Survey shows only 68% of people with hepatitis C aware of the infection

Atlanta, GA - A nationally representative survey revealed that of the more than 2 million people with current hepatitis C virus infection, only 68% are aware of their infection.  “The annual number of new hepatitis C virus (HCV) infections has steadily increased over the past decade,” said Karon C. Lewis, DrPH, MPH, MSBMS, Epidemiologist in CDC’s Division of Viral Hepatitis  “This study was conducted to determine the prevalence of HCV infection among people in the United States who are represented in the most current National Health and Nutrition Examination Survey (NHANES), overall and by select characteristics,” Lewis said. Just over one-third of people with HCV in the United States were cured or cleared the virus over the last decade, according to a study published in MMWR in June — a rate that CDC researchers called "jarringly low." Health insurance and access were linked to the low number of people cured of HCV, but further research has shown incomplete screening tests have also contributed to the low rate. Using NHANES, a multistage, stratified probability survey, Lewis and colleagues collected data from between January 2019 and March 2020 and combined them with data from 2017-2018 to create a nationally representative sample of the U.S. citizens during the 39-month period before the COVID-19 pandemic.  Blood samples from NHANES participants were tested with an HCV antibody screening test, and participants with a reactive screening test then received an HCV RNA test. Estimates of current HCV infection and awareness of HCV infection were calculated among study participants aged 18 years and older, with additional estimates done by sex, age, race and ethnicity, health insurance type and poverty status. The CDC recently updated it's guidance for HCV screening to recommend that patients receive both the HCV antibody test and an HCV RNA test at the same visit to increase complete HCV screenings. Previously, the antibody test and RNA test were done in separate visits, leaving patients with incomplete tests if they did not return for the second visit. Between January 2017 and March 2020, the estimated prevalence of current HCV infection was 0.9% (95% CI, 0.5%-1.4%), or 2.2 million (95% CI, 1.3-3.6 million), although Lewis said that the actual number of infections is likely higher due to limitations of the NHANES survey, which did not include people who were incarcerated or experiencing homelessness and are thus at an increased risk of HCV exposure.  Approximately 67.7% (95% CI, 50.2%-82.2%) of these participants were aware of their infection — but the researchers noted that this estimate was considered unreliable because the absolute confidence interval width was more than 30% based on published National Center for Health Statistics standards. When assessed by age, people aged 55 to 64 years were 6.4 times as likely to have current HCV infection compared with those aged 18 to 40 years (prevalence ratio [PR] = 6.4; 95% CI, 2.5-16.4) and that men were 2.9 times as likely as women to have current HCV infection (PR = 2.9; 95% CI, 1.1-7.7).  When assessed by race and ethnicity, the study showed that non-Hispanic white and non-Hispanic Black people were 5 times (PR = 5; 95% CI, 1.6-15.7) and 4.9 times (PR = 4.9; 95% CI, 1.7-14) as likely to have current HCV infection compared with participants of other races and ethnicities.  Additionally, the study revealed that prevalence of HCV infection was 5.3 times as high among people experiencing poverty compared with those not experiencing poverty (PR = 5.3; 95% CI, 2.3-12.2).  Similar results were seen among people with public insurance and persons with no insurance who were 4.7 times (PR = 4.7; 95% CI, 1.6-14.3) and 5.8 times (PR = 5.8; 95% CI, 1.7-19.8) as likely to have current HCV infection compared with people with private insurance.  “Safe and highly effective medicines to cure hepatitis C have been available since 2014, but this estimate reiterates that millions of people still have not been cured — and we estimate there are more than 60,000 new infections every year. National action is urgently needed to reach, test, and treat everyone with hepatitis C,” Lewis said. “We need to work toward making testing and treatment available in all settings where people with hepatitis C receive care,” Lewis said. “All people with hepatitis C should know their status and benefit from treatment.” 

For more information: https://tinyurl.com/bdfmr8w6

Edmonton, AB - CBC reports that ambulances responded to 753 overdose calls in Edmonton over the past month, more than twice last year's number Emergency services in Edmonton are responding to drug poisonings in record high numbers.  Ambulances responded to 753 overdose calls in the past month, compared to 306 responses during the same period last year, according to provincial statistics. "I have never seen so many opiate overdoses and out-of-hospital cardiac arrests as a result of drug poisoning in my entire life, and that's saying something for a doctor who has worked 20 years in an inner city hospital," said Dr. Darren Markland, an Edmonton intensive care physician at the Royal Alexandra Hospital. Markland said up to 30 per cent of the overdose patients in his unit are unidentified because they are just found unconscious or dead on streets, alleyways and river valley trails. 'People are dropping dead on the streets," he said. Across the province, emergency workers have responded to 1,321 drug calls since June 26, meaning 57 per cent of those responses were in Edmonton. "I've seen at least nine or 10 overdoses in the last seven days," Marshall Dines, who stays in shelters and carries a naloxone kit with him, told CBC News Wednesday. The UCP government has faced significant criticism from front-line health and outreach workers for its increased focus on a recovery-oriented model as more and more harm reduction services are cut. Alberta's Health Minister Adriana LaGrange declined comment Wednesday, but the province has said it is building a system that uses harm reduction services where appropriate. "This has felt very much like a disaster," said Marliss Taylor, the director of health services for Boyle Street Community Services. Taylor recalled being mortified in 2005, when four overdoses in one week was too much. "We've had up to 18 in a day around the building recently," Taylor said, adding that many of the overdoses are managed on site without calling 911. Doctors and front-line workers say the crisis is rooted in a number of complex issues, including a rise in mental illness and encampment living, the amount and severity of the drugs now available, and a lack of access to safe inhalation sites and testing kits to make sure drugs aren't laced. CBC News requested comment from the Ministry of Mental Health and Addiction about access to drug testing kits from Alberta Health Services. Press secretary Hunter Baril said, "the nation-wide increase in drug use and overdoses further shows the need for a comprehensive, compassionate approach that offers the opportunity for anyone to pursue recovery. "We are focused on expanding treatment capacity by funding more addiction treatment spaces and building 11 new recovery communities throughout the province," Baril said in an emailed statement Thursday. "We are providing services such as drug consumption sites and naloxone distribution alongside services such as the Virtual Opioid Dependency Program, which offers same-day access to life-saving medication for those suffering from the deadly disease of addiction. "These important initiatives will work with recovery communities and treatment programs to form the Alberta Model, which is uniquely focused on helping Albertans pursue recovery, unlike what we see in other jurisdictions." 

For more information: https://tinyurl.com/3e87tx5k

CDC recommends single-visit testing for hepatitis C

Atlanta, GA - The CDC now recommends offering both testing steps during the same visit. In new guidance, the CDC recommended that the two-step testing process for hepatitis C virus be completed in one visit, eliminating the need for multiple visits, which often leads to incomplete testing. Writing in MMWR, Emily J. Cartwright, MD, and colleagues from the CDC’s Division of Viral Hepatitis said roughly one-third of people who receive a reactive HCV antibody test do not return to receive an HCV RNA test, making their testing incomplete.  “This update clarifies that all sites performing HCV screening should ensure single-visit sample collection,” Cartwright and colleagues wrote. “This approach allows for automatic HCV RNA testing when an HCV antibody test is reactive to avoid incomplete testing.” Previous CDC guidelines allowed for the two steps to take place over multiple visits. The change will reduce the number of incomplete tests by reducing the patient burden of a second visit, the authors said. “Complete and accurate testing is the first step to identifying persons with current HCV infection to ensure linkage to care and initiation of curative antiviral therapy,” Cartwright and colleagues wrote. According to recently published statistics, just 34% of people in the United States diagnosed with HCV are cured or cleared of the virus and up to 1 million people are unaware they have HCV. Cartwright and colleagues analyzed data from the Chronic Hepatitis Cohort Study, New York City Department of Health and Mental Hygiene, the Veterans Administration, Cherokee Nation health Services and the Mid-Atlantic Permanente Medical Group, finding that roughly one-third of patients did not complete both steps of HCV testing. In facilities that later implemented single-visit sample collection, test completion increased to between 85% and 98%, according to the authors. “Use of strategies that require multiple visits to collect HCV testing samples should be discontinued,” Cartwright and colleagues wrote. “Automatic HCV RNA testing on all HCV antibody reactive samples will increase the percentage of patients with current HCV infection who are linked to care and receive curative antiviral therapy.” 

For more information: https://tinyurl.com/yc2s46xa

Hepatitis C cure rates ‘jarringly low’ as many lack access to treatment

Atlanta, GA - An analysis of data from 2013 to 2022 showed that only 34% of people diagnosed with hepatitis C in the United States were cured or cleared of the virus, with many still lacking access to highly effective treatments. Among the approximately 2.4 million people in the U.S. who are estimated to have HCV, up to 1 million do not know they have it, said Jonathan Mermin, MD, MPH, director of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention. “It's known as the silent killer because initial infection usually has few to no symptoms, but over time, the virus can slowly cause damage to the liver, causing liver cancer, liver failure and death,” Mermin said during a press briefing Thursday, ahead of the release of the new report in MMWR. Carolyn Wester, MD, MPH, director of the CDC’s Division of Viral Hepatitis, and colleagues used data from Quest Diagnostics to assess the clearance cascade — testing to clearance to subsequent infection — among people with HCV from Jan. 1, 2013 to Dec. 31, 2022 — the decade after safe and highly effective direct-acting antivirals for HCV became available, Wester noted. The analysis identified 1,719,493 people as having been ever infected with HCV between Jan. 1, 2013, and Dec. 31, 2021. During the follow-up period from Jan. 1, 2013 to Dec. 31, 2022, 88% of them received viral testing.  Among those who received viral testing during the follow-up period, 69% had evidence of a detectable HCV RNA. Among these participants, 34% were classified as cured or cleared, whether that be through treatment or spontaneous resolution, which Wester called “jarringly low.”  Among patients who were cured or cleared, 7% had evidence of subsequent viremia, indicating persistent infection or reinfection. Further analysis by age showed that among those ever infected, 29%, 43% and 27% were people aged 20 to 39 years, 40 to 59 years and 60 years or older, respectively. Initial infection was lowest among people aged 0 to 19 years (41%), whereas the prevalence of being cured or cleared was lowest among people aged 20 to 29 years (24%), and highest among those aged 60 years or older (42%). Persistent infection or reinfection was highest among patients aged 20 to 39 years (9%). Additional analysis by insurance type showed that among the more than 1.7 million people ever infected, 50% were covered by commercial health insurance, 23% by another payer — including self-payers — 11% by Medicaid, 9% by an unspecified payer and 8% by Medicare.

