Comparative study of three doses of interferon-alpha 2a in chronic active hepatitis B. The International Hepatitis Trial Group.

Abstract

To determine the efficacy of interferon-alpha 2a in chronic active hepatitis B, 238 patients were randomly divided, into four groups: three groups received either 2.5 MIU m-2, 5.0 MIU m-2 or 10.0 MIU m-2, three times weekly by intramuscular injection for 12-24 weeks; and a control group received no treatment. Patients were followed for up to 12 months after treatment was discontinued. There was a statistically significant difference in response [clearance of hepatitis B e antigen (HBeAg) and hepatitis B viral DNA (HBV-DNA)] between treated and untreated patients (37 vs 13%) but no statistically significant difference was seen between treatment groups (33%, 34% and 43% for the 2.5, 5.0 and 10.0 MIU m-2 groups, respectively). A transient rise in transaminases (seroconversion hepatitis) was seen in responders, but levels returned to within the normal range after response to treatment. In patients responding to interferon therapy there was a significant reduction in the severity of the hepatitis. Interferon-alpha 2a was generally well tolerated with respect to vital signs and laboratory parameters.

• Authors: H C Thomas, A S Lok, V Carreño, G Farrell, H Tanno, V Perez, G M Dusheiko, G Cooksley, J C Ryff
• Journal: Journal of viral hepatitis (J Viral Hepat) Vol. 1 Issue 2 Pg. 139-48 ( 1994) ISSN: 1352-0504 [Print] England
• PMID: 8790569 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Interferon alpha-2
• Interferon-alpha
• Recombinant Proteins
• Alanine Transaminase

Topics

• Adolescent
• Adult
• Aged
• Alanine Transaminase (blood)
• Dose-Response Relationship, Drug
• Female
• Hepatitis B (therapy)
• Hepatitis, Chronic (therapy)
• Humans
• Interferon alpha-2
• Interferon-alpha (adverse effects, immunology, therapeutic use)
• Male
• Middle Aged
• Recombinant Proteins