdose and death in our nation’s communities,” HHS Secretary Xavier Becerra said in the press release. “In line with HHS’ Overdose Prevention Strategy, this funding helps facilitate state- and territory-level efforts to ensure the full continuum of prevention, harm reduction, treatment and long-term recovery supports are in place and accessible to all who need them.” The State Opioid Response program will provide care for stimulant misuse and use disorders, including cocaine and methamphetamine. The goal of the program is to help reduce overdose deaths and close the gap in treatment needs by giving states and territories flexibility in funding evidence-based practices and support across different settings. “SAMHSA will continue supporting our nation’s states and territories as they confront the overdose crisis that has brought tragedy to so many American families and communities,” SAMHSA leader Miriam E. Delphin-Rittmon, PhD, said in the release. “The State Opioid Response grant program delivers funding and guidance needed for states and territories to increase efforts to provide accessible, lifesaving medications and services in the communities where people most need them.” Overdose deaths have increased during the COVID-19 pandemic, with the CDC estimating more than 107,000 overdose deaths in the last year, the highest ever reported in a 12-month span.  In addition to the State Opioid Response program, states and territories will be asked to develop naloxone distribution and saturation plans that will increase availability and accessibility for the overdose reversal medication.

For more information: https://tinyurl.com/yu9pvaxc

As monkeypox cases emerge in US and Europe, Bavarian Nordic inks vaccine order

Copenhagen, Denmark - A monkeypox outbreak is emerging in the U.S. and Europe, and at least one country is amping up countermeasure preparedness. Bavarian Nordic has secured a contract with an unnamed European country to supply its smallpox vaccine, called Imvanex in Europe, in response to the emergence of monkeypox cases, the Danish company said Thursday. The vaccine is approved under the brand name Jynneos in the U.S. with a label that also specifically covers monkeypox. Because monkeypox virus is closely related to the variola virus that causes smallpox, smallpox vaccines can also protect against monkeypox, the Centers for Disease Control and Prevention (CDC) says.

For more information: https://tinyurl.com/yhk7bedz

CDC reports more than 107,000 overdose deaths in 2021

Atlanta, GA - The CDC estimates that 107,622 overdose deaths occurred in 2021, a 14.9% increase from 2020, which previously held the record for overdose deaths in a 12-month period, according to a report from the National Center for Health Statistics. Rahul Gupta, MD, MPH, MBA, FACP, White House Office of National Drug Control Policy director, said in the report that a life is lost to overdose every 5 minutes. “That is why President [Joe] Biden’s new National Drug Control Strategy signals a new era of drug policy centered on individuals and communities, focusing specifically on the actions we must take right now to reduce overdoses and save lives,” Gupta said.  This strategy proposes targeted actions to expand access to evidence-based prevention, harm reduction, and treatment and recovery services, while reducing the supply of drugs such as fentanyl, Gupta said. “Those actions include expanding access to high impact harm reduction tools like naloxone, quickly connecting more people to treatment, disrupting and dismantling drug trafficking operations, and improving data to systems that drive the nation’s drug policy,” Gupta said.

For more information: https://tinyurl.com/3xhu3csr

Over million people initiated DAA treatment for HCV between 2014 and 2020

Atlanta, GA - Approximately 1.2 million people in the United States initiated treatment with direct-acting antivirals for hepatitis C virus infection between 2014 and 2020, more than half of whom were baby boomers, according to a study. “In the U.S., hepatitis C virus infection is a leading cause of chronic liver disease, liver cirrhosis, and liver cancer, with an estimated 2.4 million people living with the infection during 2013 to 2016,” Eyasu H. Teshale, MD, an epidemiologist in the CDC’s Division of Viral Hepatitis, told Healio. Of the approximately 1.2 million people who initiated treatment with DAAs for HCV between 2014 and 2020 in the U.S., 65% were baby boomers.  “Beginning in 2013, direct-acting antiviral agents became available to cure hepatitis C and to reduce hepatitis C-related morbidity and mortality,” Teshale said. “Although treatment is recommended for nearly all people with hepatitis C infection, there remains a huge disparity in access to treatment.Teshale noted that WHO developed an action plan in 2016 to eliminate HCV as a public health threat by 2030. “A key element of this elimination plan focuses on expanded treatment access. However, in the U.S., the characteristics of people treated for HCV infection was not well described prior to this analysis.” Teshale said. “We did this study to better understand the characteristics of people who received hepatitis C treatment in the U.S. to strengthen efforts to address disparities and eliminate hepatitis C.” Teshale and colleagues collected data on DAA use from IMS Health & Quintiles — a prescription claims database that contains DAA prescriptions from 93% of retail pharmacies, 69% of mail order pharmacies and 76% of long-term care pharmacies in the U.S. The database showed that approximately 843,000 people initiated DAA treatment for HCV between 2014 and 2020. Teshale and colleagues adjusted that total for pharmacies that do not report to the database and added people treated by the Veteran’s Health Administration and estimated that approximately 1.2 million people initiated DAAs during this period — an average of 171,000 each year. The study found that approximately 65% of people treated with DAAs from 2014 to 2020 were baby boomers born between 1945 and 1965, although the researchers said the number and proportion of people treated who were born after 1965 have increased in recent years.

For more information: https://tinyurl.com/mrw5spny

CDC investigating acute hepatitis in children

Atlanta, GA - The CDC reported during a media telebriefing that it is investigating cases of acute hepatitis of unknown etiology among children in the United States but warns it will take time to evaluate evidence.  The agency’s investigation currently includes 109 cases of acute hepatitis in children in 25 states over the past 7 months. More than 90% of these patients were hospitalized and 14% received liver transplants; there have been five deaths. Cases have been reported in Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, Nebraska, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Washington and Wisconsin. “Although rare, children can have serious hepatitis, and it's not uncommon for the cause to be unknown,” Jay Butler, MD, CDC deputy director for infectious diseases, said during the briefing. “The 109 patients under investigation were identified as having been ill within the past 7 months. Some may ultimately wind up not being linked to the current investigation, and based on a preliminary analysis of limited data, there has not been a significant increase in pediatric hepatitis cases or liver transplant, including from before the COVID -19 pandemic.” Some of the hepatitis cases identified in Alabama between October 2021 and February 2022 had adenovirus type 41 infection, which is not known to cause hepatitis in otherwise healthy children. Other causes, including hepatitis A, B, C, D and E, were considered but were not found. Investigators also ruled out a possible link to the COVID-19 vaccine. “We know that none of the children in Alabama had received the COVID-19 vaccine prior to being hospitalized for hepatitis,” Butler said. “The children affected are young, with a median age of 2 years, which means that most are not eligible to receive the COVID-19 vaccine. COVID-19 vaccination is not the cause of these illnesses, and we hope that this information helps clarify some of the speculation circulating online.” According to Butler, the CDC is currently unaware of any cases of children with acute hepatitis and documented COVID-19 infection. “That certainly is true among that initial nine cases in Alabama, but it's a question that I think is still unanswered,” Butler said. “We are working to be able to assess whether or not some of the kids have serologic evidence of past infection that may not have been clinically apparent. Regarding the assessment of adenovirus infections, that's also ongoing work.” Although the adenovirus has been detected in several cases in the U.S. and around the globe, it is not yet known whether that is the cause of acute hepatitis, Butler said. In addition, it is not known whether other factors, such as environmental exposures, medications or other infections, might play a role.

