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Sofosbuvir‐velpatasvir‐voxilaprevir with or without ribavirin in direct‐acting antiviral–experienced patients with genotype 1 hepatitis C virus
Author(s) -
Lawitz Eric,
Poordad Fred,
Wells Jennifer,
Hyland Robert H.,
Yang Yin,
DvorySobol Hadas,
Stamm Luisa M.,
Brainard Diana M.,
McHutchison John G.,
Landaverde Carmen,
Gutierrez Julio
Publication year - 2017
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.29130
Subject(s) - medicine , ribavirin , sofosbuvir , gastroenterology , adverse effect , regimen , hepatitis c virus , nausea , immunology , virus
The optimal retreatment strategy for hepatitis C virus (HCV) genotype 1–infected patients who fail direct‐acting antiviral (DAA)‐based regimens remains unknown. In this phase 2, open‐label study conducted at a single center in the United States, patients with HCV genotype 1 infection who previously failed to achieve sustained virological response (SVR) on a DAA‐based regimen were randomized to receive treatment with a fixed‐dose combination tablet of sofosbuvir‐velpatasvir‐voxilaprevir with or without ribavirin (RBV) for 12 weeks. Patients were stratified by their cirrhosis and past nonstructural protein (NS) 5A inhibitor exposure. The primary efficacy endpoint was the proportion of patients with SVR at 12 weeks after treatment (SVR12). SVR12 was achieved by 24 of 24 patients (100%; 95% confidence interval [CI], 86‐100) receiving sofosbuvir‐velpatasvir‐voxilaprevir alone and 24 of 25 (96%; 95% CI, 80‐100) receiving the same treatment with RBV. None of the patients discontinued sofosbuvir‐velpatasvir‐voxilaprevir therapy because of an adverse event (AE). The most commonly reported AEs with sofosbuvir‐velpatasvir‐voxilaprevir alone were diarrhea and bronchitis; and with sofosbuvir‐velpatasvir‐voxilaprevir plus RBV were fatigue, anemia, gastroenteritis, and nausea. Conclusion : A fixed‐dose combination of sofosbuvir‐velpatasvir‐voxilaprevir was well tolerated and effective at achieving virological response in patients with HCV genotype 1 infection and past DAA treatment experience. (H epatology 2017;65:1803‐1809).