Z Gastroenterol 2013; 51 - P_5_72
DOI: 10.1055/s-0032-1332186

Treatment of hepatitis C genotype 1 patients with severe fibrosis or compensated cirrhosis: The german telaprevir early access program

H Wedemeyer 1, S Mauss 2, HW Busch 3, A Umgelter 4, P Buggisch 5, H Klinker 6, S Zeuzem 7, W Iraqi 8, A Hill 9, JM Läuffer 10, I Lonjon-Domanec 8, M Colombo 11
  • 1Medizinische Hochschule Hannover, Hannover, Germany
  • 2Zentrum für HIV und Hepatogastroenterologie, Düsseldorf, Germany
  • 3Zentrum für Interdisziplinäre Medizin Münster GmbH, Münster, Germany
  • 4Klinikum rechts der Isar der TU München, II. Medizinische Klinik und Poliklinik, München, Germany
  • 5Asklepios Klinik, ifi-Institut für interdisziplinäre Medizin, Hamburg, Germany
  • 6Universitätsklinik Würzburg, Zentrum für Innere Medizin (ZIM), Würzburg, Germany
  • 7University Hospital, Johann Wolfgang Goethe-University, Frankfurt am Main, Germany
  • 8Janssen Pharmaceuticals, Paris, France
  • 9MetaVirology Ltd, London, UK
  • 10Janssen-Cilag AG, Baar, Switzerland
  • 11Università degli Studi di Milano, Department of Medicine, Division of Gastroenterology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy

Background and aims: 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.

Methods: Patients were treated with telaprevir, pegylated interferon-alpha and ribavirin (PR) for 12 weeks, followed by PR. Liver biopsy or non-invasive tests showing severe fibrosis (Metavir F3 or Ishak 3–4) or cirrhosis (Metavir F4 or Ishak 5–6) and platelet count >90 000/mm3 were required at entry. This interim (ITT) analysis included 16 week data from the first 93 patients in Germany.

Results: For the 93 patients in Germany, the mean age was 53 years and mean weight 83kg; 65% were Male and 100% Caucasian, 68% had HCV RNA levels ≥800,000 IU/mL, 53%/46% had severe fibrosis/cirrhosis, 31% had genotype 1a. Overall, 13 (14%) were treatment naïve, 23 (25%) prior relapsers, 49 (53%) prior non-responders and 8 (9%) had prior viral breakthrough. Up to week 16, 36 patients (39%) developed drug-related grade 1–4 anemia (Hb<11g/dL or >2.5g/dL reduction), 36 patients (39%) developed grade 1–3 rash and 27 patients (29%) developed pruritus. Sixteen patients (17%) discontinued telaprevir for adverse events, including 8 patients (9%) who discontinued for rash and 2 (2%) who discontinued for anemia. One cirrhotic patient, with diabetes at baseline, developed anaemia and hepatic failure and then died of multi-organ failure, one month after stopping telaprevir.

In the Intent to Treat analysis, the percentage of patients who had HCV RNA suppression <25 IU/mL (or undetectable) at Week 4 was 100% (62%) for treatment naïves, 91% (74%) for prior relapsers, and 65% (39%) for prior non-responders and viral breakthroughs. The percentage of patients who had HCV RNA suppression <25 IU/mL (or undetectable) at Week 12 was 100% (92%) for treatment naïves, 87% (83%) for prior relapsers, and 74% (63%) for prior non-responders and viral breakthroughs.

Conclusions: In this telaprevir early access program for patients with severe fibrosis or compensated cirrhosis, 72% of patients had undetectable HCV RNA by week 12 (ITT). Sixteen patients (17%) discontinued telaprevir for adverse events.