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 135180 Μg/week, plus RBV 2001200 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.
To cite this abstract in AMA style:Aleid H, Sania F, Musa D, Almeshari K, Shoail G, Madani A, Bzaizi K. Safety and Efficacy of Peginterferon-α2a Plus Ribavirin Treatment in Renal Transplant Recipients with Chronic Hepatitis C; Prospective Cohort Study [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/safety-and-efficacy-of-peginterferon-2a-plus-ribavirin-treatment-in-renal-transplant-recipients-with-chronic-hepatitis-c-prospective-cohort-study/. Accessed May 17, 2021.
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