Efficacy and safety of sofosbuvir/velpatasvir/voxilaprevir for HCV NS5A-inhibitor experienced patients with difficult to cure characteristics

Papaluca, T, Roberts, SK, Strasser, SI, Stuart, KA, Farrell, G, MacQuillan, G, Dore, GJ, Wade, AJ, 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, Emily, Sievert, W, Sood, S, Tse, E, Valaydon, Z, Bowden, S, Douglas, M, New, K, O’Keefe, J, Hellard, M, Doyle, J, Stoove, M and Thompson, AJ 2020, Efficacy and safety of sofosbuvir/velpatasvir/voxilaprevir for HCV NS5A-inhibitor experienced patients with difficult to cure characteristics, Clinical Infectious Diseases, pp. 1-31, doi: 10.1093/cid/ciaa1318.

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Title Efficacy and safety of sofosbuvir/velpatasvir/voxilaprevir for HCV NS5A-inhibitor experienced patients with difficult to cure characteristics
Author(s) Papaluca, T
Roberts, SK
Strasser, SI
Stuart, KA
Farrell, G
MacQuillan, G
Dore, GJ
Wade, AJ
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, Emily
Sievert, W
Sood, S
Tse, E
Valaydon, Z
Bowden, S
Douglas, M
New, K
O’Keefe, J
Hellard, M
Doyle, J
Stoove, M
Thompson, AJ
Journal name Clinical Infectious Diseases
Start page 1
End page 31
Total pages 31
Publisher Oxford University Press
Place of publication Oxford, Eng.
Publication date 2020-09-05
ISSN 1058-4838
1537-6591
Keyword(s) Hepatitis C
cirrhosis
genotype 3
relapse
sofosbuvir/velpatasvir/voxilaprevir
Summary Abstract Background In clinical trials, 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 four serious AEs including one death and three hepatic decompensation events. NS5A resistance-associated substitutions detected at baseline did not affect SVR12. Conclusion 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.
Notes In Press
Language eng
DOI 10.1093/cid/ciaa1318
Indigenous content off
Field of Research 06 Biological Sciences
11 Medical and Health Sciences
HERDC Research category C1 Refereed article in a scholarly journal
Persistent URL http://hdl.handle.net/10536/DRO/DU:30143222

Document type: Journal Article
Collections: Faculty of Health
School of Medicine
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