November 16, 2012
BMS’s Hep C Therapy Shows 94% Cure Rate in Hard-to-Treat Patients
Bristol-Myers Squibb’s interferon-, ribavirin- and ritonavir-free triple combination hepatitis C virus (HCV) therapy showed a 94 percent cure rate in hard-to-treat patients, MedPage Today reports. The pharmaceutical company announced early results from its open-label, two-part Phase II study of three direct acting antivirals at the annual meeting of the American Association of the Study of Liver Disease (AASLD) in Boston. A previous study of HCV genotype-1-infected patients taking the agents daclatasvir, an NS5A replication complex inhibitor, and asunaprevir, an NS3 protease inhibitor, proved ineffective without pegylated-interferon and ribavirin (which are difficult to tolerate). So this study included BMS-791325, a non-nucleos(t)ide NS5B polymerase inhibitor, in hopes of achieving proof of both safety and significant antiviral activity with a triple therapy.
The drug regimen studied included once-a-day daclatasvir and twice-a-day asunaprevir and BMS-791325. Sixteen patients underwent 12 weeks of therapy, and another 16 participants took the regimen for 24 weeks. Three quarters of each study group had genotype 1a virus, which is the most difficult to treat, and the other quarter genotype 1b. Among the 12-week arm, 100 percent achieved undetectable viral load by the end of treatment, with 94 percent maintaining a sustained virologic response (SVR, considered a cure) 12 weeks after completing therapy. In the 24-week arm, 94 percent achieved an undetectable viral load by the end of treatment and an SVR four weeks later. It is still too early for data on their SVR rates 12 weeks after therapy. The combination therapy proved well tolerated, with no discontinuations due to side effects.
To read the MedPage Today article, click here.
To read the BMS release, click here.
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