gms | German Medical Science

10. Kongress für Infektionskrankheiten und Tropenmedizin (KIT 2010)

Deutsche Gesellschaft für Infektiologie,
Deutsche AIDS-Gesellschaft,
Deutsche Gesellschaft für Tropenmedizin und Internationale Gesundheit,
Paul-Ehrlich-Gesellschaft für Chemotherapie

23.06. - 26.06.2010, Köln

Final results from Telaprevir (TVR) phase II studies in genotype 1 treatment – naive or experienced subjects with chronic hepatitis C

Ergebnisse des Phase II Studienprogramms mit Telaprevir (TVR) in der Erstlinientherapie und bei therapieerfahrenen Patienten mit chronischer Hepatitis C

Meeting Abstract

  • T. Berg - Universitätsklinikum Leipzig, Klinik und Poliklinik für Gastroenterologie und Rheumatologie – Sektion Hepatologie, Leipzig, Germany
  • T. Goeser - Uniklinik Köln, Klinik für Gastroenterologie und Hepatologie, Cologne, Germany
  • P. Buggisch - ifi – Institut für Interdisziplinäre Medizin, Hamburg, Germany
  • S. Mauss - Gemeinschaftspraxis, Düsseldorf, Germany
  • H. Wedemeyer - Medizinische Hochschule Hannover, Medizinische Klinik, Hannover, Germany
  • M. Beumont - Tibotec BVBA, Mechelen, Belgium
  • C. Vogt - Tibotec – Division of Janssen-Cilag GmbH, Neuss, Germany
  • S. Zeuzem - Universitätsklinikum Frankfurt, Medizinische Klinik 1, Frankfurt, Germany

10. Kongress für Infektionskrankheiten und Tropenmedizin (KIT 2010). Köln, 23.-26.06.2010. Düsseldorf: German Medical Science GMS Publishing House; 2010. DocP108

DOI: 10.3205/10kit163, URN: urn:nbn:de:0183-10kit1630

Published: June 2, 2010

© 2010 Berg et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.


Outline

Text

Introduction and objectives: Current standard of care (SOC) for treatment of HCV Genotype 1 (G1) naïve patients comprises of pegylated interferon (P) plus ribavirin (R) for 48 weeks resulting in a sustained viral response (SVR) of 42 to 46% in treated patients. Telaprevir (TVR) is a novel selective inhibitor of the HCV NS3-4A protease. We report here results from the phase II program.

Material and methods: PROVE 1 (n=263) and PROVE 2 (n=334) were randomized controlled phase IIb comparisons of 12 weeks telaprevir plus PR up to 48 weeks versus PR alone in G1 treatment-naïve patients. In the same population, the C208 study (n=161) compared Telaprevir dosed every 8 hours or every 12 hours in combination with P2a or P2b with a response guided therapy design. In treatment experienced patients, the PROVE 3 trial (n=453) compared different Telaprevir-based regimens to PR.

Results: Higher SVRs compared to SOC in treatment-naïve subjects were observed in the Telaprevir groups (61-69%) in the PROVE 1 and 2 studies as well as the C208 study (81–85%). In PROVE 3, 51% (vs. 14% in control) of previous non-responders achieved SVR. The most common AEs through week 48 included; pruritus, rash, anemia, fatigue, weakness and headaches. Overall discontinuation of all drugs due to rash was observed in 4–7% of the subjects.

Conclusion: Telaprevir-based triple therapy significantly improves SVR rates in comparison to SOC in G1 HCV infected patients. It offers the potential to reduce treatment duration by half in the majority of treatment-naive patients. Phase III studies of telaprevir-based regimen are currently underway.