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. 2021 Nov 2;73(9):e3288-e3295.
doi: 10.1093/cid/ciaa1318.

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

Timothy Papaluca  1   2 , Stuart K Roberts  3   4 , Simone I Strasser  5   6 , Katherine A Stuart  7 , Geoffrey Farrell  8 , Gerry MacQuillan  9   10 , Gregory J Dore  11   12 , Amanda J Wade  13   14 , Jacob George  15   16 , Simon Hazeldine  17 , James O'Beirne  18   19 , Alan Wigg  20 , Leslie Fisher  2   21 , Bruce McGarity  22 , Rohit Sawhney  4   23 , Marie Sinclair  2   24 , James Thomas  7   18   25   26 , Ivan Valiozis  27 , Martin Weltman  28 , Mark Wilson  29 , Aidan Woodward  26   30 , Golo Ahlenstiel  31 , Mazhar Haque  26   30 , Miriam Levy  32 , Emily Prewett  13   33 , William Sievert  4   34 , Siddharth Sood  2   35 , Edmund Tse  36 , Zina Valaydon  2   37 , Scott Bowden  38 , Mark Douglas  15   16 , Kate New  1 , Jacinta O'Keefe  38 , Margaret Hellard  3   4   14 , Joseph Doyle  3   4   14 , Mark Stoove  4   14 , Alexander J Thompson  1   2
Affiliations

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

Timothy Papaluca et al. Clin Infect Dis. .

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.

Methods: 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).

Findings: 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.

Conclusions: 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.

Keywords: cirrhosis; genotype 3; hepatitis C; relapse; sofosbuvir/velpatasvir/voxilaprevir.

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