THREE-YEAR FOLLOW-UP OF CHRONIC HEPATITIS C PATIENTS TREATED
WITH RIBAVIRIN PLUS INTERFERON- ALFA COMBINATION THERAPY: EVIDENCE
FOR LONG-TERM EFFICACY AND SAFETY.
S.Brillanti, M Foli, C Masci, and M Miglioli. Clinica Medica
I, University of Bologna, Italy.
Between September 1992 and May 1993, 15 consecutive patients
with interferon-alfa-resistant chronic hepatitis C (8 relapsers
[RR] and 7 non- responders [NR]) were treated with ribavirin (800
mg daily) plus interferon- alfa (3 MU tiw) for 6 months, in a
randomized interferon-controlled study (1, 2). Six months after
stopping treatment, 7 patients had normal ALT (all RR) and 7
patients were negative for serum HCV-RNA, by Amplicor HCV Test
(Roche), (6 RR and 1 NR). Up to June 1996, all these patients were
prospectively followed and both biochemical and virological
analyses were performed at 3-month intervals. RESULTS: Between 6
and 12 months after therapy, normalization of ALT was observed in
the HCV-RNA negative NR patient and an RR patient with normal ALT
became HCV-RNA negative. No further changes in ALT or HCV-RNA were
observed afterwards.
1 year + 2 years + 3 years
Normal ALT 7 RR + 1 NR 7 RR + 1 NR 7 RR + 1 NR
Negative HCV-RNA 7 RR + 1 NR 7 RR + 1 NR 7 RR + 1 NR
No patient with sustained response showed
deterioration in liver function tests (albumin, bilirubin, PT)
during the follow-up. Persistent abnormalities in hemoglobin and/or
RBC and/or uric acid and/or bilirubin and/or ferritin values due to
ribavirin-induced hemolytic anemia were not observed in any
patient. A sustained response to combination therapy was more
frequent in non-cirrhotic (7/9) than in cirrhotic (1/6) patients
(p< 0.04). Pretreatment HCV genotype and HCV-RNA levels were not
significantly associated with sustained response to combination
therapy.
CONCLUSIONS: A 12- month post therapy follow-up is required to
assess sustained biochemical and virological responses. A 3-year
follow-up demonstrates that these beneficial effects are sustained
and that no long-term side effects due to ribavirin are found.
(1. Gastroenterology 1994; 107: 812-7;2. J Hepatol 1995; 23
(Suppl. 2): 13-6.
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