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Original article

Ribavirin priming improves the virological response to antiviral treatment in transplanted patients with recurrent hepatitis C: a pilot study

Manuela Merli, Valerio Giannelli, Federica Gentili, Michela Giusto, Maurizio Simmaco, Luana Lionetto, Stefano G Corradini, Elisa Biliotti, Adolfo F Attili, Massimo Rossi, Gloria Taliani

Corresponding author name: Manuela Merli
Corresponding author e-mail: Manuela.merli@uniroma1.it

Citation: Antiviral Therapy 2011; 16:879-885
doi: 10.3851/IMP1834

Date accepted: 20 January 2011
Date published online: 29 June 2011

Abstract

Introduction: Patients with hepatitis C recurrence after liver transplantation represent a clinical challenge. Antiviral treatment in transplant patients has usually poor tolerability and limited efficacy, with a mean sustained virological response (SVR) of 30%. Our pilot study was aimed at evaluating whether 8-week ribavirin pre-treatment could increase either adherence or antiviral effect of a 48-week combination therapy.

Methods: Ribavirin pre-treatment (8 weeks) was started with 600 mg daily and increased to 10.4 mg/kg/day. After pre-treatment, 1.5 μg/kg/week pegylated interferon-α2b was added for 48 additional weeks of combination therapy. Blood count, liver function tests and plasma HCV-RNA were examined monthly. Ribavirin plasma concentrations were determined by HPLC.

Results: Thirteen patients (mean age 53 ±2 years, 11 males) were treated: eight were HCV genotype 1/4; five were genotype 2/3. The median baseline HCV RNA level was 6.5 log10 (range 5.84–7.42 log10). During ribavirin pre-treatment the median HCV RNA levels decreased significantly (5.7 log10; P=0.023). During combination therapy 6/13 (46%) patients exhibited a rapid virological response (RVR) and 10/13 (77%) patients a complete early virological response, two were non-responders. A decline of 0.5 log10 HCV RNA during pre-treatment predicted RVR. SVR occurred in six patients (46%): four were genotype 2/3. Stable ribavirin dose reduction was required in only two patients (15%) in whom transient interferon reduction was also required.

Conclusion: This proof-of-concept study indicates that ribavirin pre-treatment increased the tolerability of the antiviral treatment, and improved its efficacy in liver transplant patients. Moreover, the degree of HCV RNA decline during pre-treatment allowed one to predict on-treatment response.

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