BioCentury
ARTICLE | Clinical News

Danoprevir: Phase IIb data

April 9, 2012 7:00 AM UTC

The double-blind, international Phase IIb INFORM-SVR trial in 169 treatment-naive patients with HCV genotype 1 infection showed that 41% of 63 evaluable patients who received twice-daily oral mericitabine, danoprevir and ritonavir, plus ribavirin for 24 weeks achieved an SVR defined as undetectable HCV RNA levels 8 weeks after the end of treatment. A subgroup analysis showed that rates of SVR 8 were 71% and 26% in patients with HCV genotype 1b (n=21) and 1a infections (n=42), respectively. At week 4, 91% of patients receiving mericitabine, danoprevir and ritonavir, plus ribavirin and 93% of patients receiving mericitabine, danoprevir and ritonavir, plus placebo achieved HCV RNA levels <=15 IU/mL. The combination was well tolerated with only 4 serious adverse events and 2 discontinuations due to adverse events reported. ...