Long-term follow-up of a randomized trial of interferon therapy for chronic hepatitis B in a predominantly homosexual male population.
OBJECTIVE
Extended follow-up of a previously published therapeutic trial with interferon alfa is now available to further clarify the long-term outcome of HIV-negative and HIV-positive subjects with chronic hepatitis B virus infection after interferon alfa therapy.


METHODS
Forty-five subjects with compensated liver disease and chronic hepatitis B infection with evidence of active hepatitis B replication were studied. These subjects were enrolled between 1986 and 1991 and had been randomized, stratified by HIV status, to either receive interferon therapy (10 MU/m2 of lymphoblastoid interferon alfa 3 times per week for 12 weeks) or no treatment. Hepatitis B serology, serum hepatitis B viral DNA and alanine aminotransferase were measured on an annual to biannual basis. CD4-positive T lymphocyte counts and HIV RNA concentration were also obtained.


RESULTS
From 9 months post-interferon alfa treatment to the end of the extended follow-up (4 to 9 years), the relative risk of seroconverting to anti-HBe positive for subjects who had received interferon alfa therapy compared to those who did not was not significant in either HIV-negative (p = 0.80) or HIV-positive (p = 0.62) subjects.


CONCLUSIONS
Unlike the first 9 months following interferon alfa therapy, the rate of elimination of markers of hepatitis B virus replication, regardless of HIV status, was not increased above the natural rate beyond 9 months following interferon alfa therapy.
Chen
D K
DK
Department of Medicine, Toronto Hospital, University of Toronto, Ontario, Canada.
Yim
C
C
O'Rourke
K
K
Krajden
M
M
Wong
D K
DK
Heathcote
E J
EJ
D000328:Adult; D004279:DNA, Viral / Q000097:blood; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006508:Hepatitis Antibodies / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000097:blood / Q000276:immunology / Q000628:therapy*; D018451:Homosexuality, Male; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D013997:Time Factors
D004279:DNA, Viral; D006508:Hepatitis Antibodies; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha