Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection

Phase 2 Completed 196 enrolled Bristol-Myers Squibb

RandomizedParallel-groupTriple-blindTreatment

Summary

To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.

Timeline

Start: 2010-12
Primary completion: 2012-05
Completion: 2012-09

Outcome

Met primary endpoint

registry Difference 20.8 (80% CI 4.9 to 36.8) NCT01257204 ↗

registry Difference 20.1 (80% CI 3.9 to 36.3) NCT01257204 ↗

paper the lower bound of the 80% confidence interval of the difference in SVR24 rates between the daclatasvir and placebo arms was above -20%, establishing noninferiority. PMID 25311593 ↗

Publications

Dore GJ, Lawitz E, Hezode C, Shafran SD, Ramji A, Tatum HA, Taliani G, Tran A, Brunetto MR, Zaltron S, Strasser SI, Weis N, Ghesquiere W, Lee SS, Larrey D, Pol S, Harley H, George J, Fung SK, de Ledinghen V, Hagens P, McPhee F, Hernandez D, Cohen D, Cooney E, Noviello S, Hughes EA. Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection. Gastroenterology. 2015 Feb;148(2):355-366.e1. doi: 10.1053/j.gastro.2014.10.007. Epub 2014 Oct 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daclatasvir	Small molecule	60 mg	Oral
Background	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Background	Ribavirin	Small molecule	800 mg	Oral