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Hepatology April 1998; E. JENNY L. HEATHCOTE,1 EMMET B.
KEEFFE,2 SAMUEL S. LEE,3 SAYA V. FEINMAN,1 MYRON J. TONG,4 K. R.
REDDY,5 DONALD G. ALBERT, JR.,6 KARSTEN WITT,6 LAWRENCE M. BLATT,6
AND THE CONSENSUS INTERFERON STUDY GROUP
A multicenter, open-label, phase 3 study was conducted in 337
patients with chronic hepatitis C virus (HCV) infection who had
either not responded to previous interferon therapy or had relapsed
after discontinuation of therapy with either consensus interferon
(9 µg) or interferon -2b (3 million U) three times a week for
24 weeks. Patients were randomized to receive a higher dose of
consensus interferon (15 µg) administered subcutaneously three
times a week for 24 or 48 weeks and then were observed for an
additional 24 weeks. Patients who had relapsed after prior
interferon therapy were more likely to have a sustained alanine
aminotransferase response and HCV RNA response (as measured by
reverse transcription-polymerase chain reaction with a sensitivity
of less than 100 copies/mL) than were patients who had not
responded to prior interferon therapy. For relapsers, the sustained
HCV RNA response rate was 58% (48 weeks) and 28% (24 weeks). The
sustained alanine aminotransferase response for relapsers was 52%
(48 weeks) and 39% (24 weeks). The sustained HCV RNA response rate
among prior nonresponders was 13% (48 weeks) and 5% (24 weeks), and
the sustained alanine aminotransferase response rate for
nonresponders was 17% (48 weeks) and 12% (24 weeks). The
administration of 15 µg of consensus interferon was well
tolerated and was not associated with an increase in the incidence
of side effects. These data demonstrate that re-treatment with 15
µg of consensus interferon is safe and effective therapy for
patients with chronic hepatitis C who have either not responded to
previous interferon therapy or relapsed after discontinuation of
interferon therapy.
Address reprint requests to: E. Jenny L. Heathcote, M.D.,
Division of Gastroenterology, Toronto Hospital, University of
Toronto, 4th Floor West Wing, 399 Bathurst Street, Toronto, Ontario
M5T 2S8, Canada.
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