For more information: https://tinyurl.com/3u4bkh22

Study finds that  vertical hepatitis C transmission more common than assumed

Bristol, UK - The rate of vertical hepatitis C transmission is nearly 25% higher than commonly assumed, according to a reanalysis of data from more than 1,700 children born to mothers infected with the virus. The study also found, however, that the rate of spontaneous clearance within 5 years of birth is underestimated. Hepatitis C vertical transmission rates are approximately 24% higher than previously assumed, whereas the risk for infection persisting beyond the age of 5 years is about 38% lower.  Anthony E. Ades, PhD, MSc, professor in the Bristol Population Health Science Institute at University of Bristol Medical School in England, and colleagues noted the “widely accepted” estimate that the risk for vertical transmission of HCV is 5% to 6% among monoinfected women, and that 25% to 40% of infants spontaneously clear their infection within 5 years. The problem with these estimates is that the methods for calculating them were variable and poorly reported, Ades said. Ades and colleagues previously published a study that assessed the spontaneous clearance of vertically acquired HCV. “What prompted both these studies was the need to establish the timing of mother-to-child transmission of HCV, as well as the vertical transmission rate,” Ades told Healio. “Our objective was to inform the design of trials of direct-acting antiviral interventions in pregnancy to prevent transmission to the fetus and newborn.” Ades and colleagues reanalyzed data on 1,749 children from three prospective studies to obtain estimates of overall rates of vertical transmission and clearance at different ages. According to the study, they used the clearance rates to determine the proportion of uninfected children who were infected and then cleared the infection before testing negative. The researchers then estimated the proportion of transmission early in utero, late in utero and at delivery using data on the proportion of positive HCV RNA tests within 3 days of birth. Overall, the study showed that rates of vertical transmission were 7.2% (95% credible interval [CI], 5.6-8.9) among mothers who were HIV negative and 12.1% (95% CI, 8.6-16.8) among mothers co-infected with HCV and HIV. The corresponding rates of clearance at 5 years were 2.4% (95% CI, 1.1-4.1) and 4.1% (95% CI, 1.7-7.3).  Ades and colleagues estimated that 24.8% (95% CI, 12.1-15 40.8) of infections occur early in utero, 66% (95% CI, 42.5-83.3) later in utero and 9.3% (95% CI, 0.5-30.6) during delivery.  Based on the data, they concluded that rates of vertical transmission are approximately 24% higher than previously assumed. However, the risk for infection persisting beyond the age of 5 years is about 38% lower. According to Ades, it is recommended that infants at risk for vertical transmission are tested at 18 months and, if positive, are presumed infected, followed to 3 years of age, and then tested for HCV RNA to confirm infection. If they remain infected, they are treated with DAAs.  “These recommendations, however, are difficult to implement. Even in the U.S., a high proportion of children at risk are lost to follow-up, and many of those who are infected are likely to remain untreated,” Ades said, adding that in countries with fewer resources, it is unlikely that the recommended management could be implemented at all.  “The development of interventions in pregnancy and approaches to earlier diagnosis and treatment are therefore a priority,” he said. He said the findings of the study have “no immediate clinical application” but instead clarify the extent of transmission and spontaneous clearance and provide a solid basis for the design of trials of interventions in pregnancy, and trials of early vs. deferred treatment when treatments before age 3 become available.

For more information: https://tinyurl.com/37dub9zx

Misinterpretation of the “Overdose Crisis” fuels misunderstanding of the role of prescription opioids

Sarasota Springs, NY - The United States overdose epidemic hit yet another devastating record in 2021, with drug overdose deaths surpassing 100,000 for the first time in history, representing almost a 21% increase compared to 2020.1 While undoubtedly several societal, personal, and behavioral phenomena highlighted and created by the COVID-19 pandemic have contributed to the sharp incline in overdoses our nation has witnessed over the past two years, it is imperative to recognize that all cause opioid-related overdose death rates had been rising precipitously since 2014. There are a variety of factors that have influenced the progressive pacing of opioid-related overdoses witnessed throughout the second decade of the 21st century. Perhaps the most significant has been the introduction and availability of illicitly manufactured synthetic opioid products (namely “fentalogues”), although additional contributors include increasing rates of polysubstance abuse, continued poor access to medication assisted treatments and behavioral health supports, and restrictions and reductions of legitimate opioid access when clinically indicated.  Despite the multifactorial nature of the current overdose epidemic, there continues to be a disturbing and disproportionate narrative pertaining to the involvement and overall influence of opioid prescribing. A trend in misinformation has affected almost all facets of society, from politics to healthcare. Accordingly, it should not be surprising that the opioid overdose crisis has also been entangled in a messy web of a politicized revenue stream associated with lawsuits by various states and other municipalities, and the law firms and expert witnesses that frequently and repeatedly participate. One of the most notorious groups that continues to perpetuate false narratives regarding the prescribing of opioids is Physicians for Responsible Opioid Prescribing (PROP). However, they are certainly not alone in the persistent misinterpretation and misrepresentation of data and shared responsibility for adverse consequences such as increased suicidality and escalated use of non-prescription opioids, particularly those containing fentalogues that are the most frequent cause of accidental overdoses and deaths. This study will address several ongoing false narratives regarding opioid prescribing and its involvement in the ongoing overdose epidemic. We utilize specific quotations excerpted from a recent press release by the PROP organization that best highlight the falsehoods that too many legislators and media outlets are sadly accepting as accurate information.  Prevention may be even more important, and decreasing new opioid prescriptions is key to ending this [overdose] epidemic... a conventional view is that the prescription opioid crisis is over. In fact, deaths due to prescription opioids have continuously increased from 1999 through 2017.  The concept of “prevention” by means of reducing prescription and supplies of opioids as a way to end the opioid crisis (often hyperbolically identified as the “opioid epidemic”) continues to be a running narrative put forth by several organizations. It is one that is quite puzzling, particularly in the context of the above excerpt, as there is concomitantly an acknowledgement that approximately 99% of fentanyl-related deaths now involve illicitly synthesized fentalogues. It is well-accepted in scientific circles that current overdose deaths involve fentanyl-related compounds that are illicitly manufactured and not FDA approved pharmaceutical fentanyl (or its FDA approved chemical derivatives alfentanil, remifentanil, and sufentanil) used in both acute and chronic settings. This is a distinction that must be accurately described in order to diminish untoward apprehension in prescribing pharmaceutical fentanyl and its related compounds safely in a both monitored clinical settings and for home use. Despite the acknowledgement that fentalogues are now involved in “almost all opioid-related overdose deaths” in the aforementioned excerpt, it is disingenuously claimed that the reason why “prevention” (in terms of reducing prescription opioids) is supported is the “fact” that “prescription opioid deaths have been increasing from 1999 through 2017”. Not only is this characterization inaccurate, but it is vastly generalized and lacking clarity. The primary shortcoming of such a statement is that the terminology of “deaths due to prescriptions opioids” is neither specifically defined nor clear. This is an important reality that is often ignored when assessing overdoses, as, perhaps most importantly, there is usually no way (or attempt) to actually verify whether patients overdosed on opioids that were prescribed to them, opioids that were prescribed to someone else that they obtained illicitly, opioids manufactured illicitly, or a combination thereof.  Accordingly, even to label the category of overdoses involving “natural and semi-synthetic opioids” as “prescription opioids” (which it appears PROP has attempted to conjecture in their news release) is misleading and unequivocally false. However, this type of “slight of hand” is persistently used by anti-opioid factions, as the narrative is “convenient” for them, albeit false. Adding to the lack of clarity resulting from such mislabeling of “prescription opioid deaths” is that the majority of drug overdose deaths appear to involve more than one substance. Lead author of this report is Jeffrey J Bettinger, Saratoga Hospital Medical Group, Saratoga Springs, NY.

