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Title: Danazol Increases Platelet Counts in Thrombocytopenic Patients With Chronic Hepatitis C or Cirrhosis: Presented at AASLD

"Danazol Increases Platelet Counts in Thrombocytopenic Patients With Chronic Hepatitis C or Cirrhosis: Presented at AASLD"

By Maria Bishop BOSTON, MA -- November 5, 2007 -- Patients receiving the standard treatment of pegylated interferon alfa 2a plus ribavirin for chronic hepatitis C virus (HCV) may become thrombocytopenic, but are able to achieve increased platelet counts through danazol therapy, according to research presented here at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). This is the first report of using a novel alternative treatment for thrombocytopenia in this difficult patient population, noted lead author, Guillermo Cabrera-Alvarez, MD, Gastroenterology and Liver Department, Internal Medicine Division, Regional General Hospital - Family Medicine Unit #1, Mexican Social Security Institute, Cuernavaca, Morelos, Mexico. Dr. Cabrera-Alvarez and colleagues conducted an open-label clinical trial of 41 danazol-naďve patients with chronic HCV (90% with cirrhosis of the liver), who had developed thrombocytopenia as a result of treatment with pegylated interferon alga 2a plus ribavirin. The treatment group (n = 26, 20 female) received danazol at 300-600 mg/day until the end of the HCV therapy. Fifteen control subjects (9 females) were matched for baseline platelet count, presence of cirrhosis, age, sex, and HCV genotype, but were not considered thrombocytopenic. The mean baseline platelet count for treated patients was 75,300 ą 11,502, which was increased at the end of the study to 123,900 ą 30,411 ([P =.0063) in the 23 patients available for evaluation (20 females).

Of those 23 danazol-treated patients, 4 were considered non-responders, 7 were mild responders, and 12 were considered to have had a good response. Efficacy was evaluated as the capacity to increase platelet counts until the end of the treatment period.

In the control group (non-thrombocytopenic), the mean platelet count went from 238,953.3 ą 141,962.9 at baseline to 174,200 ą 91,643 at end of treatment (P =.9246).

Only two danazol-treated patients developed reversible cholestasis, noted Dr. Cabrera-Alvarez. No other patients presented with side effects.

"We believe that maybe [the mechanism of action] involves impairment of macrophage-mediated clearance of antibody-coated platelets via decreased Fc receptor expression, as in autoimmune thrombocytopenia," said Dr. Cabrera-Alvarez. Danazol has been used successfully to treat patients with autoimmune thrombocytopenia.

Danazol is a derivative of the synthetic steroid ethisterone, a modified testoterone. This drug decreases the follicle-stimulating hormone and luteinizing hormone. Liver function must be monitored on a periodic basis in patients receiving long-term therapy with danazol, as it is metabolised by the liver.

[Presentation title: Danazol Increases the Platelets Count in Thrombo-Cytopenic Patients with Chronic Hepatitis C and Liver Cirrhosis Treated With Peg-Interferon Alfa 2a and Ribavirin. Abstract 260]

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