Gastroenterology

Gastroenterology

Volume 132, Issue 5, May 2007, Pages 1746-1756
Gastroenterology

Clinical–liver, pancreas, and biliary tract
Efficacy of Antiviral Therapy on Hepatitis C Recurrence After Liver Transplantation: A Randomized Controlled Study

https://doi.org/10.1053/j.gastro.2007.03.041Get rights and content

Background & Aims: Recurrence of hepatitis C virus (HCV) infection is a relevant problem of liver transplantation programs. We evaluated the effect of antiviral therapy on disease progression in 81 HCV-infected liver transplantation recipients. Methods: Patients with mild hepatitis C recurrence (fibrosis stage F0 to F2, n = 54) were randomized to no treatment (group A, n = 27) or peginterferon alfa-2b/ribavirin for 48 weeks (group B, n = 27). Patients with severe recurrence (F3 to F4, cholestatic hepatitis) were treated (group C, n = 27). All patients (n = 81) underwent a liver biopsy at baseline and after follow-up; paired hepatic venous pressure gradient (HVPG) measurements were available in 51 patients. Results: Thirteen (48%) patients of group B and 5 (18.5%) of group C achieved sustained virological response. Liver fibrosis progressed ≥1 stage in 40 (49%) of 81 patients: 19 (70%) of group A versus 7 (26%) of group B (P = .001) and in 14 (54%) of group C. HVPG increased (6.5 to 13 mm Hg, P < .01) in patients in whom fibrosis worsened, whereas it decreased (5 to 3.5 mm Hg, P = .017) or remained unchanged in those with fibrosis improvement or stabilization, respectively. The only variable independently associated with fibrosis improvement/stabilization was treatment (odds ratio [OR] =3.7, 95% confidence interval [CI] 1.3 to 10, P = .009). Among treated patients, alanine aminotransferase (ALT) normalization and viral clearance were independently associated with histological or hemodynamic improvement/stabilization (OR 5.3, 95% CI 1.5 to 18, P < .01; OR 7.4, 95% CI 1.4 to 38, P = .01; respectively). Conclusions: Our data demonstrate that in liver transplantation recipients, antiviral therapy slows disease progression (particularly in sustained virological responders), as shown by its effects on liver histology and on HVPG.

Section snippets

Patients

All patients were enrolled at our institution (Hospital Clinic, Barcelona, Spain) between July 2001 and September 2004 (Figure 1). The study protocol was approved by our institution’s Ethical Committee and by the Spanish Health Ministry. All patients gave their written informed consent before entering the study.

Eligible patients were liver transplantation recipients 18 to 70 years of age and who had a diagnosis of hepatitis C recurrence. The diagnosis of hepatitis C recurrence was established

Patient Baseline Characteristics

From July 2001 to September 2004, 54 patients were considered to have a mild hepatitis C recurrence and were randomized to receive pegylated interferon and ribavirin (n = 27) versus no treatment (n = 27). The baseline characteristics of these patients are summarized in Table 1. Except for gender and ALT levels, we did not find significant differences between both groups. A cohort of 27 consecutive patients in whom hepatitis C recurrence was considered severe underwent antiviral treatment during

Discussion

Hepatitis C recurrence after liver transplantation is the most relevant problem of transplant programs. Liver damage caused by hepatitis C recurrence is accelerated, and cirrhosis develops in a significant proportion of patients only a few years after transplantation.2, 3 Most centers indicate antiviral therapy once a liver biopsy specimen demonstrates the presence of significant histological damage.6, 22 Recent reports suggest that the efficacy of pegylated interferon and ribavirin is higher

References (27)

Cited by (0)

Supported in part by grants from Instituto de Salud Carlos III (PI 05/1285, FIS 05/0258). José A. Carrión received a grant from Hospital Clínic (Premi Fi de Residència). ClinicalTrials.gov Identifier: NCT00383864.

1

Xavier Forns has received research support from Schering-Plough and Roche.

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