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GSK moves closer to hepatitis C indication for eltrombopag

GSK has reported encouraging results from two Phase III trials of its drug eltrombopag when used to boost low blood platelet counts in patients with hepatitis C virus infection, potentially opening up a lucrative new market for the drug

GSK has reported encouraging results from two Phase III trials of its drug eltrombopag when used to boost low blood platelet counts in patients with hepatitis C virus infection, potentially opening up a lucrative new market for the drug.

Hepatitis C patients often experience marked reductions in platelet counts (thrombocytopenia), which exclude them from therapy or require antiviral treatment to be halted early. The new data suggest that using eltrombopag as a supportive therapy can boost cure rates. 


Eltrombopag is already marketed as Promacta in the US and Revolade in Europe for low platelet counts in patients with the rare disorder idiopathic thrombocytopenic purpura (ITP), a small market with sales running at around $80m year-to-date.  

Some analysts have suggested that new indications in hepatitis C and thrombocytopenia linked to other forms of chronic liver disease could boost the sales potential of the drug up to blockbuster territory within the next five years.

Full results of the ENABLE 1 study and interim data from ENABLE 2 were presented at the American Association for the Study of Liver Diseases in San Francisco where it was also reported that deaths associated with hepatitis C have overtaken those caused by HIV.

ENABLE 1 showed that 14 per cent of hepatitis C patients treated with a widely-used regimen based on Roche's Pegasys (peginterferon alfa-2a) and ribavirin were cleared of the virus, but this increased to 23 per cent if eltrombopag was added to treatment.  

This finding was backed up in ENABLE 2, which found viral clearance rates of 19 per cent for the eltrombopag group and 13 per cent for placebo when given on top of treatment with Merck & Co's PEG-Intron (peginterferon alfa-2a) plus ribavirin.

While serious side effects were seen more commonly in the eltrombopag group (20 per cent versus 15 per cent), the rate of thromboembolic events was the same in both groups. 

Last year, the Food and Drug Administration (FDA) warned doctors to use caution when administering eltrombopag to patients at risk of thromboembolism, after a clinical trial in chronic liver disease patients was halted because of an excess of thrombotic events in the treatment arm compared to placebo.

"The ENABLE trials provide insight into a population that has generally been excluded from clinical trials because they are unable to initiate interferon therapy," said Rafael Amado, senior vice president, oncology development at GSK.

The company has however not yet divulged its plans to file for approval of eltrombopag for hepatitis C. 

"We will fully examine the efficacy and safety findings of both studies to evaluate the overall clinical benefit to these patients," added Amado.

9th November 2011

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