Newswise — Los Angeles, Calif. – The AIDS Clinical Trials Group (ACTG), the world’s largest and longest established HIV research network, presented today The “Keep it Simple and Safe” Approach to HCV Treatment: Primary Outcomes from the ACTG A5360 (MINMON) Study at AASLD’s virtual 2020 Liver Meeting. The study found that in a diverse, global patient population, a minimal monitoring (MINMON) approach to hepatitis C treatment was safe and achieved comparable sustained virologic response (SVR) to current standard of care.
“The ACTG has long been committed to improving treatment outcomes for hepatitis C, and the MINMON study builds upon this history,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles. “By minimizing the burden of treatment on people living with hepatitis C while ensuring efficacy and safety, this study has the potential to simplify how we treat hepatitis C around the world.”
In order to achieve the World Health Organization’s (WHO’s) global hepatitis C elimination agenda by 2030, an estimated 80 percent of the approximately 71 million people with chronic infection will need to be treated. To accomplish this, treatment delivery and associated laboratory monitoring need to be simplified without compromising efficacy or safety. The COVID-19 pandemic has hampered progress of public health programs, including those focused on viral hepatitis, further highlighting the need for simple and safe models of healthcare delivery that minimize face-to-face patient-provider contact without compromising efficacy.
“Wide adoption of the MINMON strategy, coupled with innovative case-finding strategies, has the potential to facilitate the worldwide elimination of hepatitis C, while simultaneously minimizing in-person appointments and resource use,” said Sunil Solomon, M.B.B.S., Ph.D., M.P.H., Johns Hopkins University and Protocol Chair of A5360. “This is particularly relevant in the context of the COVID-19 pandemic as well as in low- and middle-income settings where on-treatment monitoring is a major barrier to treatment.”
A5360 is a single-arm, open-label trial that evaluated the safety and efficacy of a MINMON approach to hepatitis C therapy in people who had not received prior treatment and had no evidence of decompensated cirrhosis (in which the liver is unable to perform its normal functions and has extensive scarring). All participants received a single-tablet, fixed-dose regimen of sofosbuvir/velpatasvir once daily for 12 weeks. The MINMON strategy evaluated in A5360 included four elements: no genotyping of the hepatitis C virus prior to treatment, all 84 tablets provided at study entry, no scheduled clinic visits or labs while participants were taking treatment, and two remote contacts with study staff at weeks four (an adherence assessment) and 22 (scheduling an SVR visit). SVR means that the hepatitis C virus is not detected by standard blood tests at least 22 weeks after starting treatment.
A5360 enrolled 400 participants with hepatitis C at 38 sites across four continents between October 2018 and July 2019. The median age of participants was 47 years, 139 (35%) were cisgender women, 22 (6%) self-identified across the transgender spectrum, and 166 (42%) were white. At study entry, 34 participants (9%) had compensated cirrhosis (in which the liver is able to perform its normal functions, despite some scarring of liver tissue) and 166 (42%) had HIV co-infection. The study was able to measure SVR for 396 participants. Overall, SVR was 95.0% (95% CI: 92.4%, 96.7%). Of the 166 participants enrolled in the trial who were co-infected with HIV and hepatitis C, 157 (94.6%) achieved SVR. While serious adverse events through week 24 were reported in 14 (3.5%) participants, none were treatment-related or resulted in death.
The SVR observed in MINMON is similar to SVR results from phase 3 studies for hepatitis C treatment. Notably, these phase 3 hepatitis C treatment studies were conducted with more frequent laboratory and clinical monitoring. Until now, no trial has tested the elimination of pre-treatment genotyping and all on-treatment laboratory and clinical assessments except for the final test of treatment response in a globally diverse sample with representation from high-income and low- and middle-income countries, where the majority of people living with hepatitis C reside. Implementation of the MINMON strategy would facilitate access to curative hepatitis C therapy in settings with limited medical facilities or clinical resources and bring us closer to the goal of eliminating hepatitis C worldwide, including among those living with HIV.
The A5360 study was funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and by Gilead Sciences Inc., which also provided study medications. NIAID funds the ACTG.
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