FDA approval of a new drug, eltrombopag, capable of boosting low platelet counts, in patients with hepatitis C virus (HCV) may mean new treatment options for thousands of veterans currently struggling with the disease.
And, for those patients who cannot tolerate interferon even with higher platelet counts, two recent studies provide hope of alternative treatments in the coming years.
Nearly 150,000 veterans in VHA care have hepatitis C. About 13% of them — or about 19,000 veterans — have developed cirrhosis as a complication of their hepatitis. For many cirrhotics, thrombocytopenia, or low platelet count, has prevented treatment of HCV.
“Patients with cirrhosis, complicated by thrombocytopenia, are in the greatest need of treatment for hepatitis C,” Mitchell Shiffman, MD, director of the Liver Institute of Virginia at Bon Secours Health Systems told U.S. Medicine. “If they can’t be treated, they must wait until their liver deteriorates enough to get a transplant.”
A recent study of 467 patients found that 7.6% of HCV infected individuals had thrombocytopenia. A 2010 review of 27 studies suggested that the rate might be 24% or higher.
Severe thrombocytopenia is considered a contraindication for use of interferon, because the drug suppresses platelet development. Even patients with moderate thrombocytopenia might not be good candidates for standard HCV therapy because of the risk of interferon-induced thrombocytopenia that could require termination of therapy or reductions in dosage.
“Patients with severe thrombocytopenia and cirrhosis cannot afford to have therapy managed with dose reduction, because the effectiveness of treatment is substantially impaired,” said Shiffman. “The approval of eltrombopag allows us to pharmacologically increase platelet counts so that we can initiate and maintain treatment in patients who could not otherwise be treated and achieve a sustained virologic response.”
New Therapies for HCV Infection on the Horizon
Eltrombopag is not without risks. The drug may cause hepatotoxicity and, when combined with interferon and ribavirin in HCV treatment, may increase the risk of liver decompensation. As a result, the drug contains a boxed warning that eltrombopag should only be used in patients whose thrombocytopenia is so severe that they could not otherwise start interferon-based HCV therapy.
Compensating for the effects of interferon will help some patients with HCV, but a different approach may be needed for others. A pair of studies recently published in the New England Journal of Medicine indicate that interferon-free therapies for HCV infection might be on the horizon.
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Clinical Trials for Viral Hepatitis
Clinical trials offer patients with chronic liver disorders the opportunity to receive new and potentially highly effective medications that are not currently available by prescription.
Source: U.S. Medicine