Three months of rifapentine and isoniazid for latent tuberculosis infection

Timothy R. Sterling, M. Elsa Villarino, Andrey S. Borisov, Nong Shang, Fred Gordin, Erin Bliven-Sizemore, Judith Hackman, Carol Dukes Hamilton, Dick Menzies, Amy Kerrigan, Stephen E. Weis, Marc Weiner, Diane Wing, Marcus B. Conde, Lorna Bozeman, C. Robert Horsburgh, Richard E Chaisson

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Treatment of latent Mycobacterium tuberculosis infection is an essential component of tuberculosis control and elimination. The current standard regimen of isoniazid for 9 months is efficacious but is limited by toxicity and low rates of treatment completion. METHODS: We conducted an open-label, randomized noninferiority trial comparing 3 months of directly observed once-weekly therapy with rifapentine (900 mg) plus isoniazid (900 mg) (combination-therapy group) with 9 months of self-administered daily isoniazid (300 mg) (isoniazid-only group) in subjects at high risk for tuberculosis. Subjects were enrolled from the United States, Canada, Brazil, and Spain and followed for 33 months. The primary end point was confirmed tuberculosis, and the noninferiority margin was 0.75%. RESULTS: In the modified intention-to-treat analysis, tuberculosis developed in 7 of 3986 subjects in the combination-therapy group (cumulative rate, 0.19%) and in 15 of 3745 subjects in the isoniazid-only group (cumulative rate, 0.43%), for a difference of 0.24 percentage points. Rates of treatment completion were 82.1% in the combination- therapy group and 69.0% in the isoniazid-only group (P

Original languageEnglish (US)
Pages (from-to)2155-2166
Number of pages12
JournalNew England Journal of Medicine
Volume365
Issue number23
StatePublished - Dec 8 2011

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rifapentine
Latent Tuberculosis
Isoniazid
Tuberculosis
Group Psychotherapy
Mycobacterium Infections
Intention to Treat Analysis
Mycobacterium tuberculosis
Spain
Canada
Brazil

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Sterling, T. R., Villarino, M. E., Borisov, A. S., Shang, N., Gordin, F., Bliven-Sizemore, E., ... Chaisson, R. E. (2011). Three months of rifapentine and isoniazid for latent tuberculosis infection. New England Journal of Medicine, 365(23), 2155-2166.

Three months of rifapentine and isoniazid for latent tuberculosis infection. / Sterling, Timothy R.; Villarino, M. Elsa; Borisov, Andrey S.; Shang, Nong; Gordin, Fred; Bliven-Sizemore, Erin; Hackman, Judith; Hamilton, Carol Dukes; Menzies, Dick; Kerrigan, Amy; Weis, Stephen E.; Weiner, Marc; Wing, Diane; Conde, Marcus B.; Bozeman, Lorna; Horsburgh, C. Robert; Chaisson, Richard E.

In: New England Journal of Medicine, Vol. 365, No. 23, 08.12.2011, p. 2155-2166.

Research output: Contribution to journalArticle

Sterling, TR, Villarino, ME, Borisov, AS, Shang, N, Gordin, F, Bliven-Sizemore, E, Hackman, J, Hamilton, CD, Menzies, D, Kerrigan, A, Weis, SE, Weiner, M, Wing, D, Conde, MB, Bozeman, L, Horsburgh, CR & Chaisson, RE 2011, 'Three months of rifapentine and isoniazid for latent tuberculosis infection', New England Journal of Medicine, vol. 365, no. 23, pp. 2155-2166.
Sterling TR, Villarino ME, Borisov AS, Shang N, Gordin F, Bliven-Sizemore E et al. Three months of rifapentine and isoniazid for latent tuberculosis infection. New England Journal of Medicine. 2011 Dec 8;365(23):2155-2166.
Sterling, Timothy R. ; Villarino, M. Elsa ; Borisov, Andrey S. ; Shang, Nong ; Gordin, Fred ; Bliven-Sizemore, Erin ; Hackman, Judith ; Hamilton, Carol Dukes ; Menzies, Dick ; Kerrigan, Amy ; Weis, Stephen E. ; Weiner, Marc ; Wing, Diane ; Conde, Marcus B. ; Bozeman, Lorna ; Horsburgh, C. Robert ; Chaisson, Richard E. / Three months of rifapentine and isoniazid for latent tuberculosis infection. In: New England Journal of Medicine. 2011 ; Vol. 365, No. 23. pp. 2155-2166.
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AU - Gordin, Fred

AU - Bliven-Sizemore, Erin

AU - Hackman, Judith

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AU - Menzies, Dick

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AU - Weis, Stephen E.

AU - Weiner, Marc

AU - Wing, Diane

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N2 - BACKGROUND: Treatment of latent Mycobacterium tuberculosis infection is an essential component of tuberculosis control and elimination. The current standard regimen of isoniazid for 9 months is efficacious but is limited by toxicity and low rates of treatment completion. METHODS: We conducted an open-label, randomized noninferiority trial comparing 3 months of directly observed once-weekly therapy with rifapentine (900 mg) plus isoniazid (900 mg) (combination-therapy group) with 9 months of self-administered daily isoniazid (300 mg) (isoniazid-only group) in subjects at high risk for tuberculosis. Subjects were enrolled from the United States, Canada, Brazil, and Spain and followed for 33 months. The primary end point was confirmed tuberculosis, and the noninferiority margin was 0.75%. RESULTS: In the modified intention-to-treat analysis, tuberculosis developed in 7 of 3986 subjects in the combination-therapy group (cumulative rate, 0.19%) and in 15 of 3745 subjects in the isoniazid-only group (cumulative rate, 0.43%), for a difference of 0.24 percentage points. Rates of treatment completion were 82.1% in the combination- therapy group and 69.0% in the isoniazid-only group (P

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