ALLY 3+ Trial Investigating Daklinza (daclatasvir) in Combination with Sofosbuvir and Ribavirin Demonstrates High Cure Rates in Chronic Hepatitis C Genotype 3 Patients with Advanced Fibrosis or Cirrhosis

Daclatasvir+sofosbuvir+ribavirin regimen achieves SVR12 rates of 88% and 92% overall for 12 or 16 weeks of therapy respectively in GT-3 patients with advanced fibrosis or cirrhosis

MONTREAL, Nov. 16, 2015 /CNW/ - Bristol Myers-Squibb today announced late-breaking data from the Phase 3 ALLY-3+ Trial investigating a regimen of Daklinza™ (daclatasvir, DCV) in combination with sofosbuvir (SOF) and ribavirin (RBV) in genotype 3 hepatitis C (HCV) patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. This patient population is one of the most difficult to treat, among whom sustained virologic response (SVR) rates, or cure, have proved harder to achieve with existing therapies.

The results show that SVR12 rates in cirrhotic patients only were 83 per cent  and 89 per cent in the 12- and 16-week arms, respectively. Results will be presented at The Liver Meeting® 2015, the Annual Meeting of The American Association for the Study of Liver Diseases (AASLD), in San Francisco, CA, November 13 – 17.

Daklinza is a potent, pan-genotypic NS5A replication complex inhibitor (in vitro) that has been approved for use in combination with sofosbuvir (marketed in Canada by Gilead Sciences Canada Inc. as SOVALDI™) as a convenient, all-oral, once-daily regimen for the treatment of adult patients with hepatitis C genotypes 1 and 2 with compensated liver disease including cirrhosis. Daklinza has also received a Notice of Compliance with conditions (NOC/c) from Health Canada for the treatment of genotype 3 patients with compensated liver disease including cirrhosis. In Canada, genotypes 3 accounts for 20 per cent of hepatitis C infections.


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