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Positive Phase III Results With Simeprevir in Hepatitis Patients

NDA submitted for treatment of genotype 1 hepatitis C (May 21)

Positive results have been reported from the global phase III PROMISE trial, which compared the investigational protease inhibitor simeprevir (TMC435; Janssen R&D Ireland), administered once daily with pegylated interferon (peg-IFN) and ribavirin, with placebo plus peg-IFN and ribavirin in treatment-experienced genotype 1 chronic hepatitis C adult patients with compensated liver disease, including all stages of liver fibrosis.

Simeprevir plus peg-IFN and ribavirin achieved a sustained virologic response 12 weeks after the end of treatment (SVR12) in 79% of patients, compared with 37% of patients receiving placebo plus peg-IFN and ribavirin.

In the simeprevir arm, the on-treatment failure rate was 3% and the relapse rate was 19%, compared with 27% and 48%, respectively, in the placebo arm. All of the patients had previously relapsed following peg-IFN–based therapy.

The new findings were presented May 21 at the Digestive Disease Week 2013 conference in Orlando, Florida.

Patients enrolled in the PROMISE trial were stratified by hepatitis C virus (HCV) genotype 1 subtype and IL28B genotype. SVR12 rates among patients treated with simeprevir according to IL28B genotype were 89% for the CC allele, 78% for the CT allele, and 65% for the TT allele, compared with 53%, 34%, and 19%, respectively, in the placebo arm.

The most common adverse events observed in patients receiving simeprevir versus placebo included fatigue (32% vs. 42%, respectively), headache (32% vs. 36%), and influenza-like illness (30% vs. 20%).

Simeprevir is an investigational NS3/4A protease inhibitor developed for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. The drug works by blocking the protease enzyme that enables HCV to replicate in host cells. A new drug application (NDA) was recently submitted for simeprevir for the treatment of genotype 1 hepatitis C.

Source: Johnson & Johnson; May 21, 2013.

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