INCIVO® Receives Positive Opinion from the Committee for Medicinal Products for Human Use (CHMP) for Twice Daily Dosing

        
        1) Horsmans Y, Brown Jr. RS, Buti M et al. Safety and efficacy of twice
          daily versus every 8 hour telaprevir with peginterferon/ribavirin (PR) in patients
          with cirrhosis. 2013. European Association for the Study of the Liver (EASL) Poster
          985.
        2) Zeuzem S, Buti M, Agarwal K et al. Anemia and its management in patients
          treated with telaprevir twice-daily versus every 8 hours in the Phase III OPTIMIZE
          study. 2013. European Association for the Study of the Liver (EASL) Abstract 919.
        3) Buti M, Agarwal K, Horsmans Y. Efficacy of telaprevir dosed twice daily
          versus every 8 hours by IL28B genotype: results from the Phase III OPTIMIZE study.
          2013. European Association for the Study of the Liver (EASL) Abstract 798.
        4) Sievert W, Buti M, Agarwal K. Adherence with telaprevir BID vs q8h dosing in
          treatment-naïve HCV-infected patients: results from the Phase III OPTIMIZE study.
          2013. European Association for the Study of the Liver (EASL) Abstract 905.
        5) Buti M, Agarwal K, Horsmans Y, et al. OPTIMIZE Trial: Non-inferiority of
          twice-daily telaprevir versus administration of every 8 hours in treatment-naïve,
          genotype 1 HCV infected patients. 2012. American Association for the Study of Liver
          Diseases (AASLD) Abstract LB-8
        6) Colombo M, Fernández I, Abdurakhmanov D. Management and outcomes of anaemia
          in the International telaprevir Early Access Program, for patients with hepatitis C
          genotype 1 infection. 2013. European Association for the Study of the Liver (EASL)
          Abstract 806.
        7) Mathurin P, Sarrazin C, Reesink HW. Treatment with telaprevir-based therapy
          after exposure to PEG-IFN/RBV in the REALIZE study: results from the Phase IIIB C219
          rollover study. 2013. European Association for the Study of the Liver (EASL) Abstract
          868.
        8) Sarrazin C, Reesink HW, Zeuzem S. Treatment with telaprevir/PEG-IFN/RBV after
          14-day telaprevir exposure in Phase I studies: results from the Phase IIIB C219
          rollover study. 2013. European Association for the Study of the Liver (EASL) Abstract
          898.
        9) Nelson DR, Poordad F, Feld JJ, et al. High SVR rates (SVR4) for 12-week
          total telaprevir combination therapy in IL28B CC treatment-naïves and prior
          relapsers with G1 chronic hepatitis C: CONCISE interim analysis. 2013. European
          Association for the Study of the Liver (EASL) Abstract.
          10) INCIVO(R) Summary of Product Characteristics, updated 2013.
          11) Centres for Disease Control and Prevention. Hepatitis C FAQs. Available at:
          http://www.cdc.gov/hepatitis/C/cFAQ.htm#... (last accessed March 2013).
          12) Rosen, HR. Clinical practice. Chronic hepatitis C infection. N Engl J Med.
          2011 Jun 23;364(25):2429-38.
          13) World Health Organization. Hepatitis C Fact Sheet. Available at:
          http://www.who.int/mediacentre/factsheet... (last accessed March
          2013).
          14) WHO. State of the art of vaccine research and development. Viral Cancers.
          Available at: http://www.who.int/vaccine_research/docu...
          (last accessed March 2013).
          15) Mühlberger, N et al. HCV-related burden of disease in Europe: a systematic
          assessment of incidence, prevalence, morbidity, and mortality. BMC Public Health.
          2009;9(34):1-14.

        
        MEDIA CONTACT:
        Ronan Collins
        +44(0)7876-257-746
        Ines Hammer
        +33(6)8809-33-35