HCV: alcohol use tied to lower treatment adherence in pooled analysis

  • Brown A & al.
  • Liver Int
  • 30 Sep 2019

  • International Clinical Digest
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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).

Limitations

  • Clinical trial vs real-world data.