Skip to main content


  • Poster presentation
  • Open Access

Treatment of hepatitis C genotype 1 patients with severe fibrosis or compensated cirrhosis: the telaprevir early access program in patients from Romania

  • 1, 2Email author,
  • 3, 4,
  • 1, 2,
  • 5,
  • 1, 6,
  • 5,
  • 1, 6,
  • 1, 6,
  • 7,
  • 8,
  • 9 and
  • 10, 11
BMC Infectious Diseases201313 (Suppl 1) :P58

  • Published:


  • Virological Response
  • Telaprevir
  • Severe Fibrosis
  • Viral Breakthrough
  • Null Responder


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.


Mean age was 52 years; 47% were male and 100% Caucasian, 59% had HCV RNA levels ≥800,000 IU/mL, 58%/42% had severe fibrosis/cirrhosis, 2% had genotype 1a, 14% were treatment naïve, 75% prior relapsers, 3% prior partial responders, 7% prior null responders and 1% had prior viral breakthrough. HCV RNA responses (percent undetectable) at weeks 4 and 12 (ITT analysis) are shown in Table 1.

Table 1

Percent HCV RNA not detected

Week 4 (RVR)

Week 4+12 (eRVR)

Week 12

Treatment-naïve (n=30)




Prior relapser (n=156)




Prior partial responder (n=6)




Prior null responder (n=15)




Overalla (n=209)




aincludes 2 patients with prior virological break-through, not in four categories above

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.

Authors’ Affiliations

Carol Davila University of Medicine and Pharmacy, Bucharest, Romania
National Institute for Infectious Diseases “Prof.Dr. Matei Balş”, Bucharest, Romania
“Gr.T.Popa” University of Medicine and Pharmacy, Iaşi, Romania
Institute of Gastroenterology and Hepatology, “St Spiridon” Emergency Hospital, Iaşi, Romania
Victor Babeş University of Medicine and Pharmacy, Timişoara, Romania
Center for Digestive Diseases and Liver Transplantation, Fundeni Clinical Institute, Bucharest, Romania
Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania
Janssen Pharmaceuticals, Paris, France
MetaVirology Ltd, London, UK
Ovidius University, Constanța, Romania
Clinical Hospital of Infectious Diseases, Constanța, Romania


© Streinu-Cercel et al; licensee BioMed Central Ltd. 2013

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 (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.