The European Commission has granted an additional indication for GlaxoSmithKline's (GSK's) Revolade (eltrombopag) as a treatment for low platelet counts (thrombocytopenia) in adult patients with chronic hepatitis C infection, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon (IFN)-based therapy.
Thrombocytopenia (platelet count =150Gi/L) can occur in people with chronic hepatitis C infection as a consequence of liver damage. It is also a common side effect of peginterferon (pIFN)-based therapy.
Twenty Five per cent of patients with chronic hepatitis C have thrombocytopenia and up to nine per cent of patients are severely thrombocytopenic (platelet count <50Gi/L).
Thrombocytopenia may prevent the initiation and maintenance of pIFN-based treatment, thereby reducing a patient’s chances of achieving a sustained virologic response (SVR) - the primary goal of hepatitis C treatment.
“Until now, prescribers were without an option for treating low platelet counts in patients with chronic hepatitis C infection” said Paolo Paoletti, president, GlaxoSmithKline Oncology. “Today’s announcement is important as it means that healthcare professionals can now use Revolade to help patients start and stay on interferon therapy which will facilitate achieving the best outcome for these individuals - that being a sustained virologic response.”
The marketing authorisation granted to eltrombopag is based on results from ENABLE-1 and -2 (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C related Liver DiseasE), two phase III global, multicentre, two-part studies (n=1,520), that comprised an open-label pre-antiviral treatment phase and a randomised, double-blind, placebo-controlled antiviral treatment phase. Eighty percent of the patients had bridging fibrosis or cirrhosis. ENABLE-1 utilised peginterferon alfa-2a plus ribavirin for antiviral treatment and ENABLE-2 utilised peginterferon alfa-2b plus ribavirin.
Phase III clinical studies demonstrated that eltrombopag may achieve and maintain target platelet counts in chronic hepatitis C patients with associated thrombocytopenia.
Eltrombopag, marketed under the brand name Revolade in Europe and most ex-US countries, and Promacta in the US, is an oral thrombopoietin receptor agonist licensed in over 90 countries around the world as a treatment for thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP). Eltrombopag, indicated in adult patients as a once-daily oral therapy, was approved for chronic hepatitis C-associated thrombocytopenia by the European Commission on Thursday 19 September 2013. Promacta/ Revolade is approved for chronic hepatitis C associated thrombocytopenia in Argentina, Australia, Bangladesh, Pakistan, Philippines and the US.
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