Janssen announces Incivo data from Phase 3 studies

18th April 2012 (Last Updated April 18th, 2012 18:30)

Janssen Pharmaceutica has reported the results from the Phase 3 retrospective sub-analyses of Incivo (telaprevir), indicated for the treatment of genotype-1 chronic hepatitis C virus (HCV) in adult patients.

Janssen Pharmaceutica

Janssen Pharmaceutica has reported the results from the Phase 3 retrospective sub-analyses of Incivo (telaprevir), indicated for the treatment of genotype-1 chronic hepatitis C virus (HCV) in adult patients.

Incivo is a small molecule, selective inhibitor of the HCV serine protease, and a member of the new class of medicine for the treatment of genotype-1 chronic HCV, direct acting antivirals (DAAs).

The Advance, Illuminate and Realize Phase 3 studies involved 2,290 patients to assess the efficacy, safety and tolerability of telaprevir in combination with peginterferon alfa and ribavirin (PR).

Additionally, the trials evaluated the impact of ribavirin dose reduction on sustained virologic response (SVR) rates in HCV patients who received treatment with telaprevir in combination with peginterferon alfa and ribavirin (T12PR) or PR alone.

In the T12PR arms, SVR was achieved by 74% of patients who received a dose reduction to 600mg and 75% who received a ribavirin dose reduction to 800-1000mg/day, compared to 79% of those who had no reduction in the ribavirin dose.

In 12 weeks of telaprevir and PR plus 36 weeks PR alone (T12PR48) arm, SVR was achieved by 93% of patients who received a dose reduction to 600mg and 83% who received a ribavirin dose reduction to 800-1000mg/day, compared to 82% who had no reduction in their ribavirin dose.

The data suggested that timing, duration and extent of ribavirin dose reduction showed no impact on SVR rates in the telaprevir treatment arms.

Medicine professor at the Johns Hopkins University School of Medicine, US, Mark Sulkowski said the results demonstrated that the reduction of ribavirin to help manage treatment-related anaemia when treating with telaprevir did not compromise the chance of clearing the virus.

Janssen senior medical director Jim Witek said the results of the analyses further support the efficacy of Incivo in genotype-1 chronic HCV compared to PR alone, even when ribavirin doses are reduced to help manage treatment-related anaemia.

 

Image: Incivo drug from Janssen Pharmaceutica exhibited no impact on SVR rates regardless of ribavirin dose reduction. Photo: Vberger.