Clinical and laboratory studies of DDB in treatment of chronic hepatitis C 4. Combination therapy with amantadine hydrochloride, a pilot study in Egypt

ABSTRACT

The aim of this pilot study was to evaluate the efficacy and safety of Dimethyl Dimethoxy Biphenyl Dicarboxylate [DDB] and amantadine hydrochloride [amantadine] in treatment of patients with chronic hepatitis C virus infection [HCV]. For this objective, 80 patients with chronic HCV were selected and divided randomly into four equal groups Group I treated with DDB, Group 2 treated with amantadine, Group 3 treated with DDB and amantadine while Group 4 treated with silymarine and acted as control group. Follow up of those patients 12 months after initiation of therapy, revealed dramatic clinical improvement of the main symptoms in patients treated with DDB and DDB-amantadine combined therapy, sustained normalization of the mean serum ALT level in 100% of DDB and DDB-amantadine combined therapy group versus 45% of patients treated with amantadine only. On the other hand there was statistically significant decrease in the mean serum AST and bilirubin level in patients treated with DDB and amantadine in comparison with the control group. Estimation of the mean serum albumin revealed statistically significant increase in DDB and DDB-amantadine treated groups, while estimation of the serum alpha-fetoprotein showed statistically significant decrease in DDB and DDB-amantadine treated groups in comparison with amantadine and control groups. Follow up of DDB and amantadine treated patients [Groups 1, 2 and 3] 6 months after therapy revealed sustained normalization of the mean serum ALT levels in 85% of patients treated with DDB-amantadine combination versus 75% of patients treated with DDB and 30% of patients treated with amantadine. Also there was statistically significant sustained decrease in the mean serum AST, bilirubin and alpha- fetoprotein levels. Serum HCV RNA detected by PCR 12 months after initiation of therapy become negative in 40% of case treated by DDB and amantadine combination, versus 15% in both DDB and amantadine treated patients and 0% in control group. Six months after cessation of therapy serum HCV RNA detected by PCR remained negative in 35% of DDB and amantadine combination treated patients versus 10% and 15% in DDB and amantadine treated patients respectively. It could be concluded that the additive value of DDB-amantadine combined therapy in chronic hepatitis C patients is a beneficial strategy which needs further studies [This is the 4[th] study in this field, Montasser, 1999, Montasser, 2000 and Montasser et al. 2000, This study was presented in Ain Shams Clinical and Scientific Society Symposium Chronic Hepatitis C Up date 1[st] November 2000]