Hepatitis C: Adherence Is Associated with Sustained Virological Response

The AIDS Clinical Trials Group (ACTG), the world’s largest HIV research network, announces the publication of “Perspectives on Adherence from the ACTG 5360 MINMON Trial: A Minimal Control Approach with 12 Weeks of Sofosbuvir/Velpatasvir in Treatment of chronic hepatitis C" in the journal Clinical Infectious Diseases .

Comments

This publication found that 100% self-reported compliance in the first four weeks of hepatitis C treatment with sofosbuvir/velpatasvir was associated with a sustained virological response (no hepatitis C virus found in the blood 12 weeks after completing the treatment). Sustained virologic response is the generally accepted criterion 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 They may benefit from additional supportive treatments.

Direct-acting antivirals have transformed the treatment landscape for people with hepatitis C, resulting in dramatic improvements in treatment outcomes. However, multiple barriers continue to limit equitable access to treatment. The MINMON trial was designed to reduce the overall cost of treatment by having fewer in-person clinic visits and fewer laboratory checks 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 delivering it has limited global acceptance of the treatment,” said Judith Currier, MD, MSc, president of ACTG, University of California. , The Angels. “The MINMON study has expanded our understanding of how we can simplify the delivery of hepatitis C treatment to ultimately make it more accessible to people around the world. “It is especially exciting to see the correlation between self-reported optimal adherence and sustained virologic response described in this publication.”

This single-arm, open-label, phase 4 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 baseline visit. In-person visits occurred at baseline and 24 weeks later. Adherence data were collected remotely at four weeks and categorized as optimal (no missed doses, 100 percent) versus suboptimal (less than 100 percent).

The publication reports that among the 395 people who provided adherence information during the week 4 remote contact, 368 reported optimal adherence. The sustained virologic response in this group was 96.5% versus 77.8% in the group reporting suboptimal adherence (p value <0.001). The researchers found that being under 30 years old and participating in a US site was independently associated with suboptimal adherence . Participants under 30 years of age were 7.1 times more likely to have suboptimal adherence compared to their older counterparts.

“These findings provide important information that may allow us to identify individuals who may be at higher risk of treatment failure and therefore more likely to benefit from additional support,” said Leonard A. Sowah, MBChB, MPH. , main author of this publication. “It may be especially important to prioritize adherence interventions to maximize sustained virologic response among younger people.”