Skip directly to site content Skip directly to page options Skip directly to A-Z link Skip directly to A-Z link Skip directly to A-Z link

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released.

Volume 31, Number 3—March 2025
CME ACTIVITY - Research

Efficacy and Safety of 4-Month Rifapentine-Based Tuberculosis Treatments in Persons with Diabetes

Ekaterina V. KurbatovaComments to Author , William C. Whitworth, Lakshmi Praveena Peddareddy, Patrick P.J. Phillips, Nigel A. Scott, Kia E. Bryant, Rodney Dawson, Sandra Wagner Cardoso, Wadzanai Samaneka, Melissa Engle, Ziyaad Waja, Erin Sizemore, Wendy Carr, Kelly E. Dooley, Radojka Savic, Susan Swindells, Richard E. Chaisson, Susan E. Dorman, Payam Nahid, Nhung V. Nguyen, and AIDS Clinical Trials Group A5349,1 and Tuberculosis Trials Consortium Study 312
Author affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia, USA (E.V. Kurbatova, W.C. Whitworth, L.P. Peddareddy, N.A. Scott, K.E. Bryant, E. Sizemore, W. Carr); University of California– San Francisco Center for Tuberculosis, San Francisco, California, USA (P.P.J. Phillips, R. Savic, P. Nahid); University of Cape Town Lung Institute, Cape Town, South Africa (R. Dawson); Fundação Oswaldo Cruz Insituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro, Brazil (S. Wagner Cardoso); Milton Park Clinical Research Site, Harare, Zimbabwe (W. Samaneka); Audie L. Murphy Veterans Administration Medical Center, San Antonio, Texas, USA (M. Engle); Wits Health Consortium Perinatal HIV Research Unit, Johannesburg, South Africa (Z. Waja); Vanderbilt University Medical Center, Nashville, Tennessee, USA (K.E. Dooley); University of Nebraska Medical Center, Omaha, Nebraska, USA (S. Swindells); Johns Hopkins University School of Medicine, Baltimore, Maryland, USA (R.E. Chaisson); Medical University of South Carolina, Charleston, South Carolina, USA (S.E. Dorman); Vietnam National Tuberculosis Program/University of California–San Francisco Research Collaboration Unit, Hanoi, Vietnam (N.V. Nguyen)

Main Article

Table 1

Diabetes status of 181 participants at enrollment, by tuberculosis drug regimen, in a study assessing efficacy and safety of 4-month rifapentine-based tuberculosis treatments in persons with diabetes at sites in 12 countries,* January 2016–October 2018

Criterion† No. patients (%)
Control, n = 59 Rifapentine/moxifloxacin, n = 66 Rifapentine, n = 56 Total, N = 181
Hemoglobin A1c >6.5% 49 (83.1) 43 (65.2) 43 (76.8) 135 (74.6)
Prior reported diagnosis of diabetes 31 (52.5) 36 (54.5) 16 (28.6) 83 (45.9)
Receiving antidiabetic drugs‡ 22 (37.3) 29 (43.9) 11 (19.6) 62 (34.3)
Fasting blood glucose >126 mg/dL 14 (23.7) 18 (27.3) 13 (23.2) 45 (24.9)
Nonfasting blood glucose >200 mg/dL 5 (8.5) 13 (19.7) 4 (7.1) 22 (12.2)

*Brazil, Haiti, India, Kenya, Malawi, Peru, South Africa, Thailand, Uganda, United States, Vietnam, and Zimbabwe. †Diabetes criteria were assessed at enrollment (baseline). Randomized trial participants meeting >1 of these criteria at enrollment were included in these analyses. ‡World Health Organization Drug Dictionary’s standardized drug groupings were used to identify class 2 category drugs used in diabetes (18).