For more information: https://tinyurl.com/4k62j43f

FMT shows promise in restoring gut barrier function, immunity in cirrhosis

London, UK - Fecal microbiota transplantation improved gut barrier function, mucosal immunity and ammonia metabolism in patients with cirrhosis, which could reduce hepatic encephalopathy and other infections, according to data from the PROFIT trial. “Patients with cirrhosis have enteric dysbiosis,” Lindsey A. Edwards, BSC, MSc, PhD, research director of fecal microbiota transplant program at the Institute of Liver Studies at King’s College London, said during EASL Congress. “This means they lose beneficial [gut] species and they have enhanced pathogens. These cause damage and you get a leaky gut. Then, those microbes translocate across the gut and their microbial products. This chronic stimulation of your immune system means that you have a dysregulated immune response to infection.” “[FMT] shows great promise for modifying hepatic encephalopathy, deadly infections and possibly tackling antimicrobial resistance," Lindsey A. Edwards, BSC, MSc, PhD, said during EASL Congress. She continued: “Cirrhosis patients are really susceptible to infection, and this can lead to multiorgan failure and sadly death. Because of this chronic stimulation they have immune paralysis, so they are not able to kill and tackle those infections. We aimed to tackle this by doing fecal microbiota transplantation. We wanted to see if we could stop translocation across by improving barrier function and restoring host immunity.” In the placebo-controlled, randomized, single-blinded feasibility PROFIT trial, Edwards and colleagues assessed the use of FMT in 32 patients (mean age, 57.1 years; mean MELD score, 13.1) with advanced cirrhosis. Patients were administered 50 grams of liquid frozen FMT (n = 15) or placebo (n = 6) into the jejunum via endoscopy. At baseline and 7, 30 and 90 days after FMT or placebo administration, researchers collected blood, saliva, stool and urine samples to assess the efficacy of FMT in modulating a patient’s microbiome and inflammatory status, as well as fecal and plasma cytokine production and barrier integrity markers, metabolomics and fecal proteomics. Using deep metagenomic sequencing, researchers confirmed FMT increased fecal microbial richness with donor engraftment. They also reported reduced biomarkers of inflammation and enhanced antimicrobial response and barrier function, including lactic acid and fermenting bacteria. A donor diet high in fiber and protein improved clinical outcomes. “What we are doing with FMT is resetting those host responses to pathogens, but reducing inflammation and damage to the barrier,” Edwards said. Researchers also identified 301 proteins via fecal proteomics, of which 154 were of human origin and 147 were bacterial. FMT also significantly decreased plasma ammonia at 30 days (P = .0006). Compared with placebo, fecal ammonia was higher in patients administered FMT at both days 30 and 90. “We reduced pathogens that produce ammonia in the blood and sure enough, we actually see a reduction in plasma ammonia after FMT and an increase in fecal ammonia,” Edwards said. “We are excreting out that ammonia and that actually correlates with a reduction in hepatic encephalopathy grade.” In addition, researchers reported that FMT may reduce antibiotic-resistant infections and the need for antibiotics. “By changing these species, what we are doing is enriching the enzymes that can metabolize and this is giving us the energy to restore the gut barrier and the energy to fight infection and promote colonization of the microbiome,” Edwards said. “We are enhancing metabolic reprogramming and intestinal barrier function and enhancing responses to infection.” She added: “[FMT] shows great promise for modifying hepatic encephalopathy, deadly infections and possibly tackling antimicrobial resistance.”

For more information: https://tinyurl.com/44nfn7wa

Transplant medicine contends with organ shortage and pandemic-related disruptions

New York, NY - Transplant medicine and the field of transplant infectious diseases have faced numerous disruptions and challenges during the COVID-19 pandemic, according to experts. “The number of transplants declined transiently during the height of the COVID-19 pandemic but are now at the pre-pandemic level and growing overall,” Sarah Taimur, MD, associate professor of medicine at the Icahn School of Medicine at Mount Sinai in New York, told Healio | Infectious Disease News.  Despite incredible challenges brought on by the pandemic and organ shortages, there continue to be exciting developments in transplant ID, including transplants from donors with HIV and hepatitis C, xenotransplantation, and new therapies. We touched base with experts in the field and asked about these issues and more. Like many areas of medicine, transplant ID was disrupted by the COVID-19 pandemic. The disease itself has become the subspecialty’s No. 1 issue, according to Michael G. Ison, MD MS, chief of the NIH’s Respiratory Diseases Branch. “It has kind of trumped everything in the field,” said Ison, who was previously a medical professor of infectious diseases and organ transplantation surgery at the Northwestern University Feinberg School of Medicine.  Because transplant recipients are at an increased risk for COVID-19 and may have a suboptimal immune response to vaccination, they have been prioritized in guidance for COVID-19 vaccines and booster shots. “There are strategies to improve response to vaccines, but so far, no ‘magic bullet’ has been identified,” Ison said. The results of a systematic review and meta-analysis of more than 6,100 solid organ transplant recipients found that only 8.6% and 34.2% had a serologic response after one or two doses of COVID-19 vaccine, according to findings published last year in the journal Viruses. A third dose raised that rate to only 66%. “The vaccines have been a game-changer for the general population and for transplant recipients, although, unfortunately, some of our transplant recipients are not generating robust responses to the vaccines. They still are quite vulnerable to COVID-19,” said Christine Durand, MD, a transplant ID physician at Johns Hopkins University School of Medicine. Antivirals come with their own challenges, according to Durand. Paxlovid, for example, is difficult to prescribe for transplant recipients because of drug-drug interactions, and there is still a need for an oral antiviral for this patient population, she said. However, monoclonal antibodies, which were hugely successful for the nontransplant population, have also been beneficial for transplant recipients, according to Durand. An early study that assessed the first 73 solid organ transplant recipients at the Mayo Clinic to receive infusions of bamlanivimab or casirivimab-imdevimab for the treatment of mild to moderate COVID-19 found that no patients required mechanical ventilation, died or experienced rejection. More recently, a single-center retrospective study examined the effectiveness of casirivimab-imdevimab or sotrovimab for kidney transplant recipients infected with the omicron variant of SARS-CoV-2 and found that only two of the 47 patients were hospitalized to receive oxygen and none died or required ICU admission within 30 days. “Unfortunately, the virus evolves so quickly that [mAbs] tend to only be of benefit for short time frames,” Durand said, “but they certainly have saved many lives [among] our transplant recipients. Taimur said, ”transplant practitioners must keep up with CDC guidance and work with patients to ensure they are up to date on their COVID-19 vaccines, including boosters. “COVID-19 remains an infection to contend with in relation to organ donors and recipients,” she said. The United States is in the midst of an organ shortage crisis, which the pandemic exacerbated, according to experts. “Particularly for transplant patients, COVID-19 had an outsized impact on multiple fronts, including reducing the number of transplants being done transiently at the beginning of the pandemic” because organs from donors with SARS-CoV-2 were underutilized, Ison said. Durand recalled that living donor transplantation was shut down when COVID-19 “first came on the scene” and remained that way while the field worked to get its footing during the initial surges. According to a study published in The Lancet in May 2020, there was a more than 51% decline in deceased donor transplantations in the U.S. in the early months of the COVID-19 pandemic as hospitals diverted resources and staff to respond to the initial surge in cases. The decrease was driven mostly by declines in kidney transplants, researchers found. More than 104,000 people in the U.S. are currently waiting for a transplant, with one new person added to the national list every 10 minutes on average, according to the Health Resources & Services Administration (HRSA). There were around 42,000 transplants performed in the U.S. in 2022. “The organ shortage is still one of our most challenging issues,” Durand said. 

For more information: https://tinyurl.com/58xbc9m8

US drug overdose deaths top 109,000 in the past year

Atlanta, GA - More than 109,000 Americans died from drug overdoses in the 12-month period ending January 2023, a slight increase from the previous year, according to provisional data from the U.S. Centers for Disease Control and Prevention (CDC) released last week. The figure is up 0.7% from 108,825 overdoses recorded in the 12-month period ending January 2022, according to U.S. data. The increase comes despite a push by President Joe Biden's administration for action to tackle drug addiction and overdoses. The Biden administration in May imposed sanctions on 17 people and entities based in China and Mexico it accused of enabling production of counterfeit fentanyl-laced pills. Illicit fentanyl has played an outsized role in the U.S. opioid crisis and drug overdoses. The U.S. drug overdose death toll crossed the 100,000-mark for the first time in 2021, as the COVID pandemic disrupted medical care and increased mental health problems. The effect was exacerbated by the widespread availability of lethal drugs such as fentanyl, which is 50 times stronger than heroin and increasingly mixed in with other illegal drugs. During the pandemic, rates of mental illness, depression and anxiety went up dramatically, and people increasingly began to switch to substances, said Tom Britton, CEO of American Addiction Centers. U.S. drug overdose deaths rose 13.7% between January 2021 and January 2022 and by 31.4% in the prior 12 months at the height of the pandemic. But the surge in overdose deaths began before the pandemic took hold due to abuse of prescription opioid painkillers and illegal drugs like heroin. Stacey McKenna, senior fellow at the R Street Institute, a Washington, D.C.-based independent think tank, said the crackdown on fentanyl and other addictive drugs could be having the opposite of the intended affect. "There's this iron law of prohibition that the harder you crack down on the supply, the more likely you are to get a more potent supply or a more dangerous supply," McKenna said. The CDC noted that the latest numbers represent an estimate to include underreporting and cases pending investigation.

