Wednesday, December 29, 2010

Low-Dose Ribavirin Helpful in HCV and Thalassemia

NEW YORK (Reuters Health) Dec 27 -

Low-dose ribavirin can be safely - and beneficially - added to peginterferon for adults with hepatitis C virus (HCV) infection and thalassemia major, Iranian researchers say.

Combination treatment with the two drugs is standard for HCV - but not for patients who have thalassemia major, because ribavirin therapy puts them at risk for life-threatening anemia.
In a December 9th online paper in the Journal of Hepatology, Dr. Seyed-Moayed Alavian and colleagues report on an open-label study testing the efficacy and safety of treating these patients with ribavirin, but at a reduced dose.

They enrolled 280 patients, all with quantifiable serum HCV RNA levels and liver biopsy findings consistent with chronic HCV infection. Patients received subcutaneous peginterferon alfa-2a weekly either alone or in combination with ribavirin 600 to 800 mg daily. The treatment choice was up to the patients themselves. The authors felt that since ribavirin is not approved for patients with hemoglobinopathies, randomization and blinding would be unethical.
Ribavirin was adjusted according to hemoglobin levels.
Everyone in the monotherapy group received 48 weeks of therapy. Combination therapy lasted 48 weeks if patients had genotype 1 or mixed infection, or 24 weeks if the virus was genotype 2 or 3.

At 24 weeks after the end of treatment, the rate of sustained virological response was significantly higher in the combination group than in monotherapy patients (51% versus 38%). Treatment discontinuations due to safety concerns were comparable between groups (6.5% versus 8.0%).

Further analysis showed that use of ribavirin increased the odds ratio of a sustained virologic response to 2.2.
However, transfusion intervals to maintain hemoglobin above 10 g/dL were almost halved in combination patients. The rate of decline to below 8 g/dL was 43% in the combination group and 37% in the monotherapy patients, but hemoglobin dynamics were not significantly different between groups.

The combination approach was less successful than monotherapy in the 30 patients aged 11 to 18 years. In that age group, the rates of sustained response were 64% with combination therapy vs 75% with peginterferon alone.

Most likely to respond were patients older than 24, or those with low serum ferritin (<2006 ng/mL), a previous treatment failure, an elevated ALT, liver fibrosis, a history of splenectomy, a viral load below 600,000 IU/mL, or HCV genotype 1.
"We strongly advise combination therapy in thalassemia patients with (the) aforementioned clinical characteristics," the researchers conclude. "However, ribavirin does not seem to be beneficial in thalassemia patients below 18 years of age."

J Hepatol 2010.

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