What is FDA approved for the treatment of thrombocytopenia in chronic hepatitis C (hep C) infection?

Updated: Oct 07, 2019
  • Author: Vinod K Dhawan, MD, FACP, FRCPC, FIDSA; Chief Editor: BS Anand, MD  more...
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In November 2012, the FDA approved eltrombopag (Promacta), an oral thrombopoietin agonist, for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of IFN-based therapy. The approval was based on results from the phase 3 ltrombopag to Iitiate and Maintain Interferon ntiviral Treatment to enefit Subjects with Hepatitis C related iver Diseas (ENABLE) 1 and 2 trials, which showed eltrombopag significantly reduced the time to the first IFN dose reduction compared with placebo. [95, 96]

Because of this, a significant improvement in the virologic response was observed in the eltrombopag group compared with placebo. These randomized, double-blind, placebo-controlled, multicenter studies collectively enrolled 1521 patients with platelet counts less than 75,000/mcL. ENABLE 1 utilized PEG-IFN alfa-2a plus ribavirin for antiviral treatment and ENABLE 2 utilized PEG-IFN alfa-2b plus ribavirin.

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