Abstract
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 year s 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.
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