For more information: https://tinyurl.com/39ruv85r

Province expands access to opioid agonist treatment medications

Victoria, BC - British Columbia is taking action on the toxic drug crisis by being the first province in Canada to provide universal coverage for eligible medications used for the treatment of opioid-use disorder. “Improving access to medication is an important part of strengthening the public health-care system,” said Adrian Dix, Minister of Health. “By reducing financial barriers to opioid agonist treatment medication, we’re making it easier for people to get the care they need and helping create more equitable health outcomes for people in B.C.” Effective June 6, 2023, opioid agonist treatment (OAT) medications will be covered through Plan Z, the Province’s universal coverage plan, providing full coverage for B.C. residents with an active medical services plan (MSP). OAT, also referred to as medication-assisted treatment, is an option for people struggling with opioid-use disorder. It has been shown to improve retention in treatment, sustained abstinence from illicit opioid use, and helps reduce the risk of death. OAT differs from prescribed safer supply. Safer supply is a harm-reduction model of care in which clinicians prescribe pharmaceutical alternatives to illicit drugs in order to separate people from the toxic illicit street-drug market. However, prescribed safer supply can often be a first step for someone to begin accessing addictions care, including OAT. “The toxic drug crisis continues to claim lives at an unprecedented rate. When people reach out for help, we want them met with support regardless of the size of their pocketbook,” said Jennifer Whiteside, Minister of Mental Health and Addictions. “Removing these cost barriers to medication-assisted treatment will help more people stabilize their lives, prevent deaths and stay on their journey to wellness as our government continues to build a system of mental-health and addictions care that works for everyone.” In fiscal year 2021-22, of the 34,520 patients who utilized OAT medications, 32,882 received coverage through PharmaCare. Effective June 6, 2023, approximately 1,638 patients who paid out of pocket will now be 100% covered for eligible OAT medication costs under Plan Z for residents with MSP coverage. Additionally, eligible B.C. patients who did not access OAT medications due to the cost or because of challenges getting registered for Plan G or getting tax information to register for Fair PharmaCare will now have immediate, barrier-free access to OAT medication. 

For more information: https://news.gov.bc.ca/releases/2023MMHA0036-000933

Evidence Mounts That ‘War on Drugs’ Has Failed 

Melbourne, Australia - Harm Reduction Advocates Call for New Policies. After fifty years into the world “war on drugs”, the drugs are winning. Global levels of drug use and production, as well as drug-related deaths and incarcerations, are at all-time highs. Leading proponents of drug-policy reform who have gathered at the International Harm Reduction Conference in Melbourne this week say the evidence is in that it is time for the world to adopt a new approach.  “The irony of the profound failure of the war on drugs is that it has actually driven the illicit production of more and more substances and has led to more toxic drug supply,” said Naomi Burke-Shyne, executive director of Harm Reduction International, the UK-based drug-policy justice NGO that convened the conference.  “In order to save lives, we must offer overdose prevention and supervised space for people injecting drugs; together with pill testing to understand the potency, adulteration or toxicity of a substance,” she said.  Helen Clark, chair of the Global Commission and Drug Policy and former prime minister of New Zealand, called the war on drugs “a complete failure”. “The war on drugs is completely counterproductive. It has failed, and we need to try new approaches,” she told the conference. “Drug use continues to grow around the world, millions of people are imprisoned for drug possession and millions more are unnecessarily contracting HIV and hepatitis C because of lack of access to effective harm reduction measures.” “Human beings have been using substances, for whatever reason, for thousands of years,” Clarke said. “We’re not dealing with new issues here. We’re dealing with totally inappropriate and wrong ways of tackling them.” Drug overdose in the US continues to climb despite the ‘war on drugs’.  People who inject drugs in medically supervised settings are less likely to overdose, share needles, report emergency room visits, or develop abscesses when compared to people without access to such facilities, according to a new study presented to the conference on Tuesday by researchers from the French Institute of Health and Medical Research (INSERM).  The 12-month study is the first-ever controlled trial on the efficacy and impacts of medically supervised injection rooms, which are hygienic facilities where people struggling with addiction can inject drugs under the watchful eye of medical staff. These facilities are government-operated, stocked with drug-testing kits and overdose-prevention medications like naloxone, and allow patients to access other health services like mental health support, blood tests and essential primary care. “People can get tested for hepatitis and get started on treatment within two hours, there are sexual reproductive health services for women, lawyers dropping around, housing officers,” Burke-Shyne said.  “Yes, the space has drug consumption, but I think that really underplays how important the holistic approach to supporting vulnerable communities is.” The study compared the behaviour of people who injected drugs in the supervised injection sites in Paris and Strasbourg to users in Bordeaux and Marseille, where no centers exist. In addition to the benefits to health and overdose reduction, the study found that people with access to supervised injection services were also far less likely to inject in public spaces or commit crimes. Today, 16 countries around the world officially operate medically supervised injection rooms. These include the Netherlands, the United States, Canada, Australia and Switzerland – which pioneered the approach by legalizing prescription heroin in 1994.  Results from a control study at New York City’s new supervised injection site are expected by the end of June.  “Medically supervised injection rooms, the medicine naloxone to reverse overdoses, and drug checking technology work,” Burke-Shyne said. “They are public health no-brainers.” As the consequences of the push by Purdue Pharma to mainstream the prescription of high doses of the opiate pain-medication, Oxycontin, continues to ravage the United States, a new lethal drug has taken over: fentanyl. The synthetic opiate, which is up to 50 times stronger than heroin and 100 times stronger than morphine, was identified in 66% of US drug overdose deaths in 2021. The growing infiltration of fentanyl in the country’s drug supply has resulted in many users unintentionally taking the drug – with deadly consequences.  In New York City, where drug overdose deaths have nearly tripled since 2015, only 18% of people who inject drugs reported intentional fentanyl use, yet over 80% tested urine-positive for fentanyl, according to new toxicology data presented by researchers from the University of New York (NYU) on Tuesday. Fentanyl is used by cartels and drug-smuggling networks to cheapen their up-front costs for heroin, which is more expensive to produce. Cutting heroin with fentanyl greatly increases their profit margins at the cost of heightened danger for users unaware their supply is mixed with a far more potent drug.

For more information: https://tinyurl.com/53ychj68 

Alcohol-related cirrhosis worsened during pandemic, remains ‘top public health issue’

Chicago, IL - Hospital admissions for alcohol-related cirrhosis jumped from March 2020 to March 2021, with associated increases in costs and mortality, according to study results presented at Digestive Disease Week. “The most striking finding from our study was the more than doubling in hospital admission for alcohol-related cirrhosis during the post-pandemic time period in both men and women,” Dina Halegoua-De Marzio, MD, associate professor of medicine and director of the Jefferson Fatty Liver Center at Thomas Jefferson University in Philadelphia, told Healio. “This was also associated with increased hospital costs and increased mortality rates. Costs increased in NASH cirrhosis patients, but we did not see increased admissions in this group.” Using the Vizient clinical database, Halegoua-De Marzio and colleagues collected data from 809 U.S. hospitals from March 2019 to March 2021 to determine the impact of the COVID-19 pandemic in adult patients with alcohol-related and nonalcoholic steatohepatitis cirrhosis. They defined March 2019 to February 2020 as the pre-pandemic period and March 2020 to March 2021 as the post-pandemic period, and evaluated the number of hospital admissions, mean length of stay, percent deaths, 30-day readmission rate, mortality index and hospital cost during these times. Researchers included 346,494 patients in the analysis, of whom 243,235 had alcoholic cirrhosis and 103,259 had NASH cirrhosis. Among the alcoholic cirrhosis cases, 75,363 were pre-pandemic and 167,872 were post-pandemic compared with 51,736 and 51,523, respectively, for NASH. For women with alcoholic cirrhosis, researchers reported increases in mean length of stay (7.46 to 7.77), percent deaths (7.13% to 8.42%), mortality index (1.03 to 1.05) and mean direct cost ($13,899 to $15,066), although 30-day readmissions dropped from 22.43% to 22.08%. In men with alcoholic cirrhosis, researchers reported similar increases in mean length of stay (7.4 to 7.67), percent deaths (6.79% to 8.12%), mortality index (1 to 1.05) and mean direct cost ($14,058 to $15,081), with a decrease from 21.71% to 21.26% in 30-day readmission. Among women with NASH cirrhosis, increases also were reported in length of stay (7.1 to 7.53), percent deaths (4.88% to 5.88%), mortality index (0.92 to 0.95) and mean direct cost increased ($14,938 to $16,381), while 30-day readmissions decreased from 20.03% to 19.6%. Men with NASH also had increases in mean length of stay (7.58 to 7.92), percent deaths (5.13 to 6.18), mortality index (0.90 to 0.95) and mean direct cost ($18,325 to $18,875). Thirty-day readmission decreased from 20.17% to 19.47%. “This study emphasized that alcoholic liver disease remains a top public health issue, worsened with the COVID pandemic, and more patient education needs to be devoted to the potential danger of alcohol overuse,” Halegoua-De Marzio said. 

For more information: https://tinyurl.com/3skz77z9

Dried blood spot test can detect HIV and hepatitis

Copenhagen, Denmark - A dried blood spot test can be used to detect HIV, hepatitis B and hepatitis C in a single drop of blood, researchers reported at the European Congress of Clinical Microbiology & Infectious Diseases. The process, which uses commercial technology already available in many hospitals, can cut down on the need to refrigerate blood samples and time to get test results back, the researchers said. “The motivation to develop this method was to have a more practical and safer method to screen in high-risk settings such as prisons, rehabilitation centers and homeless shelters,” Stephen Nilsson-Møller, MSc, molecular biologist in the department of clinical microbiology at Herlev Hospital in Denmark, told Healio. WHO in 2022 added HBV to a group of infectious diseases — including HIV and HCV — which it aims to eliminate worldwide by 2030. Although efforts to increase screening for all three viruses are in progress for some groups in some nations, it can be logistically challenging. Nilsson-Møller and colleagues sought a method of screening for all three without the need for vials of blood, which need to properly transported. Using 20 plasma samples that were positive for HCV, HBV and HIV, the researchers deposited whole blood on a protein saver card, letting it dry and then transferring it to an Aptima tube containing 2.9 mL of specimen transport medium. The tubes were incubated at room temperature on a rocking table for 30 minutes and then centrifuged. The researchers then analyzed the samples using the Hologic Panther system with commercial Aptima assays.  The process detected a viral load in all samples. Nilsson-Møller said the test has been approved in his department in a team that includes a chief physician and a professor, and that Hologic has validated the HIV portion of the study’s findings but not the findings for HBV and HCV. According to the study, the researchers plan to present data from both ongoing clinical tests and from validation at some point in the future. “The test is now being [used as] part of a PhD project by Jonas Demant, who is screening in prisons, homeless shelters and rehabilitation centers in Copenhagen,” Nillson-Møller said. “There has [also] been a lot of interest, so the department is now looking to open the test so that other clinicians and physicians can order it.” 

