- Alcohol use is a significant predictor of nonadherence to glecaprevir/pibrentasvir (GLE/PIB, Mavyret) among HCV-infected patients.
- High clearance rates were observed despite nonadherence.
Why this matters
- Opioid substitution therapy (OST) and injection drug use had no effect on adherence.
- Pooled analysis of data from 8 phase 3 clinical trials (n=2091) of GLE/PIB administered for 8, 12, or 16 weeks according to genotype, prior treatment experience, and cirrhosis status.
- Adherence was monitored with pill counts every 4 weeks and defined as taking 80%-120% of prescribed medication.
- Primary outcome: sustained virologic response at 12 weeks posttherapy (SVR12).
- Funding: AbbVie.
- 96.8% of patients were adherent to GLE/PIB at all visits.
- 8-week course: 96.2% (n=711).
- 12-week course: 97.2% (n=1264).
- 16-week course: 95.7% (n=116).
- Nonadherence primarily consisted of missed pills (67.2%).
- Alcohol use significantly predicted nonadherence (OR, 2.38; P=.022).
- No significant association observed for OST (P=.660) or injection drug use (P=.830).
- In the intent-to-treat population, SVR12 rates among adherent and nonadherent patients were 98.0% (1983/2024) and 86.6% (58/67), respectively.
- On-treatment virologic failure was more common in nonadherent patients (3% vs 0.3%; P=.46).
- After excluding nonvirologic failures, overall SVR12 rate was similar between groups (98.7% vs 95.1%, P=.047).
- Clinical trial vs real-world data.