Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients With HCV Genotype 5/6: An Integrated Analysis of Phase 2/3 Studies. Liver international : official journal of the International Association for the Study of the Liver Yao, B. B., Fredrick, L. M., Schnell, G. n., Kowdley, K. V., Kwo, P. Y., Poordad, F. n., Nguyen, K. n., Lee, S. S., George, C. n., Wong, F. n., Gane, E. n., Abergel, A. n., Spearman, C. W., Nguyen, T. n., Le, M. H., Thuy, P. T., Mensa, F. n., Asselah, T. n. 2020


Hepatitis C virus (HCV) has high genetic diversity with 6 major genotypes (GT) GT1-6 and global distribution. HCV GT5 and 6 are rare with <10 million people infected worldwide. Data on direct-acting antiviral use in these rare HCV genotypes are limited. The study aimed to evaluate the efficacy and safety of glecaprevir/pibrentasvir (G/P) in a pooled analysis of phase 2/3 trials in HCV GT5 or 6-infected patients without cirrhosis or with compensated cirrhosis.Patients with chronic HCV GT5 or 6 infection received oral G/P (300 mg/120 mg) once daily for 8 or 12 weeks. The primary efficacy endpoint was sustained virologic response at post-treatment week 12 (SVR12) in the intention-to-treat population.One hundred eighty-one patients were evaluated; 56 with HCV GT5 and 125 with HCV GT6. The majority were treatment-naïve (88%) and non-cirrhotic (85%). Overall SVR12 rate with 8- or 12-week G/P treatment was 98% (178/181). Eight-week treatment with G/P yielded SVR12 rates of 95% (21/22) in HCV GT5- and 99% (69/70) in HCV GT6-infected non-cirrhotic patients. Eight- and 12-week treatment of patients with compensated cirrhosis achieved SVR12 rates of 100% (10/10) and 94% (17/18), respectively. The G/P regimen was well-tolerated; 3% (6/181) Grade 3 or higher adverse events, and no serious adverse events were attributed to G/P or led to study drug discontinuation.This integrated dataset demonstrates a high SVR12 rate following 8-week G/P treatment in patients with HCV GT5 (96%) or GT6 (99%) infection without cirrhosis or with compensated cirrhosis.

View details for DOI 10.1111/liv.14535

View details for PubMedID 32445613