Glecaprevir/Pibrentasvir for Acute Hepatitis C Virus Infection in Individuals with a History of Prior Hepatitis C Infection.

Abstract

Introduction: In a phase 3b study, glecaprevir/pibrentasvir (G/P) for 8 weeks was well tolerated and effective in treatment-naive adults with acute hepatitis C virus (HCV) infection. Here we analyze the efficacy and safety of G/P in adults with acute HCV infection with a history of prior HCV infection.

Methods: Participants with acute HCV were stratified by presence of prior HCV infection. Efficacy was assessed in the intention-to-treat population (ITT; all patients receiving ≥ 1 G/P dose) and modified ITT virologic failure population, which excluded non-virologic failures (mITT-VF). Safety (adverse events [AEs] and laboratory values) was assessed, as well as viral kinetics.

Results: Among 286 participants, 52 (18.2%) had ≥ 1 prior HCV infection and 234 (81.8%) did not. High-risk characteristics in those with prior infection versus those without: human immunodeficiency virus (HIV) coinfection, 92.3% versus 40.2%; unprotected male-male sexual activity, 78.8% versus 63.7%; and current/recent injection drug use, 23.1% versus 12.4%, respectively. In the ITT, SVR12 was 98.1% (95% confidence interval [CI] 89.9-99.7) in those with a prior infection and 95.7% (95% CI 92.3-97.7) in those without. There were no virologic failures (SVR12 = 100% in the mITT-VF). Rates of serious AEs (5.8% versus 3.0%) and treatment-related AEs (17.3% versus 15.4%) were similar in those with or without prior HCV infection.

Conclusions: Individuals with acute HCV infection with a history of prior HCV infection can be successfully treated with G/P. Risk of reinfection in high-risk populations, such as high-risk sexual activity or injection drug use, highlights the need for ongoing testing for reinfection along with subsequent treatment.

Trial registration: ClinicalTrials.gov identifier: NCT04903626.