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.
Calleri
G
G
Department of Infectious Diseases, Amedeo di Savoia Hospital, Torino, Italy.
Colombatto
P
P
Gozzelino
M
M
Chieppa
F
F
Romano
P
P
Delmastro
B
B
Macor
A
A
Cariti
G
G
Brunetto
M R
MR
Grillone
W
W
Bonino
F
F
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