Antiviral therapy and fibrosis progression in patients with mild–moderate hepatitis C recurrence after liver transplantation. A randomized controlled study

Backgrounds/aimsWe evaluated the effect of antiviral therapy on fibrosis progression in patients with histological features of mild/moderate HCV disease recurrence defined by a Grading score ≥ 4 and Staging score up to 3 (Ishak) at 1 year after liver transplantation.MethodsSeventy-three consecutive patients with mild/moderate recurrence were randomized either to no treatment or to receive Pegilated-Interferon-alfa-2b and ribavirin for 52 weeks. Liver biopsies obtained at baseline (1 year after transplantation) and 2 years afterwards were evaluated for assessment of disease progression, defined as worsening of at least 2 staging points or progression to stage 4 or higher.ResultsAs for these two major histological end points there were no statistically significant differences between the 2 groups (36.1% vs. 50%, p = 0.34 and 36.1% vs. 38.9%, p = 1). Fifteen treated patients (41%) achieved a sustained virological response which was associated with a reduced risk of fibrosis worsening for both endpoints when compared to viremic patients (p = 0.04).ConclusionsAlthough antiviral-therapy was beneficial in preventing fibrosis progression in patients achieving a sustained virological response, the majority of the overall population of our patients with mild–moderate disease recurrence could not benefit from antiviral therapy either because they either could not be treated or did not respond to treatment (EudraCT number: 2005-005760).