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Twelve weeks of ledipasvir/sofosbuvir all‐oral regimen for patients with chronic hepatitis C genotype 2 infection: Integrated analysis of three clinical trials
Author(s) -
Asahina Yasuhiro,
Liu ChunJen,
Gane Edward,
Itoh Yoshito,
Kawada Norifumi,
Ueno Yoshiyuki,
Youn Jin,
Wang ChenYu,
Llewellyn Joe,
Matsuda Takuma,
Gaggar Anuj,
Mo Hongmei,
DvorySobol Hadas,
Crans Gerald,
Chuang WanLong,
Chen PeiJer,
Enomoto Nobuyuki
Publication year - 2020
Publication title -
hepatology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.123
H-Index - 75
eISSN - 1872-034X
pISSN - 1386-6346
DOI - 10.1111/hepr.13546
Subject(s) - sofosbuvir , ledipasvir , medicine , ribavirin , regimen , cirrhosis , hepatitis c virus , hepatitis c , gastroenterology , ns5a , genotype , hepacivirus , virology , virus , biology , biochemistry , gene
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.