For more information: https://tinyurl.com/5fhn5z5n

Women, younger injection drug users have a higher risk for HIV, HCV

Bristol, UK - Young people who inject drugs and women who inject drugs had higher risk for HIV and HCV. Limited data on incidence underscores the need to monitor global HIV and HCV epidemics among injection drug users. Results from a systematic review and meta-analysis demonstrated greater risk for hepatitis C virus and HIV infection among women and younger people who inject drugs, according to data reported in The Lancet Gastroenterology & Hepatology. “Globally, around 18% of people who inject drugs (PWID) are living with HIV and more than 50% have been infected with HCV,” Adelina Artenie, PhD, of the department of population health sciences at Bristol Medical School in the United Kingdom, and colleagues wrote. “Over the past two decades, the incidence rates of HIV and HCV have declined among PWID in some high-income countries (HICs). ... Meanwhile, persistently high levels or outbreaks of HIV and HCV among PWID have been reported in other HICs and low-income or middle-income countries (LMICs).” They continued: “A better understanding of these shifting epidemiological patterns and the availability of data globally are needed to orient surveillance and programming efforts. However, no global study has summarized HIV and HCV incidence among PWID.” In a systematic review and meta-analysis, Artenie and colleagues searched Medline, Embase and PsycInfo databases and identified 125 records with data on HIV and HCV incidence among PWID and associations with age and sex. Of these records, 64 estimated HIV incidence (30 HICs, 34 LMICs) from 1987 to 2021 and 66 estimated HCV incidence (52 HICs, 14 LMICs) from 1992 to 2021. Pooled incidence was 1.7 per 100 person-years (95% CI, 1.3-2.3) for HIV and 12.1 per 100 person-years (95% CI, 10-14.6) for HCV. Compared with older PWID, young PWID had a higher risk for HIV (RR = 1.5; 95% CI, 1.2-1.8) and HCV (RR = 1.5; 95% CI, 1.3-1.8). Similarly, women were at greater risk for HIV and HCV (RR = 1.4; 95% CI, 1.1-1.6 and RR = 1.2; 95% CI, 1.1-1.3, respectively) compared with men. “Given the higher risks of HIV and HCV acquisition in young vs. older PWID and in women vs. men who inject drugs, age-appropriate and gender-appropriate prevention and harm reduction measures are also urgently needed to serve these subgroups at high risk,” Artenie and colleagues concluded. “Factors other than age and sex or gender are also likely to be influencing HIV and HCV acquisition risks (eg, types of drugs injected and the context of injection, identifying as men who have sex with men and engaging in sex work) and research is also needed to synthesize the role of these other factors to better strengthen HIV and HCV prevention responses.”

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Hepatitis C diagnosis increasing among pregnant women

New York, NY - From 2000 to 2019, the average annual percent change was 12.5% in HCV prevalence in pregnancy. Identifying and treating women at high risk for infection before pregnancy may be important in optimizing care. Hepatitis C virus among the U.S. obstetric population rose nearly 10-fold over 20 years, which might reflect an increase in screening or prevalence, according to researchers. “The opioid epidemic and resultant increasing rates of intravenous drug use are thought to account for a large proportion of the rising incidence of HCV infection. However, 50% of individuals with HCV infection report no history of intravenous drug use,” Brittany Arditi, MD, MSCR, resident physician in the department of obstetrics and gynecology at NewYork-Presbyterian/Columbia University Irving Medical Center, and colleagues wrote. “As such, there is a knowledge gap with regards to other risk factors, demographic and clinical characteristics, and comorbidities associated with HCV infection among pregnant patients.” Researchers analyzed data o 76.7 million delivery hospitalizations using the National Inpatient Sample and assessed trends in both diagnosis of HCV infection and clinical characteristics associated with the infection.  Overall, 182,904 delivering women had an HCV infection diagnosis. There was a nearly 10-fold increase in the prevalence of HCV diagnosed in pregnancy, from 0.05% in 2000 to 0.49% in 2019, which came out to an average annual percent change of 12.5%. In addition, researchers observed an increase from 2000 to 2019 in the prevalence of clinical characteristics per 10,000 birth hospitalizations associated with HCV infection: opioid use disorder (10 vs. 71), nonopioid substance use disorder (71 vs. 217), mental health conditions (219 vs. 1,117) and tobacco use (61 vs. 842). Researchers also noted an increase during the study period in the rate of deliveries among women with two or more clinical characteristics associated with HCV, rising from 26 to 377 cases per 10,000 birth hospitalizations, which resulted in an average annual percent change of 13.4%. HCV was also associated with an increased risk for severe maternal morbidity (adjusted OR = 1.78; 95% CI, 1.61-1.96), preterm birth (aOR = 1.88; 95% CI, 1.8-1.95) and cesarean delivery (aOR = 1.27; 95% CI, 1.23-1.31). “These findings support universal screening for HCV infection in pregnancy and that, identifying and treating women at high risk for infection before pregnancy may be an important focus for optimizing care and mitigating perinatal HCV transmission,” the researchers wrote.

For more information: https://tinyurl.com/h2ywd8du

Drug overdose deaths highlight racial disparities

Los Angeles, CA - The most recent annual statistics available show that overdose deaths for visible minorities, due to psychostimulants and semi-synthetic and synthetic opioids, rose more than expected. Black people had more fentanyl and psychostimulant deaths compared with white people. There were more drug overdose deaths in 2020 than anticipated based on trends from 2013 to 2019, with more fatalities among Black people compared with white people, according to findings published in PLOS Global Public Health. “The third wave of drug overdose deaths began in 2013 with the arrival of fentanyl on the illicit drug market,” Maria R. D’Orsogna, PhD, an associate adjunct professor in the department of computational medicine at UCLA, said in a press release. “Although overdose deaths have steadily increased since then, the pandemic year 2020 saw a significant rise of fatalities in many states.” D’Orsogna and colleagues reviewed overdose death data from the CDC WONDER database, which includes information on number of deaths, cause of death and demographics. The researchers specifically examined drug poisoning mortality rates among four subclasses of drugs: natural and semi-synthetic opioids such as morphine (termed prescription opioids), synthetic opioids other than methadone (termed fentanyl), psychostimulants with abuse potential (termed methamphetamines) and heroin. From 2013 to 2019, national overdose death rates caused by fentanyl and methamphetamines increased steadily for both men and women. However, in 2020, fentanyl death rates among men were 30% higher than expected and 28% higher than expected among women. For methamphetamines, the death rates exceeded the expected rates by 19% and 18%, respectively. Analyses by race revealed that fentanyl overdose death rates among Black men in 2018 and women first surpassed the rate of fentanyl overdose death among their white counterparts in 2019. In 2020, the rate was 38% greater among Black men compared with white men, and the rate was 19% greater among Black women compared with white women. Methamphetamine deaths were consistently greater among white people compared with Black people from 2013 to 2020. For prescription opioids and heroin, overdose death rates increased from 2013 to 2016 and began decreasing in 2017. In 2020, prescription opioid death rates increased significantly, while heroin overdose death rates continued to decrease. Analyses by census region and jurisdiction revealed further racial disparities in overdose mortalities. “Perhaps most surprising to us were the results for the District of Columbia,” Lucas Böttcher, PhD, an assistant professor of computational social science at the Frankfurt School of Finance & Management in Frankfurt am Main, Germany, said in the release. “Here, the 2020 fentanyl-induced mortality was 134 deaths per 100,000 Black male residents but only 14 deaths per 100,000 white male residents. These disparities existed even prior to the pandemic, and are seen in other states as well, such as Illinois or Missouri.” The findings suggest that pandemic-related anxieties and isolation may have contributed to the increased overdose mortality rates, the researchers said. Moving forward, they emphasized the importance of tailoring prevention programs to at-risk populations such as Black men.

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Medical cannabis use rising in US, highlighting need for clinical guidelines

New Haven, CT - The prevalence of U.S. residents who used medical cannabis was 1.2% in 2013-2014 vs. 2.5% in 2019-2020. Researchers said a surveillance system is needed to assess the long-term effects of medical cannabis use.  The prevalence of medical cannabis use in the United States has increased significantly from 2013 to 2020, according to study results published in the American Journal of Preventive Medicine. Taeho Greg Rhee, PhD, FACE, an assistant professor of medicine and public health at Yale University, and Robert A. Rosenheck, MD, a professor of psychiatry and of health policy and affiliated faculty at the Yale Institute for Global Health, wrote that medical cannabis has been legalized in 37 states in the United States as well as the District of Columbia.  The prevalence of medical cannabis use in the United States increased significantly in recent years, according to the results of a study published in the American Journal of Preventive Medicine.  The researchers conducted a study to evaluate correlates and temporal trends of medical cannabis use in the U.S. They used data from the 2013 to 2020 National Survey on Drug Use and Health (NSDUH), which includes a question asking those who had used cannabis in the past 12 months whether any cannabis use was recommended by a physician. They then used a modified Poisson model to approximate the average annual percent change (AAPC) of medical cannabis use from 2013 to 2020 and repeated the analyses for key sociodemographic and clinical subgroups. Rhee and Rosenheck found a continued national increase in medical cannabis use for a variety of medical purposes 2 decades after the first state passed legalizing legislation. In 2013 to 2014, the prevalence of U.S. residents who used medical cannabis was 1.2%. In 2019 to 2020, the prevalence was 2.5%, with an AAPC of 12.9% (95% CI, 10.4-15.5). In the multivariable-adjusted model, residing in a state where medical cannabis was legalized was significantly linked to greater odds of medical cannabis use (adjusted OR = 4.1; 95% CI, 3.68-4.56). The researchers additionally noted that many of the clinical subgroups and sociodemographic groups studied indicated similar significant increases in medical cannabis use. The clinically relevant subgroups that saw significantly greater odds of medical cannabis use included: use of non-prescription pain relievers, poorer self-rated health statuses, cocaine use disorder and a past-year major depressive episode.  “The association of medical cannabis use with depression, cocaine use disorder, and nonmedical use of pain relievers suggests that it may have either been prescribed for those conditions or used on patient initiative for these problems,” the researchers wrote. “Because NSDUH is cross-sectional, the findings cannot establish temporality.”  Rhee and Rosenheck concluded that “substantially increased use of cannabis for medical purposes warrants further research to assess its diverse potential benefits and risks.” Additionally, they noted two “important implications of the persistent increase in medical cannabis use nationally.”  First, medical cannabis is assumed to be primarily used for chronic pain, MS or for nausea among patients with terminal illnesses. However, “there is a wide variation of qualifying medical or psychiatric conditions across states,” they wrote.  “Further, there is no consensus across the states or strong therapeutic evidence to support medical cannabis use for specific conditions (e.g., arthritis),” they wrote. “Because medical cannabis use is increasing in the US, clinical practice guidelines should be developed with evidence-based principles to follow in counseling patients about medical cannabis use.” Second, Rhee and Rosenheck noted the lack of available data on any long-term effects medical cannabis might have, “limiting understanding of the cumulative public health effects of medical cannabis use.” “While cannabis does not generally lead to overdose deaths (in contrast to opioids), several unintended consequences (eg, developing psychosis and motor vehicle crashes) have been documented,” they wrote. “Given the increasing medical cannabis use coupled with use for recreational purposes, a comprehensive, longitudinal surveillance system is needed to determine long-term benefits and harms of medical cannabis use.”

