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Viral hepatitis
P66 SVR with telaprevir, peginterferon alfa-2A and ribavirin in HCV patients with well-characterised prior null response, partial response, viral breakthrough or relapse after peginterferon+ ribavirin
  1. G Dusheiko1,
  2. T Berg2,
  3. J M Pawlotsky3,
  4. P Ferenci4,
  5. S Zeuzem5,
  6. A J Muir6,
  7. F Poordad7,
  8. M L Shiffman8,
  9. J Heathcote9,
  10. H Reesink10,
  11. N Adda11,
  12. J G McHutchison6
  1. 1Royal Free and University College School of Medicine, London, UK
  2. 2University Clinic of Leipzig, Leipzig, Germany
  3. 3Hôpital Henri Mondor, Créteil, France
  4. 4University of Vienna, Vienna, Austria
  5. 5Johann Wolfgang Goethe University Medical Center, Frankfurt/Main, Germany
  6. 6Duke University Medical Center, Durham, NC, USA
  7. 7Cedars-Sinai Medical Center, Los Angeles, CA, USA
  8. 8Bon Secours Health System, Liver Institute of Virginia, Newport News, VA, USA
  9. 9University of Toronto, Toronto, ON, Canada
  10. 10Academisch Medical Center, University of Amsterdam, Amsterdam, The Netherlands
  11. 11Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA

Abstract

Introduction Study107 is an open-label rollover study of telaprevir (T) with peginterferon+ ribavirin (PR) in genotype-1 HCV patients who did not achieve SVR following PR treatment in telaprevir Phase 2 studies.

Method Null responders (<1-log10 HCV RNA decrease at week-4 or <2-log10 at week-12), partial responders (=2-log10 decrease at week 12, detectable at week 24), patients with viral breakthrough and relapsers from PROVE1/2/3 PR arms were eligible for treatment. Initially all patients received T 750 mg q8h plus PR at standard doses for 12 weeks, followed by 12 weeks of PR (T12/PR24). Protocol was amended to allow partial responders, viral breakthroughs and relapsers with undetectable HCV RNA at weeks 4 and 12 (eRVR) to receive T12/PR24. Partial responders, viral breakthroughs and relapsers with detectable HCV RNA at week 4 and/or week 12 and null responders received an additional 24 weeks of PR (T12/PR48).

Results Of 117 patients included in an ITT analysis, 97 (83%) had baseline HCV RNA=800 000 IU/ml, (69) 59% had genotype subtype 1a, 44 (38%) had cirrhosis or bridging fibrosis, and 9 (8%) were black. Viral breakthrough and relapse rates occurred in 25%, 23% of prior null responders; 10%, 22% of prior partial responders; 13%, 0% of prior viral breakthroughs; and 0%, 4% of prior relapsers.

Conclusion Patients with prior relapse, breakthrough and partial response exhibited high SVR rates after 24 weeks of telaprevir-based regimen. High SVR rates were also observed in patients with previous null response after 48 weeks of therapy.

Abstract P66 Table 1

Results: Patients achieving SVR

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