The New England Journal of Medicine has just published results on two different Phase II studies of all-oral combination therapies for the treatment hepatitis C. One study evaluating Daclatasvir plus Sofosbuvir and the other ABT-450 with ritonavir (ABT-450/r), combined with ABT-267/ABT-333. The two studies achieved a high rate of sustained virologic response (SVR) with few side effects.
HCV Therapy: High Rate of Viral Clearance, No Injections
Two phase 2, open-label studies evaluating the safety and efficacy of all-oral combination therapies for patients infected with hepatitis C virus (HCV) have shown that high rates of sustained virologic response (SVR) are possible even in the absence of interferon. Results from both studies were published in the January 16 issue of the New England Journal of Medicine.
Patients enrolled in both studies were between 18 and 70 years of age with no evidence of cirrhosis.
In the first study, Mark S. Sulkowski, MD, from Johns Hopkins University, Baltimore, Maryland, and colleagues evaluated the efficacy of combination therapy with once-daily, oral antiviral drugs daclatasvir (60 mg daily) and sofosbuvir (400 mg daily) for patients infected with HCV genotypes 1, 2, or 3. Patients were treated for 24 weeks, and use of ribavirin as part of the treatment protocol was optional.
The US Food and Drug Administration recently approved sofosbuvir for the treatment of HCV in combination with ribavirin or ribavirin and interferon, depending on the HCV genotype being treated. Daclatasvir remains an investigational agent.
Overall, 211 patients enrolled in the study. Among those with genotype 1 infection, 126 were previously untreated and 41 had failed previous therapy with telaprevir or boceprevir plus peginterferon alfa-ribavirin.