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Hepatology 1998 Aug;28(2):341-346
Sequential versus concomitant administration of ribavirin and interferon
alfa-n3 in patients with chronic Hepatitis C not responding to interferon alone:
results of a randomized, controlled trial.
Sostegni R, Ghisetti V, Pittaluga F, Marchiaro G, Rocca G, Borghesio
E, Rizzetto M, Saracco G
Dipartimento di Gastroenterologia, Ospedale Molinette, Universita di
Torino, Italy.
We conducted a three-arm, randomized trial in 96 patients with chronic Hepatitis
C who did not respond to interferon alfa to compare treatments. Group 1 (33
patients) received ribavirin alone (1,000 mg/daily for 6 months) followed by
interferon alfa n-3 alone (3 MU thrice weekly for 6 months); group 2 (33 patients)
received ribavirin plus interferon alfa n-3 for 6 months at the above doses;
and group 3 (30 patients) received interferon alfa n-3 alone (3 MU thrice weekly
for 6 months). At the end of treatment, 3 patients (10%) in group 1, 13 (41%)
in group 2, and 5 (17%) in group 3 had normal alanine transaminase (ALT) levels
(group 2 vs. groups 1 and 3, P = .008). After 6 months of follow-up, only 4
patients (12.5%) in group 2 still had normal ALT values (P = .03). At the end
of therapy, Hepatitis C virus (HCV) RNA was no longer detectable by polymerase
chain reaction in 4 (13%), 9 (27%), and 2 (7%) patients, respectively, in groups
1, 2, and 3 (P = NS). Six months posttherapy, only 5 (15%) patients in group
2 were still HCV RNA negative (P = .02). At the time of follow-up liver biopsy,
performed 6 months after the end of treatment, a significant improvement of
the necroinflammatory scores was observed among group 2 patients (P = .01) but
not in the other two groups. Side effects reflected the profile of each drug
as monotherapy; mild hemolytic anemia was the most frequent side effect caused
by ribavirin. In conclusion, concomitant administration of ribavirin and interferon
alfa n-3 was significantly superior to the sequential schedule or interferon
alfa n-3 monotherapy in inducing a sustained response in patients with chronic
Hepatitis C who had not responded to interferon alone. However, combination
therapy at the dose and duration adopted in this study is capable of modifying
the natural course of the disease in only a minority of these patients.
PMID: 9695995, UI: 98359166
Vikki Shaw
Hepatitis Central
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