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Annual Tuberculosis Preventive Therapy for Persons With HIV Infection : A Randomized Trial.
Ann Intern Med. 2021 10; 174(10):1367-1376.AIM

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.

Authors+Show Affiliations

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.).The Aurum Institute, Parktown, South Africa (V.C., K.M., M.S., W.B., L.M., Z.W.).The Aurum Institute, Parktown, South Africa (V.C., K.M., M.S., W.B., L.M., Z.W.).The Aurum Institute, Parktown, South Africa (V.C., K.M., M.S., W.B., L.M., Z.W.).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.).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.).Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique (A.L.G., D.N.).The Aurum Institute, Parktown, South Africa (V.C., K.M., M.S., W.B., L.M., Z.W.).The Aurum Institute, Parktown, South Africa (V.C., K.M., M.S., W.B., L.M., Z.W.).KNCV Tuberculosis Foundation, Den Haag, the Netherlands, and National Institute for Public Health and the Environment, Bilthoven, the Netherlands (S.V.).The Aurum Institute, Parktown, South Africa, and University of the Witwatersrand, Johannesburg, South Africa (V.C., S.C.).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.).No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

34424730

Citation

Churchyard, Gavin, et al. "Annual Tuberculosis Preventive Therapy for Persons With HIV Infection : a Randomized Trial." Annals of Internal Medicine, vol. 174, no. 10, 2021, pp. 1367-1376.
Churchyard G, Cárdenas V, Chihota V, et al. Annual Tuberculosis Preventive Therapy for Persons With HIV Infection : A Randomized Trial. Ann Intern Med. 2021;174(10):1367-1376.
Churchyard, G., Cárdenas, V., Chihota, V., Mngadi, K., Sebe, M., Brumskine, W., Martinson, N., Yimer, G., Wang, S. H., Garcia-Basteiro, A. L., Nguenha, D., Masilela, L., Waggie, Z., van den Hof, S., Charalambous, S., Cobelens, F., Chaisson, R. E., Grant, A. D., & Fielding, K. L. (2021). Annual Tuberculosis Preventive Therapy for Persons With HIV Infection : A Randomized Trial. Annals of Internal Medicine, 174(10), 1367-1376. https://doi.org/10.7326/M20-7577
Churchyard G, et al. Annual Tuberculosis Preventive Therapy for Persons With HIV Infection : a Randomized Trial. Ann Intern Med. 2021;174(10):1367-1376. PubMed PMID: 34424730.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Annual Tuberculosis Preventive Therapy for Persons With HIV Infection : A Randomized Trial. AU - Churchyard,Gavin, AU - Cárdenas,Vicky, AU - Chihota,Violet, AU - Mngadi,Kathy, AU - Sebe,Modulakgotla, AU - Brumskine,William, AU - Martinson,Neil, AU - Yimer,Getnet, AU - Wang,Shu-Hua, AU - Garcia-Basteiro,Alberto L, AU - Nguenha,Dinis, AU - Masilela,LeeAnne, AU - Waggie,Zainab, AU - van den Hof,Susan, AU - Charalambous,Salome, AU - Cobelens,Frank, AU - Chaisson,Richard E, AU - Grant,Alison D, AU - Fielding,Katherine L, AU - ,, Y1 - 2021/08/24/ PY - 2021/8/24/pubmed PY - 2021/11/9/medline PY - 2021/8/23/entrez SP - 1367 EP - 1376 JF - Annals of internal medicine JO - Ann Intern Med VL - 174 IS - 10 N2 - 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. SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/34424730/Annual_Tuberculosis_Preventive_Therapy_for_Persons_With_HIV_Infection_:_A_Randomized_Trial_ DB - PRIME DP - Unbound Medicine ER -