Hepatology 1995 Feb;21(2):322-7

Interferon and ursodeoxycholic acid combined therapy in the treatment of chronic viral C hepatitis: results from a controlled randomized trial in 80 patients

Boucher E, Jouanolle H, Andre P, Ruffault A, Guyader D, Moirand R, Turlin B,
Jacquelinet C, Brissot P, Deugnier Y

Clinique des Maladies du Foie, Hopital Pontchaillou, Rennes, France.

Abstract
Because 70% to 75% of patients with chronic hepatitis C either do not respond to
or relapse after interferon (IFN) therapy, and because ursodeoxycholic acid
(UDCA) has been shown to reduce aminotransferase levels in patients with chronic
hepatitis, we undertook a prospective controlled randomized trial of IFN (group
I) versus IFN plus UDCA (group II) in 80 patients with chronic hepatitis C. IFN
was administered in both groups for 6 months (3 to 5 million units [MU] three
times a week), and in group II UDCA (10 mg/kg/d) was administered with IFN and
then alone for 3 additional months. Response to therapy was defined as the
normalization of alanine transaminase (ALT) levels. The results showed that 6
months after cessation of IFN, 59% of responders had relapsed in group I but
only 27% had relapsed in group II (P = .03). There was no difference between the
two groups for the initial (month 6) and the late (months 15 and 18) response
rates to IFN. There was no virological effect or significant histological
improvement attributable to the addition of UDCA to IFN treatment. In
conclusion, the results of this study show that the addition of UDCA to IFN
therapy significantly prolongs the period for which serum ALT remain, within the
normal range after discontinuation of IFN. Further studies would be required to
determine whether UDCA has any potential for long-term amelioration of the
histological severity of liver disease caused by hepatitis C virus (HCV)
infection, and, therefore, whether it could be advocated as an adjunct to
antiviral therapy.