Phase III data for INCIVO® (telaprevir) was presented at the American Association for the Society of Liver Disease (AASLD) 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 (PR), was associated with cure rates (defined as a sustained virologic response (SVR)) significantly higher than PR alone in patients with genotype-1 chronic HCV and cirrhosis (47% vs. 10% respectively).
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 (except previous treatment relapsers), 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 (DAAs), including telaprevir,” said Prof. Stanislas Pol, Lead Study Investigator, Hôpital Cochin, Paris, France.
“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.”
REALIZE was a randomised, double-blind, placebo-controlled Phase 3 trial to compare the efficacy, safety and tolerability of telaprevir in 662 patients with chronic genotype-1 HCV who failed prior treatment with PR.
Patients received 48 weeks total treatment with PR alone or one of two telaprevir- based regimens (T/PR): 12 weeks T/PR plus 36 weeks PR alone, or four weeks PR alone followed by 12 weeks T/PR and 32 weeks PR alone.
In this sub-analysis, efficacy and safety variables were reanalysed for 662 patients with and without baseline cirrhosis.
Adverse events were consistent with those reported in the Phase 3 studies. Rash, pruritus and anemia (Hb <10 g/dL) were more frequent in cirrhotic patients receiving telaprevir (42%, 53% and 39% respectively) than PR alone. Adverse events led to discontinuation of telaprevir in 15% of cirrhotic and 12% of non-cirrhotic patients.
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.