Volume 13 Supplement 1
Treatment of hepatitis C genotype 1 patients with severe fibrosis or compensated cirrhosis: the telaprevir early access program in patients from Romania
© Streinu-Cercel et al; licensee BioMed Central Ltd. 2013
Published: 16 December 2013
HEP3002 is an ongoing, open-label, early access program of telaprevir in 16 countries, for patients with genotype 1 hepatitis C with severe fibrosis or compensated cirrhosis. This interim analysis is of 16 week data from the 209 patients from Romania.
Patients were treated with telaprevir in combination with peginterferon alfa and ribavirin (PR) for 12 weeks, followed by PR for 12 or 36 weeks. Severe fibrosis/cirrhosis was defined by liver biopsy (Metavir F3-4 or Ishak 3-6) or non-invasive tests. Platelet count >90,000/cmm was required at entry. HCV RNA was evaluated at baseline and Weeks 4 and 12 of treatment. Virological response was defined as serum HCV RNA not detected, for the Intent to Treat (ITT) population.
Percent HCV RNA not detected
Week 4 (RVR)
Week 4+12 (eRVR)
Prior relapser (n=156)
Prior partial responder (n=6)
Prior null responder (n=15)
Nine patients (4%) discontinued TVR due to adverse events, including six (3%) for rash and one (<1%) for anaemia. The rate of serious adverse events was 9% and no patients died during the study.
In this telaprevir early access program for hard-to-cure patients with severe fibrosis or compensated cirrhosis, early on-treatment virological responses are encouraging. Rates of discontinuation of telaprevir for adverse events were similar to Phase 3 trials.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.