Background
With the advent of efficacious oral Direct-acting antivirals (DAAs) for hepatitis C virus(HCV), identification of characteristics associated with adherence is critical to treatment success. We examined correlates of sub-optimal adherence to HCV therapy in a single-arm, multinational, clinical trial.
Methods
ACTG A5360 enrolled HCV treatment-naïve persons without decompensated cirrhosis from 5 countries. All participants received a 12-weeks course of sofosbuvir/velpatasvir at entry. In-person visits occurred at initiation and week 24, sustained virologic response (SVR) assessment. Adherence at week 4 was collected remotely and was dichotomized optimal (100%, no missed doses) versus sub-optimal (<100%). Correlates of sub-optimal adherence were explored using logistic regression.
Results
400 participants enrolled; 399 initiated treatment; 395/397 (99%) reported completing at week 24.. Median age was 47 years with 35% female. Among the 368 reporting optimal adherence at week 4 SVR was 96.5% (95% CI [94.1%, 97.9%]) vs. 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 sub-optimal adherence. Participants < 30 years were 7.1 times more likely to have early sub-optimal adherence compared to their older counterparts.
Conclusion
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 individuals < 30 years may also be prioritized for additional adherence support.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.