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Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.

Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis.

Author information

  • 1Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine and Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
  • 2Center for Liver Diseases, University of Chicago Medical Center, Chicago, IL, USA.
  • 3Hannover Medical School, Hannover, Germany.
  • 4German Center for Infection Research, Hannover-Braunschweig, Germany.
  • 5Department of Medicine at Mount Sinai Beth Israel Medical Center, New York, NY, USA.
  • 6Toranomon Hospital, Tokyo, Japan.
  • 7Sapporo-Kosei General Hospital, Sapporo, Japan.
  • 8College of Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital, Busan, South Korea.
  • 9Veterans Affairs Medical Center, Baylor College of Medicine, Houston, TX, USA.
  • 10Monash Health and Monash University, Melbourne, Victoria, Australia.
  • 11Hospital Provincial del Centenario, Servicio de Gastroenterología y Hepatología, Universidad Nacional de Rosario, Rosario, Argentina.
  • 12School of Medicine, China Medical University, Taichung, Taiwan.
  • 13Alfred Hospital and Monash University, Melbourne, Victoria, Australia.
  • 14Inje University Busan Paik Hospital, Busan, South Korea.
  • 15Bristol-Myers Squibb Research and Development, Princeton, NJ, USA.

Abstract

BACKGROUND & AIMS:

We compared outcomes by cirrhosis status across studies of the all-oral combination of daclatasvir (DCV) plus asunaprevir (ASV).

METHODS:

Outcomes from global and Japanese phase 2 and 3 clinical studies of DCV+ASV in patients with genotype (GT) 1b infection were assessed by cirrhosis status. Sustained virological response (SVR) was assessed in individual phase 3 studies; a pooled analysis was carried out for safety outcomes.

RESULTS:

In the Japanese phase 3 study, SVR12 was achieved by 91% of patients with cirrhosis (n = 22) and 84% of patients without cirrhosis (n = 200); in the global phase 3 study, SVR12 was achieved by 84% of patients with cirrhosis (n = 206) and by 85% of patients without cirrhosis (n = 437). The frequency of serious adverse events, adverse events leading to treatment discontinuation and treatment-emergent grade 3/4 laboratory abnormalities was low (<10%) and similar among patients with (n = 229) or without (n = 689) compensated cirrhosis receiving DCV+ASV. Grade 3/4 reductions in platelets and neutrophils were more common among patients with cirrhosis (1.3 and 2.2%, respectively) compared with those without cirrhosis (both 0.6%). Grade 3/4 liver function test abnormalities were less common among patients with cirrhosis (1.8%) compared with those without cirrhosis (3.5-4.7%). Alanine aminotransferase elevations were not associated with hepatic decompensation.

CONCLUSIONS:

The safety and efficacy of DCV+ASV were similar in patients with or without compensated cirrhosis. This all-oral, interferon- and ribavirin-free combination is an effective and well-tolerated treatment option for patients with HCV GT1b infection and cirrhosis. Trial registrations numbers: Clinicaltrials.gov identifiers: NCT01012895; NCT01051414; NCT01581203; NCT01497834.

KEYWORDS:

cirrhosis; direct acting antiviral; hepatitis C; safety

PMID:
26683763
DOI:
10.1111/liv.13049
[PubMed - in process]
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