For more information: https://tinyurl.com/4bedvmj9

Fentanyl vaccine: Could it be a turning point in the opioid pandemic?

Houston, TX - Researchers have developed a fentanyl vaccine, tested in rodents, that generates significant anti-fentanyl antibodies that bind to fentanyl and prevent it from entering the brain. To date, the vaccine has not been tested in humans, but it has the potential to be a game-changer in the opioid epidemic. The risk of adverse events in humans is low, as two components of the vaccine are both utilized in other existing vaccines approved for use in humans. Researchers at the University of Houston have developed a fentanyl vaccine that blocks the synthetic opioid from entering the brain. Not yet tested on humans yet, if effective, the vaccine has the potential to be a major breakthrough in the opioid epidemic.  The number of opioid-related overdose deaths has increased dramatically since 1999, with levels 5 times higher in 2020 than in 1999, according to the CDC. Over those years, more than 564,000 people have died from an opioid overdose. This includes both prescription and illegal opioids.   The CDC reports that the increase in opioid overdose deaths has occurred in three waves. The first wave coincided with the increase in opioid prescriptions beginning in the 1990s. In 2010, the second wave began, with a surge in overdose deaths related to heroin use. Synthetic opioids, such as fentanyl, ushered in the third wave in 2013. Back in 2010, only 14.3% of opioid-related deaths were due to fentanyl use. But by 2017, this proportion was 59%, making fentanyl and other synthetic opioids the most common drugs involved in overdose deaths in the United States. Current treatments for opioid use disorder include methadone, buprenorphine, and naltrexone. The efficacy of these medications depends on many factors, including the kind of opioid, the formulation of the drug, patient compliance, and access to the medications. Fentanyl overdose is treated with naloxone, a short-acting antagonist that works by binding to opioid receptors and reversing the effects of opioid drugs.  One of the drawbacks associated with the use of naloxone is the need for multiple doses in order to counteract the potentially fatal effects associated with fentanyl use.  Researchers at the University of Houston have proposed that, to overcome the treatment challenges, there is a need for immunotherapies capable of blocking fentanyl from entering the brain. Their preclinical studies provide evidence that a fentanyl vaccine is possible. The University of Houston investigators studied an anti-fentanyl conjugate vaccine composed of a fentanyl-like compound that is linked to CRM197, a carrier protein present in various FDA-approved conjugate vaccines. The fentanyl-CRM conjugate is then combined with dmLT, an adjuvant that is found in other vaccines that have been assessed in multiple human clinical trials.  In their previous studies in mice, the research team had discovered that administration of the fentanyl vaccine produced a significant amount of anti-fentanyl antibodies, blocking the analgesic effects of fentanyl. The preclinical results presented in this study have significant implications for the treatment of opioid use disorder and overdose in humans, as discussed in a press release announcing the study.[4] Because CRM and dmLT are both utilized in existing vaccines approved for use, the risk of adverse events to humans is likely low.  In the press release, Colin Haile, MD, PhD, research associate professor of psychology at the University of Houston and the study’s lead author, expressed his opinion on the implications. “We believe these findings could have a significant impact on a very serious problem plaguing society for years—opioid misuse.” Colin Haile, MD, PhD, study author "Our vaccine is able to generate anti-fentanyl antibodies that bind to the consumed fentanyl and prevent it from entering the brain, allowing it to be eliminated out of the body via the kidneys," said Dr. Haile. "Thus, the individual will not feel the euphoric effects and can ‘get back on the wagon’ to sobriety.”

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HCV elimination represents ‘win-win-win’ for patients, public health, cost savings

Geneva, Switzerland - Every year nearly 3 million patients are diagnosed with hepatitis B and C infections, ultimately leading to 1.1 million deaths worldwide, WHO reported. In response to this immense public health burden, WHO and other international organizations have developed goals and plans for elimination. Although implemented by most countries with many on track to reach their goals, analyses have revealed a persistent reservoir of chronic hepatitis viruses and new infections remain a threat, Sheikh Mohammad Fazle Akbar, MD, PhD, and colleagues wrote in Infectious Diseases & Immunity. In the U.S., only 6% of states are on track to achieve HCV elimination by 2030, according to a 2020 report by Mark Sulkowski, MD, and colleagues. Researchers further reported 35% of states are not expected to meet their margins by 2040. In 2016, WHO outlined HCV elimination goals of 90% reduction in incidence and 65% reduction in mortality by 2030. While challenges persist in meeting those goals, John Ward, MD, director of the Coalition for Global Hepatitis Elimination and senior scientist at the CDC Task Force for Global Health, cited many achievements. “There have been large improvements in infection control and prevention in health care. Blood bank screening has averted contaminated equipment exposure where millions of cases have been prevented that, in the past, were occurring,” Ward told Healio Gastroenterology. “There have also been clear improvements in hepatitis C testing and treatment. It is miraculous that we have the first cure for a chronic viral infection in the history of medicine that has proven incredibly safe and effective with very low rates of resistance.” Although many countries continue to falter in their efforts toward HCV elimination, others have shown that effective programs and health care delivery are possible for reaching this goal. Analysis of data from the Polaris Observatory, which was presented at The Liver Meeting in 2022, showed Australia, Canada, Denmark, Egypt, Finland, France, Georgia, Japan, Norway, Spain and the United Kingdom are all on track to reach 2030 targets. John Ward  “We are definitely achieving some of the global goals for hepatitis elimination currently, and countries are demonstrating that elimination is possible, but we need more,” Ward said. “The challenge is to get more countries to make similar commitments to hepatitis elimination and put in place effective, widely available programs to detect and cure patients with hepatitis C.” Healio Gastroenterology spoke with experts across the field to identify barriers to HCV screening and treatment and determine the necessary steps to achieve elimination. Although HCV mortality rates will continue to modestly decline if the U.S. maintains the status quo on current elimination efforts, the Hepatitis C Disease Burden Simulation (HEP-SIM) model — a dynamic microsimulation of epidemic, disease progression and elimination strategies — revealed how an accelerated, nationally organized plan has potential to save more lives and billions in health care costs by 2050. “By 2030, approximately 10,000 deaths can be avoided. ... We expect to find by 2050 this program can result in 90,000 lives saved,” Jagpreet Chhatwal, PhD, director of the Institute for Technology Assessment at Massachusetts General Hospital and associate professor at Harvard Medical School, told attendees at The Liver Meeting. “Very similar story for hepatocellular carcinoma cases: By 2030 we would expect to see 70,000 cases avoided. By 2050, more than 100,000 cases avoided. With decompensated cirrhosis: By 2030 close to 30,000 cases can be avoided. By 2050, 90,000 cases.” While the HEP-SIM model considers various factors, such as advances in therapeutics and diagnostics and rising incidence, it also takes into account the cost of treatment associated with different insurance models. According to Chhatwal, accelerated elimination is estimated to save $59.3 billion in health care utilization with treatment costs dropping from $45.2 billion to $20.3 billion and disease management from $87 billion to $54.1 billion. “We cannot talk about hepatitis C or elimination without talking about the cost,” he said. “The accelerated program can result in approximately $14 billion savings in the next 10 years. ... This is unprecedented. We are not just eliminating a disease as a public health threat, but also saving money, which is not common. That gives us a lot of impetus to implement such a program.”

For more information: https://tinyurl.com/3kh2x3a3

Drug use, homelessness double HCV reinfection risk

Boston, MA - Hepatitis C reinfection rates were high among a population of people who had experienced homelessness but increased even more among those experiencing homelessness at the time of treatment, researchers found. “The primary care-based hepatitis C treatment program at Boston Health Care for the Homeless Program works to share its experience and outcomes,” Marguerite Beiser, ANP-BC, director of Hepatitis C Virus (HCV) Services at the Boston Health Care for the Homeless Program, told Healio. “We believe that describing the unique successes and challenges we encounter caring for this highly vulnerable population can help us devise better systems to meet their unique needs.” She added, “Anecdotally, we knew our patients were experiencing reinfection, and we wanted to explore this outcome.” Beiser and colleagues conducted a time-to-event analysis to understand reinfection risk over time among what she said is the “biggest homeless-experienced community-based cohort in published literature.” According to the study, the researchers assessed people receiving HCV direct-acting antiviral treatment through the Boston Health Care for the Homeless Program between 2014 and 2020 with post-treatment follow-up assessments. HCV reinfection was identified based on recurrent HCV RNA following SVR. Overall, 535 people were included in the study — 70% of whom were facing homelessness or unstable housing at treatment initiation. A total of 74 HCV reinfections were detected, including five second reinfections.  According to the study, HCV reinfection rate was 12/100 person-years (95% CI, 9.5-15.1) overall, 18.9/100 person-years (95% CI, 13.3-26.7) among individuals with unstable housing, and 14.6/100 person-years (95% CI, 10-21.3) among those experiencing homelessness. Beiser added that the risk of reinfection increased to 25/100 person-years among people experiencing homelessness or unstable housing and reporting recent drug use before their HCV treatment. An adjusted analysis showed that experiencing homelessness vs. stable housing (adjusted HR = 2.14; 95% CI, 1.09-4.2) and drug use within 6 months before treatment (aHR = 5.23; 95% CI, 2.25-12.13) were associated with increased reinfection risk. “In the near-term, expansion and reinforcement of HCV care, including post-treatment care that is closely integrated within routine care structure in which people are already engaged is urgently needed,” Beiser said, adding that individual-level social determinants of health and the systems-level factors that contribute to community transmission need to be addressed. “Ultimately, housing, particularly permanent supportive housing, should be recognized as a primary intervention for HCV elimination,” she said.

