The FINANCIAL — Janssen Pharmaceutica NV, today presented new data for INCIVO at the American Association for the Society of Liver Disease Annual Meeting, highlighting the safety and efficacy of a telaprevir based regimen in cirrhotic patients who had previously failed treatment.
Results from a sub-analysis of the REALIZE Phase 3 study showed that telaprevir, in combination with peginterferon alfa and ribavirin, was associated with cure rates significantly higher than PR alone in patients with genotype-1 chronic HCV and cirrhosis.1 HCV is a curable condition in the majority of cases, however, if left untreated can result in serious long-term health problems including cirrhosis. Cirrhosis causes permanent scarring of the liver which can eventually lead to liver failure and mortality.
Results showed that cirrhotic patients experienced significantly higher cure rates following treatment with a telaprevir-based regimen compared with PR alone. Overall, cirrhotic patients had lower cure rates than those without cirrhosis, however, treatment with a telaprevir-based regimen cured nearly half of all patients with cirrhosis.
“This year has seen significant advances in the treatment of HCV with the availability of direct-acting antivirals, including telaprevir. This is even more important for those patients who are experiencing the potentially devastating effects of HCV, such as cirrhosis. The REALIZE sub-analysis demonstrates that telaprevir maintains superior efficacy compared to PR alone in a group of patients that is typically hard to treat.” said Prof. Stanislas Pol, Lead Study Investigator, Université Paris Descartes, Inserm U-1016 and Liver Department, Hôpital Cochin, Paris, France.
Adverse events were consistent with those reported in the Phase 3 studies. Rash, pruritus and anemia were more frequent in cirrhotic patients receiving telaprevir than PR alone. Adverse events led to discontinuation of telaprevir in 15% of cirrhotic and 12% of non-cirrhotic patients.1
Telaprevir was approved by the European Commission for the treatment of genotype-1 chronic HCV in previously untreated and treatment-experienced patients in combination with peginterferon alfa and ribavirin in September 2011. The approval was based on the results of three Phase 3 studies in 2,290 patients: ADVANCE, ILLUMINATE and REALIZE.
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