Article
Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons
Registro en:
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
Autor
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
Resumen
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. 2020-04-05