An escalating dose regimen of pegylated interferon and ribavirin in HCV cirrhotic patients referred for liver transplant.

ABSTRACT

BACKGROUND: To lessen the severity of recurrent hepatitis C virus (HCV) postliver transplantation (post-LT) by treating HCV patients with cirrhosis, we assessed the safety and efficacy of an escalating dose pegylated interferon (PEG-IFN)/ribavirin protocol in pre-LT patients. METHODS: Ninety patients were treated with 90 microg PEG-IFN alpha-2a and 400 mg ribavirin and advanced to 180 microg and 800 to 1200 mg, respectively, over 8 weeks. RESULTS: Mean age was 55.3 years. Thirty-four percent of patients received prior interferon treatment, 77% had genotype 1 or 4. Mean Child's score was 6.7 and model for end-stage liver disease 11.2; 49% reached full-dose PEG-IFN and 85% ribavirin, 18% required dose reduction, 33% stopped treatment because of adverse effects, 9% had deterioration of liver function, and 7% died. Follow-up of 9.6 months showed sustained virological response in 13% of patients. The rate of serious complications was 16.3% in Child's class A, 48% in B, and 100% in C (P=0.005). Serum albumin was a significant predictor for worsening liver function (P=0.007). CONCLUSIONS: Using an escalating dose regimen of PEG-IFN alpha-2a and ribavirin, we achieved only a 13% sustained virological response in HCV cirrhotic pre-LT patients with an accompanying 9% risk of worsening liver function and 7% risk of death.