| Author | Sterling, Timothy R. | |
| Author | Scott, Nigel A. | |
| Author | Miro, Jose M. | |
| Author | Calvet, Guilherme | |
| Author | La Rosa, Alberto | |
| Author | Infante, Rosa | |
| Author | Chen, Michael P. | |
| Author | Benator, Debra A. | |
| Author | Gordin, Fred | |
| Author | Benson, Constance A. | |
| Author | Chaisson, Richard E. | |
| Author | Villarino, M. Elsa | |
| Author | Tuberculosis Trials Consortium and the AIDS Clinical Trials Group for the PREVENT TB Trial | |
| Access date | 2019-04-04T14:31:40Z | |
| Available date | 2019-04-04T14:31:40Z | |
| Document date | 2016 | |
| Citation | 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. | pt_BR |
| ISSN | 0954-0121 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/32366 | |
| Language | eng | pt_BR |
| Publisher | Lippincott, Williams & Wilkins | pt_BR |
| Rights | open access | pt_BR |
| Title | Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1097/QAD.0000000000001098 | |
| Abstract | 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. | pt_BR |
| Affilliation | Vanderbilt University School of Medicine. Nashville, TN | pt_BR |
| Affilliation | Centers for Disease Control and Prevention. Atlanta, GA, USA. | pt_BR |
| Affilliation | University of Barcelona. Barcelona. Spain / Hospital Clínic – IDIBAPS. Barcelona, Spain. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | Asociación Civil Impacta Salud y Educación. Lima, Peru. | pt_BR |
| Affilliation | Asociación Civil Impacta Salud y Educación. Lima, Peru. | pt_BR |
| Affilliation | Centers for Disease Control and Prevention. Atlanta, GA, USA. | pt_BR |
| Affilliation | George Washington University. Veterans Affairs Medical Center. Washington D.C., USA. | pt_BR |
| Affilliation | University of California at San Diego. San Diego, CA, USA. | pt_BR |
| Affilliation | Johns Hopkins University School of Medicine. Baltimore, MD, USA. | pt_BR |
| Affilliation | Centers for Disease Control and Prevention. Atlanta, GA, USA. | pt_BR |
| Subject | M. tuberculosis | pt_BR |
| Subject | Latent tuberculosis | pt_BR |
| Subject | HIV | pt_BR |
| Subject | Rifapentine | pt_BR |
| Subject | Isoniazid | pt_BR |
| Embargo date | 2020-04-05 | |
