ACTG to Publish Phase 4 Hepatitis C Study Soon
Pivotal study will help identify individuals at a higher risk for treatment failure and who’d benefit from additional support
LOS ANGELES, CA — 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 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.
The MINMON clinical trial
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 costs 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,” said Judith Currier, MD, MSc, chair of the ACTG, University of California, Los Angeles, CA. “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.”
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 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 suboptimal (less than 100 percent).
Findings of Phase 4 trial
The publication reports that among 395 individuals who provided adherence information during the week four 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 suboptimal adherence (p value <0.001).
Researchers found that being younger than 30 years old and participating at a US site were independently associated with suboptimal adherence. Participants under the age of 30 were 7.1 times more likely to have suboptimal 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 of this publication. “It may be especially important to prioritize adherence interventions to maximize sustained virologic response among younger individuals.”
- This press release was supported by the AIDS Clinical Trials Group (ACTG)