Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir for Hepatitis C Virus (HCV) NS5A-Inhibitor Experienced Patients With Difficult to Cure Characteristics
| Autor: | Mazhar M Haque, K. New, Alan Wigg, Simone I. Strasser, Jacinta O'Keefe, Bruce McGarity, James O'Beirne, Ivan Valiozis, Miriam T. Levy, Mark Wilson, Zina Valaydon, Margaret Hellard, Rohit Sawhney, Scott Bowden, Martin Weltman, Emily Prewett, Gerry MacQuillan, Siddharth Sood, Timothy Papaluca, Edmund Tse, Mark W. Douglas, William Sievert, Leslie Fisher, Katherine A. Stuart, Gregory J. Dore, Alexander J. Thompson, Marie Sinclair, Amanda Wade, James Thomas, Jacob George, Golo Ahlenstiel, Simon Hazeldine, Joseph Doyle, Mark Stoove, Stuart K. Roberts, Aidan J. Woodward, Geoffrey C. Farrell |
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| Rok vydání: | 2020 |
| Předmět: |
Microbiology (medical)
Cyclopropanes Male medicine.medical_specialty Cirrhosis Aminoisobutyric Acids Sofosbuvir Genotype Proline Sustained Virologic Response Voxilaprevir medicine.medical_treatment Lactams Macrocyclic Hepacivirus Liver transplantation Gastroenterology Antiviral Agents Heterocyclic Compounds 4 or More Rings 03 medical and health sciences Liver disease 0302 clinical medicine Leucine Internal medicine Quinoxalines medicine Humans 030212 general & internal medicine Adverse effect Online only Articles Sulfonamides business.industry Hepatitis C Hepatitis C Chronic Middle Aged medicine.disease Infectious Diseases Treatment Outcome Portal hypertension 030211 gastroenterology & hepatology Carbamates business medicine.drug |
| Zdroj: | Clin Infect Dis |
| ISSN: | 1537-6591 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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