For more information: https://tinyurl.com/5n77zssb

UN launches Group of Friends to eliminate hepatitis

New York, NY - At a side event to the 77th UN General Assembly in New York (NY, USA), representatives from Ministries of Health of nine countries (Egypt, Georgia, Sierra Leone, Nigeria, Tanzania, Ghana, Chile, Ukraine, and Mongolia) and six UN permanent missions (Egypt, Malaysia, Tanzania, Brazil, Chile, and Portugal) joined together to form a Group of Friends to eliminate hepatitis. They were accompanied by WHO, Africa Centres for Disease Control and Prevention, the World Hepatitis Alliance, and other international institutes and global non-governmental organisations. All representatives spoke of the urgency of the moment and shared their support for the Group of Friends initiative. Egypt's Minister of Health and Population (KAG), pledged Egypt's leadership in bringing together UN member states in a call for formation of a UN Group of Friends to support health diplomacy around viral hepatitis elimination. The Minister expressed Egypt's willingness to lead the group's international efforts to accelerate the elimination of hepatitis by 2030, in line with the achievement of the UN Sustainable Development Goals and the goals of WHO. The UN Group of Friends to eliminate hepatitis will create a forum for member states to exchange information on progress, innovations, and lessons learned with other member states, organisations within the UN system, technical experts, civil society organisations, and other stakeholders. By raising awareness at the diplomatic level, the UN Group of Friends aims to bring high-level attention of donor agencies, development banks, philanthropic organisations, and national governments, helping low-income and middle-income countries to eliminate viral hepatitis. On Dec 20, 2022, Ambassador Abdelkhalek, the UN Permanent Representative of Egypt in New York, invited all member states to join the Group of Friends to eliminate hepatitis. He stated: “As we engage in three UN General Assembly health-related high-level meetings in 2023, I believe the formation of this Group can lead to the promotion of our efforts towards attaining the international goal of hepatitis elimination by 2030.” In consultation with WHO, The Task Force for Global Health's Coalition for Global Hepatitis Elimination serves as the group's secretariat. The Group of Friends will hold periodic meetings to exchange information, best practices, and lessons learned.

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Cleveland Clinic surpassed 1,000 organ transplant milestone in 2022

Cleveland, OH - The Cleveland Clinic reached an institutional milestone in 2022, with 1,050 heart, kidney, liver, intestine and lung transplants, surpassing its previous record high set in 2021, according to a press release. “We want to thank organ donors and their families who make the gift of life possible,” Charles Miller, MD, enterprise director of transplantation at Cleveland Clinic, said in the release.  As the second largest transplant program in the U.S., Cleveland Clinic performed 726 transplants in 2022, including 215 liver transplants and 320 kidney transplants, the highest numbers in the history of its program. Additionally, Cleveland Clinic is one of the few hospitals worldwide that offer laparoscopic living-donor surgeries for liver transplants. Among its notable accomplishments in 2022, Cleveland Clinic successfully performed a first-in-the-world full multi-organ transplant to treat a patient with pseudomyxoma peritonei, during which the patient received a liver, stomach, pancreas, duodenum and small intestine. Cleveland Clinic’s milestone organ transplant numbers contributed to another record-setting announcement from the Organ Procurement and Transplantation Network: As of September 9, 2022, 1 million solid organ transplants have been performed in the United States.

For more information: https://tinyurl.com/ycx5t5v7

Pill for skin disease also curbs excessive drinking, new study shows

Seattle, OR - Researchers from Oregon Health & Science University and institutions across the country have identified a pill used to treat a common skin disease as an "incredibly promising" treatment for alcohol use disorder. Their study was recently published in the Journal of Clinical Investigation. On average, the people who received the medication, called apremilast, reduced their alcohol intake by more than half—from five drinks per day to two. "I've never seen anything like that before," said co-senior author Angela Ozburn, Ph.D., associate professor of behavioral neuroscience in the OHSU School of Medicine and a research biologist with the Portland VA Health Care System. The lead author is Kolter Grigsby, Ph.D., a postdoctoral fellow in the Ozburn laboratory at OHSU. Beginning in 2015, Ozburn and collaborators searched a genetic database looking for compounds likely to counteract the expression of genes known to be linked to heavy alcohol use. Apremilast, an FDA-approved anti-inflammatory medication used to treat psoriasis and psoriatic arthritis, appeared to be a promising candidate. They then tested it in two unique animal models that had a genetic of risk for excessive drinking, as well as in other strains of mice at laboratories across the country. In each case, apremilast reduced drinking among a variety of models predisposed to mild to heavy alcohol use. The researchers found that apremilast triggered an increase in activity in the nucleus accumbens, the region of the brain involved in controlling alcohol intake. Researchers at the Scripps Research Institute in La Jolla, California, then tested apremilast in people. The Scripps team conducted a double-blind, placebo-controlled clinical proof-of-concept study involving 51 people who were assessed over 11 days of treatment. "Apremilast's large effect size on reducing drinking, combined with its good tolerability in our participants, suggests it is an excellent candidate for further evaluation as a novel treatment for people with alcohol use disorder," said co-senior author Barbara Mason, Ph.D., Pearson Family professor in the Department of Molecular Medicine at Scripps. The clinical study involved people with alcohol use disorder who weren't seeking any form of treatment, and Mason predicts that apremilast may be even more effective among people who are motivated to reduce their alcohol consumption. "It's imperative for more clinical trials to be done on people seeking treatment," Ozburn said. "In this study, we saw that apremilast worked in mice. It worked in different labs, and it worked in people. This is incredibly promising for treatment of addiction in general." An estimated 95,000 people in the United States die every year from alcohol-related deaths, according to the National Institute on Alcohol Abuse and Alcoholism. Currently, there are three medications approved for alcohol use disorder in the United States: Antabuse, which produces an acute sensitivity akin to a hangover when alcohol is consumed; acamprosate, a medication thought to stabilize chemical signaling in the brain that is associated with relapse; and naltrexone, a medication that blocks the euphoric effects of both alcohol and opioids.

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Is the brain wired differently in people with addiction?

Montreal, PQ - Some 10% to 15% of people will have a substance abuse problem at some point in their life, making it one of the most common psychiatric disorders. Risks associated with substance abuse include dangerous driving, missed work, problems with depression, anxiety, health and money problems. Yet people with addictions seem to experience a sort of myopia, getting in deeper and deeper to cope with unpleasant emotions and to feel good, regardless of the cost. Research has clearly established that psychosocial and environmental factors play a role in the development of substance abuse disorders. But there is more to the story, and now functional magnetic resonance imaging (MRI) studies are highlighting the importance of biological factors, in particular how the brain functions. "The influence of such factors can be as much as 50%—this astonishingly high figure is why we're so interested in what's going on in the brains of substance abusers," explained Stéphane Potvin, a professor in Université de Montréal's Department of Psychiatry and Addiction whose research focuses primarily on the harmful effects of cannabis and alcohol on the brain structures of people with schizophrenia. Zeroing in on markers. Potvin, who coordinates the Neurobiology and Mental Health division of the Centre de recherche de l'Institut universitaire en santé mentale de Montréal, wanted to zero in on the neurobiological markers associated with addiction. With his student Jules R. Dugré, a Ph.D. candidate in biomedical sciences, he conducted a meta-analysis of 96 studies involving a total of 5,757 subjects with some form of substance dependence—alcohol, nicotine, cannabis, psychostimulants or another drug. Rather than focusing on brain activity as a whole, in his analysis Potvin and Dugré looked at what is known as "functional connectivity," in other words, how well different parts of the brain communicate with each other. This is the first time an analysis of this type has been done. Published in November in Addiction Biology, the study reveals a number of anomalies in the brain's reward, decision-making and habit formation systems:

1. Reward: "The brains of substance abusers tend to show hyperconnectivity between the ventromedial prefrontal cortex and ventral striatum, two key areas of the reward system," said Potvin. "This could explain the tendency to choose immediate gratification and why the substance's motivational value increases over time despite the negative impact on other spheres of life."

2. Decision-making: "We also see reduced connectivity in certain brain areas involved in decision-making, such as the prefrontal cortex and amygdala," added Potvin. "This is consistent with the fact that substance abusers can seem indifferent to the harmful consequences of their choices."

3. Habit formation: The most original finding is the presence of anomalies in the brain regions associated with habit formation, including the dorsal striatum and premotor cortex. "This hyperconnectivity could explain the compulsive nature of substance abuse," Potvin noted.

The meta-analysis did not, however, show changes in the brain regions and networks associated with impulse control. This contrasts with previous studies, which showed abnormalities in these regions using other neuroimaging approaches. Potvin is quick to point out the limitations of his study. "In our analysis, we included all relevant studies of substance abusers, whatever the substance. But are brain systems equally affected by different substances? We really don't know." Ultimately, these findings will help guide the development of neuromodulation-based interventions in the field of addiction. "First we need a better understanding of the brain systems involved in substance abuse," said Potvin. "This will allow us to pinpoint the areas to stimulate or inhibit in order to rebalance the brain and change behavior. The more solid evidence we have, the more treatment centers will be motivated to invest in the equipment needed to carry out this type of intervention."