For the full article with citations: https://tinyurl.com/47m6mfek

Toronto’s New Hospital-Based Safe Consumption Site Is a First for Ontario

Toronto, ON - A specialized hospital in Toronto opened the doors to a new supervised consumption site for its patients recently, as reported by Filter magazine. Casey House is a small hospital that provides care for people living with HIV. It is now home to the first hospital-based SCS in the province, though two others in the country—Edmonton’s Royal Alex Hospital and St. Paul’s Hospital in Vancouver—have previously opened. Casey House staff believe this is a good step that will help patients who use drugs remain safe and comfortable. Other Toronto harm reductionists echoed this sentiment, but—without criticizing the facility itself—said there is room for improvement in the model. The SCS is now open to registered clients at the inpatient unit 24 hours a day. Outpatients can also access it from 10 am to 4 pm. Drugs that have been obtained elsewhere can be injected, snorted or swallowed in the private consumption booths at the facility. “It’s a service that we think all hospitals should be providing.” “It was very important to us because a lot of our clients use substances,” Lee Hodge, Casey House’s director of strategic initiatives, told Filter. “We know that when clients [who] use substances are engaged in hospital care, they’re often highly stigmatized. That can lead to people not accessing the care that they need or discharging from care early.” Trying to prevent patients from doing drugs can lead to them simply using hospital bathrooms for this purpose, which, Hodge noted, can be a safety issue. “For us, what’s really important is that people have a safe place that they can receive the health care that they need,” he said. “It’s a service that we think all hospitals should be providing for their clients.” Nick Boyce, director of the Ontario Harm Reduction Network, said that the SCS is something that should have been started a long time ago. It’s also something that his organization hopes to see in other hospitals. “We know that people who use drugs have big barriers when it comes to accessing health care because there’s a lot of stigma within health care settings,” he told Filter. While the SCS will be good for people who inject or snort, it currently leaves out people who inhale or smoke drugs. Setting up an expanded safe supply program could also help, Boyce said. Although, he noted, there are a few safe supply programs in the surrounding area, many are at capacity. At Casey House, the hospital’s doctors can prescribe safe supply to inpatients, Hodge said, but they are unable to maintain it after the patients are discharged. And while the SCS will be good for people who inject or snort, it currently leaves out people who inhale or smoke drugs. This is an issue when, according to Boyce, at least a third of overdose deaths in Ontario are from people smoking or vaping drugs. Hodge said that the SCS does have a purpose-built room for inhalation, with an HVAC system that can quickly clear the room of any smoke. The hospital also has a Health Canada exemption for the facility. However, the Smoke-Free Ontario Act currently prevents them from actually operating it. “We are working on advocating with the provincial government to allow us to open this portion of the service,” he wrote.

For more information: https://filtermag.org/toronto-hospital-safe-consumption

Steps that may identify patients eligible for shorter DAA therapy

Chicago, IL - Measuring hepatitis C virus at baseline and on days 7 and 14 of therapy — and eliminating blood draws on days 2 and 28 — can identify patients who may be eligible for a shorter duration of therapy, according to a study. Direct-acting antivirals have “revolutionized” the treatment of HCV infection, leading to a cure in most patients, but their cost remains one of the barriers to elimination, according to Harel Dahari, PhD, an associate professor of hepatology in the Loyola University Chicago Stritch School of Medicine, and Ohad Etzion, MD, director of the department of gastroenterology and liver diseases at Soroka University Medical Center in Israel. Cutting out hepatitis C virus blood draws on days 2 and 28 can successfully identify patients eligible for shorter therapy duration. Source: Adobe Stock.  “The goal of our study was to examine whether response-guided therapy based on mathematical modeling of viral kinetics during the first 2 weeks of DAA therapy would enable optimization of the length of treatment on an individualized basis,” Dahari and Etzion told Healio in a joint email. They said being able to shorten therapy duration in carefully selected patients would lead to substantial cost savings in HCV management. These patients may include people who inject drugs (PWID), who experience suboptimal adherence to therapy, and pregnant women. Dahari and Etzion used a model that was based on an analysis of individual kinetic patterns of viral decline obtained from blood samples taken at baseline, day 2, week 1, week 2 and week 4 after initiation of DAA treatment. According to the researchers, for each patient, calculation of time to cure based on the mathematical model was done after the week 4 blood draw, and according to the model’s estimation, patients were instructed to either continue therapy according to standard of care or to shorten therapy as determined by the model. They then reanalyzed the results to determine whether omitting specific time points of viral load determination would be possible. According to the study, the first confirmed time-to-cure for each of the 10 patients agreed with the reported estimated time-to-cure. In two of the 10 patients, HCV was detected at day 28 and was used for predicting time-to-cure. The researchers found that excluding day 28 in these two patients had “a limited effect” on time-to-cure projections, which led to underprediction by 2 days in one patient and overprediction by 6 days in the other. Similarly, they determined that excluding the day 2 HCV measurement also had a limited effect on maximum time-to-cure projections, which they said remained accurate in eight of the 10 cases. The study demonstrated that excluding day 7 disproportionality affected the maximum time-to-cure projections, resulting in skewed predictions by at least 1 week in six study participants and overprediction by nearly 5 weeks in two additional patients.  Based on these findings, the researchers said omitting day 2 and week 4 blood draws did not significantly alter the accuracy of the model for determining expected time-to-cure. “Treatment of HCV infection does not mandate a fixed duration in all patients. Treatment length can be individualized by utilizing a simple mathematical model for prediction of time-to-cure in a response guided approach,” Dahari and Etzion said. “Implementation of the approach on a larger scale could lead to significant cost saving and optimize therapy duration in specialized population such as PWID and pregnant women.”

For more information: https://tinyurl.com/2p8ad97r

Make Naloxone more accessible to at-risk Americans,

White Oak, Maryland - Experts say that US should allow OTC sale, reimburse pharmacists, and support harm-reduction groups. Strategies to expand access to naloxone (Narcan) for the prevention of opioid overdoses were explored during a webinar hosted by the Reagan-Udall Foundation for the FDA. Over 100,000 people died from drug overdoses over a 12-month period ending in April 2021, according to CDC's provisional data. Stigma, regulatory barriers, and lack of education prevent people with substance use disorders, as well as their close friends and family members, from accessing the drug, experts said. "Here we have an essential medication that people have literally run into pharmacies, thinking it's going to be there, and it's not there. And people have died," said Jeffrey Bratberg, PharmD, a clinical professor in the College of Pharmacy at the University of Rhode Island. All three FDA-approved formulations of the drug -- injectable, auto-injector, and intranasal -- require a prescription. One way to make naloxone easier to obtain is to make it available over the counter instead of by prescription. "Over the years, we have explored all options available under our authorities and acknowledge that the transition to OTC remains challenging," said Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research (CDER). Legally, the FDA can transition naloxone from a prescription drug to an OTC product, but not without collaboration from manufacturers. According to FDA statute, non-prescription drugs must be safe and effective for the general public without the supervision of a healthcare professional. To receive approval for OTC use, a manufacturer must complete "product-specific testing of device instructions," showing that it is easy for the general public to understand and use the product, said Marta Sokolowska, PhD, associate director for controlled substances at CDER. In an effort to encourage manufacturers to seek OTC approval for naloxone, the FDA tested and validated a Drug Facts Label for OTC naloxone -- one of the key requirements needed to approve an OTC product, she noted. Understanding instructions on the use of the vials and syringes involved in the intramuscular formulation could be challenging for people who aren't accustomed to injecting products, she pointed out. "This may be more straightforward for relatively user-friendly formulations such as nasal spray or auto-injectors." However, Nabarun Dasgupta, MPH, PhD, senior scientist at the University of North Carolina Gillings School of Global Public Health and co-founder of Project Lazarus, argued that intramuscular products need to be available over the counter. They have been sidelined by stigma and misinformation, but are "often preferred" over the nasal device, because they cause fewer withdrawal symptoms and are "30 times cheaper," he said. As for needle-phobia, "the needle used for intramuscular naloxone is the very same tool that we use to give vaccines to babies," he noted. Many manufacturers and distributors require not only a medical license to ship naloxone to a harm-reduction program, but also a DEA license number, despite the fact that naloxone is not a controlled substance. Additionally, if a program operates at multiple sites, distributors often ask for a separate physician license for each address. To that end, Dasgupta argued that community groups should be exempt from wholesale distribution regulations, particularly during a public health emergency, so that they can more easily purchase and distribute naloxone. He also pointed out that the greatest increase in overdose deaths occurred in communities of color, and the harm-reduction groups serving these communities are the least likely to have access to physicians who can order naloxone. "Due to generational hostility and harassment encountered within the healthcare system, these groups are understandably reluctant to waste their time begging doctors they don't know to purchase naloxone for them," he explained. "If we honestly want to dismantle structures of injustice, we have to make it easy for them to get naloxone, and pay their outreach workers and then we need to step out of the way."

