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AIDS. 2016 Jun 19;30(10):1607-15. doi: 10.1097/QAD.0000000000001098.

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

Author information

1
aVanderbilt University School of Medicine, Nashville, Tennessee bCenters for Disease Control and Prevention, Atlanta, Georgia, USA cHospital Clinic - IDIBAPS, University of Barcelona, Barcelona, Spain dInstituto Nacional de Infectologia, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil eAsociacion Civil Impacta Salud y Educacion, Lima, Peru fVeterans Affairs Medical Center gGeorge Washington University, Washington, District of Columbia hUniversity of California at San Diego, California iJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Abstract

OBJECTIVE:

Compare the effectiveness, tolerability, and safety of 3 months of weekly rifapentine and isoniazid under direct observation (3HP) versus 9 months of daily isoniazid (9H) in HIV-infected persons.

DESIGN:

Prospective, randomized, and open-label noninferiority trial.

SETTING:

The United States , 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 versus 9H.

MAIN OUTCOME MEASURES:

The effectiveness endpoint was tuberculosis; the noninferiority margin was 0.75%. The tolerability endpoint was treatment completion; the safety endpoint was drug discontinuation because of adverse drug reaction.

RESULTS:

Median baseline CD4 cell counts were 495 (IQR 389-675) and 538 (IQR 418-729) cells/μl 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 follow-up] 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 versus 3.50% in the 3HP and 9H arms, respectively (rate difference: -2.49%; upper bound of the 95% confidence interval of the difference: 0.60%). Treatment completion was higher with 3HP (89%) than 9H (64%) (P < 0.001), and drug discontinuation because of an adverse drug reaction was similar (3 vs. 4%; P = 0.79) in 3HP and 9H, respectively.

CONCLUSION:

Among HIV-infected persons with median CD4 cell count of approximately 500 cells/μl, 3HP was as effective and safe for treatment of latent Mycobacterium tuberculosis infection as 9H, and better tolerated.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00023452.

PMID:
27243774
PMCID:
PMC4899978
DOI:
10.1097/QAD.0000000000001098
[Indexed for MEDLINE]
Free PMC Article

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