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

About three in ten adults with chronic pain use medical cannabis

Ann Arbor, MI - About three in 10 adults with chronic pain who live in states with medical cannabis laws reported using cannabis to manage their pain, according to researchers, highlighting the need for more research on the subject.  Although most states have laws that allow people to use cannabis for chronic pain treatment, accurate estimates of cannabis use or its substitution of treatments for chronic pain are unavailable, Mark C. Bicket, MD, PhD, an assistant professor in the department of anesthesiology at the University of Michigan School of Medicine, and colleagues wrote in JAMA Network Open.  “Evidence is mixed about whether medical cannabis serves as a substitute for prescription opioids or other pain treatments,” they added. Bicket and colleagues conducted a cross-sectional study, surveying a representative sample of people aged 18 years or older who have chronic pain residing in the 36 states and Washington, D.C., with active medical cannabis programs from March 3, 2022, to April 11, 2022. They fielded the survey with the National Opinion Research Center AmeriSpeak panel, a probability-based panel that includes roughly 54,000 people and is sourced from a sample covering 96% of United States households. The final analysis included 1,661 people with chronic pain, 57.1% of whom were women.  Of the participants, 31% reported ever having used cannabis to manage their pain (95% CI, 28.2-34.1). More specifically, 25.9% (95% CI, 23.2-28.8) reported cannabis use to manage their pain in the last year and 23.2% (95% CI, 20.6-26) reported use in the past 30 days.  “Our results suggest that state cannabis laws have enabled access to cannabis as an analgesic treatment despite knowledge gaps in use as a medical treatment for pain,” the researchers wrote. Additionally, most of those who used cannabis to manage chronic pain also reported using at least one nonpharmacologic pain treatment or pharmacologic treatment — 70.6% (95% CI, 64.8-75.7) and 94.7% (95% CI, 91.3-96.8), respectively. Fewer than half of the participants said cannabis use altered their nonpharmacologic pain treatments, the researchers wrote. But 38.7% reported that their cannabis use led to decreased physical therapy use (5.9% reported increased use); 26% reported it led to decreased cognitive behavioral therapy use (17.1% reported increased use); and 19.1% reported that it led to decreased meditation use (23.7% reported increased use). More than 50% of those who used cannabis said it led them to decrease the use of prescription nonopioid and opioids and over the counter pain medications. Fewer than 1% reported increased use.  “Most persons who used cannabis as a treatment for chronic pain reported substituting cannabis in place of other pain medications including prescription opioids,” Bicket and colleagues wrote. “The high degree of substitution of cannabis with both opioid and nonopioid treatment emphasizes the importance of research to clarify the effectiveness and potential adverse consequences of cannabis for chronic pain.”

For more information: https://tinyurl.com/bdekth7b

FDA panel backs moving opioid antidote Narcan over the counter

Washington, DC - The overdose-reversing drug naloxone should be made available over the counter to aid the national response to the opioid crisis, U.S. health advisers said Wednesday. The panel of Food and Drug Administration experts voted unanimously in favor of the switch after a full day of presentations and discussions centered on whether untrained users would be able to safely and effectively use the nasal spray in emergency situations. The positive vote, which is not binding, came despite concerns from some panel members about the drug’s instructions and packaging, which caused confusion among some people in a company study. The manufacturer, Emergent Biosolutions, said it would revise the packaging and labeling to address those concerns. The FDA will make a final decision on the drug in coming weeks. Panel members urged the FDA to move swiftly rather than waiting for Emergent to conduct a follow-up study with the easier-to-understand label. “There’s perhaps a far greater risk of delaying the availability of the product given the climate of this crisis and its devastating consequences,” said Maria Coyle, a pharmacy professor from Ohio State University, who chaired the panel. The prefilled nasal device, Narcan, is the leading version of the drug in the U.S., which is also available as an injection. If FDA approves, Narcan would be the first opioid treatment to make the regulatory switch to a non-prescription drug. The potential move represents the latest government effort to increase use of a medication that has been a key tool in the battle against the U.S. overdose epidemic that kills more than 100,000 people annually. The decades-old drug can counteract the effects of an opioid overdose in minutes. Narcan is already available without a prescription in all 50 states, where state leaders have issued standing orders for pharmacists to sell the drug to anyone who asks for it. But not all pharmacies carry it and those that do must keep it behind the counter. Also, the stigma of opioids can discourage people from asking for the drug. “We believe that nonprescription naloxone may help address these barriers,” said FDA’s Dr. Jody Green, noting the switch would allow the drug to be sold in vending machines, convenience stores and supermarkets. Emergent presented results from a 70-person study designed to show that people of various ages and backgrounds could quickly and correctly understand how to use the device in an emergency. About a third of people in the study had low reading ability, a group that FDA said should have been larger. FDA staffers also cautioned that a number of participants had trouble following the directions, in part because of the way the multi-step instructions were laid out across two sides of the carton, FDA noted.  “Where is step one?” one participant asked, according to interview transcripts from the study presented by the FDA. Emergent said it plans to move all the directions to a single panel and add pictograms, per FDA’s suggestion. Despite flaws in the original packaging, the panel of 19 pain and medical education experts expressed confidence that the product could be used effectively by most adults and adolescents. “Perfect should not be the enemy of the good and the evidence we saw today provides clear indication that the drug can be used without the direction of a health care provider,” said Dr. Brian Bateman of Stanford University. Government officials hope that moving naloxone beyond the pharmacy counter will boost sales, with the potential to lower costs. Currently the drug can cost $50 for a two-pack, when not covered by insurance. Community advocates and organizations that favor distributing the drug welcomed the potential approval of an over-the-counter version. “It’s going to make a tremendous impact on how people view the medication,” said Sheila Vakharia, deputy director of research and academic engagement at the Drug Policy Alliance. “It will help to destigmatize it and make people know it’s safe and easy to use.” But Maya Doe-Simkins, a co-director of Remedy Alliance/For The People, worried that an over-the-counter version of Narcan could also lead to a perception that it’s better than other forms of naloxone. “We have some trepidation about how companies that have ‘over-the-counter’ products may misrepresent injectable products,” said Doe-Simkins, who has long advocated for an over-the-counter version. U.S. overdose death rates began steadily climbing in the 1990s, driven by painkillers. Waves of deaths followed, led by other opioids like heroin and — most recently — illicit fentanyl. Nearly 107,000 Americans died of drug overdoses in 2021, an all-time high, though recent data suggests deaths may be plateauing. Gaithersburg, Maryland-based Emergent Biosolutions makes most of its money from medical products purchased by the federal government for the Strategic National Stockpile, including drugs and vaccines against anthrax. In 2021, the company came to the public’s attention for its disastrous handling of COVID-19 vaccine production for Johnson & Johnson and AstraZeneca. Contamination problems at the company’s Baltimore plant ultimately forced the drugmakers to discard the equivalent of hundreds of millions of vaccine doses.

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

HIV incidence in sub-Saharan Africa ‘appears low,’ but rates remain ‘staggering’

Chapel Hill, NC - Despite some progress being made, sub-Saharan Africa remained a hot spot for new HIV infections, with approximately 689,000 new infections annually among HIV-negative adults between 2015 and 2019, according to data pooled from 15 countries. “We were surprised that there [were] no empirical data characterizing HIV incidence in sub-Saharan Africa,” Nora E. Rosenberg, PhD, MSP, associate professor in the Gillings School of Global Public Health’s department of health behavior at the University of North Carolina at Chapel Hill, told Healio.  “These 15 nationally representative datasets provided an opportunity to characterize HIV incidence across much of the continent,” she said. For the study, Rosenberg and colleagues analyzed data from 13 Population-based HIV Impact Assessment surveys, as well as two additional population-based surveys conducted between 2015 and 2019 in 15 sub-Saharan African countries.  HIV-seropositive samples collected from adults aged 15 to 59 years and older were tested for recent infection using an algorithm consisting of the HIV-1-limiting antigen avidity enzyme immunoassay, HIV-1 viral load and qualitative detection of antiretroviral agents. Data were then pooled across countries, and sampling weights were incorporated to represent all adults in the 15 national populations.  Among 445,979 adults sampled, 382 had recent HIV-1 infection, generating an estimated HIV-1 incidence rate of 3.3 per 1,000 person-years (95% CI, 2.6-4) among women and 2 per 1,000 person-years (95% CI, 1.2-2.7) among men (incidence rate difference: 1.3 per 1,000 person-years; 95% CI, 0.3-2.3).  In an age-adjusted analysis, the study demonstrated that the incidence rate was higher among women aged 15 to 24 years (3.5 per 1,000 person-years) than among men (3.5 vs. 1.2 per 1,000 person-years; difference of 2.3, 95% CI, 0.8-3.8), although infection rates were similar between sexes in all other age groups. When broken down by location, the study showed that the HIV-1 incidence rate was 7.4 per 1,000 person-years (95% CI, 5-9.7) in southern sub-Saharan Africa, 2.3 per 1,000 person-years (95% CI, 1.7-2.9) in the eastern subregion and 0.9 per 1,000 person-years (95% CI, 0.6-1.2) in the western and central subregion.  Rosenberg said that although these rates “may appear low,” they translate to approximately 689,000 adult infections each year, which she said is a “staggering number.”

For more information: https://tinyurl.com/2p86tzc2

Australia to allow prescription of MDMA and psilocybin for treatment-resistant mental illnesses

Sydney, Australia – According to a report published in the Guardian, authorised psychiatrists in Australia will soon be able to prescribe the drugs for post-traumatic stress disorder and severe depression. Experts say the decision will make Australia the first country in the world to officially recognise MDMA and psilocybin as medicines.  After decades of “demonisation”, psychiatrists will be able to prescribe MDMA and psilocybin in Australia from July this year. The Therapeutic Goods Administration made the surprise announcement on Friday afternoon. The drugs will only be allowed to be used in a very limited way, and remain otherwise prohibited, but the move was described as a “very welcome step away from what has been decades of demonisation” by Dr David Caldicott, a clinical senior lecturer in emergency medicine at Australian National University. 3,4-methylenedioxy-methamphetamine (MDMA) is commonly known as ecstasy, while psilocybin is a psychedelic commonly found in so-called magic mushrooms. Both drugs were used experimentally and therapeutically decades ago, before being criminalised. Specifically authorised psychiatrists will be able to prescribe MDMA for post-traumatic stress disorder, and psilocybin for treatment-resistant depression. Ecstasy was developed as an appetite suppressant in 1912, but in the 1970s it started being used in therapy sessions in the US. It entered Australia in the 1980s as a party drug, and was criminalised in 1987. Many species of magic mushrooms grow wild in Australia, but it is illegal to possess or supply psilocybin. Caldicott said it had become “abundantly clear” that a controlled supply of both MDMA and psilocybin “can have dramatic effects on conditions often considered refractory to contemporary treatment” and would particularly benefit returned service men and women from the Australian defence force. “The safe ‘re-medicalisation’ of certain historically illicit drugs is a very welcome step away from what has been decades of demonisation,” he said. “In addition to a clear and evolving therapeutic benefit, it also offers the chance to catch up on the decades of lost opportunity [of] delving into the inner workings of the human mind, abandoned for so long as part of an ill-conceived, ideological ‘war on drugs’.” Cognitive neuropsychologist Prof Susan Rossell, from Swinburne’s Centre for Mental Health, said she still had “a significant degree of caution” about the decision, and that further research was needed. Rossell is the lead researcher on Australia’s biggest research trial of psilocybin’s effectiveness for treatment-resistant depression. “We’ve got no data on long-term outcomes at all, so that worries me a lot, which is one of the reasons why I’m doing my very large study,” she said. Dr. Stephen Bright, a senior lecturer and director of Psychedelic Research in Science and Medicine at Edith Cowan University, said the decision made Australia “the first country in the world to officially recognise MDMA and psilocybin as medicines”. It is an “important step in drug policy reform”, he said, but added that extensive training was needed for the approved psychiatrists. He said the announcement could also lead to more people accessing the drugs illegally, “through desperation”. In a statement, the TGA said the decision acknowledged “the current lack of options for patients with specific treatment-resistant mental illnesses”. “It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting,” the TGA said. “However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.”

