Gastroenterology
Volume 141, Issue 6 , Pages 2047-2055 , December 2011

Efficacy of the Protease Inhibitor BI 201335, Polymerase Inhibitor BI 207127, and Ribavirin in Patients With Chronic HCV Infection

  • Stefan Zeuzem

      Affiliations

    • J. W. Goethe University Hospital, Frankfurt, Germany
    • Corresponding Author InformationReprint requests Address requests for reprints to: Stefan Zeuzem, MD, Johann Wolfgang Goethe University Hospital, Frankfurt, Germany. fax: (49) 696 301 6448
    • ,
  • Tarik Asselah

      Affiliations

    • Service d'Hépatologie, Hôpital Beaujon, Université Diderot-Paris 7, and INSERM U773, CRB3, Clichy, France
    • ,
  • Peter Angus

      Affiliations

    • Austin Hospital, Heidelberg, Victoria, Australia
    • ,
  • Jean–Pierre Zarski

      Affiliations

    • Hôpital Albert Michallon, Grenoble, France
    • ,
  • Dominique Larrey

      Affiliations

    • Hôpital Saint-Eloi, Montpellier, France
    • ,
  • Beat Müllhaupt

      Affiliations

    • University Hospital of Zürich, Zürich, Switzerland
    • ,
  • Ed Gane

      Affiliations

    • Auckland City Hospital, Auckland, New Zealand
    • ,
  • Marcus Schuchmann

      Affiliations

    • University Medical Center Mainz, Mainz, Germany
    • ,
  • Ansgar Lohse

      Affiliations

    • University Hospital Hamburg-Eppendorf, Hamburg, Germany
    • ,
  • Stanislas Pol

      Affiliations

    • Hôpital Cochin, Paris, France
    • ,
  • Jean–Pierre Bronowicki

      Affiliations

    • University Hospital of Nancy, Vandoeuvre-lès-Nancy, France
    • ,
  • Stuart Roberts

      Affiliations

    • Alfred Hospital, Melbourne, Victoria, Australia
    • ,
  • Keikawus Arasteh

      Affiliations

    • Epimed GmbH, Berlin, Germany
    • ,
  • Fabien Zoulim

      Affiliations

    • Hepatology Department, Hospices Civils de Lyon, Lyon University, Lyon, France
    • ,
  • Markus Heim

      Affiliations

    • University Hospital Basel, Basel, Switzerland
    • ,
  • Jerry O. Stern

      Affiliations

    • Boehringer Ingelheim, Ridgefield, Connecticut
    • ,
  • George Kukolj

      Affiliations

    • Boehringer Ingelheim (Canada) Ltd, Laval, Quebec, Canada
    • ,
  • Gerhard Nehmiz

      Affiliations

    • Boehringer-Ingelheim Pharma GmbH & Co KG, Biberach, Germany
    • ,
  • Carla Haefner

      Affiliations

    • Boehringer-Ingelheim Pharma GmbH & Co KG, Biberach, Germany
    • ,
  • Wulf Otto Boecher

      Affiliations

    • Boehringer-Ingelheim Pharma GmbH & Co KG, Biberach, Germany

Received 3 June 2011 ,Accepted 30 August 2011.

  • Image Result

    Trial schema. eRVR, extended rapid virologic response (HCV RNA level ≤25 IU/mL at week 4, and HCV RNA undetectable from weeks 5 to 18); QD, once daily; TID, 3 times daily.

    Trial schema. eRVR, extended rapid virologic response (HCV RNA level ≤25 IU/mL at week 4, and HCV RNA undetectable from weeks 5 to 18); QD, once daily; TID, 3 times daily.

  • Image Result

    Patient disposition.

    Patient disposition.

  • Image Result

    Absolute HCV RNA level from baseline to day 29 for individual patients in (A) the BI 207127 400 mg dose group and (B) the BI 207127 600 mg dose group. *Patient with virologic breakthrough observed dur

    Absolute HCV RNA level from baseline to day 29 for individual patients in (A) the BI 207127 400 mg dose group and (B) the BI 207127 600 mg dose group. *Patient with virologic breakthrough observed during treatment at day 22. **Patient with an increase in HCV RNA from nadir of 0.7 log10 IU/mL. LLOD, 17 IU/mL; LLOQ, 25 IU/mL.

 Watch this article's video abstract and others at http://tiny.cc/j026c.

 This article has an accompanying continuing education activity on page e14. Learning Objective: Upon completion of this CME activity, successful learners will be able to explain details on the design and results of the SOUND-C1 clinical trial (BI 201335, BI 207127 and RBV in treatment-naïve patients with chronic HCV GT-1 infection) and assess the potential for this regimen as a future treatment for this patient population.

 Conflicts of interest The authors disclose the following: S.Z. is a consultant for Abbott Laboratories, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, iTherX, Janssen/Tibotec, Merck, Novartis, Pfizer, Pharmasset, Roche/Genentech, Santaris Pharma, and Vertex Pharmaceuticals. T.A. is a consultant for Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, Novartis, and Roche. J.-P.Z. is a consultant for Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Roche, Janssen, and Merck/Schering-Plough. D.L. is a consultant for Boerhinger Ingelheim, Bristol-Myers Squibb, Roche, Janssen, Merck, and Cytheris. B.M. is a consultant for MSD, Roche, Janssen, and Gilead Sciences. M.S. is a consultant for Bristol-Myers Squibb and Roche and a speaker for Bristol-Myers Squibb, Falk, Gilead Sciences, Merck, and Roche. A.L. has participated in trials for Boehringer Ingelheim, Roche, MSD, Janssen, and Falk and has received lecture fees from MSD, Roche, and Falk. S.P. is a consultant for Bristol-Myers Squibb, Boehringer Ingelheim, Tibotec/Janssen-Cilag, Gilead Sciences, Roche, Merck/Schering-Plough, and Abbott Laboratories; is a speaker for GlaxoSmithKline, Bristol-Myers Squibb, Boehringer Ingelheim, Tibotec/Janssen-Cilag, Gilead Sciences, Roche, and Schering-Plough; and has received grants from Bristol-Myers Squibb, Gilead Sciences, Roche, and Merck/Schering-Plough. J.-P.B. is a consultant for Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Novartis, and Roche. F.Z. is a consultant for Janssen, Schering-Plough, and Vertex Pharmaceuticals. M.H. is a consultant for Novartis, MSD, Roche, Jansen, and Gilead Sciences. J.O.S., G.K., G.N., C.H., and W.O.B. are employees of Boehringer Ingelheim. The remaining authors disclose no conflicts.

PII: S0016-5085(11)01248-0

doi: 10.1053/j.gastro.2011.08.051

Gastroenterology
Volume 141, Issue 6 , Pages 2047-2055 , December 2011

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