You are here

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

Drug achieves sustained virologic response (Dec. 20)

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.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs