IDDF2019-ABS-0211 Efficacy and safety of glecaprevir/pibrentasvir in patients with HCV genotype 5 or 6 infection: an integrated analysis of phase 2 and 3 studies

Background The pangenotypic direct-acting antivirals (DAAs) glecaprevir (identified by AbbVie and Enanta) coformulated with pibrentasvir (G/P) are approved for the treatment of chronic HCV genotype (GT) 1–6 infection. However, the efficacy and safety data of G/P are limited in patients infected with HCV GT5 and GT6. Methods The data analysis integrated data from 10 Phase 2b, 3a (registrational) and 3b (post-registrational) studies. The patient population comprised adults with chronic HCV GT5 or GT6 infection and compensated liver disease (with or without cirrhosis) who were treatment-naive or experienced with regimens containing interferon (IFN) or pegylated IFN (pegIFN) ± ribavirin or sofosbuvir + ribavirin ± pegIFN. Patients received 8 or 12 weeks of G/P (300 mg/120 mg) depending on the design of the original study. Efficacy was evaluated as the rate of sustained virologic response (SVR) at post-treatment week (PTW) 12 (SVR12). HCV subtype was identified by phylogenetic analysis. Results Data from 181 patients were included in this integrated analysis, including 56 (30.9%) with HCV GT5 and 125 (69.1%) with HCV GT6 infection. Overall, 102 (56.4%) patients were treated for 8 weeks and 79 (43.6%) for 12 weeks, irrespective of the presence of cirrhosis. Most patients were male (54.1%), Asian (64.6%), Conclusions HCV GT5- and GT6-infected patients without cirrhosis or with compensated cirrhosis treated with G/P for 8 or 12 weeks achieved high rates of SVR12. There were no added efficacy benefits when treatment was extended from 8 to 12 weeks, even in patients with compensated cirrhosis. The G/P regimen was well-tolerated.