Sustained virological and histological response with pretransplant interferon therapy in renal transplant patients with chronic viral hepatitis C.

Patients who are anti-HCV positive before renal transplantation (Tx) have a significantly increased risk of posttransplant liver disease. We conducted a prospective, controlled study to evaluate the posttransplant outcome of renal graft candidates with HCV-associated chronic hepatitis (n = 30). Patients were randomly assigned to either of two groups. All patients on enrollment underwent liver biopsy, which showed mild-to-moderate hepatitis activity (mean 4.1, range 2-6). Half the patients received interferon-alpha (IFN-a) administered at a dosage of 3 million units three times weekly for 1 year. Liver biopsy was repeated for treated patients at the end of IFN-a treatment. Of these, 11 patients received renal transplant (group A). The other half did not receive IFN-a and to date 10 patients have been transplanted (group B). Renal transplant recipients were prospectively followed for a period of 12 months and a follow-up liver biopsy was also done at the end of this period (end of study). Biochemical and virological responses were evaluated and the histologic activity index (HAI) scoring according to Knodell was assessed. The mean pretreatment serum HCV RNA level was 1.14 +/- 0.84 and 1.0 +/- 0.89 mEq/ml for groups A and B, respectively (bDNA assay sensitivity threshold is <0.2 mEq/ml). HCV RNA became undetectable in 4 patients of group A. At the end of study period the mean quantitative HCV RNA titers were 1.43 +/- 4.07 and 15.18 +/- 11.08 mEq/ml in groups A and B, respectively (p < 0.0001). In group A, the mean HAI score decreased from 4.27 +/- 1.19 to 1.64 +/- 0.67 after IFN-a treatment (p < 0.0001). This score was maintained till the end of the study period with a mean of 1.82 +/- 0.6. Mean HAI score of group B on enrollment was 3.9 +/- 1.2 and at the end of study increased to 5.5 +/- 1.35 (p = 0.01). There was statistically significant difference (p value less than 0.0001) between the HAI scores at the end of the study period between the two groups. These results demonstrate that interferon therapy while on dialysis is associated with less viremia and decreased progression of chronic liver disease in renal transplant patients with hepatitis C. Copyright 2001 S. Karger AG, Basel

RCT Entities:   Population Interventions Outcomes