Main Article

References
  1. World Health Organization. Global tuberculosis report 2023. 2023 Nov 7 [cited 2024 Aug 2]. https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2023
  2. Baker  MA, Harries  AD, Jeon  CY, Hart  JE, Kapur  A, Lönnroth  K, et al. The impact of diabetes on tuberculosis treatment outcomes: a systematic review. BMC Med. 2011;9:81. DOIPubMedGoogle Scholar
  3. Alisjahbana  B, Sahiratmadja  E, Nelwan  EJ, Purwa  AM, Ahmad  Y, Ottenhoff  TH, et al. The effect of type 2 diabetes mellitus on the presentation and treatment response of pulmonary tuberculosis. Clin Infect Dis. 2007;45:42835. DOIPubMedGoogle Scholar
  4. Salindri  AD, Kipiani  M, Kempker  RR, Gandhi  NR, Darchia  L, Tukvadze  N, et al. Diabetes reduces the rate of sputum culture conversion in patients with newly diagnosed multidrug-resistant tuberculosis. Open Forum Infect Dis. 2016;3:ofw126. DOIPubMedGoogle Scholar
  5. Workneh  MH, Bjune  GA, Yimer  SA. Diabetes mellitus is associated with increased mortality during tuberculosis treatment: a prospective cohort study among tuberculosis patients in South-Eastern Amahra Region, Ethiopia. Infect Dis Poverty. 2016;5:22. DOIPubMedGoogle Scholar
  6. Ma  Y, Huang  ML, Li  T, Du  J, Shu  W, Xie  SH, et al. Role of diabetes mellitus on treatment effects in drug-susceptible initial pulmonary tuberculosis patients in China. Biomed Environ Sci. 2017;30:6715.PubMedGoogle Scholar
  7. Güler  M, Unsal  E, Dursun  B, Aydln  O, Capan  N. Factors influencing sputum smear and culture conversion time among patients with new case pulmonary tuberculosis. Int J Clin Pract. 2007;61:2315. DOIPubMedGoogle Scholar
  8. Dooley  KE, Chaisson  RE. Tuberculosis and diabetes mellitus: convergence of two epidemics. Lancet Infect Dis. 2009;9:73746. DOIPubMedGoogle Scholar
  9. Jiménez-Corona  ME, Cruz-Hervert  LP, García-García  L, Ferreyra-Reyes  L, Delgado-Sánchez  G, Bobadilla-Del-Valle  M, et al. Association of diabetes and tuberculosis: impact on treatment and post-treatment outcomes. Thorax. 2013;68:21420. DOIPubMedGoogle Scholar
  10. Restrepo  BI, Schlesinger  LS. Impact of diabetes on the natural history of tuberculosis. Diabetes Res Clin Pract. 2014;106:1919. DOIPubMedGoogle Scholar
  11. Hodgson  K, Morris  J, Bridson  T, Govan  B, Rush  C, Ketheesan  N. Immunological mechanisms contributing to the double burden of diabetes and intracellular bacterial infections. Immunology. 2015;144:17185. DOIPubMedGoogle Scholar
  12. Martinez  N, Smulan  LJ, Jameson  ML, Smith  CM, Cavallo  K, Bellerose  M, et al. Glycerol contributes to tuberculosis susceptibility in male mice with type 2 diabetes. Nat Commun. 2023;14:5840. DOIPubMedGoogle Scholar
  13. Alfarisi  O, Mave  V, Gaikwad  S, Sahasrabudhe  T, Ramachandran  G, Kumar  H, et al. Effect of diabetes mellitus on the pharmacokinetics and pharmacodynamics of tuberculosis treatment. Antimicrob Agents Chemother. 2018;62:e0138318. DOIPubMedGoogle Scholar
  14. Chiang  CY, Bai  KJ, Lin  HH, Chien  ST, Lee  JJ, Enarson  DA, et al. The influence of diabetes, glycemic control, and diabetes-related comorbidities on pulmonary tuberculosis. PLoS One. 2015;10:e0121698. DOIPubMedGoogle Scholar
  15. Dorman  SE, Nahid  P, Kurbatova  EV, Phillips  PPJ, Bryant  K, Dooley  KE, et al.; AIDS Clinical Trials Group; Tuberculosis Trials Consortium. Tuberculosis Trials Consortium. Four-month rifapentine regimens with or without moxifloxacin for tuberculosis. N Engl J Med. 2021;384:170518. DOIPubMedGoogle Scholar
  16. Carr  W, Kurbatova  E, Starks  A, Goswami  N, Allen  L, Winston  C. Interim guidance: 4-month rifapentine-moxifloxacin regimen for the treatment of drug-susceptible pulmonary tuberculosis—United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71:2859. DOIPubMedGoogle Scholar
  17. World Health Organization. Treatment of drug-susceptible tuberculosis: rapid communication. 2021 Jun 14 [cited 2024 Aug 2]. https://www.who.int/publications/i/item/9789240028678
  18. Lagerlund  O, Strese  S, Fladvad  M, Lindquist  M. WHODrug: a global, validated and updated dictionary for medicinal information. Ther Innov Regul Sci. 2020;54:111622. DOIPubMedGoogle Scholar
  19. National Clinical Trials Network. Common Terminology Criteria for Adverse Events (CTCAE). 2021 Apr 19 [cited 2024 Aug 2]. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm
  20. US Food and Drug Administration. Population pharmacokinetics: guidance for industry. 2022 Feb 3 [cited 2024 Aug 2]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/population-pharmacokinetics
  21. Magee  MJ, Salindri  AD, Kyaw  NTT, Auld  SC, Haw  JS, Umpierrez  GE. Stress hyperglycemia in patients with tuberculosis disease: epidemiology and clinical implications. Curr Diab Rep. 2018;18:71. DOIPubMedGoogle Scholar
  22. International Diabetes Federation. International Diabetes Federation diabetes atlas. 10th edition. 2021 [cited 2024 Aug 2]. https://diabetesatlas.org/atlas/tenth-edition

Main Article

1Members of group listed at the end of this article.

2Members of group listed at the end of this article.

Page created: January 15, 2025
Page updated: February 24, 2025
Page reviewed: February 24, 2025
The conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above.
file_external