Bristol-Myers Squibb Company (NYSE: BMY) today 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 (SVR 12) in 93% (13/14) of treatment-naïve, genotype 1b chronic hepatitis C patients who achieved a protocol-defined response (PDR) 1. The SVR12 rate for all genotype 1 infected patients in the Lambda/RBV/DCV group was 76% (28/37). These study findings were presented in a late breaker presentation at the American Association for the Study of Liver Diseases (AASLD) congress in Boston. The Company also presented SVR 4 results from the D-LITE Japanese sub-study, where all subjects were infected with HCV genotype 1b and SVR 12 was 100%. SVR results from the EMERGE Phase IIb study of Lambda versus alfa interferon (alfa) in treatment-naïve genotype 1 or 4 patients were also presented.
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.
“Despite the desire for all-oral regimens without alfa interferons for the treatment of chronic hepatitis C, it is likely that certain patient populations will require interferon-based therapies to eradicate hepatitis C. Development of lambda interferon is an important goal for such patients, especially those who cannot tolerate or refuse to use alfa interferon,” said D-LITE lead investigator John M. Vierling, M.D., FACP, Professor of Medicine and Surgery, Director of Baylor Liver Health, and Chief of Hepatology at the Baylor College of Medicine in Houston, TX. “Treatment with lambda interferon combined with daclatasvir and ribavirin achieved high rates of sustained virologic response, and the data support further study of regimens using lambda interferon to address the medical needs of hepatitis C patients who cannot use alfa interferons.”