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

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 alpha-2a vs alpha-tocopherol in these patients by histology, morphometry and blood markers of fibrosis. METHOD: Hundred and five HCV patients with a Metavir fibrosis score > or = 2 were randomized to receive peginterferon alpha-2a 180 microg/week (PEG) (n=55) or alpha-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 alpha-2a did not reduce liver fibrosis degree assessed by morphometry and blood tests as compared with alpha-tocopherol. Blood tests could be useful to assess liver fibrosis changes in clinical trials.

HEPACOM: multicenter, observational prospective study of outcome and monitoring of HCV positive antiviral-naïve patients managed in the French health care system.

OBJECTIVE: To study management practices in the French health care system for antiviral-naïve patients with chronic hepatitis C virus (HCV) infection. METHODS AND PATIENTS: Two groups of general practitioners, group I (special training and experience in drug addiction) and group II (other general practitioners) enrolled untreated HCV positive patients and noted management practices for a 12-month period. RESULTS: Among 4660 enrolled patients, 2038 enrolled by 462 general practitioners in group I and 1756 enrolled by 588 general practitioners in group II were retained for analysis. These patients were adults, aged 42+/-14 years, who were naïve to antiviral treatment. The male/female ratio was 1: 7. Ten percent were coinfected with HIV, 12% had excessive alcohol intake, and 61% were current drug users, 75% of whom (45% of the total population) were taking replacement therapy. Minimal hepatic lesions (stageor=F2). At the end of the monitoring period, 64% of the patients had been referred to a specialist. Antiviral treatment had been started in 20%, i.e. 32% of the patients who consulted a specialist. Occupational activity (P<0.0001), young age (P=0.007), more recent diagnosis (P<0.0001), lack of HIV co-infection (P=0.015), male gender (P=0.006), lack of replacement treatment (P=0.006), previous liver histology with METAVIR A and F>or=2 (P<0.0001) and enrollment by a group I general practitioner (P<0.007) were the independent predictive factors of initiation of antiviral treatment. CONCLUSION: Only one-third of patients with access to the French health care system started antiviral treatment and some categories of patients, including women, patients co-infected with HIV and patients on replacement therapy, were less likely to be treated than others. The recommendations of the French Consensus Conference, held in the middle of the study period (2002), might have been implemented (probably followed) by a minority of general practitioners.