Victrelis boceprevir: Additional Phase IIb data

Additional data from a double-blind Phase IIb trial in 95 evaluable patients with previously untreated HCV genotype 1 infection and stable HIV infection showed that a greater proportion of patients receiving thrice-daily 800 mg oral Victrelis plus standard of care (SOC; peginterferon alfa-2b and ribavirin) for 48 weeks achieved an SVR defined as undetectable HCV RNA levels (<9.3 IU/mL) 12 weeks after the end of treatment vs. placebo plus SOC (60.7% vs. 26.5%). HIV breakthrough, defined as a viral load >50 copies/mL for 2 consecutive visits, was observed in 3 patients receiving Victrelis plus SOC and 4 patients receiving placebo plus SOC.

Patients underwent a 4-week lead-in with SOC alone before being randomized to Victrelis or placebo in combination with SOC for 44 weeks. Patients with detectable HCV RNA and a <2 log10 reduction in HCV RNA at week 12 or detectable HCV RNA at week 24 were considered treatment failures and discontinued all treatment. The trial enrolled 100 patients. Data were presented at the Retroviruses and Opportunistic Infections meeting in Seattle. Merck previously reported 24-week data from the trial (see BioCentury, Oct. 24, 2011). ...