Long-Term Efficacy of Interferon-alpha and Ursodeoxycholic Acid in Treatment of Chronic Type C Hepatitis
Interferon-alpha (IFN) and ursodeoxycholic acid(UDCA) combined have a controversial role in thetreatment of chronic type C hepatitis. We studied thelong-term efficacy of both drugs alone or incombination. In a three-year period, 108 patients wererandomized into three treatment arms: (1) IFN alone 3 MUthree times a week (N = 49), (2) IFN 3 MU three times aweek + UDCA 250 mg twice a day (N = 45), and (3) UDCA alone 250 mg twice a day (N = 14). Response wasdefined as complete normalization of serum ALT. For theresponders at the end of six months, the treatment wasrun to 12 months. Nonresponders (NRs) of the first group were crossed over to combinationand NRs of the combination received 6 MU three times aweek IFN + UDCA for the next six months. The enrollmentto the UDCA alone arm was stopped early, since only 1/14 normalized serum ALT at the end of thirdmonth. However, 12/14 completed six months and 11 NRsreceived IFN 3 MU three times a week alone for the nextsix months. Twelve discontinued treatment due to side effects. Responders were followed-upuntreated for 18 months. Sustained response (SR) wasdefined as persistence of normal serum ALT levels inthis period. At the end of six months, 22/45 (48%) from the IFN-alone and 23/39 (58%) from thecombination group responded. Twenty NRs from former and15 of latter group were crossed over. While none of the20 from the IFN-alone group responded to thecombination, 1/15 NRs of the combination group responded todose escalation. SR was achieved in 9/45 (20%) of theIFN alone and 7/39 (18%) of the combination group. Themean time form the end of the treatment to the relapse was not different between the groups.Five of 11 UDCA NRs responded to IFN with SR in 2. Itwas concluded that UDCA as a single agent is ineffectivein achieving response in the treatment of chronic type C hepatitis. Combined with IFN, itincreases response rate insignificantly although this isnot sustained.