ACTG publishes study to simplify the administration of hepatitis C treatment

The AIDS Clinical Trials Group (ACTG), the world's largest HIV research network, is announcing 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 publication found that self-reported 100 percent adherence in the first four weeks of hepatitis C treatment with sofosbuvir/velpatasvir was associated with sustained virologic response (which is when no hepatitis C virus is found in the blood 12 weeks after completing treatment). Sustained virologic response is the generally accepted criteria for an individual to be considered "cured" of hepatitis C. These findings suggest that early self-reported adherence could be used to identify individuals who may be more likely to experience treatment failure and may benefit from additional support.

Direct-acting antivirals have transformed the treatment landscape for people with hepatitis C, resulting in dramatically improved treatment outcomes. However, multiple barriers continue to limit equitable treatment access. The MINMON trial was designed to reduce overall treatment cost by having fewer in-person clinic visits, and less laboratory monitoring that typically accompany hepatitis C treatment.

The evolution of hepatitis C treatment has made a radical difference in the lives of people with hepatitis C, but the complexity of administering it has limited global treatment uptake. The MINMON study has expanded our understanding of how we can simplify the administration of hepatitis C treatment to ultimately make it more accessible to people around the world. It is especially exciting to see the correlation between optimal self-reported adherence and sustained virologic response that is described in this publication."

Judith Currier, M.D., MSc, Chair of the ACTG, University of California, Los Angeles

This phase 4, open-label, single-arm trial enrolled 400 treatment-naïve participants without decompensated cirrhosis from the United States, Brazil, South Africa, Thailand, and Uganda. The median age of participants was 47 years, and 35 percent of participants were women. All participants received supplies to complete a 12-week course of sofosbuvir/velpatasvir at the study initiation visit. In-person visits took place at study initiation and 24 weeks later. Data about adherence was collected remotely at four weeks and was categorized as optimal (no missed doses, 100 percent) versus sub-optimal (less than 100 percent).

The publication reports that among 395 individuals who provided adherence information during the week 4 remote contact, 368 reported optimal adherence. Sustained virologic response in this group was 96.5 percent versus 77.8 percent in the group that reported sub-optimal adherence (p-value <0.001). Researchers found that being younger than 30 years old and participating at a U.S. site were independently associated with sub-optimal adherence. Participants under the age of 30 were 7.1 times more likely to have sub-optimal adherence compared to their older counterparts.

"These findings provide important insights that may enable us to identify individuals who may be at higher risk for treatment failure and are thus more likely to benefit from additional support," said Leonard A. Sowah, MBChB, MPH, lead author on this publication. "It may be especially important to prioritize adherence interventions to maximize sustained virologic response among younger individuals."