Service d'Hepato-Gastroenterologie, APHP-UPMC Paris Liver Center, Paris, France. Electronic address: email@example.com.
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.
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.
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.
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.