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Grazoprevir plus peginterferon and ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection: a randomized trial

Journal article
Authors Martin Lagging
A. Brown
P. S. Mantry
A. Ramji
F. Weilert
J. M. Vierling
A. Howe
I. N. Gendrano
P. Hwang
B. Zhang
J. Wahl
M. Robertson
N. Mobashery
Published in Journal of Viral Hepatitis
Volume 23
Issue 2
Pages 80-88
ISSN 1352-0504
Publication year 2016
Published at Institute of Biomedicine
Pages 80-88
Language en
Links dx.doi.org/10.1111/jvh.12464
Keywords adverse event, clinical trial, direct-acting antiviral drugs, resistance, sustained virologic response, combination therapy, boceprevir, sofosbuvir, ledipasvir, mk-5172, Gastroenterology & Hepatology, Infectious Diseases, Virology
Subject categories Virology, Infectious Medicine, Gastroenterology and Hepatology

Abstract

Grazoprevir (MK-5172, Merck & Co., Inc.) is a selective inhibitor of the hepatitis C virus (HCV) NS3/4a protease. The aim of this study was to evaluate the safety and efficacy of grazoprevir at doses of 25-100mg/day in combination with peginterferon and ribavirin (PEG-IFN/RBV). In this randomized, dose-ranging, multicentre trial, treatment-naive adults with chronic HCV genotype 1 infection received once-daily grazoprevir 25mg, 50mg or 100mg plus PEG-IFN/RBV for 12weeks. Patients with quantifiable HCV RNA (25IU/mL) at week 4 received an additional 12weeks of PEG-IFN/RBV. The primary endpoint was sustained virologic response (HCV RNA <25IU/mL 12weeks after completing therapy [SVR12]). Eighty-seven patients were randomly assigned and received 1 dose of therapy. Median time to undetectable HCV RNA was 16days in the 100-mg arm and 22days in the 25- and 50-mg arms. All patients except one had HCV RNA undetectable or unquantifiable at week 4 and received 12weeks of therapy. SVR12 was achieved by 13 of 24 (54.2%), 21 of 25 (84.0%) and 23 of 26 (88.5%) patients in the 25-, 50- and 100-mg arms, respectively (per-protocol analysis). Three patients discontinued as a result of nonserious adverse events (AEs) and three patients experienced serious AEs. Transaminase elevations occurred in two patients (one each in the 25- and 100-mg arms). Conclusion: These data support further study of the grazoprevir 100-mg dose. Phase 3 studies of grazoprevir 100mg in combination with elbasvir are currently ongoing (NCT01710501; protocol P038).

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