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Some Improvement in Hepatitis C Treatment.

Only a small minority of patients with hepatitis C who are treated with interferon alpha alone achieve sustained responses. The combination of ribavirin and interferon alpha was recently approved by the FDA for hepatitis C. Three international studies, all manufacturer-supported, summarize data on the combination.

Two placebo-controlled studies compared interferon alpha alone with combination treatment in almost 2,000 previously untreated hepatitis C-infected adults with abnormal liver enzyme levels and liver histology showing chronic hepatitis. Patients were treated for either 24 or 48 weeks. In both studies, significantly more patients receiving the combined treatment had undetectable HCV RNA levels, normalized liver enzymes, and histologic improvement on liver biopsy at the end of treatment than those receiving interferon alpha alone. Six months after treatment ended, 30 percent to 40 percent of patients in the combination groups had sustained virologic and liver enzyme improvement, significantly more than the 10 percent to 20 percent who responded to IFN alone.

A third study compared the combined treatment to interferon alpha alone in 345 patients who had already received a course of interferon alpha and relapsed after treatment ended. Among those receiving combination therapy, almost 50 percent had normal liver enzymes and undetectable HCV RNA six months after treatment, in contrast to 5 percent of those receiving interferon alpha alone. Toxicity from interferon, mostly severe flulike symptoms, was common in all the studies. Hemolytic anemia from ribavirin required dose reduction in 5 percent to 10 percent of patients.

Comment: Adding ribavirin to interferon clearly improves antiviral efficacy in chronic hepatitis C. Unfortunately for clinicians and patients, it does little to reduce the extreme unpleasantness of the therapy, which requires a great deal of motivation to endure.

— A Zuger

Published in Journal Watch General Medicine November 24, 1998

Citation(s):

McHutchison JG et al. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. N Engl J Med 1998 Nov 19 339 1485-1492.

Davis GL et al. Interferon alfa-2b alone or in combination with ribavirin for the treatment of relapse of chronic hepatitis C. N Engl J Med 1998 Nov 19 339 1493-1499.

Liang TJ. Combination therapy for hepatitis C infection. N Engl J Med 1998 Nov 19 339 1549-1550.

Poynard T et al. Randomised trial of interferon {alpha}2b plus ribavirin for 48 weeks or for 24 weeks versus interferon {alpha}2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus. Lancet 1998 Oct 31 352 1426-1432.

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