Randomized, controlled trial of recombinant human alpha-interferon in patients with chronic hepatitis B.
Forty-five patients with chronic hepatitis B were entered into a randomized controlled trial of recombinant human alpha-interferon therapy. All patients had hepatitis B surface antigen in serum for at least 1 yr and had stable serum levels of both hepatitis B virus deoxyribonucleic acid and hepatitis B e antigen. During the 4-mo period of therapy, 10 of 31 (32%) treated patients and only 1 of 14 (7%) control patients became negative for serum hepatitis B virus deoxyribonucleic acid and deoxyribonucleic acid polymerase. All 10 patients who became negative for serum hepatitis B virus deoxyribonucleic acid subsequently had a marked improvement in serum aminotransferase activities and lost hepatitis B e antigen from serum, and 9 of them had improvement in liver histology. Comparison of responders to nonresponders indicated that female sex and a high initial level of serum aspartate aminotransferase correlated best with response to interferon therapy. These findings indicate that a 4-mo course of recombinant alpha-interferon can induce a remission in disease in approximately one-third of patients with chronic hepatitis B.
D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D004279:DNA, Viral / Q000097:blood; D004259:DNA-Directed DNA Polymerase / Q000097:blood; D005260:Female; D005500:Follow-Up Studies; D006509:Hepatitis B / Q000097:blood / Q000276:immunology / Q000628:therapy*; D006512:Hepatitis B Core Antigens / Q000032:analysis; D006515:Hepatitis B virus / Q000032:analysis; D006801:Humans; D007370:Interferon Type I / Q000627:therapeutic use*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011897:Random Allocation; D011994:Recombinant Proteins
D004279:DNA, Viral; D006512:Hepatitis B Core Antigens; D007370:Interferon Type I; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D004259:DNA-Directed DNA Polymerase