PMID- 35086621
OWN - NLM
STAT- MEDLINE
DCOM- 20220323
LR  - 20220323
IS  - 1815-7920 (Electronic)
IS  - 1027-3719 (Print)
IS  - 1027-3719 (Linking)
VI  - 26
IP  - 2
DP  - 2022 Feb 1
TI  - Implementing the 4R and 9H regimens for TB preventive treatment in Indonesia.
PG  - 103-110
LID - 10.5588/ijtld.21.0318 [doi]
AB  - BACKGROUND: The implementation of tuberculosis preventive treatment (TPT) is 
      challenging especially in resource-limited settings. As part of a Phase 3 trial 
      on TPT, we described our experience with the use of rifampicin for 4 months (4R) 
      and isoniazid for 9 months (9H) in Indonesia.METHODS: In 2011-2017, children and 
      adults with latent TB infection were randomised to either 4R or 9H and followed 
      until 16 months after randomisation for children and 28 months for adults. The 
      primary outcome was the treatment completion rate. Secondary outcomes were Grade 
      3-5 adverse events (AEs), active TB occurrence, and health costs.RESULTS: A total 
      of 157 children and 860 adults were enrolled. The 4R treatment completion rate 
      was significantly higher than that of 9H (78.7% vs. 65.5%), for a rate difference 
      of 13.2% (95% CI 7.1-19.2). No Grade 3-5 AEs were reported in children; in 
      adults, it was lower in 4R (0.4%) compared to 9H (2.8%). The incidence of active 
      TB was lower with 4R than with 9H (0.09/100 person-year vs. 0.36/100 person-year) 
      (rate difference: -0.36/100 person-year). The total cost per patient was lower 
      for the 4R regimen than for the 9H regimen (USD151.9 vs. USD179.4 in adults and 
      USD152.9 vs. USD206.5 in children)CONCLUSIONS: Completion and efficacy rates for 
      4R were better than for 9H. Compared to 9H, 4R was cheaper in all age groups, 
      safer in adults and equally safe in children. The Indonesian TB program could 
      benefit from these benefits of the 4R regimen.
FAU - Apriani, L
AU  - Apriani L
AD  - TB Working Group, Infectious Disease Research Center, Universitas Padjadjaran, 
      Bandung, Indonesia, Department of Public Health, Faculty of Medicine, Universitas 
      Padjadjaran, Bandung, Indonesia.
FAU - Koesoemadinata, R C
AU  - Koesoemadinata RC
AD  - TB Working Group, Infectious Disease Research Center, Universitas Padjadjaran, 
      Bandung, Indonesia.
FAU - Bastos, M L
AU  - Bastos ML
AD  - Outcomes Research and Evaluation, Research Institute of the McGill University 
      Health Centre, Montreal, QC, Canada.
FAU - Wulandari, D A
AU  - Wulandari DA
AD  - Department of Child Health, Universitas Padjadjaran/Dr Hasan Sadikin General 
      Hospital, Bandung, Indonesia.
FAU - Santoso, P
AU  - Santoso P
AD  - TB Working Group, Infectious Disease Research Center, Universitas Padjadjaran, 
      Bandung, Indonesia, Department of Internal Medicine, Faculty of Medicine, 
      Universitas Padjadjaran/Dr Hasan Sadikin General Hospital, Bandung, Indonesia.
FAU - Alisjahbana, B
AU  - Alisjahbana B
AD  - TB Working Group, Infectious Disease Research Center, Universitas Padjadjaran, 
      Bandung, Indonesia, Department of Internal Medicine, Faculty of Medicine, 
      Universitas Padjadjaran/Dr Hasan Sadikin General Hospital, Bandung, Indonesia.
FAU - Rutherford, M E
AU  - Rutherford ME
AD  - Centre for International Health, Department of Preventive and Social Medicine, 
      University of Otago, Otago, New Zealand.
FAU - Hill, P C
AU  - Hill PC
AD  - Centre for International Health, Department of Preventive and Social Medicine, 
      University of Otago, Otago, New Zealand.
FAU - Benedetti, A
AU  - Benedetti A
AD  - Outcomes Research and Evaluation, Research Institute of the McGill University 
      Health Centre, Montreal, QC, Canada, Departments of Epidemiology, Biostatistics 
      and Occupational Health, and Medicine, McGill University, Montreal, QC, Canada.
FAU - Menzies, D
AU  - Menzies D
AD  - Outcomes Research and Evaluation, Research Institute of the McGill University 
      Health Centre, Montreal, QC, Canada, Departments of Epidemiology, Biostatistics 
      and Occupational Health, and Medicine, McGill University, Montreal, QC, Canada.
FAU - Ruslami, R
AU  - Ruslami R
AD  - TB Working Group, Infectious Disease Research Center, Universitas Padjadjaran, 
      Bandung, Indonesia, Department of Biomedical Sciences, Faculty of Medicine, 
      Universitas Padjadjaran, Bandung, Indonesia.
LA  - eng
GR  - CIHR/Canada
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - France
TA  - Int J Tuberc Lung Dis
JT  - The international journal of tuberculosis and lung disease : the official journal 
      of the International Union against Tuberculosis and Lung Disease
JID - 9706389
RN  - 0 (Antitubercular Agents)
RN  - V83O1VOZ8L (Isoniazid)
RN  - VJT6J7R4TR (Rifampin)
SB  - IM
MH  - Adult
MH  - *Antitubercular Agents/adverse effects
MH  - Child
MH  - Humans
MH  - Incidence
MH  - Indonesia/epidemiology
MH  - Isoniazid/adverse effects
MH  - *Latent Tuberculosis/drug therapy/epidemiology/prevention & control
MH  - Rifampin/adverse effects
PMC - PMC8802562
COIS- Conflicts of interest: none declared.
EDAT- 2022/01/29 06:00
MHDA- 2022/03/24 06:00
PMCR- 2022/02/01
CRDT- 2022/01/28 05:34
PHST- 2022/01/28 05:34 [entrez]
PHST- 2022/01/29 06:00 [pubmed]
PHST- 2022/03/24 06:00 [medline]
PHST- 2022/02/01 00:00 [pmc-release]
AID - 10.5588/ijtld.21.0318 [doi]
PST - ppublish
SO  - Int J Tuberc Lung Dis. 2022 Feb 1;26(2):103-110. doi: 10.5588/ijtld.21.0318.