Volume 13 Supplement 1

Proceedings of the 9th Edition of the Scientific Days of the National Institute for Infectious Diseases “Prof Dr Matei Bals”

Open Access

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

  • Adrian Streinu-Cercel1, 2Email author,
  • Anca Victorița Trifan3, 4,
  • Florin Alexandru Căruntu1, 2,
  • Ioan Sporea5,
  • Liliana Simona Gheorghe1, 6,
  • Manuela Curescu5,
  • Mihai Mircea Diculescu1, 6,
  • Mihai Voiculescu1, 6,
  • Oliviu Pascu7,
  • Isabelle Lonjon-Domanec8,
  • Andrew Martin Hill9 and
  • Sorin Rugină10, 11
BMC Infectious Diseases201313(Suppl 1):P58

https://doi.org/10.1186/1471-2334-13-S1-P58

Published: 16 December 2013

Background

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.

Methods

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.

Results

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)

73%

70%

93%

Prior relapser (n=156)

85%

81%

94%

Prior partial responder (n=6)

100%

83%

83%

Prior null responder (n=15)

80%

73%

80%

Overalla (n=209)

83%

79%

92%

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.

Conclusion

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

(1)
Carol Davila University of Medicine and Pharmacy
(2)
National Institute for Infectious Diseases “Prof.Dr. Matei Balş”
(3)
“Gr.T.Popa” University of Medicine and Pharmacy
(4)
Institute of Gastroenterology and Hepatology, “St Spiridon” Emergency Hospital
(5)
Victor Babeş University of Medicine and Pharmacy
(6)
Center for Digestive Diseases and Liver Transplantation, Fundeni Clinical Institute
(7)
Regional Institute of Gastroenterology and Hepatology
(8)
Janssen Pharmaceuticals
(9)
MetaVirology Ltd
(10)
Ovidius University
(11)
Clinical Hospital of Infectious Diseases

Copyright

© 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 (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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