For more information: https://tinyurl.com/2p8w442f

In Cirrhosis, Less Activity Equals Worse Outcomes

Pittsburgh, PA - The lower the daily step count, the higher the risk of hospitalization and death concluded a study reported on in MedPage Today. Daily step count measured by a a wearable sensor-based personal activity tracker predicted risk of hospital admission and mortality for patients with cirrhosis, the study found. After adjusting for model for end-stage liver disease sodium (MELD-Na) and usage of a smartphone-based app designed for patients with end-stage liver disease, those in the lowest quartile of daily steps (<1,200 steps per day) had a significantly greater risk of hospitalizations and death: Hospitalization HR 1.90 (95% CI 1.09-3.30) Death HR 3.46 (95% CI 1.23-9.68) Independent of MELD-Na and use of the app, the risk of hospital admission was reduced by 5% and the risk of death was reduced by 12% with every additional 500 steps walked per day, reported Andrés Duarte-Rojo, MD, PhD, of the University of Pittsburgh School of Medicine in Pennsylvania, and colleagues in Clinical Gastroenterology and Hepatology. In addition, better performance on the 6-minute walk test and gait speed test were each associated with lower risk of hospital admission and death, respectively: 6-minute walk test: HR 0.63 (95% CI 0.47-0.83) and HR 0.66 (95% CI 0.44-0.99) per 100 m;  Gait speed test: HR 0.29 (95% CI 0.11-0.72) and (HR 0.21, 95% CI 0.05-0.84). "This is the first study to demonstrate the relationship between step counts and prevalence of frailty in patients with end-stage liver disease," the authors wrote. "Daily step count can potentially substitute or supplement the current recommended frailty metrics when assessing and identifying physical frailty in community-dwelling adults with end-stage liver disease," they added. "I think the bottom line is people who don't move are going to stay sick. I would say the average patient is not overly aggressive in documenting their steps or exercise because many of the patients are so sick by the time they get to us, they are nearly immobile," said Joseph Galati, MD, of Houston Methodist Hospital in Texas, who was not involved in this study. "If we could give our patients access to these monitoring devices to keep track of their steps and movement that would help," he told MedPage Today. "We need to do this before they become really end-stage." For this study, Duarte-Rojo and colleagues examined data on 116 patients with cirrhosis from the University of Pittsburgh Medical Center. Mean age was 56 years, 55% were men, mean MELD-Na score was 15, and mean body mass index was 31. The most common etiologies of liver disease were alcohol-related cirrhosis (33%) and non-alcoholic steatohepatitis (30%). Over half of patients were listed for liver transplant. Patients were excluded if they had received or were ineligible for a liver transplant, did not have access to a smartphone or wireless internet, or had overt hepatic encephalopathy. The study participants were divided into those using a personal activity tracker alone (FitBit; n=71) or a tracker plus the EL-FIT app (n=45). Weekly monitoring of steps was completed in 80% of those who used the tracker with the app versus 62% of those who used the tracker alone (P=0.040). During a follow-up of 223 days, 55% of patients were hospitalized and 15% died. Duarte-Rojo and colleagues acknowledged that patients with gait disturbances, poor digital literacy, or those who experience physical discomfort during exercise may not be able to use a personal activity tracker, which was a limitation to their study.

For more information: https://tinyurl.com/yrsmyet4

Moderna working on second mRNA - HIV vaccine

Cambridge, MA - Moderna announced recently that it has dosed the first patient in a trial testing its second mRNA HIV jab, less than six weeks after launching human trials for its first jab in January, a proverbial starting gun in the race for a breakthrough HIV therapy that’s now underway between Moderna and Excision BioTherapeutics.  Moderna’s second HIV shot, mRNA-1574, takes a different approach to the first by targeting HIV envelope trimers via mRNA instead of eliciting broad antibodies against the virus. Its trial is another collaboration between the Cambridge-based biotech and the National Institutes of Health, this time partnering with the Division of AIDS within the National Institute of Allergy and Infectious Diseases. The trial is slated to test the candidate in 100 HIV-negative adults ages 55 and under.  It follows the January launch of the company’s phase 1 trial for its other HIV jab, which tests sequential administration of HIV immunogens via mRNA as a way to elicit strong and durable B-cell responses. The company’s hypothesis, built upon research from William Schief, Ph.D., at Scripps University, is that B-cell response will over time develop into more broad and robust neutralizing antibodies.  The dosing of its second trial is the latest development in the race for a new HIV therapy that now appears to be a two-horse race between Moderna and Excision BioTherapeutics, with the latter initiating its own nine-patient phase 1/2 trial at the end of January to test its CRISPR-based therapeutic that it boldly touts as a “functional cure” for the virus.  Both Moderna's and Excision's therapies come as potential breakthrough alternatives to the standard course of care for HIV-positive patients, known as antiretroviral therapy, the first of which was approved more than 30 years ago. Antiretroviral treatments work by reducing the viral load of HIV to an undetectable level, thus making it impossible to spread. But such treatments must be taken daily and are ultimately not a cure. The phase 1 trials from both companies are not the only potential breakthroughs for HIV treatment. A day before they were launched in late January, new research indicated that popular PD-1 inhibitor cancer therapy Keytruda further wrestled HIV out of its dormant state in patients on antiretroviral therapy. The findings provided promise that future therapies could be both more effective and less frequent.  As for Moderna, a release time for top-line data for mRNA-1574 wasn't provided, but the primary completion date of the phase 1 trial for its other vaccine is slated for April 2023.

