The impact of efficacy for treatment with directacting antiviral drugs in the treatment of HCV infection with suboptimal adherence, particularly with shorter treatment durations was evaluated further. Evaluation with post-hoc analyses evaluated adherence (based on pill count), in patients prescribed 8- or 12- week Glecaprevir/ Pibrentasvir (G/P), the impact of nonadherence on the SVR at post-treatment week 12 (SVR12), and the factors associated with nonadherence and efficacy in patients interrupting G/P treatment.
Data was pooled from 10 phase 3 clinical trials of treatment-naïve patients with HCV genotype 1-6, without cirrhosis, with compensated cirrhosis (treatment adherence analysis), and 13 phase 3 clinical trials of all patients with HCV (interruption analysis).
A total of 2,149 patients were included. Overall meet adherence was 99.4%. Over the treatment duration, adherence decreased (week 0-4 – 100%; weeks 5-8 – 98.3%, and weeks 9-12; 97.1%). The percentage of patients with greater than 80% or 90% adherence declined. SVR12 rate in the intention-to-treat (ITT) population was 97.7% and remained high in nonadherent patients in a modified ITT population.
Psychiatric disorders were associated with less than 80% adherence and shorter treatment duration was associated with greater than 80% adherence. Among 2,902 patients in the interruption analysis, 33 (1.1%) had a G/P treatment interruption of greater than 1 day with an SVR12 rate of 93.9% (31/33). No virologic failures occurred. The findings support the impact of treatment duration and adherence rate and further reinforce the concept of “treatment forgiveness” with directacting antivirals.
Zamor, P., Brown, A., Dylla, D., et al. “HighSustained Virologic Response Rates of Glecaprevir/Pibrentasvir in Patients with Dosing Interruption or Suboptimal Adherence.” American Journal of Gastroenterology; Vol. 116, September 2021, pp. 1897-1904.
Murray H. Cohen, DO, “From the Literature” Editor, is on the Editorial Board of Practical Gastroenterology.