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Randomised controlled trial of lymphoblastoid interferon alfa in Europid men with chronic hepatitis B virus infection
- Source :
- BMJ. 299:652-656
- Publication Year :
- 1989
- Publisher :
- BMJ, 1989.
-
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 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.
- Subjects :
- Adult
Male
medicine.medical_specialty
Adolescent
Alpha interferon
Enzyme-Linked Immunosorbent Assay
Gastroenterology
Virus
law.invention
Randomized controlled trial
Antigen
law
Internal medicine
medicine
Humans
Hepatitis B e Antigens
Interferon alfa
Aged
Randomized Controlled Trials as Topic
General Environmental Science
Hepatitis
Hepatitis B Surface Antigens
business.industry
General Engineering
General Medicine
Middle Aged
Hepatitis B
medicine.disease
Confidence interval
Liver
Chronic Disease
Interferon Type I
Immunology
General Earth and Planetary Sciences
beta 2-Microglobulin
business
Research Article
medicine.drug
Subjects
Details
- ISSN :
- 14685833 and 09598138
- Volume :
- 299
- Database :
- OpenAIRE
- Journal :
- BMJ
- Accession number :
- edsair.doi.dedup.....e50adcb4b643836e122ca1c79f790842