For more information: https://tinyurl.com/bdhapnvj

Medical students join calls for safe consumption site funding

Saskatoon, SK - For first-year University of Saskatchewan med student Ryan Krochak, Saskatchewan’s overdose and drug use crisis has been hitting close to home. “I was raised just north of Yorkton, so right now I can speak to the HIV epidemic within the Kamsack region, and in the past five years the HIV rate has gone up over 700 per cent,” Krochak recently told Global reporters in Regina. People who use drugs comprise about 20 per cent of those in Canada infected with HIV and about 30 per cent of new infections, according to the Canadian AIDS Society. “It’s such a surreal moment watching an attending physician break the news that a patient is now diagnosed with HIV. That’s a chronic infection. That’s a lifelong infection, and it’s preventable.” Krochak was joined Wednesday in the legislative building by several fellow students and members of Students for Harm Reduction and Informed Policy, for which he is the incoming president. Together, pointing out that 2021 again brought a record number of overdose deaths to Saskatchewan, the group called on the provincial government to directly fund safe consumption sites as well as increase access to needle exchange programs. “It’s well documented that we’re in an overdose epidemic. Now more than ever there is a contaminated illicit supply of drugs,” Krochak said. “Right now people are dying in Saskatchewan and we need to address it. The time is now to publicly fund safe consumption sites.” The safe consumption sites in both Regina and Saskatoon are currently privately operated and funded. While the province has taken steps to make available take-home naloxone kits and drug testing strips, and are in the process of purchasing four spectrometer testing machines, requests for safe consumption site funding have so far been denied. Mental Health and Addictions Minister Everett Hindley said his ministry is reviewing another funding proposal from Prairie Harm Reduction and that are “looking at all of the options on the table right now.”“We have a budget coming up in a couple of weeks’ time. We’ve made some significant investments in past years both new initiatives and we’ve also annualized some initiatives when it comes to harm reduction across this province,” Hindley said. “That remains our goal. We’re trying to make sure that as part of our overall addictions and mental health strategy that we’re providing treatment options but also providing harm reduction services for people across this province regardless of where they live.” But NDP Health Critic Vicki Mowat said the province is “dragging its feet” and has been “paying lip service to harm reduction for years now.” “The proof is in the pudding,” Mowat said. “The last minister of health also said he supported harm reduction initiatives but we haven’t seen the dollars follow those words.” Recounting how she had recently witnessed a Prairie Harm Reduction staff member revive an overdose victim before the consumption site was actually open for the day, Mowat called the number of overdose death trend “heartbreaking” and that the recent increase in mental health and addictions funding “was needed ten years ago.” “We’ve heard from the harm reduction CBOs themselves that the government isn’t doing enough. Expanding hours and having trained people on site is what’s really going to make a difference for them and we haven’t seen that funding from government,” she said. For first-year University of Saskatchewan med student Ryan Krochak, Saskatchewan’s overdose and drug use crisis has been hitting close to home.

For more information: https://globalnews.ca/news/8671131/u-of-s-students-safe-consumption-site/

A pathway to HCV elimination and model for delivering health care to vulnerable populations

Montreal, PQ - The availability of safe, effective, short-course, all oral direct-acting antivirals (DAAs) has opened the door to the possibility that chronic hepatitis C virus (HCV) infection could one day be eliminated. Consequently, in 2016, WHO set targets for the elimination of HCV as a public health threat by 2030. Achieving elimination without a vaccine requires that more than 80% of the 58 million people currently estimated to be living with chronic HCV worldwide are treated. With less than 10 years to go, the treatment gap remains enormous—only an estimated 21% of the global population with chronic HCV had been diagnosed and, of these, only 62% treated by the end of 2019. Progress towards HCV elimination has been hampered by the many steps required before HCV treatment is initiated and unduly complex follow-up that some health systems and patients cannot complete. In high-income countries, HCV principally affects those who are marginalised or disenfranchised from health services, such as people who inject drugs or those in rural or remote communities and in prisons. Low-income and middle-income countries face additional challenges. While generic drugs have become increasingly accessible and have substantially lowered the cost of treatment, The cost and complexity of pre-treatment assessments such as genotyping, liver fibrosis staging, and on-treatment monitoring place considerable burden on health resources, precluding the expansion of treatment more widely. Notwithstanding the COVID-19 pandemic, which has slowed progress towards HCV elimination worldwide by disrupting health systems and shifting health priorities, there were already signs that elimination efforts had stalled. Even in countries on track to eliminate HCV, treatment rates had reached a plateau after patients who were already engaged in the health system and waiting to access treatment did so. Reaching those remaining will require simplifying therapeutic models, task shifting to community and primary health-care settings, and reducing the economic burden on health systems and for patients. As early as 2018, recommendations for simplifying the approach to initial HCV treatment for adults who do not have cirrhosis or HIV were made. Indeed, a variety of real-world studies reporting on decentralised care models have shown such approaches achieve similarly high cure rates as care delivered by specialists across a range of populations and settings. Evidence from randomised trials further supports simplified monitoring. For example, the SMART-C trial compared standard to simplified monitoring using glecaprevir–pibrentasvir, dispensing the entire 8-week treatment and requiring only two in-person visits. Sustained virological response (SVR) was 92%, compared with 95% in the standard of care group, although the difference was not non-inferior. However, this trial excluded active injection drug users and people with cirrhosis, only 7% of participants had HIV infection, pre-treatment HCV genotyping was required, and the trial was conducted in high-income settings. In The Lancet Gastroenterology & Hepatology, Sunil Solomon and colleagues report the results of the MINMON (ACTG A5360) trial, which simplifies HCV treatment even further. All participants received the entire 12-week course of sofosbuvir–velpatasvir at entry; no pre-treatment genotyping was required; FIB-4, a simple laboratory-based test, was used to classify cirrhosis; and there were no scheduled visits or laboratory monitoring while on treatment. Two remote contacts were made using the participant's preferred method of electronic communication. Although there was no comparator arm, this trial demonstrated this highly simplified, patient-friendly approach is both feasible and results in high cure rates (SVR 95·0%, 95% CI 92·4–96·7), similar to those those seen in registration trials. The trial had remarkably few dropouts (n=2) or losses to follow-up (n=2) and was conducted in low-income, middle-income, and high-income settings including participants with a wide range of HCV genotypes. The approach was not only highly effective but also safe. This trial should have important practice-changing implications. Although the benefits for resource-constrained settings are evident, paradoxically it might be more impactful for high-income settings, which have been particularly slow to adopt decentralised models widely. Given the large proportion of participants enrolled who were co-infected with HIV (42%, 99% of whom were virologically suppressed) and a reasonable proportion (9%) with compensated cirrhosis, the study is generalisable and supports the expansion of simplified treatment to these groups. Are there patients for whom a simplified approach might not yet be recommended? Although the trial included patients with a history of substance use, there were relatively few active users (14%). The proportion actively using injection drugs was not clear—a group for whom concerns regarding adherence and difficulties with follow-up due to a lack of mobile phones, computers, or fixed addresses are often raised. That said, only three of 20 non-responders were active substance users. This leaves relatively few patients who still require specialty care (eg, those with prior treatment, advanced cirrhosis, after transplantation, pregnancy, and other liver diseases such as hepatitis B). More research is needed to support such approaches for these special populations. The MINMON trial adds to the growing body of evidence that DAAs can be delivered safely and simply to a wide range of populations without the need for intensive monitoring and follow-up. It is time to reframe modern HCV treatments. Aside from their continued high price tag, these antivirals are more akin to antibiotics, and we should move to adopt simplification more broadly. Dispensing the full treatment course and offering flexible means of communication increases autonomy for patients and allows them to take control of an infection that remains stigmatising, without risking treatment failure. Adopting such simplified treatment can support a greater role for primary care, community-based, and nurse-led strategies, bringing treatment closer to people living with HCV. Not only can such simplified approaches advance HCV elimination efforts, but they could also serve as models for delivering health care that could change the way we manage infectious diseases affecting vulnerable populations. The lead researcher, Marina B. Klein, has received research support and consulting fees from ViiV, AbbVie, and Gilead Sciences, all outside the submitted work. She is also supported by a Tier I Canada Research Chair.

