Postmarketing surveillance of telaprevir-based triple therapy for chronic hepatitis C in Japan

Aim An observational postmarketing study was conducted to evaluate the real‐world safety and efficacy of an NS3‐4A protease inhibitor, telaprevir (TVR), in combination with pegylated interferon‐α‐2b (PEG IFN) and ribavirin (RBV), for patients with chronic hepatitis C (CHC). Here, we report an interi...

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Bibliographic Details
Published in:Hepatology research 2015-12, Vol.45 (13), p.1267-1275
Main Authors: Shiraishi, Muneshige, Umebayashi, Itsuro, Matsuda, Hiroaki, Sawamura, Keisuke, Okada, Aiko, Karino, Masako, Nogami, Yoshihide
Format: Article
Language:English
Subjects:
anemia
postmarketing surveillance
serious renal dysfunction
skin disorders
telaprevir
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Summary:Aim An observational postmarketing study was conducted to evaluate the real‐world safety and efficacy of an NS3‐4A protease inhibitor, telaprevir (TVR), in combination with pegylated interferon‐α‐2b (PEG IFN) and ribavirin (RBV), for patients with chronic hepatitis C (CHC). Here, we report an interim analysis of data from 3563 patients. Methods Patients were treated with TVR, PEG IFN and RBV for 12 weeks, followed by PEG IFN and RBV for 12 weeks (triple therapy). Safety was evaluated throughout the 24‐week treatment period. Risk factors for development of the three important adverse drug reactions (ADR), skin disorders, grade 3 anemia (hemoglobin level
ISSN:1386-6346
1872-034X
DOI:10.1111/hepr.12502