Annual Tuberculosis Preventive Therapy for Persons With HIV Infection,Annals of Internal Medicine

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Annual Tuberculosis Preventive Therapy for Persons With HIV Infection
Annals of Internal Medicine ( IF 39.2 ) Pub Date : 2021-08-24 , DOI: 10.7326/m20-7577
Gavin Churchyard ₁ , Vicky Cárdenas ₂ , Violet Chihota ₃ , Kathy Mngadi ₂ , Modulakgotla Sebe ₂ , William Brumskine ₂ , Neil Martinson ₄ , Getnet Yimer ₅ , Shu-Hua Wang ₅ , Alberto L Garcia-Basteiro ₆ , Dinis Nguenha ₆ , LeeAnne Masilela ₂ , Zainab Waggie ₂ , Susan van den Hof ₇ , Salome Charalambous ₃ , Frank Cobelens ₈ , Richard E Chaisson ₉ , Alison D Grant ₁₀ , Katherine L Fielding ₁₁ ,

Affiliation

The Aurum Institute, Parktown, South Africa, Vanderbilt University, Nashville, Tennessee, and University of the Witwatersrand, Johannesburg, South Africa (G.C.).
The Aurum Institute, Parktown, South Africa (V.C., K.M., M.S., W.B., L.M., Z.W.).
The Aurum Institute, Parktown, South Africa, and University of the Witwatersrand, Johannesburg, South Africa (V.C., S.C.).
University of the Witwatersrand, Johannesburg, South Africa, and Amsterdam University Medical Centres, Amsterdam, the Netherlands (N.M.).
The Ohio State University, Addis Ababa, Ethiopia (G.Y., S.W.).
Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique (A.L.G., D.N.).
KNCV Tuberculosis Foundation, Den Haag, the Netherlands, and National Institute for Public Health and the Environment, Bilthoven, the Netherlands (S.V.).
Amsterdam University Medical Centres, Amsterdam, the Netherlands (F.C.).
Johns Hopkins University, Baltimore, Maryland (R.E.C.).
London School of Hygiene & Tropical Medicine, London, United Kingdom, University of the Witwatersrand, Johannesburg, South Africa, and University of KwaZulu-Natal, Durban, South Africa (A.D.G.).
London School of Hygiene & Tropical Medicine, London, United Kingdom, and University of the Witwatersrand, Johannesburg, South Africa (K.L.F.).

**Visual Abstract. Trial of Annual Tuberculosis Preventive Therapy for HIV-Positive Persons.**
Tuberculosis (TB) is a major health threat for HIV-positive persons living in areas of high TB transmission; thus, developing optimal approaches to TB prevention is critical. This clinical trial, conducted in South Africa, Ethiopia, and Mozambique, compared 3 approaches to TB prophylaxis: weekly rifapentine–isoniazid given for 3 months in 1 year, weekly rifapentine–isoniazid given for 3 months in each of 2 consecutive years, and daily isoniazid given for 6 months.

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.

中文翻译：

每年对 HIV 感染者进行结核病预防治疗

背景：

对 HIV 感染者进行结核病预防治疗是有效的，但其持久性尚不确定。

客观的：

比较每周异烟肼-利福喷丁治疗 3 个月与每日异烟肼治疗 6 个月的治疗完成率，以及 3 个月利福喷丁-异烟肼方案每年给药 2 年与一次的有效性。

设计：

随机试验。（ClinicalTrials.gov：NCT02980016）

环境：

南非、埃塞俄比亚和莫桑比克。

参与者：

正在接受抗逆转录病毒治疗、年龄在 2 岁或以上且没有活动性结核病的 HIV 感染者。

干涉：

参与者被随机分配接受每周一次的利福喷丁 - 异烟肼治疗，为期 3 个月，每年给药一次，持续 2 年或一次，或每天给药异烟肼，持续 6 个月。在每个研究年度的第 0 至第 3 个月和第 12 个月以及在第 12 和 24 个月使用胸片和痰培养筛查参与者的结核病症状。

测量：

使用药丸计数评估治疗完成情况。在 24 个月内测量了结核病发生率。

结果：

2016 年 11 月至 2017 年 11 月期间，共招募了 4027 名参与者；4014 人被纳入分析（中位年龄为 41 岁；69.5% 为女性；均使用抗逆转录病毒疗法）。利福喷丁-异烟肼联合治疗组 ( n = 3610)的第一年治疗完成率为 90.4%，而异烟肼组 ( n = 404) 的治疗完成率为 50.5% （风险比，1.78 [95% CI，1.61 至 1.95]）。接受利福喷丁-异烟肼方案两次 ( n = 1808) 或一次 ( n = 1802) 的参与者的结核病发病率相似（风险比，0.96 [CI，0.61 至 1.50]）。