For more information: https://tinyurl.com/2p9dfcvk

Restoring Function in Gene Suppresses Liver Cancer and Boosts Immunotherapy

Boston, MA - A team of researchers from Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital (BWH) has reprogrammed the tumor microenvironment of liver cancer by using mRNA nanoparticles. This technology, similar to the one used in COVID-19 vaccines, restored the function of the p53 master regulator gene, a tumor suppressor mutated in not just liver but also other types of cancer. When used in combination with immune checkpoint blockade (ICB), the p53 mRNA nanoparticle approach not only induced suppression of tumor growth but also significantly increased antitumor immune responses in hepatocellular carcinoma (HCC) laboratory models. The results of the study were published in Nature Communications. “The reprogramming of the cellular and molecular components of the tumor microenvironment could be a transformative approach for treating HCC and other cancers,” says co-senior author Jinjun Shi, PhD, with the Center for Nanomedicine at BWH, who developed the platform with MGH liver cancer biologist and co-senior author Dan G. Duda, DMD, PhD. “By using this new approach, we’re targeting specific pathways in tumor cells with mRNA nanoparticles. These tiny particles provide the cells with the instructions to build proteins, which, in the case of HCC, delayed tumor growth and rendered the tumor more responsive to treatment with immunotherapy.” HCC is the most prevalent form of liver cancer, characterized by a high mortality rate and dismal prognosis for patients. Immune checkpoint blockers, a revolutionary new class of drugs that enable the body’s immune system to recognize and attack cancer cells, have shown efficacy in treating HCC, but most patients do not benefit. To overcome this resistance, multiple strategies are being developed to improve ICBs by combining them with other existing therapies, such as anti-VEGF drugs and radiotherapy. However, even these approaches are expected to benefit only a small number of patients, creating an urgent need for new combination therapies. Encouraged by the success of mRNA in COVID-19 vaccines, Shi decided to apply the technology (with certain modifications) to targeting cancer cells. He teamed up with Duda, whose MGH lab had already created sophisticated animal models to analyze the microenvironment of liver tumors in response to immunotherapy. They developed and optimized an mRNA nanoparticle strategy to restore loss of function of p53, a tumor suppressor gene whose function is lost in more than one-third of HCC cases. In doing so, they uncovered evidence that p53 regulates the tumor microenvironment by modulating the interaction of cancer cells with immune cells as part of ICB therapy. “In our previous work we had developed nanoparticles to target CXCR4—a chemokine receptor expressed by liver cancer cells—and selectively co-deliver drugs such as kinase inhibitors,” explains Duda. “We’ve now adapted this platform to use CXCR4 as a kind of ZIP code to selectively target the tumor with nanoparticles encapsulating therapeutic mRNAs. When we combined this nanomedicine with anti-programmed death receptor 1 (PD-1) antibodies, a standard immunotherapy for HCC patients, it induced global reprogramming of the tumor microenvironment and tumor response by restoring p53 expression.” The next step for the team is to transfer their research from animal models to patients in a clinical trial. “Scientists have struggled for decades to find an effective way to target the tumor suppressor pathways,” emphasizes Shi. “Our proof-of-concept study is an exciting development that clearly shows that p53 mRNA nanoparticles in combination with ICB not only works, but also could make a big difference by reversing immunosuppression in HCC and potentially other cancers.” Shi is an associate professor of Anesthesia at Harvard Medical School (HMS). Duda is associate professor of Radiation Oncology at HMS and director of translational research in GI radiation oncology at MGH. Yuling Xiao, PhD, and Jiang Chen, MD, PhD, are the lead authors of the study and postdoctoral fellows at HMS. The study was supported by a U.S. Department of Defense Peer Reviewed Cancer Research Program (PRCRP) Idea Award.

For more information: https://tinyurl.com/yck72use

CDC proposes to roll back restrictions previously recommended for prescribing opioids

Atlanta, GA - The CDC released a draft of its updated guidelines for prescribing opioids, which emphasize patient-centered decisions and would reduce some limitations on prescribing that were previously set in 2016.  The draft guidance was released amid an increase in opioid-related deaths in the U.S. According to a recent report published in The Lancet, the incidence of fatal opioid overdoses in the U.S. increased 37% from 2019 to 2020. CDC released a draft of updated guidelines for prescribing opioids. Source: Adobe Stock.  The 12 recommendations included in the draft guidance, which come from the CDC’s National Center for Injury Prevention and Control, are voluntary and not intended as “inflexible standards of care” or a replacement for clinical judgment or patient-centered care, the CDC wrote in a press release. The agency advised clinicians to “collaborate with patients when making treatment decisions and designing a treatment plan.”  “It is important that amidst a rising opioid crisis and global pandemic, we continue to focus on patient-centered policies and equitable innovation,” Anita Gupta, DO, PharmD, MPP, a Healio Primary Care Peer Perspective Board member and faculty member in the departments of anesthesiology and critical care at Johns Hopkins School of Medicine, told Healio.  CDC officials said the agency’s 2016 opioid guidelines, which recommended restrictions on prescribing, led to a reduction in prescriptions but also prompted some providers to avoid prescribing opioids to patients who may have benefited from them, according to the Associated Press. Out of consideration of the “constant tension” that followed the 2016 guidelines, the CDC proposed removing certain opioid dosage ceilings. Specifically, the draft guidance does not state that physicians should avoid increasing the dosage to a level equivalent to 90 mg of morphine per day. The working group that reviewed the draft recommendations reported that “specific opioid doses would be misapplied as absolute cutoffs or thresholds for policies or practices.” Prior to prescribing opioids to patients, the draft guidance states that physicians should consider toxicology testing to determine whether the patients are using other controlled and illicit drugs. However, the CDC did not recommend requiring having such tests done annually. For patients already receiving opioid therapy, the draft guidance advises physicians to work with them to incorporate risk mitigation strategies to avoid overdose or misuse. Also, the draft guidance discourages sudden discontinuation of opioids, especially for patients on high-dose opioid therapy, unless it is a life-threatening situation.  In addition, the CDC stated in its draft guidance that nonopioid therapies are preferred as first-line treatment for acute, subacute and chronic pain. Opioid therapy should only be considered when the expected benefits of its use outweigh the risks. The draft guidance does not apply to inpatient care in a hospital or ED setting but does extend to prescriptions made at discharge. It is accessible on the Federal Register and open to public comment for 60 days. The CDC will consider the comments before deciding on its final updated recommendations, which the agency expects to release at the end of 2022. “This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” Christopher M. Jones, PharmD, DrPH, MPH, the acting director for the National Center for Injury Prevention and Control, said in the release. “The ultimate goal of this clinical practice guideline is to help people set and achieve their personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal.”

