Back to Search Start Over

Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir for Hepatitis C Virus (HCV) NS5A-Inhibitor Experienced Patients with Difficult to Cure Characteristics.

Authors :
Papaluca T.
Roberts S.K.
Strasser S.I.
Stuart K.A.
Farrell G.
Macquillan G.
Dore G.J.
Wade A.J.
George J.
Hazeldine S.
O'Beirne J.
Wigg A.
Fisher L.
McGarity B.
Sawhney R.
Sinclair M.
Thomas J.
Valiozis I.
Weltman M.
Wilson M.
Woodward A.
Ahlenstiel G.
Haque M.
Levy M.
Prewett E.
Sievert W.
Sood S.
Tse E.
Valaydon Z.
Bowden S.
Douglas M.
New K.
O'Keefe J.
Hellard M.
Doyle J.
Stoove M.
Thompson A.J.
Papaluca T.
Roberts S.K.
Strasser S.I.
Stuart K.A.
Farrell G.
Macquillan G.
Dore G.J.
Wade A.J.
George J.
Hazeldine S.
O'Beirne J.
Wigg A.
Fisher L.
McGarity B.
Sawhney R.
Sinclair M.
Thomas J.
Valiozis I.
Weltman M.
Wilson M.
Woodward A.
Ahlenstiel G.
Haque M.
Levy M.
Prewett E.
Sievert W.
Sood S.
Tse E.
Valaydon Z.
Bowden S.
Douglas M.
New K.
O'Keefe J.
Hellard M.
Doyle J.
Stoove M.
Thompson A.J.
Publication Year :
2021

Abstract

Background: In clinical trials, hepatitis C virus (HCV) salvage treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) achieved an SVR12 rate of >95% in NS5A-experienced participants. Lower SVR12 rates have been reported in real-world studies, particularly for genotype (GT)3 infection and cirrhosis. We determined the efficacy and safety of SOF/VEL/VOX in a large real-world cohort. Method(s): We assessed the efficacy of salvage SOF/VEL/VOX for HCV infection in NS5A-inhibitor experienced participants with cirrhosis and portal hypertension, prior liver transplantation (LT) or severe extra-hepatic manifestations. SOF/VEL/VOX was available via an early access program. The primary outcome was SVR12. Secondary outcome was frequency of adverse events (AE). Finding(s): Ninety-seven participants were included. Median age was 58, 82% were male, 78% had cirrhosis, most with portal hypertension (61%, n=46/76), and 18% had prior-LT. Of the cirrhotic participants, 96% were Child-Turcotte-Pugh class A, and 4% were class B. Of the 72% with GT3, 76% were also cirrhotic. By intention-to-treat analysis, SVR12 rate was 85% (n=82/97). Per protocol, the SVR12 rate was 90%, including 91% in GT1 (GT1a n=18/18, GT1b n=2/4), 89% in GT3 (n=59/66) and 100% in GT6 (n=3/3). SVR12 in participants with GT3 and cirrhosis was 90%. No predictors of non-SVR12 were identified. There were 4 serious AEs including 1 death and 3 hepatic decompensation events. NS5A resistance-associated substitutions detected at baseline did not affect SVR12. Conclusion(s): This real-world study confirms high efficacy of SOF/VEL/VOX for the treatment of difficult-to-cure NS5A-inhibitor experienced patients, including those with GT3 and cirrhosis. Treatment was well tolerated in most; however, serious AEs can occur in those with advanced liver disease.Copyright © 2020 The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail

Details

Database :
OAIster
Publication Type :
Electronic Resource
Accession number :
edsoai.on1305138056
Document Type :
Electronic Resource