Chronic hepatitis C virus (HCV) significantly impacts on the survival of renal transplant (RT) recipients. Interferon (IFN)-based therapy in RT recipients has been associated with a high risk of acute allograft rejection (AAR) and poor efficacy. We assessed the safety and efficacy of PegIFN-Α2a and ribavirin (RBV) combination therapy in post-RT HCV-infected patients. Methods: Thirty-two adult RT recipients of >12 months duration, infected with HCV genotype 1 or 4, and significant fibrosis (Metavir ≥F2) were recruited in two centers in an open-label trial with PegIFN-alpha-2a 135–180 Μg/week, plus RBV 200–1200 mg/day for 48 weeks, based on creatinine clearance. Safety assessments were performed weekly for 4 weeks, 2-weekly for 8 weeks, and 6-weekly for 36 weeks. Study end-points were sustained virologic response (SVR) or development of AAR. Allograft biopsies were performed for 20% increases in serum creatinine from pretreatment levels and optional at week 12 of therapy on survellence protocol. Results: Four patients (12.5%) stopped treatment due to adverse events. Dose reductions of PegIFN and RBV were required in 34.4% and 78.1%, respectively. No patient showed AAR in those biopsied (n=4) for raised creatinine. The mean pretreatment and end-of-assessment creatinine levels of the overall cohort remained similar (106.8±32.0 vs. 112.1±64.3, P=0.588). Incremental and sustained increases in creatinine occurred in 2 (6.3%) patients. Rapid, early virologic response (EVR) and SVR occurred in 12.5%, 56.3% and 37.5%, respectively. SVR was similar in genotypes 1 and 4 (P=1.000). Logistic regression analysis identified EVR (OR, 11.7; 95% CI: 1.1 – 124.9; P=0.043) as an independent predictor of SVR. Conclusions: PegIFN/RBV therapy wa not associated with rejection in RT recipients at low risk for rejection but has modest efficacy in the treatment of chronic HCV.

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