For more information: https://tinyurl.com/f6eas2wa

Universal HCV Screening in Pregnancy Boosts Detection

Pittsburgh, PA - If you want to find undiagnosed hepatitis C virus (HCV) infection in mothers-to-be, a universal testing program for the disease among all pregnant individuals is the way to go, a researcher reported. Under a risk-based testing program in effect during 2019, doctors diagnosed 11 positive cases of HCV infection in pregnant people, but use of a universal testing approach that went into effect in mid-2020 detected 85 cases of HCV infection in the following 12 months (P<0.01), said Catherine Chappell, MD, of Magee-Women's Research Institute and Foundation/University of Pittsburgh. During the risk-based screening only about 23% of 12,142 pregnant people were screened for HCV, as compared with 81% of 12,588 in the universal screening period (P<0.001), according to the findings presented at the virtual Conference on Retroviruses and Opportunistic Infections. Chappell said she and her colleagues initiated the study after the American College of Obstetrics and Gynecology joined the CDC and other agencies in recommending universal HCV screening of pregnant people. "Universal hepatitis C virus screening is hypothesized to increase the detection of hepatitis C virus among pregnant people, resulting in fewer undetected perinatal hepatitis C virus transmissions," Chappell said. She noted that universal screening was implemented at her institution in June 2020 using a best practice alert in the electronic medical record, which provided a reminder if HCV testing was not ordered with the new obstetrics panel and reflex testing for HCV RNA if immunoglobulin G positive. Given the HCV perinatal transmission rate of 5.8%, an additional four infants with perinatal HCV in 12 months would have been identified with universal screening that would have previously gone undetected with risk-based screening within the healthcare system, Chappell said. "Risk-based HCV screening is insensitive for hepatitis C virus detection within the general obstetric population," she said. "Universal hepatitis C virus screening resulted in a 7.5-fold increased detection rate of active hepatitis C virus detection in pregnant people." Chappell suggested that since pregnancy is a time of high healthcare engagement, these individuals should be part of an HCV-elimination program. "Our findings strongly support universal HCV screening of pregnant people, not only to ensure that the pregnant person is linked to treatment, but also to ensure detection of all cases of perinatal hepatitis C virus transmission," she said. At a press conference that discussed the study, co-moderator Elaine Abrams, MD, of Columbia University Mailman School of Pubic Health in New York City, told MedPage Today that although she had not seen any related cost-effectiveness studies, she thought "it would be very feasible to add hepatitis C virus testing to the routine pregnancy panel." Also at the press conference, Chappell told MedPage Today that while a formal inquiry into risk factors for HCV was not conducted, anecdotally "several of the women who were detected with hepatitis C virus infection reported remote incidences of injected drug use that had not been previously reported." Study limitations, she noted, included that the research was performed at a single health system in Western Pennsylvania; that some individual providers could have used different screening practices during the two time periods, which might have contaminated the results; and that because the investigators were unable to link infant records in the current analysis, perinatal infant transmission had to be estimated, relying on a historical estimate on risk of mother-to-child transmission.

For more information: https://tinyurl.com/bde78anz

Salivary microRNA shows promise in detecting HCC

Cleveland, OH - Molecules in saliva may be highly sensitive and specific noninvasive biomarkers of hepatocellular carcinoma, according to a study published in PeerJ. “As liver cancers increase, better tools are needed to detect these cancers early to improve survival,” Daniel Rotroff, PhD, MSPH, senior author of the study and researcher in the department of quantitative health sciences at the Cleveland Clinic Lerner Research Institute, told Healio. “We believe this study represents an important step demonstrating that molecules in saliva may serve as promising, noninvasive indicators for the presence of liver cancer. We hope with continued work in this area, that someday patients may be able to be tested for liver cancer by simply mailing a saliva sample from the comfort of their home.”  Rotroff worked with lead author Arshiya Mariam, also of the Cleveland Clinic, and colleagues to perform small RNA sequencing in 20 adult patients with HCC and 19 with cirrhosis, all of whom underwent LT for HCC, surgical resection for liver tumors or liver biopsy. Twelve patients had HCC patients with chronic liver disease, and investigators analyzed those combined samples and stratified them by the presence of chronic liver disease.  Rotroff and colleagues compared differential expression of salivary microRNAs (miRNAs) with a previously published report of miRNAs in liver tissues of patients with HCC vs. cirrhosis and performed leave-one-out cross-validation and support vector machine models to determine if salivary miRNAs could potentially detect HCC. They adjusted P values for multiple comparisons using a false discovery rate (FDR) approach and miRNA with FDR P < 0.05 were considered statistically significant. Researchers detected 4,565 precursor and mature miRNAs in saliva, of which 365 were significantly different between patients with HCC compared with cirrhosis (FDR P < 0.05), and noted that 283 miRNAs were significantly downregulated among patients with HCC. A combination of 10 miRNAs and covariates, which accurately classified patients with HCC, were identified with machine-learning models, as well as three miRNAs that were expressed in HCC saliva samples and in a previously published study in HCC tissue compared with cirrhotic liver tissue.  “Overall, this study provides the first evidence that salivary miRNAs may serve as useful, noninvasive biomarkers for HCC,” Rotroff and colleagues wrote. “In addition, many of the identified miRNAs in saliva are concordant with previous findings of miRNAs in both plasma from HCC patients and HCC tissue. Future work should consider whether salivary miRNAs can help to improve detection of HCC either alone or in combination of other non-invasive biospecimens.”

For more information: https://tinyurl.com/2p8msjwy

Safe supply of drugs committee chairs group of addictions and recovery experts

Edmonton, AB - Alberta’s committee to examine “safe supply” has invited a tremendous group of addictions and recovery experts who have incomparable experience in drug policy to present to committee members later this month. The stakeholder list includes the renowned Stanford Professor Dr. Keith Humphreys, who served in the White House Office of National Drug Control Policy under Presidents George Bush and Barack Obama; Medical Lead of the Alberta Health Services Virtual Opioid Dependency Program Dr. Nathaniel Day; and, Harvard Medical Professor Dr. Bertha K. Madras. The following link takes you to the full list of experts and their biographies here. “We are thankful to this group of Canadian and American experts for lending their expertise and sharing their diverse experiences to help support our committee and the well-being of our province,” committee spokesperson and Calgary-Cross MLA Mickey Amery said. “We have to get this right for Albertans and this diverse group of world-renowned experts will help us do just that.” The Select Special Committee to Examine Safe Supply has a mandate to examine the consequences or benefits of a proposed “safe supply” and whether the policy can realistically work to reduce overdoses and deaths. It is also tasked with examining the historical evidence regarding the over-prescribing of opioids. “We will follow the evidence and use the information provided by North America’s leading experts, not the radicals or the activists,” Amery said. “These experts will help ensure we get the policy right in Alberta, so we don’t repeat any of the mistakes of the past.”

For more information: https://tinyurl.com/2y828vs7

British Columbia to allow COVID-positive and double-vaxxed patients to share hospital rooms

Victoria, BC - Health officials in B.C. say due to surging hospital demand, COVID-positive patients can share a room with non-COVID-19 patients who have received two vaccine doses. The policy is in use by the Fraser Health Authority. It's unclear if the policy is limited to hospitals in Fraser Health. Due to record-high hospitalizations, patients who have COVID-19 are being placed in the same room with double-vaccinated people who do not have the virus, British Columbia health officials said. B.C. Provincial Health Officer Dr. Bonnie Henry confirmed the policy at a Friday news conference, responding to a specific question about the policy's use by the Fraser Health Authority. It is unclear if the policy is limited to hospitals in Fraser Health, the province's largest health-care authority with 12 hospitals, and which hospitals have the policy in place. A spokesperson for Fraser Health refused to answer questions when asked about the specifics of the "cohorting" policy, instead pointing to the answers given at Friday's news conference. Cohorting refers to assigning different patients into different groups for the purposes of disease management. At the news conference, Henry said the protocol was to "maximize space" in health-care facilities amid a rapidly mounting hospitalization rate due to the more infectious Omicron variant. 'We cannot eliminate all risk': B.C. health officials shift emphasis to preventing transmission of COVID-19. B.C. reports 33 more people in hospital with COVID-19, 11 more in ICU "That is an infection prevention and control team decision made at a hospital-by-hospital and, actually, room-by-room and ward-by-ward, basis," she said. Henry mentioned that additional precautions would be put in place if double-vaccinated patients were placed with COVID-positive patients in the same room. Fraser Health said the protections were consistent with "droplet precautions," with COVID-positive patients' beds being placed a minimum of two metres away from any other patients. In addition, COVID-positive patients will not be sharing rooms with immunocompromised patients, and they must either be asymptomatic or mildly symptomatic in order to share rooms. Those experiencing significant symptoms will continue to be placed in COVID-19-only cohorts. The memo outlining the new guidelines said they were being put in place "due to the evolving epidemiology of the COVID-19 virus, specifically Omicron, and that this virus generally causes mild disease particularly in fully vaccinated individuals."  "The challenge of having more people in a hospital is the challenge of cohorting everybody is much more difficult," Health Minister Adrian Dix said at the Friday news conference. "When you have a lot of people in the hospital, you have to manage within the space you have and ensure that infection control stays high — and that's what our teams are doing in hospitals across B.C." At the same news conference, health officials said they would not be focusing on contact tracing and would shift their COVID-19 management strategies.

