학술논문

Annual Tuberculosis Preventive Therapy for Persons With HIV Infection : A Randomized Trial.
Document Type
Journal Article
Source
Annals of Internal Medicine. 10/19/2021, Vol. 174 Issue 10, p1367-1376. 10p. 1 Diagram, 4 Charts, 1 Graph.
Subject
*HIV infections
*TUBERCULOSIS
*HIV-positive persons
*ANTIRETROVIRAL agents
*SYMPTOMS
*HIV infection complications
*TUBERCULOSIS prevention
*ANTI-HIV agents
*RESEARCH
*COMBINATION drug therapy
*RESEARCH methodology
*MEDICAL cooperation
*EVALUATION research
*ISONIAZID
*DRUG administration
*COMPARATIVE studies
*RANDOMIZED controlled trials
*ANTITUBERCULAR agents
*RIFAMPIN
*STATISTICAL sampling
Language
ISSN
0003-4819
Abstract
Background: Tuberculosis preventive therapy for persons with HIV infection is effective, but its durability is uncertain.Objective: To compare treatment completion rates of weekly isoniazid-rifapentine for 3 months versus daily isoniazid for 6 months as well as the effectiveness of the 3-month rifapentine-isoniazid regimen given annually for 2 years versus once.Design: Randomized trial. (ClinicalTrials.gov: NCT02980016).Setting: South Africa, Ethiopia, and Mozambique.Participants: Persons with HIV infection who were receiving antiretroviral therapy, were aged 2 years or older, and did not have active tuberculosis.Intervention: Participants were randomly assigned to receive weekly rifapentine-isoniazid for 3 months, given either annually for 2 years or once, or daily isoniazid for 6 months. Participants were screened for tuberculosis symptoms at months 0 to 3 and 12 of each study year and at months 12 and 24 using chest radiography and sputum culture.Measurements: Treatment completion was assessed using pill counts. Tuberculosis incidence was measured over 24 months.Results: Between November 2016 and November 2017, 4027 participants were enrolled; 4014 were included in the analyses (median age, 41 years; 69.5% women; all using antiretroviral therapy). Treatment completion in the first year for the combined rifapentine-isoniazid groups (n = 3610) was 90.4% versus 50.5% for the isoniazid group (n = 404) (risk ratio, 1.78 [95% CI, 1.61 to 1.95]). Tuberculosis incidence among participants receiving the rifapentine-isoniazid regimen twice (n = 1808) or once (n = 1802) was similar (hazard ratio, 0.96 [CI, 0.61 to 1.50]).Limitation: If rifapentine-isoniazid is effective in curing subclinical tuberculosis, then the intensive tuberculosis screening at month 12 may have reduced its effectiveness.Conclusion: Treatment completion was higher with rifapentine-isoniazid for 3 months compared with isoniazid for 6 months. In settings with high tuberculosis transmission, a second round of preventive therapy did not provide additional benefit to persons receiving antiretroviral therapy.Primary Funding Source: The U.S. Agency for International Development through the CHALLENGE TB grant to the KNCV Tuberculosis Foundation. [ABSTRACT FROM AUTHOR]