Clinco-biochemical, virological and histopathological evaluation of dimethyl biphenyl dicarboxylate [DDB] in treatment of chronic HCV infection in Egyptian patients

ABSTRACT

The present study was designed to evaluate the efficacy and safety of DDB and DDB- amantadine HCL combined therapy in treatment of patients with chronic HCV infection for 6 months. The study included 90 patients with chronic HCV were selected and divided into three groups Group 1 [Control group] included 30 patients of chronic HCV infection treated by silymarin for 6 months in a dose of 420 mg / day in three divided doses. Group II [DDB group] included 30 patients of chronic HCV infection treated by DDB for 6 months in a dose of 15 pilules bid, each pilule 1.5mg Group III [Combined group] included 30 patients of chronic HCV infection treated by DDB and amantadine HCL for 6 months. Amantadine HCL was given in a dose of 100mg twice daily. Good history taking and clinical examinations, also laboratory investigations including complete liver functions [AST, ALT, S. Bilirubin, S. Albumin, alpha fetoprotein and prothrombin time and concentrations], kidney functions tests, Quantitative HCV RNA PCR and histopathological examination before and at the end of therapy for some selected cases. Follow up of these cases 3 and 6 months revealed that- there was statistically significant in the main clinical symptoms [Fatigue, Rt hypochondrial pain and epistaxis] and in the mean serum, transaminasis [ALT and AST] more in group III than G II in comparison to the control group. In addition, there were no improvements statistically significant between groups in the mean serum albumin, alpha feto-protein, prothromibin time and concentration, serum bilirubin, hematological parameters and kidney function before and after treatment. The results showed that there was decrease in the viral load at the end of treatment in group III than group II in comparison to the control group but no patients turned negative for HCV RNA PCR. Also, there were improvements statistically at the end of treatment in the degree of the histological criteria [Steatosis, lymphocytes infiltration and bile duct injury] in g II than G II in comparisons to the control group. Finally, it has concluded that DDB is beneficial drugs for treatment of chronic HCV patients and the additive value of DDB as immunomodulorty to amantadine HCL as anti viral as a combined therapy in chronic HCV infections is a new beneficial strategy