Source

Service d'Hepato-Gastroenterologie, APHP-UPMC Paris Liver Center, Paris, France. Electronic address: tpoynard@teaser.fr.

Abstract

BACKGROUND AND AIMS:

Therapeutic options for patients failing hepatitis C retreatment are limited. EPIC(3) included a prospective trial assessing long-term peginterferon alfa-2b (PEG-IFN alfa-2b) maintenance therapy in patients with METAVIR fibrosis scores (MFS) of F2 or F3 who previously failed hepatitis C retreatment.

METHODS:

Patients with F2/F3 MFS who failed retreatment were randomized to PEG-IFN alfa-2b (0.5 μg/kg/week, n=270) or observation (n=270) for 36 months. Blinded liver biopsies obtained before retreatment and after maintenance therapy were evaluated using MFS and activity scores, and confirmatory testing was performed using FibroTest and ActiTest.

RESULTS:

In total, 348 patients had paired biopsies: 192 patients had missing post-treatment biopsies and were considered as having no change in fibrosis/activity scores. In total, 16% of patients receiving PEG-IFN alfa-2b and 11% of observation patients had improvement in MFS (p=0.32). More PEG-IFN alfa-2b than observation patients had improvement in activity score (20% vs 9%; p<0.001). Among patients treated for >2.5 years, improvement in MFS or activity score was more common with PEG-IFN alfa-2b than observation (21% vs 14%, p=0.08 and 26% vs 10%, p<0.001). FibroTest and ActiTest evaluations indicated significant benefit associated with PEG-IFN alfa-2b in terms of reduced fibrosis progression and improved activity score. The safety profile of PEG-IFN alfa-2b was similar to previous studies.

CONCLUSIONS:

PEG-IFN alfa-2b did not significantly improve MFS estimated by biopsy compared with observation; however, activity scores were significantly improved and MFS trended toward increased improvement with treatment durations >2.5 years. Both FibroTest and ActiTest were significantly improved during maintenance therapy.