作者
Susan Swindells, Ritesh Ramchandani, Amita Gupta, Constance A Benson, Jorge Leon-Cruz, Noluthando Mwelase, Marc A Jean Juste, Javier R Lama, Javier Valencia, Ayotunde Omoz-Oarhe, Khuanchai Supparatpinyo, Gaerolwe Masheto, Lerato Mohapi, Rodrigo O da Silva Escada, Sajeeda Mawlana, Peter Banda, Patrice Severe, James Hakim, Cecilia Kanyama, Deborah Langat, Laura Moran, Janet Andersen, Courtney V Fletcher, Eric Nuermberger, Richard E Chaisson
发表日期
2019/3/14
期刊
New England Journal of Medicine
卷号
380
期号
11
页码范围
1001-1011
出版商
Massachusetts Medical Society
简介
Background
Tuberculosis is the leading killer of patients with human immunodeficiency virus (HIV) infection. Preventive therapy is effective, but current regimens are limited by poor implementation and low completion rates.
Methods
We conducted a randomized, open-label, phase 3 noninferiority trial comparing the efficacy and safety of a 1-month regimen of daily rifapentine plus isoniazid (1-month group) with 9 months of isoniazid alone (9-month group) in HIV-infected patients who were living in areas of high tuberculosis prevalence or who had evidence of latent tuberculosis infection. The primary end point was the first diagnosis of tuberculosis or death from tuberculosis or an unknown cause. Noninferiority would be shown if the upper limit of the 95% confidence interval for the between-group difference in the number of events per 100 person-years was less than 1.25.
Results
A total of 3000 patients were …
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S Swindells, R Ramchandani, A Gupta, CA Benson… - New England Journal of Medicine, 2019