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A TRIAL OF INTERFERON BETA 1a (IFN ß1a) FOR 4 WEEKS FOR THERAPY OF ACUTE HEPATITIS C

WM Lee, ML Shiffman, JW Gnann Jr, A Samanta, J Alam. UT South-western, Dallas; Med Coll of VA, Richmond; Univ of Alabama, Birmingham; East Orange VAMC and Biogen, Inc., Cambridge

Acute hepatitis C infection virtually always results in chronic viremia. Few studies have examined the responses of infected patients to interferon therapy given during acute infection. As part of a study to assess tolerability and activity of IFN ß1a, 38 patients with acute non-A, non-B hepatitis were evaluated and treated. All patients had symptoms of acute hepatitis for less than 8 wks, and ALT > 2.5 x ULN at presentation. IFN ß1a was given at 60 µg (12 MU) TIW for 12 doses. Reverse transcriptase polymerase chain reaction (RT-PCR) was performed using an assay with a lower limit of 100 copies/ml. Thirty-five patients completed at least half the treatment and, in 26, adequate RT-PCR documentation and follow-up data were available. Of the 9 excluded, 3 had all negative PCR's and 6 had no follow-up samples available. Several of the excluded patients did not complete therapy or follow-up because of continued substance abuse. All 26 patients were anti-HCV-positive and RT-PCR-positive at start of therapy. Follow-up with RT-PCR was complete for a mean of 8.9 mons (minimum, 5 mons) after onset of symptoms. In this group, two patients missed either one or two doses. Dosing was complete for the rest, and no untoward side effects beyond flu-like symptoms were recognized. At the end of follow-up, 8/26 (31%) were RT-PCR negative, and 18/26 (69%) had normal ALT's. In comparison to historical controls, these results suggest that interferon ß1a in a short course of therapy given during the acute phase of hepatitis C infection is tolerated and therapeutically active. Acute hepatitis C infection may be more susceptible to interferon treatment than chronic hepatitis C. Longer courses of therapy (beyond 4 weeks) might be associated with even better viral clearance than that observed in this small pilot study.

Source: American Association for the Study of Liver Diseases - 1996 Annual Meeting


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