Gastroenterology
Volume 138, Issue 3 , Pages 913-921 , March 2010

Rapid HCV-RNA Decline With Once Daily TMC435: A Phase I Study in Healthy Volunteers and Hepatitis C Patients

  • Henk W. Reesink

      Affiliations

    • Academic Medical Center, Amsterdam, The Netherlands
    • Corresponding Author InformationReprint requests Address requests for reprints to: Henk W. Reesink, MD, PhD, associate professor, Department of Gastroenterology and Hepatology, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. fax: (31) 2056 69582
    • ,
  • Gregory C. Fanning

      Affiliations

    • Tibotec Pharmaceuticals Ltd, Eastgate Village, Little Island, Cork, Ireland
    • ,
  • Khalid Abou Farha

      Affiliations

    • PRA International EDS, Zuidlaren, The Netherlands
    • ,
  • Christine Weegink

      Affiliations

    • Academic Medical Center, Amsterdam, The Netherlands
    • ,
  • André Van Vliet

      Affiliations

    • PRA International EDS, Zuidlaren, The Netherlands
    • ,
  • Gerben van 't Klooster

      Affiliations

    • Tibotec Pharmaceuticals Ltd, Eastgate Village, Little Island, Cork, Ireland
    • ,
  • Oliver Lenz

      Affiliations

    • Tibotec Pharmaceuticals Ltd, Eastgate Village, Little Island, Cork, Ireland
    • ,
  • Fatima Aharchi

      Affiliations

    • Tibotec Pharmaceuticals Ltd, Eastgate Village, Little Island, Cork, Ireland
    • ,
  • Kris Mariën

      Affiliations

    • Tibotec Pharmaceuticals Ltd, Eastgate Village, Little Island, Cork, Ireland
    • ,
  • Pieter Van Remoortere

      Affiliations

    • Tibotec Pharmaceuticals Ltd, Eastgate Village, Little Island, Cork, Ireland
    • ,
  • Herman de Kock

      Affiliations

    • Tibotec Pharmaceuticals Ltd, Eastgate Village, Little Island, Cork, Ireland
    • ,
  • Fabrice Broeckaert

      Affiliations

    • Tibotec Pharmaceuticals Ltd, Eastgate Village, Little Island, Cork, Ireland
    • ,
  • Paul Meyvisch

      Affiliations

    • Tibotec Pharmaceuticals Ltd, Eastgate Village, Little Island, Cork, Ireland
    • ,
  • Els Van Beirendonck

      Affiliations

    • Tibotec Pharmaceuticals Ltd, Eastgate Village, Little Island, Cork, Ireland
    • ,
  • Kenneth Simmen

      Affiliations

    • Tibotec Pharmaceuticals Ltd, Eastgate Village, Little Island, Cork, Ireland
    • ,
  • René Verloes

      Affiliations

    • Tibotec Pharmaceuticals Ltd, Eastgate Village, Little Island, Cork, Ireland

Received 22 July 2009 ,Accepted 15 October 2009.

References 

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  18. van ‘t Klooster GA, Vanwelkenhuysen I, Verloes R, et al. Pharmacokinetics of once-daily regimens of the novel HCV NS3/4a-protease inhibitor TMC435350, with and without pegIFN and ribavirin, in HCV-infected individuals. Hepatology. 2008;48:1158A
  19. Reesink H, Verloes R, Abou Farha K, et al. Safety of the HCV protease inhibitor TMC435350 in healthy volunteers and safety and activity in chronic hepatitis C infected individuals: a phase I study. J Hepatol. 2008;48:S28–S29
  20. Marcellin P, Reesink H, Berg T, et al. Antiviral activity and safety of TMC435 combined with peginterferon α-2a and ribavirin in patients with genotype 1 hepatitis C infection who failed previous IFN-based therapy. J Hepatol. 2009;50:S385
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 Conflicts of interest The authors disclose the following: Henk W. Reesink and Christine Weegink are employees of Academic Medical Center Amsterdam. Gregory C. Fanning, Gerben van 't Klooster, Oliver Lenz, Fatima Aharchi, Kris Mariën, Pieter Van Remoortere, Herman de Kock, Fabrice Broeckaert, Paul Meyvisch, Els Van Beirendonck, Kenneth Simmen, and René Verloes were all employees of Tibotec at the time of the study. Khalid Abou Farha and André Van Vliet were both employees of PRA International EDS and performed the healthy volunteer portion of the study, which was fully funded by Tibotec.

 Funding The clinical study was sponsored by Tibotec and designed by Tibotec employees and Henk Reesink.

PII: S0016-5085(09)01859-9

doi: 10.1053/j.gastro.2009.10.033

Gastroenterology
Volume 138, Issue 3 , Pages 913-921 , March 2010

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