NATURAL BETA-INTERFERON IN ACUTE TYPE-C HEPATITIS PATIENTS - A RANDOMIZED CONTROLLED TRIAL

Aim of the study. A multicentre randomized controlled trial to assess whether a short course of beta-inteferon could reduce the rate of chro nic evolution of acute hepatitis C, in line with recent observations, was started in Northern Italy in 1991. Methods, Forty acute hepatitis C patients were randomized to receive natural beta interferon 3,000,00 0 international units intramuscularly three times a week for 4 weeks o r symptomatic drugs, and were followed up for a median period of 22.5 months. Results. The chronicity rate was 75% (15/20 patients) in the i nterferon-treated group, and 80% (16/20) in the untreated group. No di fference in the duration of the acute phase of hepatitis was observed Hepatitis C virus ribonucleic acid was determined in 21 cases and was positive in 19 cases at baseline and in 15/17 chronic and 1/4 non chro nic cases at the end of follow-up. Side effects of therapy (flu-like s yndrome in 40% of cases) were mild and short-lasting. No aminotransfer ase flare-ups were observed during treatment. Conclusions. Beta interf eron at the suggested regimen is well tolerated but does not seem to s ignificantly influence the natural course of acute hepatitis C.