Randomised controlled trial of lymphoblastoid interferon alfa in Europid men with chronic hepatitis B virus infection.
OBJECTIVE
To confirm the findings of pilot studies that interferon alfa is an effective treatment of Europid men with chronic hepatitis B virus infection.


METHODS
Randomised controlled trial of three months treatment with interferon alfa followed by 12 months of observation.


METHODS
Outpatient clinic of a tertiary referral centre.


METHODS
37 Treated men (six anti-HIV positive) and 34 untreated men (nine anti-HIV positive) who met the criteria for the trial. Four controls failed to complete follow up.


METHODS
The treated group received subcutaneous injections of 5-10 MU interferon alfa/m2 daily for five days, then 10 MU/m2 thrice weekly for 11 weeks. Follow up continued at monthly intervals for 12 months. Untreated controls were monitored over the same period.


METHODS
Hepatitis B e antigen and hepatitis B virus DNA state after 15 months of observation.


RESULTS
12 Of the 37 treated patients cleared hepatitis B e antigen and hepatitis B virus DNA, whereas only one of 30 untreated controls seroconverted over the same period--an increased response rate of 29% (95% confidence interval 13% to 45%). The life table estimate of response at 15 months was 35% in treated patients, an increase of 32% above controls (95% confidence interval 16% to 48%). The response rates in groups by predictive pretreatment variables were 12 of 31 anti-HIV negative patients (excess response 34%; 95% confidence interval 14% to 54%), 12 of 26 with chronic active hepatitis before treatment (excess response 46%; 27% to 65%), and 12 of 21 with a pretreatment serum aspartate aminotransferase activity greater than 70 IU/l (excess response 46%; 16% to 76%). The combination of these factors predicted response with a sensitivity of 100% and a specificity of 80%. Four of the 12 responders, who had all been infected for less than two years, also lost hepatitis B surface antigen. Treatment was well tolerated.


CONCLUSIONS
Interferon alfa is effective in the treatment of a proportion of Europid men with chronic hepatitis B virus infection, who might be identified before treatment. Additional strategies are required to improve the rate of response.
Brook
M G
MG
Academic Department of Medicine, St Mary's Hospital Medical School, London.
Chan
G
G
Yap
I
I
Karayiannis
P
P
Lever
A M
AM
Jacyna
M
M
Main
J
J
Thomas
H C
HC
D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004797:Enzyme-Linked Immunosorbent Assay; D006509:Hepatitis B / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D006513:Hepatitis B e Antigens / Q000032:analysis; D006801:Humans; D007370:Interferon Type I / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D001613:beta 2-Microglobulin / Q000032:analysis
D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D007370:Interferon Type I; D001613:beta 2-Microglobulin