Clinical Infectious Diseases Publishes Groundbreaking Study on Treating Hepatitis C

The AIDS Clinical Trials Group (ACTG) is excited to announce the publication of “Perspectives on Adherence from the ACTG 5360 MINMON Trial: A Minimum Monitoring Approach with 12 Weeks of Sofosbuvir/Velpatasvir in Chronic Hepatitis C Treatment” in the journal Clinical Infectious Diseases.

This study found that self-reported 100 percent adherence to the first four weeks of treatment with sofosbuvir/velpatasvir resulted in a sustained virologic response, which is clinically accepted as a cure for hepatitis C. The research suggests that early adherence could be used to identify individuals at risk of treatment failure, and may benefit from additional support.

The MINMON trial has revolutionized the treatment of hepatitis C, introducing a cost-effective approach with fewer clinic visits and reduced laboratory monitoring. This revolutionary direct-acting antiviral therapy has significantly improved the outcomes of hepatitis C treatment, yet multiple barriers continue to impede equitable access.

The dramatic evolution of hepatitis C treatment has changed the lives of people with the virus, yet its complexity has impeded global treatment uptake. The MINMON study has given us an insight into how we can simplify the administration of treatment to make it more available and accessible worldwide.

The correlation between optimal adherence and sustained virologic response described in this publication is especially encouraging. According to Judith Currier, M.D., MSc, Chair of the ACTG, University of California, Los Angeles, this is a crucial step forward in the fight against hepatitis C.

In a unique open-label, single-arm trial, 400 people from the United States, Brazil, South Africa, Thailand, and Uganda, who had never received treatment for hepatitis C before, were supplied with a 12-week course of sofosbuvir/velpatasvir.

The median age of participants was 47, and 35 percent were female. In-person visits took place at the beginning and end of the trial, while data about adherence was collected remotely at four weeks. Adherence was evaluated as either optimal (no missed doses, 100 percent) or sub-optimal (less than 100 percent).

Researchers recently found that optimal adherence to treatment was associated with a sustained virologic response rate of 96.5 percent, compared to 77.8 percent in those who reported sub-optimal adherence (p-value <0.001). Interestingly, being younger than 30 years old and participating at a U.S. site were found to be independent risk factors for sub-optimal adherence.

Participants under the age of 30 were 7.1 times more likely to have sub-optimal adherence compared to those over the age of 30. These findings highlight the importance of adherence to treatment, particularly in younger individuals.

The findings of this study offer invaluable insight that could help us to recognize individuals who are more likely to be unsuccessful with treatment, and who could benefit from extra support. It is particularly important to prioritize adherence interventions to help ensure sustained virologic response – especially among younger individuals. Lead author Leonard A. Sowah, MBChB, MPH, believes that these findings could have a major impact on the way we approach treatment.

About the ACTG

For more than 30 years, the AIDS Clinical Trials Group (ACTG) has been at the forefront of HIV research and has made a global impact in the fight against HIV/AIDS. Founded in 1987 and funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, the ACTG has conducted groundbreaking studies in order to improve treatments and reduce new infections, as well as develop new approaches to prevent and cure HIV in adults and children.

With research units in 15 countries, the ACTG has helped shape HIV treatment guidelines, resulting in a dramatic decrease in HIV-related mortality. Most recently, the ACTG has expanded its focus to include the evaluation of outpatient treatments for COVID-19.

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