Beta- and gamma-interferon in chronic active hepatitis B. A pilot trial of short-term combination therapy.
A controlled, randomized trial of a short-term, medium-dose combination therapy of beta- and gamma-interferon was performed in 20 patients with chronic active hepatitis B. According to clinical, biochemical, and histologic findings that were followed up for 16-24 mo, the combined treatment was successful in 5 of 10 patients. Two of the patients eliminated the virus completely, as confirmed by Southern blotting of hepatocellular deoxyribonucleic acid (DNA) against hepatitis B virus DNA. In the other 3 responders hepatitis B surface antigen persisted in the absence of hepatitis B e antigen, replicating hepatitis B virus DNA in the liver and inflammatory disease activity. Two of these responders with persistent hepatitis B surface antigen had hepatitis B virus DNA integrated into the hepatocyte genome and 1 responder had nonreplicating, episomal virus DNA. In the control group of 10 patients one spontaneous remission occurred. Antiviral treatment was significantly (p less than 0.05) more successful within the first 4 yr after infection (5 responders of 6 treated patients) than after longer disease duration (no responder of 4 treated patients). The results of this pilot study suggest that a combination of beta- and gamma-interferon may be an effective therapy for chronic active hepatitis B when started early after infection.
Caselmann
W H
WH
Max-Planck-Institut für Biochemie, Department of Virus Research, Martinsried/München, Federal Republic of Germany.
Eisenburg
J
J
Hofschneider
P H
PH
Koshy
R
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D004279:DNA, Viral / Q000032:analysis; D004338:Drug Combinations; D005260:Female; D006509:Hepatitis B / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D006513:Hepatitis B e Antigens / Q000032:analysis; D006801:Humans; D007370:Interferon Type I / Q000009:adverse effects / Q000627:therapeutic use*; D007371:Interferon-gamma / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D000637:Transaminases / Q000032:analysis
D004279:DNA, Viral; D004338:Drug Combinations; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D007370:Interferon Type I; D007371:Interferon-gamma; D000637:Transaminases