Twelve weeks of ledipasvir/sofosbuvir all-oral regimen for patients with chronic hepatitis C genotype 2 infection: Integrated analysis of three clinical trials
Journal
Hepatology Research
Journal Volume
50
Journal Issue
10
Pages
1109-1117
Date Issued
2020
Author(s)
Asahina Y.
Gane E.
Itoh Y.
Kawada N.
Ueno Y.
Youn J.
Wang C.-Y.
Llewellyn J.
Matsuda T.
Gaggar A.
Mo H.
Dvory-Sobol H.
Crans G.
Chuang W.-L.
Enomoto N.
Abstract
Aim: The combination of ledipasvir and sofosbuvir (LDV/SOF) has been approved for the treatment of various hepatitis C virus (HCV) genotypes across many countries. This article presents an integrated analysis of three prospective phase II/III trials in the Asia-Pacific region to evaluate the efficacy and safety of 12?weeks of LDV/SOF in HCV genotype 2 patients without cirrhosis or with compensated cirrhosis. Methods: A total of 200 patients were included in the integrated analysis. The primary end-point was the rate of sustained virologic response for 12?weeks after the end of therapy (SVR12), analyzed by fibrosis stage, treatment history, HCV genotype subtype, and presence of baseline resistance-associated substitutions (RAS). Safety was evaluated by adverse events and laboratory abnormalities. Results: Twelve weeks of treatment with LDV/SOF was associated with high SVR12 rates (overall 98%) in patients with genotype 2 HCV, irrespective of fibrosis stage, treatment history, genotype 2 subtype, and presence of baseline non-structural protein 5A resistance-associated substitution (NS5A RAS), and LDV/SOF was well tolerated. Conclusions: Twelve weeks of treatment with LDV/SOF provides a highly effective and safe treatment for patients with genotype 2 HCV, including those with advanced fibrosis. As a ribavirin-free and protease inhibitor-free regimen with minimal on-treatment monitoring requirements, LDV/SOF can potentially play a crucial role in achieving the WHO's goal of HCV elimination. ? 2020 The Authors. Hepatology Research published by John Wiley & Sons Australia, Ltd on behalf of Japan Society of Hepatology
SDGs
Other Subjects
ledipasvir; sofosbuvir; adult; Article; Child Pugh score; chronic hepatitis B; chronic hepatitis C; controlled study; drug efficacy; drug safety; drug tolerability; drug withdrawal; fatigue; female; genotype; headache; Hepatitis C virus genotype 2; human; limit of quantitation; liver fibrosis; major clinical study; male; middle aged; multicenter study; nausea; phase 3 clinical trial; priority journal; randomized controlled trial; relapse; rheumatoid arthritis; rhinopharyngitis; sustained virologic response
Publisher
Blackwell Publishing Ltd
Type
journal article