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INCIVO® (Telaprevir) SVR Rates Unaffected by Ribavirin Dose Reduction in Treatment Naïve and Previously Treated Patients With Genotype-1 Chronic HCV
Date:4/18/2012

sup>[2] Anaemia is a common side-effect of HCV treatment and can often be managed by the reduction of ribavirin, among other management strategies.[2]

Jim Witek, Senior Medical Director, Janssen said "The results of these 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. Janssen remains dedicated to improving treatment options and outcomes for patients with HCV."

About the Phase 3 retrospective sub-analyses

ADVANCE, ILLUMINATE and REALIZE were Phase 3 trials involving 2,290 patients to evaluate the efficacy, safety and tolerability of telaprevir in combination with peginterferon alfa and ribavirin in patients with genotype-1 chronic HCV.[3,4,5] In these retrospective sub-analyses, the ADVANCE and ILLUMINATE patients who received 24 or 48 weeks total treatment with PR alone and 12 weeks of telaprevir (T12PR) were compared to those who received 48 weeks of PR alone (PR).[1] In the REALIZE retrospective sub-analysis, patients who received 48 weeks total treatment with PR alone (PR) were compared to patients receiving the simultaneous start telaprevir-based regimen (T12PR48): 12 weeks of telaprevir and PR plus 36 weeks PR alone.[1] Patients who took erythropoietin stimulating agents or did not have a hemoglobin measurement at baseline were excluded. Efficacy outcomes were assessed based on ribavirin dose reductions in populations from ADVANCE and ILLUMINATE, separately to those from the REALIZE trial.[1]

Among treatment-naïve patients in ADVANCE and ILLUMINATE, 68% (604/885) who received T12PR had a ribavirin dose reduction.[1] Among previously treated patients who received T12PR48 in the REA
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SOURCE Janssen Pharmaceutica N.V
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