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Non-invasive assessment of liver fibrosis progression in hepatitis C patients retreated for 96 weeks with antiviral therapy: a randomized study


Jean-Pierre Zarski, Clinique Universitaire d'Hépato-gastrentérologie, CHU, BP 217X, 38043 Grenoble Cedex 9, France
Tel: +47 6765441
Fax: +33 476765179


Background: The efficacy of a maintenance therapy in non-responder patients with chronic hepatitis C has been essentially evaluated by histological semiquantitative scores.

Aim: The aim was to evaluate the efficiency of 2 years of treatment with peginterferon α-2a vs α-tocopherol in these patients by histology, morphometry and blood markers of fibrosis.

Method: Hundred and five HCV patients with a Metavir fibrosis score≥2 were randomized to receive peginterferon α-2a 180 μg/week (PEG) (n=55) or α-tocopherol (TOCO) 1000 mg/day (n=50) for 96 weeks. The primary endpoint was improvement or stabilization of the Metavir fibrosis score by biopsy performed at week 96. Secondary endpoints included a quantitative assessment of fibrosis by morphometry and changes in blood markers of fibrosis.

Results: There was no difference at baseline between PEG and TOCO according to the metavir (83.3 vs 86.8%, P=0.751) stage. The median fibrosis rate, measured with morphometry was 2.72 and 2.86% at day 0, and 3.66 and 2.82% at week 96, in the PEG and TOCO groups (P=0.90) respectively. However, the percentage of patients with metavir activity grade improvement was significantly higher in the PEG group vs the TOCO group (52.8 vs 23.7%, P=0.016). Non-invasive markers analysis did not show any significant change in both groups.

Conclusion: Long-term therapy with peginterferon α-2a did not reduce liver fibrosis degree assessed by morphometry and blood tests as compared with α-tocopherol. Blood tests could be useful to assess liver fibrosis changes in clinical trials.