Hepatitis C is an infection of the liver characterized by inflammation of the organ, and in some cases, cancer. Glecaprevir, a pangenotypic direct-acting antiviral regimen, given in combination with pibrentasvir, is approved to treat the hepatitis C virus (HCV) genotype 1-5. This study aims to evaluate the safety and efficacy of glecaprevir/pibrentasvir in patients with HCV genotype 5 or 6.
This single-arm, open-label, multicenter, phase 3b trial included a total of 84 patients with HCV genotype 5 or 6 infections (23 with genotype 5 and 61 with genotype 6). The participants were assigned to receive glecaprevir/pibrentasvir (300 mg/120 mg) orally once daily for 8 weeks. The primary outcome of the study was sustained virological response (SVR) at 12 weeks.
Of 84 patients, 82 achieved SVR at 12 weeks (97.6%). In the genotype 5 group, 22 of 23 achieved SVR (95.7%), and in the genotype 6 group, 60 of 61 (98.4%) achieved SVR. Serious adverse events occurred in 5 patients (6%), with the most common adverse events being fatigue and headache.
The research concluded that glecaprevir/pibrentasvir achieved higher SVR rates at 12 weeks, and was well tolerated in patients with HCV genotype 5 or 6.