Randomised controlled trial of lymphoblastoid interferon alfa in Europid men with chronic hepatitis B virus infection

M. G. Brook, G. Chan, I. Yap, P. Karayiannis, A. M L Lever, M. Jacyna, J. Main, H. C. Thomas

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Abstract

Objective - To confirm the findings of pilot studies that interferon alfa is an effective treatment of Europid men with chronic hepatitis B virus infection. Design - Randomised controlled trial of three months' treatment with interferon alfa followed by 12 months of observation. Setting - Outpatient clinic of a tertiary referral centre. Patients - 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. Interventions - 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. Main outcome measure - 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 rate 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 >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.

Original languageEnglish
Pages (from-to)652-656
Number of pages5
JournalBritish Medical Journal
Volume299
Issue number6700
Publication statusPublished - 1989

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Chronic Hepatitis B
Virus Diseases
Hepatitis B virus
Interferon-alpha
Randomized Controlled Trials
Hepatitis B e Antigens
HIV
Confidence Intervals
Therapeutics
Observation
Life Tables
DNA
Chronic Hepatitis
Subcutaneous Injections
Hepatitis B Surface Antigens
Aspartate Aminotransferases
Ambulatory Care Facilities
Tertiary Care Centers
Outcome Assessment (Health Care)
Serum

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Brook, M. G., Chan, G., Yap, I., Karayiannis, P., Lever, A. M. L., Jacyna, M., ... Thomas, H. C. (1989). Randomised controlled trial of lymphoblastoid interferon alfa in Europid men with chronic hepatitis B virus infection. British Medical Journal, 299(6700), 652-656.
Brook, M. G. ; Chan, G. ; Yap, I. ; Karayiannis, P. ; Lever, A. M L ; Jacyna, M. ; Main, J. ; Thomas, H. C. / Randomised controlled trial of lymphoblastoid interferon alfa in Europid men with chronic hepatitis B virus infection. In: British Medical Journal. 1989 ; Vol. 299, No. 6700. pp. 652-656.
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abstract = "Objective - To confirm the findings of pilot studies that interferon alfa is an effective treatment of Europid men with chronic hepatitis B virus infection. Design - Randomised controlled trial of three months' treatment with interferon alfa followed by 12 months of observation. Setting - Outpatient clinic of a tertiary referral centre. Patients - 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. Interventions - 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. Main outcome measure - 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 rate 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 >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.",
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Brook, MG, Chan, G, Yap, I, Karayiannis, P, Lever, AML, Jacyna, M, Main, J & Thomas, HC 1989, 'Randomised controlled trial of lymphoblastoid interferon alfa in Europid men with chronic hepatitis B virus infection', British Medical Journal, vol. 299, no. 6700, pp. 652-656.

Randomised controlled trial of lymphoblastoid interferon alfa in Europid men with chronic hepatitis B virus infection. / Brook, M. G.; Chan, G.; Yap, I.; Karayiannis, P.; Lever, A. M L; Jacyna, M.; Main, J.; Thomas, H. C.

In: British Medical Journal, Vol. 299, No. 6700, 1989, p. 652-656.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Randomised controlled trial of lymphoblastoid interferon alfa in Europid men with chronic hepatitis B virus infection

AU - Brook, M. G.

AU - Chan, G.

AU - Yap, I.

AU - Karayiannis, P.

AU - Lever, A. M L

AU - Jacyna, M.

AU - Main, J.

AU - Thomas, H. C.

PY - 1989

Y1 - 1989

N2 - Objective - To confirm the findings of pilot studies that interferon alfa is an effective treatment of Europid men with chronic hepatitis B virus infection. Design - Randomised controlled trial of three months' treatment with interferon alfa followed by 12 months of observation. Setting - Outpatient clinic of a tertiary referral centre. Patients - 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. Interventions - 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. Main outcome measure - 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 rate 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 >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.

AB - Objective - To confirm the findings of pilot studies that interferon alfa is an effective treatment of Europid men with chronic hepatitis B virus infection. Design - Randomised controlled trial of three months' treatment with interferon alfa followed by 12 months of observation. Setting - Outpatient clinic of a tertiary referral centre. Patients - 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. Interventions - 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. Main outcome measure - 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 rate 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 >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.

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