Sofosbuvir-velpatasvir plus ribavirin in Japanese patients with genotype 1 or 2 hepatitis C who failed direct-acting antivirals

Hepatology International
Namiki IzumiMasashi Mizokami

Abstract

In Japan, there is a growing population of patients with chronic hepatitis C virus (HCV) infection who failed a direct-acting antiviral (DAA)-based regimen. In this Phase 3 study, we evaluated sofosbuvir-velpatasvir plus ribavirin in Japanese patients with genotype 1 or 2 HCV infection who previously received DAAs. Patients were randomized 1:1 to receive sofosbuvir-velpatasvir plus ribavirin for 12 or 24 weeks. Randomization was stratified by HCV genotype and presence of cirrhosis. The primary endpoint was sustained virologic response 12-week post-treatment (SVR12). Of 117 participants, 81% had HCV genotype 1 infection, 33% had cirrhosis, and 95% had NS5A resistance-associated substitutions (RAS) at baseline. Overall, SVR12 rates were 97% (58/60; 95% CI 88-100%) with 24 weeks of treatment and 82% (47/57; 95% CI 70-91%) with 12 weeks. For HCV genotype 1 and 2 infected patients, the SVR12 rates with 24 weeks of treatment were 98% and 92%, respectively. In both treatment groups, SVR12 rates in HCV genotype 1 patients were statistically superior to a historical control rate of 50% (p < 0.001). For patients with NS5A RASs at baseline, 85% (46/54) in the 12-week group and 96% (54/56) in the 24-week group achieved SVR12. The most comm...Continue Reading

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Citations

Jul 20, 2019·Hepatology Research : the Official Journal of the Japan Society of Hepatology·Akihiro TamoriNorifumi Kawada
Nov 22, 2019·Hepatology Research : the Official Journal of the Japan Society of Hepatology·Hiroki TojimaToshio Uraoka
Dec 18, 2019·Hepatology Research : the Official Journal of the Japan Society of Hepatology·Seiichi MawatariAkio Ido
Mar 20, 2020·Clinical and Molecular Hepatology·Chung-Feng Huang, Ming-Lung Yu
Jul 16, 2020·Journal of Gastroenterology and Hepatology·Goki Suda, Naoya Sakamoto
Aug 25, 2020·Annals of Laboratory Medicine·Nobuharu TamakiNamiki Izumi
May 12, 2019·Hepatology Research : the Official Journal of the Japan Society of Hepatology·Toshie MashibaNamiki Izumi
Feb 17, 2021·Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy·Koichi OnoderaHideo Harigae
May 2, 2020·Journal of the Formosan Medical Association = Taiwan Yi Zhi·Ming-Lung YuWan-Long Chuang
May 21, 2021·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Caroline E BoekeChristian B Ramers

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Methods Mentioned

BETA
biopsy
Assay

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