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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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