Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons

Detalhes bibliográficos
Autor(a) principal: Sterling, Timothy R.
Data de Publicação: 2016
Outros Autores: Scott, Nigel A., Miro, Jose M., Calvet, Guilherme, La Rosa, Alberto, Infante, Rosa, Chen, Michael P., Benator, Debra A., Gordin, Fred, Benson, Constance A., Chaisson, Richard E., Villarino, M. Elsa, Tuberculosis Trials Consortium and the AIDS Clinical Trials Group for the PREVENT TB Trial
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/32366
Resumo: 2020-04-05
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spelling Sterling, Timothy R.Scott, Nigel A.Miro, Jose M.Calvet, GuilhermeLa Rosa, AlbertoInfante, RosaChen, Michael P.Benator, Debra A.Gordin, FredBenson, Constance A.Chaisson, Richard E.Villarino, M. ElsaTuberculosis Trials Consortium and the AIDS Clinical Trials Group for the PREVENT TB Trial2019-04-04T14:31:40Z2019-04-04T14:31:40Z2016STERLING, Timothy R. et al. Three months of weekly rifapentine plus isoniazid for treatment of M. tuberculosis Infection in HIV co-infected persons. AIDS, v. 30, n. 10, p. 1-17, June 19 2016.0954-0121https://www.arca.fiocruz.br/handle/icict/3236610.1097/QAD.0000000000001098engLippincott, Williams & WilkinsThree months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected personsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article2020-04-05Vanderbilt University School of Medicine. Nashville, TNCenters for Disease Control and Prevention. Atlanta, GA, USA.University of Barcelona. Barcelona. Spain / Hospital Clínic – IDIBAPS. Barcelona, Spain.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Asociación Civil Impacta Salud y Educación. Lima, Peru.Asociación Civil Impacta Salud y Educación. Lima, Peru.Centers for Disease Control and Prevention. Atlanta, GA, USA.George Washington University. Veterans Affairs Medical Center. Washington D.C., USA.University of California at San Diego. San Diego, CA, USA.Johns Hopkins University School of Medicine. Baltimore, MD, USA.Centers for Disease Control and Prevention. Atlanta, GA, USA.Objective: Compare the effectiveness, tolerability, and safety of three months of weekly rifapentine plus isoniazid under direct observation (3HP) vs. 9 months of daily isoniazid (9H) in HIV-infected persons. Design: Prospective, randomized, open-label non-inferiority trial. Setting: U.S., Brazil, Spain, Peru, Canada, and Hong Kong. Participants: HIV-infected persons who were tuberculin skin test positive or close contacts of tuberculosis cases. Intervention: 3HP vs. 9H. Main Outcome Measures: The effectiveness endpoint was tuberculosis; the non-inferiority margin was 0.75%. The tolerability endpoint was treatment completion; the safety endpoint was drug discontinuation due to adverse drug reaction. Results: Median baseline CD4+ counts were 495 (IQR:389–675) and 538 (IQR:418–729) cells/mm3 in the 3HP and 9H arms, respectively (P=0.09). In the modified intention to treat analysis, there were two tuberculosis cases among 206 persons (517 person-years (p-y) of followup) in the 3HP arm (0.39 per 100 p-y) and six tuberculosis cases among 193 persons (481 p-y of follow-up) in the 9H arm (1.25 per 100 p-y). Cumulative tuberculosis rates were 1.01% vs. 3.50% in the 3HP and 9H arms, respectively (rate difference: −2.49%; upper bound of the 95% confidence interval (CI) of the difference: 0.60%). Treatment completion was higher with 3HP (89%) than 9H (64%) (P<0.001), and drug discontinuation due to an adverse drug reaction was similar (3% vs. 4%; P=0.79) in 3HP and 9H, respectively. Conclusions: Among HIV-infected persons with median CD4+ count of approximately 500 cells/mm3 , 3HP was as effective and safe for treatment of latent M. tuberculosis infection as 9H, and better tolerated.M. tuberculosisLatent tuberculosisHIVRifapentineIsoniazidinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83104https://www.arca.fiocruz.br/bitstream/icict/32366/1/license.txt79178e5f2a0eb066867a274556814938MD51ORIGINALve_Sterling_Timothy_etal_INI_2016.pdfve_Sterling_Timothy_etal_INI_2016.pdfapplication/pdf355496https://www.arca.fiocruz.br/bitstream/icict/32366/2/ve_Sterling_Timothy_etal_INI_2016.pdf13e3d54b78c1bd524e9cfd954de10940MD52TEXTve_Sterling_Timothy_etal_INI_2016.pdf.txtve_Sterling_Timothy_etal_INI_2016.pdf.txtExtracted 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dc.title.pt_BR.fl_str_mv Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons
title Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons
spellingShingle Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons
Sterling, Timothy R.
M. tuberculosis
Latent tuberculosis
HIV
Rifapentine
Isoniazid
title_short Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons
title_full Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons
title_fullStr Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons
title_full_unstemmed Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons
title_sort Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons
author Sterling, Timothy R.
author_facet Sterling, Timothy R.
Scott, Nigel A.
Miro, Jose M.
Calvet, Guilherme
La Rosa, Alberto
Infante, Rosa
Chen, Michael P.
Benator, Debra A.
Gordin, Fred
Benson, Constance A.
Chaisson, Richard E.
Villarino, M. Elsa
Tuberculosis Trials Consortium and the AIDS Clinical Trials Group for the PREVENT TB Trial
author_role author
author2 Scott, Nigel A.
Miro, Jose M.
Calvet, Guilherme
La Rosa, Alberto
Infante, Rosa
Chen, Michael P.
Benator, Debra A.
Gordin, Fred
Benson, Constance A.
Chaisson, Richard E.
Villarino, M. Elsa
Tuberculosis Trials Consortium and the AIDS Clinical Trials Group for the PREVENT TB Trial
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Sterling, Timothy R.
Scott, Nigel A.
Miro, Jose M.
Calvet, Guilherme
La Rosa, Alberto
Infante, Rosa
Chen, Michael P.
Benator, Debra A.
Gordin, Fred
Benson, Constance A.
Chaisson, Richard E.
Villarino, M. Elsa
Tuberculosis Trials Consortium and the AIDS Clinical Trials Group for the PREVENT TB Trial
dc.subject.en.pt_BR.fl_str_mv M. tuberculosis
Latent tuberculosis
HIV
Rifapentine
Isoniazid
topic M. tuberculosis
Latent tuberculosis
HIV
Rifapentine
Isoniazid
description 2020-04-05
publishDate 2016
dc.date.issued.fl_str_mv 2016
dc.date.accessioned.fl_str_mv 2019-04-04T14:31:40Z
dc.date.available.fl_str_mv 2019-04-04T14:31:40Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv STERLING, Timothy R. et al. Three months of weekly rifapentine plus isoniazid for treatment of M. tuberculosis Infection in HIV co-infected persons. AIDS, v. 30, n. 10, p. 1-17, June 19 2016.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/32366
dc.identifier.issn.pt_BR.fl_str_mv 0954-0121
dc.identifier.doi.none.fl_str_mv 10.1097/QAD.0000000000001098
identifier_str_mv STERLING, Timothy R. et al. Three months of weekly rifapentine plus isoniazid for treatment of M. tuberculosis Infection in HIV co-infected persons. AIDS, v. 30, n. 10, p. 1-17, June 19 2016.
0954-0121
10.1097/QAD.0000000000001098
url https://www.arca.fiocruz.br/handle/icict/32366
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Lippincott, Williams & Wilkins
publisher.none.fl_str_mv Lippincott, Williams & Wilkins
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
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