Lambda plus daclatasvir (BMS) combination success in Phase IIb trial for Hepatitis C
BMS has announced for the first time interim results from the global, D-LITE Phase IIb study, in which a 24-week regimen combining the investigational compound Peginterferon lambda-1a (Lambda) with the investigational direct-acting antiviral (DAA) daclatasvir (DCV) and ribavirin (RBV), achieved sustained virologic response 12 weeks post-treatment (SVR12) in 93% (13/14) of treatment-na�ve, genotype 1b chronic Hepatitis C patients who achieved a protocol-defined response (PDR). The SVR12 rate for all genotype 1 infected patients in the Lambda/RBV/DCV group was 76% (28/37).
In the D-LITE study, adverse events were mostly low grade and self-limiting. In the Lambda/RBV/DCV treatment group, only one of 37 patients experienced a serious adverse event (breast cancer), which was unrelated to study drug.
These study findings were presented in a late breaker presentation at the American Association for the Study of Liver Diseases (AASLD) congress in Boston.
Based on these study results, the combination regimen of Lambda/RBV/DCV will move into Phase III development in 2013.
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