AIDS
Perspectives on ACTG 5360 MINMON Trial Adherence: A Minimal 12-Week Follow-up Approach of Sofosbuvir/Velpatasvir in the Treatment of Chronic Hepatitis C
Methods
ACTG A5360 enrolled treatment-naïve HCV without decompensated cirrhosis from 5 countries. All participants received a 12-week course of sofosbuvir/velpatasvir on admission. In-person visits were conducted at baseline and at week 24, assessment of sustained virologic response (SVR). Adherence at week 4 was collected remotely and dichotomized optimally (100%, no missed doses) versus suboptimal (<100%). The correlates of suboptimal adherence were explored by logistic regression.
Results
In total, 400 participants were enrolled; 399 started treatment; 395/397 (99%) reported completing it at week 24.The median age was 47 years, with 35% female. Among the 368 who reported optimal adherence at week 4, the SVR was 96.5% (95% confidence interval (CI) [94.1%, 97.9%]) versus 77.8% (95% CI [59.2%, 89.4%]), p-value <0.001.
In the multivariate model, age <30 years and being a US participant were independently associated with early suboptimal adherence. Participants <30 years were 7.1 times more likely to have early suboptimal adherence compared to their older counterparts.
Conclusions
Self-reported optimal adherence at week 4 was associated with SVR. Early self-reported adherence could be used to identify those at higher risk of treatment failure and may benefit from additional support. Younger people — _-lt;30 years old — can also be prioritized for additional adherence support.
Clinical Trials Registry.NCT03512210.
Comments
This publication found that 100% self-reported adherence in the first four weeks of hepatitis C treatment with sofosbuvir/velpatasvir was associated with a sustained virologic response (hepatitis C virus is not found in blood 12 weeks after completion of treatment). Sustained virological response is the generally accepted criterion for an individual to be considered
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 typically accompanying 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 acceptance of the treatment,» said Judith Currier, M.D., MSc, president of ACTG, University of California. , Los Angeles. «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 virological response described in this publication.»
Source — https://www.intramed.net/103894