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EFFICACY OF URSODEOXYCHOLIC ACID IN COMBINATION WITH INTERFERON
ALPHA IN TREATING CHRONIC HEPATITIS C - RESULTS OF A LONG-TERM
FOLLOW-UP TRIAL
Ursodeoxycholic acid (UDCA) has recently been combined with
interferon (IFN) in the treatment of individuals with chronic
hepatitis C. However, whether its addition results in a long-term
favourable response to IFN remains unclear. A prospective
randomized trial of IFN alone versus IFN plus UDCA was therefore
undertaken in 52 patients with chronic hepatitis C. All patients
received a 24 week course of IFN-alpha (6 x 10(6) U/day for 2 weeks
and then three times a week for 22 weeks) and half also received
UDCA (600 mg/day) with IFN and then alone for 48 additional weeks.
Normalization of serum alanine transaminase (ALT) concentrations at
0, 24 and 48 weeks after cessation of IFN therapy was apparent in
77, 42 and 42% of patients in the IFN-alone group and in 77, 54 and
42% of patients in the IFN plus UDCA group, respectively. There was
no significant difference between the two groups with regard to
response rate to IFN and the addition of UDCA to IFN treatment had
no significant effect on hepatitis C virus (HCV) viraemia. During
the follow-up period, 10 of 20 patients with normal serum ALT at
the end of IFN treatment relapsed in the IFN-alone group compared
with 11 of 20 patients in the IFN plus UDCA group. Among these
relapsed patients, serum ALT concentration was significantly lower
in the IFN plus UDCA group than in the IFN-alone group during the
follow-up period. Twenty-four weeks after cessation of IFN therapy,
the percentage of patients with HCV-RNA in their serum who showed a
normalization of serum ALT concentrations was significantly higher
in the IFN plus UDCA group than in the IFN-alone group (44 vs 6%).
Thus, although the addition of UDCA was not associated with a
favourable long-term response to HCV viraemia, it did reduce the
risk and the severity of relapse following the cessation of IFN
therapy.
Author: TANAKA K, YOKOHAMA CITY UNIV, SCH MED, DEPT INTERNAL
MED 3, KANAZAWA KU, 3-9 FUKUURA YOKOHAMA KANAGAWA 236
Source: JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY 1996
DEC;11(12):1155-1160
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