Natural beta interferon in acute type-C hepatitis patients: a randomized controlled trial.
OBJECTIVE
A multicentre randomized controlled trial to assess whether a short course of beta-interferon could reduce the rate of chronic 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 3,000,000 international units intramuscularly three times a week for 4 weeks or 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 interferon-treated group, and 80% (16/20) in the untreated group. No difference 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 chronic cases at the end of follow-up. Side effects of therapy (flu-like syndrome in 40% of cases) were mild and short-lasting. No aminotransferase flare-ups were observed during treatment.


CONCLUSIONS
Beta interferon at the suggested regimen is well tolerated but does not seem to significantly influence the natural course of acute hepatitis C.
Department of Infectious Diseases, Amedeo di Savoia Hospital, Torino, Italy.
G
G
Calleri
P
P
Colombatto
M
M
Gozzelino
F
F
Chieppa
P
P
Romano
B
B
Delmastro
A
A
Macor
G
G
Cariti
M R
MR
Brunetto
W
W
Grillone
F
F
Bonino
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000032:analysis; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006526:Hepatitis C / Q000175:diagnosis / Q000188:drug therapy*; D018937:Hepatitis C Antibodies / Q000032:analysis; D006801:Humans; D016899:Interferon-beta / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012367:RNA, Viral / Q000032:analysis; D011863:Radioimmunoassay; D012016:Reference Values; D016896:Treatment Outcome
D000998:Antiviral Agents; D018937:Hepatitis C Antibodies; D012367:RNA, Viral; D016899:Interferon-beta; D000410:Alanine Transaminase