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Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C
  1. M Colombo1,
  2. I Fernández2,
  3. D Abdurakhmanov3,
  4. P A Ferreira4,
  5. S I Strasser5,
  6. P Urbanek6,
  7. C Moreno7,
  8. A Streinu-Cercel8,
  9. A Verheyen9,
  10. W Iraqi10,
  11. R DeMasi11,
  12. A Hill12,
  13. J M Läuffer13,
  14. I Lonjon-Domanec10,
  15. H Wedemeyer14
  1. 1Department of Medicine, Division of Gastroenterology, Fondazione IRCCS Ca` Granda Ospedale Maggiore Policlinico, Universita` degli Studi di Milano, Milan, Italy
  2. 2Hospital Universitario 12 de Octubre, Sección de Aparato Digestivo, Madrid, Spain
  3. 3I.M. Sechenov First Moscow State Medical University, E. M. Tareev Clinic for Nephrology, Internal and Occupational Medicine, Moscow, Russia
  4. 4Viral Hepatitis Division of Infectious Disease, Outpatient Clinic to HIV, Federal University of São Paulo, São Paulo, Brazil
  5. 5AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia
  6. 6Department of Internal Medicine, First Medical Faculty, Charles University, and Central Military Hospital Prague, Prague, Czech Republic
  7. 7Liver Unit, Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium
  8. 8Carol Davila University of Medicine and Pharmacy, National Institute for Infectious Diseases, "Prof. Dr. Matei Bals", Bucharest, Romania
  9. 9Janssen Pharmaceutica, Beerse, Belgium
  10. 10Janssen Pharmaceuticals, Paris, France
  11. 11Janssen Research and Development, Titusville, New Jersey, USA
  12. 12Janssen Research and Development, High Wycombe, UK
  13. 13Janssen-Cilag AG, Zug, Switzerland
  14. 14Medizinische Hochschule Hannover, Hannover, Germany
  1. Correspondence to Professor Massimo Colombo, 1st Division of Gastroenterology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via F. Sforza 35, Milan 20122, Italy; massimo.colombo{at}


Background and aim Severe adverse events (AEs) compromise the outcome of direct antiviral agent-based treatment in patients with advanced liver fibrosis due to HCV infection. HEP3002 is an ongoing multinational programme to evaluate safety and efficacy of telaprevir (TVR) plus pegylated-interferon-α (PEG-IFNα) and ribavirin (RBV) in patients with advanced liver fibrosis caused by HCV genotype 1 (HCV-1).

Methods 1782 patients with HCV-1 and bridging fibrosis or compensated cirrhosis were prospectively recruited from 16 countries worldwide, and treated with 12 weeks of TVR plus PEG-IFN/RBV, followed by 12 or 36 weeks of PEG-IFN and RBV (PR) alone dependent on virological response to treatment and previous response type.

Results 1587 patients completed 12 weeks of triple therapy and 4 weeks of PR tail (53% cirrhosis, 22% HCV-1a). By week 12, HCV RNA was undetectable in 85% of naives, 88% of relapsers, 80% of partial responders and 72% of null responders. Overall, 931 patients (59%) developed grade 1–4 anaemia (grade 3/4 in 31%), 630 (40%) dose reduced RBV, 332 (21%) received erythropoietin and 157 (10%) were transfused. Age and female gender were the strongest predictors of anaemia. 64 patients (4%) developed a grade 3/4 rash. Discontinuation of TVR due to AEs was necessary in 193 patients (12%). Seven patients died (0.4%, six had cirrhosis).

Conclusions In compensated patients with advanced fibrosis due to HCV-1, triple therapy with TVR led to satisfactory rates of safety, tolerability and on-treatment virological response with adequate managements of AEs.


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