Annual Tuberculosis Preventive Therapy for Persons With HIV Infection : A Randomized Trial.
Adolescent
Adult
Anti-HIV Agents
/ therapeutic use
Antitubercular Agents
/ administration & dosage
Drug Administration Schedule
Drug Therapy, Combination
Ethiopia
Female
HIV Infections
/ complications
Humans
Isoniazid
/ administration & dosage
Male
Mozambique
Rifampin
/ administration & dosage
South Africa
Tuberculosis, Pulmonary
/ prevention & control
Young Adult
Journal
Annals of internal medicine
ISSN: 1539-3704
Titre abrégé: Ann Intern Med
Pays: United States
ID NLM: 0372351
Informations de publication
Date de publication:
10 2021
10 2021
Historique:
pubmed:
24
8
2021
medline:
9
11
2021
entrez:
23
8
2021
Statut:
ppublish
Résumé
Tuberculosis preventive therapy for persons with HIV infection is effective, but its durability is uncertain. 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. Randomized trial. (ClinicalTrials.gov: NCT02980016). South Africa, Ethiopia, and Mozambique. Persons with HIV infection who were receiving antiretroviral therapy, were aged 2 years or older, and did not have active tuberculosis. 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. Treatment completion was assessed using pill counts. Tuberculosis incidence was measured over 24 months. 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 ( If rifapentine-isoniazid is effective in curing subclinical tuberculosis, then the intensive tuberculosis screening at month 12 may have reduced its effectiveness. 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. The U.S. Agency for International Development through the CHALLENGE TB grant to the KNCV Tuberculosis Foundation.
Sections du résumé
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 (
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.
Substances chimiques
Anti-HIV Agents
0
Antitubercular Agents
0
Isoniazid
V83O1VOZ8L
Rifampin
VJT6J7R4TR
rifapentine
XJM390A33U
Banques de données
ClinicalTrials.gov
['NCT02980016']
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
1367-1376Investigateurs
Gavin Churchyard
(G)
Vicky Cárdenas
(V)
Salome Charalambous
(S)
Violet Chihota
(V)
Zainab Waggie
(Z)
Kathy Mngadi
(K)
Sarah Yates
(S)
Jabulani Sikula
(J)
Samantha Naicker
(S)
Lihle Mchunu
(L)
Lee Anne Masilela
(LA)
Zonke Mlokoti-Fikeni
(Z)
William Brumskine
(W)
Modulakgotla Sebe
(M)
Felex Ndebele
(F)
Heeran Makkan
(H)
Nontobeko Ndlovu
(N)
Phillip Mpahlele
(P)
Nontobeko Mokone
(N)
Lerato Mngomezulu
(L)
Pule Seatlanyane
(P)
Melissa Senne
(M)
Siyethemba Khumalo
(S)
Fadzai Munedzimwe
(F)
Azwi Muthelo
(A)
Fezeka Mbonisa
(F)
Lebogang Masia
(L)
Kgaugelo Shibambo
(K)
Don Mudzengi
(D)
Katherine Fielding
(K)
Alison Grant
(A)
Anna Vassall
(A)
Fiammetta Bozzani
(F)
Richard Chaisson
(R)
Susan van den Hof
(S)
Frank Cobelens
(F)
Neil Martinson
(N)
Tumelo Moloantoa
(T)
Nompumelelo Yende
(N)
Gabriel Letoba
(G)
Itumeleng Holele
(I)
Getnet Yimer
(G)
Shu-Hua Wang
(SH)
Achenef Bekele
(A)
Leuel Lisanwork
(L)
Aster Shewamare
(A)
Miruts Atsebeha
(M)
Haymet Solomon
(H)
Dagnew Hagezoh
(D)
Mulugeta Weji
(M)
Ketema Kebede
(K)
Desalegne Mengesha
(D)
Hagos Biluts
(H)
Achenef Kidane
(A)
Haileleuel Bisrat
(H)
Oumer Berta
(O)
Genet Zeberga
(G)
Helen Mengesha
(H)
Tewodros Minwuyelet
(T)
Azeb Shewarega
(A)
Woyneshet Siyum
(W)
Rihana Hussen
(R)
Abinet Kebede
(A)
Tigist Endashaw
(T)
Yemeserach Tanka
(Y)
Wondwossen Gebreyes
(W)
Alberto L Garcia-Basteiro
(AL)
Dinis Nguenha
(D)
Belén Saavedra
(B)
Edson Mambique
(E)
David Ampuero
(D)
Santiago Izco
(S)
Joaquim Cossa
(J)
Tim Sterling
(T)
Jeremiah Chakaya
(J)
Darlene von Delft
(D)
Michael Hughes
(M)
Gary Maartens
(G)
Elizabete Nunes
(E)
Yimtubezenash Woldeamanuel
(Y)
Kogie Naidoo
(K)
Commentaires et corrections
Type : CommentIn