For more information: https://tinyurl.com/2n28v2bh

Opioid overdose deaths increased drastically among older Black men over a decade

Chicago, IL - Opioid overdose deaths among older adults increased significantly from 1999 to 2019, especially among non-Hispanic Black men, according to findings published in JAMA Network Open. “Many of us think drug misuse is a problem of the young. However, older adults are experiencing an explosion in fatal opioid overdoses,” Maryann Mason, PhD, an associate professor in the Buehler Center for Health Policy and Economics at Northwestern University, said in a press release. In a longitudinal cross-sectional study, Mason and colleagues examined data on opioid overdose deaths among adults aged 55 years and older from the CDC’s Multiple Cause of Death database. Data on deaths that occurred between Jan. 1, 1999, and Dec. 31, 2019, were stratified by sex, race and ethnicity. Overall, 79,893 adults in the U.S. died from an opioid overdose during the study period; 79.97% of these deaths were adults aged 55 to 64 years and 58.98% were men. Mason and colleagues reported that the number of opioid overdoses among older adults was 518 in 1999 and increased to 10,292 in 2019, a 1,886% increase, according to the release. Annual rates of opioid overdose deaths per 100,000 persons aged 55 years or older increased over time, ranging from 0.9 in 1999 to 10.7 in 2019. In 2013, opioid overdose rates among non-Hispanic Black men began to diverge, according to the researchers. By 2019, the opioid overdose fatality rate among older non-Hispanic Black men was 40.03 per 100,000 persons. This rate was four times greater than the overall opioid overdose fatality rate for older adults. At its lowest, the rate of overdose deaths among non-Hispanic Black men was 2.24 deaths per 100,000 persons, according to Mason and colleagues. Conversely, Hispanic women and non-Hispanic Asian or Pacific Islander individuals aged 55 years and older had the lowest rates of overdose death; the rates never exceeded 3 deaths per 100,000 persons. “As [opioid overdose] rates began increasing exponentially for Black men in 2013, fentanyl was becoming more common in the drug supply,” Mason told Healio. “This suggests to me that Black men may have had more involvement with illicit opioid use than other subgroups of older adults.” High rates of drug use among Black men may also be linked to social determinants of health such as poverty, poor housing, lack of access to health care and substance use treatment, and experiences of trauma living in communities with high burdens of violence and low resources, she added. Ending the opioid epidemic requires harm reduction in the short-term and improving social determinants of health in the long-term, Mason said.

For more information: https://tinyurl.com/ywf39h8a

Study reveals that DAAs significantly decreased risk of death from other causes

Vancouver, BC - Researchers from the British Columbia Centre for Disease Control (BCCDC) looked at the effect of DAAs on the risk for different causes of death for people with chronic hepatitis C. Their study is the first to assess the effects of DAAs on types of death with a specific cause (i.e., death from liver- and drug-related causes) using a population-based cohort. Notably, past studies have not explored the impact of DAAs on deaths from drug-related causes, something that the researchers note is of critical relevance for people with hepatitis C in Canada and other countries experiencing an ongoing and worsening drug poisoning and overdose crisis. The study draws from a large population-based cohort in British Columbia, Canada. The British Columbia Hepatitis Testers Cohort (BC-HTC) is a large data set that draws from a variety of clinical, case, testing and administrative sources. The data set captures more than 95% of the hepatitis C testing performed in the province through the public health laboratory, as well as all hepatitis C treatments and deaths that are recorded in centralized systems. The BC-HTC has been collecting data since 1990 and includes approximately 1.7 million people. Using this data set, the researchers examined 10,855 people who were treated with DAAs, as well as 10,855 untreated people who were matched with the treated group on the basis of their date of hepatitis C diagnosis as well as other relevant factors including sex, age, cirrhosis and other health conditions. Of those who were treated, 10,426 or approximately 96% were cured and 425 were not cured. The researchers compared death rates among three groups: people who were treated with DAAs and were cured (had a sustained virological response, or SVR); people who were treated with DAAs and were not cured (did not have an SVR); people who did not receive treatment. The study revealed significant decreases in the risk of death from all causes, as well as in the risk of death from liver-related causes and drug-related causes, for people who were cured of hepatitis C with DAAs. When comparing individuals who were cured with DAAs to those who hadn’t received treatment, the researchers found: 81% reduction in risk of death from all causes; 78% reduction in risk of death from liver-related causes; 74% reduction in risk of death from drug-related causes. The researchers also explored factors that were linked to having a higher risk of death from specific causes: Death from liver-related causes: Factors associated with a higher risk of death from liver-related causes included cirrhosis and older age (40 years of age or more). Death from drug-related causes: The use of injection drugs was the strongest factor linked to death from drug-related causes. Other factors included being younger, engaging in problematic alcohol use and having an HIV and/or hepatitis B co-infection.

For more information: https://tinyurl.com/5a7m3du3

Study reveals that DAAs significantly decreased risk of death from other causes

Vancouver, BC - Researchers from the British Columbia Centre for Disease Control (BCCDC) looked at the effect of DAAs on the risk for different causes of death for people with chronic hepatitis C. Their study is the first to assess the effects of DAAs on types of death with a specific cause (i.e., death from liver- and drug-related causes) using a population-based cohort. Notably, past studies have not explored the impact of DAAs on deaths from drug-related causes, something that the researchers note is of critical relevance for people with hepatitis C in Canada and other countries experiencing an ongoing and worsening drug poisoning and overdose crisis. The study draws from a large population-based cohort in British Columbia, Canada. The British Columbia Hepatitis Testers Cohort (BC-HTC) is a large data set that draws from a variety of clinical, case, testing and administrative sources. The data set captures more than 95% of the hepatitis C testing performed in the province through the public health laboratory, as well as all hepatitis C treatments and deaths that are recorded in centralized systems. The BC-HTC has been collecting data since 1990 and includes approximately 1.7 million people. Using this data set, the researchers examined 10,855 people who were treated with DAAs, as well as 10,855 untreated people who were matched with the treated group on the basis of their date of hepatitis C diagnosis as well as other relevant factors including sex, age, cirrhosis and other health conditions. Of those who were treated, 10,426 or approximately 96% were cured and 425 were not cured. The researchers compared death rates among three groups: people who were treated with DAAs and were cured (had a sustained virological response, or SVR); people who were treated with DAAs and were not cured (did not have an SVR); people who did not receive treatment. The study revealed significant decreases in the risk of death from all causes, as well as in the risk of death from liver-related causes and drug-related causes, for people who were cured of hepatitis C with DAAs. When comparing individuals who were cured with DAAs to those who hadn’t received treatment, the researchers found: 81% reduction in risk of death from all causes; 78% reduction in risk of death from liver-related causes; 74% reduction in risk of death from drug-related causes. The researchers also explored factors that were linked to having a higher risk of death from specific causes: Death from liver-related causes: Factors associated with a higher risk of death from liver-related causes included cirrhosis and older age (40 years of age or more). Death from drug-related causes: The use of injection drugs was the strongest factor linked to death from drug-related causes. Other factors included being younger, engaging in problematic alcohol use and having an HIV and/or hepatitis B co-infection.

For more information: https://tinyurl.com/5a7m3du3