For more information: https://tinyurl.com/ynvrw3w3

Stricter rules for tattoos and piercings in Wales

Cardiff, Wales - Wales is set to become the first UK nation to introduce mandatory licensing for tattoo artists, body piercers and cosmetic clinics. The tougher controls aim to reduce infections and poor working practices by creating a public register of licence holders. About 3,500 practitioners will need to be licensed and 1,868 business premises will require approval. A 12-week consultation has been launched by the Welsh government. The new rules are the final phase of changes introduced under the Public Health (Wales) Act 2017 to improve standards of infection prevention and control in the industry. The legislative work was due to be brought in during 2020 but the scheme was delayed by Brexit and the Covid pandemic.  Ashley Davies, who has been running Stronghold Tattoo in Cardiff for eight years and has been working with the Welsh government on the new qualification, said: "The increase in quality of tattoos in the last decade has been exponential so the hygiene needs to be raised. "This is all positive for the industry and helps shake the image of it being dark and shady. It's reassuring for those getting tattooed as well." The pass rate for those practitioners who have already undertaken the level 2 award in infection prevention and control voluntarily is 95%. But there are still concerns about many without licences, including self-taught tattooists, known in the industry as "scratchers". Health experts have warned of the dangers of contracting blood-borne viruses - such as hepatitis B, hepatitis C or HIV - from unlicensed tattoo artists, and warn how blood poisoning caused by dirty needles can kill. Ffion Hughes, a paramedic tattooist who helps mastectomy patients with scarring and areola loss, told BBC Radio Wales Breakfast that her clinic in Caernarfon, Gwynedd, often sees distressed patients after "having bad work, infections, viruses… a bad image on their body that they can't get rid of". "Anybody can pick up a tattoo gun and become a tattooist which is absolutely shocking," she said, "because that's actually on your body for the rest of your life." She said the new regulations bring medical tattoo practitioners and tattoo artist to the same level.  "It's going to be a huge shock for the [tattoo parlour] industry," she said, but she believes the general public will be "more accepting of it and respect it a bit better now that there's better work out there". Shaun Newman, manager at Stronghold Tattoo, said tattoos had become a lot more popular because of heavily tattooed celebrities such as David Beckham and exposure through social media, but that has brought extra issues. "There can be a real problem of people going to unlicensed tattooists at their homes because they're cheap," he said.  "People think it doesn't matter if it's cheap, but it really matters that these people have no idea how to use the machinery properly or take care of the tattoo during and after the process, which is critical." Wales' chief medical officer Frank Atherton said extra regulation was needed following an outbreak of skin infection pseudomonas at a Newport tattoo and body piercing establishment in 2014.  "This specific incident in 2014 highlighted the problem of unlicensed body art practitioners and body piercers and led to very difficult consequences for a number of people in south Wales," he said.  "Some very young people were affected, even as young as 13 and they had significant hospital treatment and reconstructive surgery. It cost the NHS nearly £250 000. "Good standards of hygiene and infection control by all special procedures practitioners and businesses is essential as these procedures are capable of causing harm if not carried out properly."

For more information: https://www.bbc.com/news/uk-wales-64372294

Another HIV vaccine fails to provide protection in discontinued trial

Leiden, Netherlands - Janssen recently announced that it has stopped the phase 3 Mosaico trial because the investigational HIV vaccine regimen it was testing was not effective in preventing HIV infection compared with placebo. No safety issues were identified, but the study’s independent data and safety monitoring board determined the study would not reach its primary endpoint of preventing HIV. “We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable and affected by HIV,” Penny Heaton, MD, global therapeutic area head for vaccines in Janssen’s research and development unit, said in a press release. It was the latest HIV vaccine trial to be stopped because the experimental regimen being tested did not work. Janssen discontinued the phase 2 Imbokodo trial — which tested a similar vaccine regimen as Mosaico — in 2021, and the National Institute of Allergy and Infectious Diseases halted a phase 2b/3 clinical trial in early 2020 that was testing a regimen based on the only investigational HIV vaccine combination ever to demonstrate efficacy in a large clinical study.  Stephaun E. Wallace, PhD, MS, director of external relations at the HIV Vaccine Trials Network (HVTN), which conducted the study, told Healio that the organization “does not have any HIV vaccine efficacy trials currently in the field that are recruiting.”  Both the Mosaico and Imbokodo studies are in follow-up, Wallace said. “In the coming weeks, (Mosaico) study participants will have a final study visit, at which they will learn which study arm they were assigned to, have blood specimens taken for HIV diagnostic testing, receive information regarding vaccine-induced seropositivity and seroreactivity, and again receive counseling regarding HIV prevention options and [be] provided with appropriate referrals,” Wallace said. The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men, transgender people or both at more than 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain and the United States. Beginning in 2019, and with vaccinations complete in October 2022, participants received either placebo or a vaccine regimen containing a mosaic-based adenovirus serotype 26 vector administered in four doses over 1 year, with the second two doses including a mix of soluble proteins. Since completion of the study vaccine series, “the number of HIV infections were equivalent between the vaccine and placebo arms of the study,” the NIAID said in a statement, adding that “the Mosaico findings track with developments in the phase 2b Imbokodo clinical trial.” In the Imbokodo study, which enrolled 2,637 women aged 18 to 35 years from Malawi, Mozambique, South Africa, Zambia and Zimbabwe, the vaccine being tested was estimated to be 25.2% efficacious. “We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine,” Heaton said.

For more information: https://tinyurl.com/268nanr2

Roche’s Tecentriq touts industry-first liver cancer win

Basel, Switzerland - The study is the first phase 3 for an immunotherapy combo to show tumor recurrence benefits in early-stage liver cancer, Roche’s chief medical officer Levi Garraway, M.D., Ph.D., noted (Roche) For Roche’s immunotherapy Tecentriq, 2023 is expected to be a prolific year filled with clinical trial readouts in early-stage cancers. In the first trial in the series, Tecentriq has delivered a win. Nearly three years after snatching a first-in-class FDA approval in metastatic liver cancer, a combination of Roche’s Tecentriq and Avastin posted a first-in-class win in early-stage disease. The combo significantly reduced the risk of tumor recurrence compared with simple surveillance when used as adjuvant treatment following surgery in people with hepatocellular carcinoma at a high risk of rebound, Roche said. Roche plans to discuss the results from the phase 3 IMbrave050 study with drug regulators, including the U.S. FDA and the European Medicines Agency. The study is the first phase 3 trial for an immunotherapy combo to show tumor recurrence benefits in early-stage liver cancer, Roche’s chief medical officer Levi Garraway, M.D., Ph.D., noted in a statement. More than 70% of early-stage liver cancer patients may see their cancer return after surgery, and recurrence is linked with shorter survival, he noted. Before the adjuvant liver cancer readout, the Tecentriq-Avastin combo in 2020 became the first immunotherapy regimen approved in newly diagnosed metastatic liver cancer. That came after the combo showed it could extend patients’ lives compared with Bayer’s Nexavar. As expected for an early-stage cancer trial, IMbrave050’s data on patients’ life expectancy remained immature at the interim analysis. Roche said the study will continue to allow for further follow-up. Investigators plan to share detailed data at an upcoming medical meeting, Roche said. Industry watchers will look for the magnitude of the recurrence-free survival benefit, as well as subgroup data, especially by PD-L1 expression levels. Recurrence-free survival in PD-L1-positive disease is a secondary endpoint of IMbrave050.

For more information: https://tinyurl.com/2zz32wr3

Sustained alcohol abstinence benefits even advanced cases of alcohol-related cirrhosis

Vienna, Austria - Abstinence from alcohol was associated with reduced risk for hepatic decompensation and mortality among patients with alcohol-related cirrhosis, regardless of disease stage, according to results in Clinical Gastroenterology and Hepatology. “Our results clearly show that all patients with alcohol-related liver cirrhosis who maintain sustained abstinence from alcohol not only suffer complications of liver cirrhosis significantly less frequently, but also live considerably longer — even in the case of pronounced portal hypertension," Benedikt Silvester Hofer, MD, of the division of gastroenterology and hepatology at the Medical University of Vienna, said in a related press release. In an observational, single-center study, Hofer and colleagues investigated the clinical implications of abstinence among 320 patients (median age, 57 years; 75.6% men) with alcohol-related cirrhosis and clinically significant portal hypertension, defined as hepatic venous pressure gradient (HVPG) of at least 10 mm Hg. At enrollment, 87.5% of patients had decompensated cirrhosis and the median HVPG was 20 mm Hg, with 53.8% of patients exceeding 20 mm Hg. During a median follow-up of 36 months, 75.3% of patients remained abstinent and 24.7% continued drinking alcohol. Researchers reported that abstinence correlated with a “significantly reduced” risk for hepatic decompensation (adjusted HR = 0.391; 95% CI, 0.276-0.555), liver-related mortality (aHR = 0.428; 95% CI, 0.263-0.697) and all-cause mortality (aHR = 0.453; 95% CI, 0.3-0.686).  Further, abstaining from alcohol also reduced the cumulative incidence of hepatic decompensation among those with an HVPG of 10 mmHg to 19 mmHg and an HVPG of 20 mmHg or greater. MELD score (aHR = 1.049; 95% CI, 1.004-1.096) was also a “significant independent predictor” of decompensation. Researchers estimated a lower probability of 3-year decompensation among those who abstained from alcohol for both HVPG measurement groups (32.4% vs. 60% and 57.5% vs. 82.6%, respectively). “Our new data provide important evidence for the daily counseling of our patients and show that it is never too late to strive for complete abstinence from alcohol,” Thomas Reiberger, MD, lead study author and associate professor of hepatology at the Medical University of Vienna, said in the release. “However, the study also showed that even patients with sustained abstinence from alcohol are at risk of developing complications, especially if the extent of portal hypertension remains very pronounced. Therefore, all those affected need regular medical check-ups.”

For more information: https://tinyurl.com/y4svk2dd