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Elbasvir/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial

Foster, Graham R. ; Agarwal, Kosh ; Cramp, Matthew E. ; Moreea, Sulleman ; Barclay, Stephen ; Collier, Jane ; Brown, Ashley S. ; Ryder, Stephen D. ; Ustianowski, Andrew ; Forton, Daniel M. ; Fox, Ray ; Gordon, Fiona ; Rosenberg, William M. ; Mutimer, David J. ; Du, Jiejun ; Gilbert, Christopher L. ; Asante‐Appiah, Ernest ; Wahl, Janice ; Robertson, Michael N. ; Barr, Eliav ; Haber, Barbara

Hepatology (Baltimore, Md.), 2018-06, Vol.67 (6), p.2113-2126 [Periódico revisado por pares]

United States: Wiley Subscription Services, Inc

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Título:
Elbasvir/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial
Autor: Foster, Graham R. ; Agarwal, Kosh ; Cramp, Matthew E. ; Moreea, Sulleman ; Barclay, Stephen ; Collier, Jane ; Brown, Ashley S. ; Ryder, Stephen D. ; Ustianowski, Andrew ; Forton, Daniel M. ; Fox, Ray ; Gordon, Fiona ; Rosenberg, William M. ; Mutimer, David J. ; Du, Jiejun ; Gilbert, Christopher L. ; Asante‐Appiah, Ernest ; Wahl, Janice ; Robertson, Michael N. ; Barr, Eliav ; Haber, Barbara
Assuntos: Adult ; Aged ; Antiviral Agents - therapeutic use ; Antiviral drugs ; Benzofurans - therapeutic use ; Cellulitis ; Cirrhosis ; Creatinine ; Drug Combinations ; Female ; Genotype ; Genotypes ; Hepacivirus - genetics ; Hepatitis ; Hepatitis C ; Hepatitis C, Chronic - complications ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - virology ; Hepatology ; Humans ; Imidazoles - therapeutic use ; Infections ; Insulin ; Interferon ; Liver cirrhosis ; Liver Cirrhosis - complications ; Liver Cirrhosis - virology ; Male ; Middle Aged ; Overdose ; Pain ; Quinoxalines - therapeutic use ; Ribavirin ; Ribavirin - therapeutic use ; Ribonucleic acid ; RNA ; Sofosbuvir - therapeutic use ; Vomiting
É parte de: Hepatology (Baltimore, Md.), 2018-06, Vol.67 (6), p.2113-2126
Notas: Supported by Merck & Co., Inc.
Potential conflict of interest: Dr. Agarwal consults for, is on the speakers’ bureau of, and received grants from Merck, Gilead, and AbbVie. Dr. Foster consults for and received grants from Merck, Gilead, and AbbVie. He consults for GlaxoSmithKline and Roche. Dr. Mutimer advises and is on the speakers’ bureau for Gilead. He advises MSD. Dr. Appiah is employed by and owns stock in Merck. Dr. Barclay advises, is on the speakers’ bureau of, and received grants from AbbVie. He advises and is on the speakers’ bureau of Gilead. He is on the speakers’ bureau of MSD. Dr. Fox advises and received grants from Gilead. He advises AbbVie and MSD. Dr. Barr is employed by and owns stock in Merck. Dr. Brown consults for and is on the speakers’ bureau of Merck and MSD. Dr. Forton consults for, received grants from, and owns stock in Gilead. Dr. Gilbert is employed by and owns stock in Merck. Dr. Haber is employed by and owns stock in Merck. Dr. Robertson is employed by and owns stock in Merck. Dr. Ustianowski advises, is on the speakers’ bureau of, and received grants from AbbVie and Gilead. He advises and is on the speakers’ bureau of Bristol‐Myers Squibb and MSD. Dr. Rosenberg advises and received grants from Gilead. He advises MSD and AbbVie. Dr. Cramp advises, is on the speakers’ bureau of, and received grants from Merck, Gilead, and AbbVie. Dr. Wahl is employed by and owns stock in Merck.
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Descrição: Many direct‐acting antiviral regimens have reduced activity in people with hepatitis C virus (HCV) genotype (GT) 3 infection and cirrhosis. The C‐ISLE study assessed the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) plus sofosbuvir (SOF) with and without ribavirin (RBV) in compensated cirrhotic participants with GT3 infection. This was a phase 2, randomized, open‐label study. Treatment‐naive participants received EBR/GZR + SOF + RBV for 8 weeks or EBR/GZR + SOF for 12 weeks, and peginterferon/RBV treatment‐experienced participants received EBR/GZR + SOF ± RBV for 12 weeks or EBR/GZR + SOF for 16 weeks. The primary endpoint was HCV RNA <15 IU/mL 12 weeks after the end of treatment (sustained virologic response at 12 weeks [SVR12]). Among treatment‐naive participants, SVR12 was 91% (21/23) in those treated with RBV for 8 weeks and 96% (23/24) in those treated for 12 weeks. Among treatment‐experienced participants, SVR12 was 94% (17/18) and 100% (17/17) in the 12‐week arm, with and without RBV, respectively, and 94% (17/18) in the 16‐week arm. Five participants failed to achieve SVR: 2 relapsed (both in the 8‐week arm), 1 discontinued due to vomiting/cellulitis (16‐week arm), and 2 discontinued (consent withdrawn/lost to follow‐up). SVR12 was not affected by the presence of resistance‐associated substitutions (RASs). There was no consistent change in insulin resistance, and 5 participants reported serious adverse events (pneumonia, chest pain, opiate overdose, cellulitis, decreased creatinine). High efficacy was demonstrated in participants with HCV GT3 infection and cirrhosis. Treatment beyond 12 weeks was not required, and efficacy was maintained regardless of baseline RASs. Conclusion: Data from this study support the use of EBR/GZR plus SOF for 12 weeks without RBV for treatment‐naive and peginterferon/RBV–experienced people with GT3 infection and cirrhosis (ClinicalTrials.gov NCT02601573). (Hepatology 2018;67:2113‐2126)
Editor: United States: Wiley Subscription Services, Inc
Idioma: Inglês

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Elbasvir/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial

United States: Wiley Subscription Services, Inc

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