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Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons.
AIDS. 2016 06 19; 30(10):1607-15.AIDS

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.

Authors+Show Affiliations

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.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

27243774

Citation

Sterling, Timothy R., et al. "Three Months of Weekly Rifapentine and Isoniazid for Treatment of Mycobacterium Tuberculosis Infection in HIV-coinfected Persons." AIDS (London, England), vol. 30, no. 10, 2016, pp. 1607-15.
Sterling TR, Scott NA, Miro JM, et al. Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons. AIDS. 2016;30(10):1607-15.
Sterling, T. R., Scott, N. A., Miro, J. M., Calvet, G., La Rosa, A., Infante, R., Chen, M. P., Benator, D. A., Gordin, F., Benson, C. A., Chaisson, R. E., & Villarino, M. E. (2016). Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons. AIDS (London, England), 30(10), 1607-15. https://doi.org/10.1097/QAD.0000000000001098
Sterling TR, et al. Three Months of Weekly Rifapentine and Isoniazid for Treatment of Mycobacterium Tuberculosis Infection in HIV-coinfected Persons. AIDS. 2016 06 19;30(10):1607-15. PubMed PMID: 27243774.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons. AU - Sterling,Timothy R, AU - Scott,Nigel A, AU - Miro,Jose M, AU - Calvet,Guilherme, AU - La Rosa,Alberto, AU - Infante,Rosa, AU - Chen,Michael P, AU - Benator,Debra A, AU - Gordin,Fred, AU - Benson,Constance A, AU - Chaisson,Richard E, AU - Villarino,M Elsa, AU - ,, PY - 2016/6/1/entrez PY - 2016/6/1/pubmed PY - 2017/12/20/medline SP - 1607 EP - 15 JF - AIDS (London, England) JO - AIDS VL - 30 IS - 10 N2 - 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. SN - 1473-5571 UR - https://www.unboundmedicine.com/medline/citation/27243774/Three_months_of_weekly_rifapentine_and_isoniazid_for_treatment_of_Mycobacterium_tuberculosis_infection_in_HIV_coinfected_persons_ L2 - https://doi.org/10.1097/QAD.0000000000001098 DB - PRIME DP - Unbound Medicine ER -