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Canadian Journal of Gastroenterology and Hepatology
Volume 2017, Article ID 8186275, 7 pages
https://doi.org/10.1155/2017/8186275
Research Article

Grazoprevir and Elbasvir in Patients with Genotype 1 Hepatitis C Virus Infection: A Comprehensive Efficacy and Safety Analysis

1Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 211166, China
2Department of Infectious Diseases, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China
3Department of Basic and Community Nursing, School of Nursing, Nanjing Medical University, Nanjing 211166, China
4Department of Infectious Diseases, The Jurong People’s Hospital, Jurong 212400, China
5Department of Epidemiology, Medical Institute of Nanjing Army, Nanjing 210002, China

Correspondence should be addressed to Peng Huang; nc.ude.umjn@gnepgnauh and Rongbin Yu; nc.ude.umjn@uynibgnor

Received 14 September 2016; Accepted 20 December 2016; Published 9 January 2017

Academic Editor: Mang Ma

Copyright © 2017 Yinan Yao et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. It is urgent for patients with hepatitis C virus (HCV) infection to find a safe, effective, and interferon-free regimen to optimize therapy. A comprehensive analysis was performed to evaluate the efficacy and safety of the grazoprevir combined with elbasvir, with or without ribavirin (RBV), in 777 treatment-naive and treatment-experienced patients with HCV genotype 1 infection from 3 randomized controlled trials (RCTs). Method. We collected data from the following trials: C-WORTHY (NCT01717326), C-SALVAGE (NCT02105454), and C-EDGE (NCT02105467). All patients received grazoprevir plus elbasvir with or without RBV for 12 or 18 weeks. The sustained virological response (SVR) 12 weeks after end of treatment was calculated for overall and subgroups. Results. 568 (73%) patients were treatment-naive. Overall, 95% (95% CI: 93–96) patients achieved SVR12, 95% (95% CI: 92–96) for treatment-naive and 96% (95% CI: 92–98) for previously treated patients, respectively. Treatment duration and treatment regimen did not have great difference in SVR12 rates. The most common AEs were fatigue (18%–29%), headache (20%), nausea (8%–14%), and asthenia (4%–12%). One patient (<1%) receiving grazoprevir plus elbasvir alone and one (<1%) receiving grazoprevir plus elbasvir plus RBV had treatment-related serious AEs. Conclusions. The result shows that 12-week grazoprevir plus elbasvir therapy is safe and effective for treatment-naive patients with HCV genotype 1.