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From the Food and Drug Administration
August 5, 1998

New Combination Therapy Approved for Hepatitis C Relapse

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JAMA. 1998;280(5):410. doi:10.1001/jama.280.5.410-JFD80007-3-1

The FDA has approved the combination therapy of ribavirin capsules with interferon alfa-2b injection for the treatment of chronic hepatitis C in patients with compensated liver disease, who have relapsed following a response to previous interferon alfa therapy. In 2 multicenter, double-blind trials, the combination appeared to suppress blood levels of the hepatitis C virus better than retreating patients with interferon alone. After 6 months of therapy followed by 6 months of follow-up without therapy, approximately 45% of patients treated with the combination were able to sustain reduced hepatitis C virus levels compared with 5% who were retreated with interferon alone. Although 34% of patients treated with interferon alone had improvement in inflammation as demonstrated by an end-of-study biopsy specimen, more patients (50%) treated with the combination had improved on biopsy findings.

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