Efficacy and safety of elbasvir/grazoprevir for 12 weeks in people with hepatitis C virus infection aged 35 years or younger compared with older people: a retrospective integrated analysis.

Background:In the United States, the number of new cases of hepatitis C virus infection has risen in recent years, driven largely by transmission among young white adults in their 20s and 30s. Herein, we report an integrated analysis of participants with hepatitis C virus infection aged <= 35 years from 12 phase II/III clinical trials of elbasvir/grazoprevir. Methods:Treatment-naive and -experienced adults with hepatitis C virus genotype 1 or 4 infection received elbasvir (50 mg/day)/grazoprevir (100 mg/day) for 12 weeks without ribavirin. Analyses were stratified according to participant age (<= 35 years vs >35 years). The primary endpoint was sustained virologic response (hepatitis C virus RNA < lower limit of quantitation at 12 weeks after completion of therapy). Results:Sustained virologic response was achieved by 98.9% (271/274) of participants aged <= 35 years and by 96.9% (2093/2160) aged >35 years. Three participants aged <= 35 years with genotype 1b infection relapsed. Eight participants with genotype 1a infection and baseline non-structural protein 5 A resistance-associated substitutions achieved sustained virologic response. Similarly, all 85 participants aged <= 35 years with genotype 1a infection and no baseline non-structural protein 5 A resistance-associated substitutions achieved sustained virologic response. Safety was favorable, with the incidence of drug-related adverse events similar in younger and older participants (30.1% vs 30.6%). One participant (0.4%) aged <= 35 years and 15 participants (0.7%) aged >35 years discontinued treatment owing to adverse events. Conclusions:Elbasvir/grazoprevir for 12 weeks was safe and highly effective in participants aged <= 35 years with hepatitis C virus genotype 1 or 4 infection.