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Daclatasvir, Sofosbuvir, and Ribavirin for Hepatitis C Virus Genotype 3 and Advanced Liver Disease: A Randomized Phase III Study (ALLY-3+)
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Hepatology 28 January 2016
Vincent Leroy,1 Peter Angus,2 Jean-Pierre Bronowicki,3 Greg J Dore,4 Christophe Hezode,5 Stephen
Pianko,6 Stanislas Pol,7 Katherine Stuart,8 Edmund Tse,9 Fiona McPhee,10 Rafia Bhore,11 Maria Jesus
Jimenez-Exposito,11 Alexander J Thompson.12
Abstract
Patients with hepatitis C virus (HCV) genotype 3 infection, especially with advanced liver disease, are a challenging population in urgent need of optimally effective therapies. The combination of daclatasvir (DCV; pangenotypic NS5A inhibitor) and sofosbuvir (SOF; nucleotide NS5B inhibitor) for 12 weeks previously showed high efficacy (96%) in noncirrhotic genotype 3 infection.
The phase III ALLY-3+ study (N = 50) evaluated DCV-SOF with ribavirin (RBV) in treatment-naive (n = 13) or treatment-experienced (n = 37) genotype 3 patients with advanced fibrosis (n = 14) or compensated cirrhosis (n = 36). Patients were randomized 1:1 to receive open-label DCV-SOF (60 + 400 mg daily) with weight-based RBV for 12 or 16 weeks.
The primary endpoint was sustained virologic response at posttreatment week 12 (SVR12). SVR12 (intention-to-treat) was 90% overall (45/50): 88% (21/24) in the 12-week (91% observed) and 92% (24/26) in the 16-week group.
All patients with advanced fibrosis achieved SVR12. SVR12 in patients with cirrhosis was 86% overall (31/36): 83% (15/18) in the 12-week (88% observed) and 89% (16/18) in the 16-week group; for treatment-experienced patients with cirrhosis, these values were 87% (26/30), 88% (14/16; 93% observed) and 86% (12/14), respectively.
One patient (12-week group) did not enter posttreatment follow-up (death unrelated to treatment). There were 4 relapses (2 per group) and no virologic breakthroughs. The most common adverse events (AEs) were insomnia, fatigue and headache. There were no discontinuations for AEs, and no treatment-related serious AEs.
Conclusion: The all-oral regimen of DCV-SOF-RBV was well tolerated and resulted in high and similar SVR12 after 12 or 16 weeks of treatment among genotype 3-infected patients with advanced liver disease, irrespective of prior HCV treatment experience. This article is protected by copyright. All rights reserved.
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