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Phase III Results Announced for Protease Inhibitor Simeprevir in Hepatitis C Patients

Drug achieves sustained virologic response (Dec. 20)

Preliminary results have been announced from three pivotal phase III trials that examined the investigational protease inhibitor simeprevir (TMC435, Medivir), administered with pegylated interferon (peg-IFN) and ribavirin, in patients with hepatitis C virus (HCV) infection.

Results from the QUEST-1 and QUEST-2 trials found that 80% and 81% of treatment- naïve patients with chronic genotype-1 HCV infection who were treated with simeprevir achieved sustained virologic response 12 weeks after the planned end of treatment (SVR 12). In additon, results from the PROMISE trial found that 79% of relapsed patients treated with simeprevir achieved SVR 12.

The overall safety, tolerability, and efficacy results from these studies were consistent with those of previous phase II trials.

In the QUEST-1 and QUEST-2 trials, 394 and 391 treatment-naïve patients with genotype-1 HCV infection, respectively, were randomly assigned to receive treatment with either 150 mg of once-daily simeprevir for 12 weeks plus peg-IFN and ribavirin for 24 or 48 weeks, based on response-guided treatment criteria (simeprevir group), or peg-IFN and ribavirin alone for 48 weeks (control group).

In the PROMISE trial, 393 patients who had relapsed after completing HCV treatment with peg-IFN and ribavirin were randomly assigned to receive treatment with either 150 mg of once-daily simeprevir for 12 weeks plus peg-IFN and ribavirin for 24 or 48 weeks, based on response-guided treatment criteria (simeprevir group), or peg-IFN and ribavirin alone for 48 weeks (control group).

In all three studies, adverse events leading to permanent discontinuation were lower in the simeprevir group compared with the control group.

Source: Medivir; December 20, 2012.

Medivir

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