BMS-790052 Demonstrates up to 83% SVR24 in Phase II Study of Genotype 1

Bristol-Myers Squibb Co. announced results from a Phase II clinical trial of 48 treatment-naive genotype 1 hepatitis C infected patients in which treatment with BMS-790052, an NS5A replication complex inhibitor, in combination with peginterferon alfa and ribavirin (pegIFNalfa/RBV) maintained undetectable viral load at 24 weeks post-treatment (SVR24) in 83% (60 mg), 83% (10 mg) and 42% (3 mg) of patients, compared with 25% of patients in the pegIFNalfa/RBV control group after 48 weeks of combination therapy.

In this study, serious adverse events were reported in one patient (8.3%) from each of the BMS-790052 treatment groups and in zero patients from the control group. The data were reported at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago. BMS-790052 plus pegIFNalfa/RBV achieved higher rates of SVR24 compared to pegIFNalfa/RBV alone across all BMS-790052 treatment groups [BMS-790052: 60 mg: 83% (n=10/12), 10 mg: 83% (10/12), 3 mg: 42% (5/12); control: 25% (3/12)].

Adverse events (AEs) leading to discontinuation with BMS-790052 plus pegINFalfa/RBV were comparable with treatment with pegIFNalfa/RBV plus placebo. One patient (8.3%) in each of the 3 mg and 10 mg groups and four patients (33.3%) in the 60 mg group discontinued due to AEs, compared with two patients (16.7%) in the control group. Reasons for discontinuation were a diverse set of AEs sometimes associated with the use of pegIFNalfa/RBV.

Source: www.reuters.com