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Oral Regimens for Rifampin-Resistant, Fluoroquinolone-Susceptible Tuberculosis.

Lorenzo Guglielmetti1, Uzma Khan1, Gustavo E Velásquez1

  • 1From Médecins Sans Frontières (L.G., F.V.), Sorbonne Université, INSERM Unité 1135, Centre d'Immunologie et des Maladies Infectieuses (L.G.), Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Universitaire Sorbonne Université, Hôpital Pitié-Salpêtrière, Centre National de Référence des Mycobactéries et de la Résistance des Mycobactéries aux Antituberculeux (L.G.), and Epicentre (M.G., E. Baudin), Paris, and Translational Research on HIV and Endemic and Emerging Infectious Diseases, Montpellier Université de Montpellier, Montpellier, Institut de Recherche pour le Développement, Montpellier, INSERM, Montpellier (M.B.) - all in France; Interactive Development and Research, Singapore (U.K.); McGill University, Epidemiology, Biostatistics, and Occupational Health, Montreal (U.K.); UCSF Center for Tuberculosis (G.E.V., P.N., P.P.J.P.) and the Division of HIV, Infectious Diseases, and Global Medicine (G.E.V.), University of California at San Francisco, San Francisco; the National Scientific Center of Phthisiopulmonology (A.A., E. Berikova) and the Center of Phthisiopulmonology of Almaty Health Department (A.K.), Almaty, and the City Center of Phthisiopulmonology, Astana (Z.D.) - all in Kazakhstan; Médecins Sans Frontières (C.B., I.M.), the Medical Research Council Clinical Trials Unit at University College London (I.M.), and St. George's University of London Institute for Infection and Immunity (S.W.) - all in London; MedStar Health Research Institute, Washington, DC (M.C.); Médecins Sans Frontières, Mumbai (V. Chavan), the Indian Council of Medical Research Headquarters-New Delhi, New Delhi (S. Panda), and the Indian Council of Medical Research-National AIDS Research Institute, Pune (S. Patil) - all in India; the Centre for Infectious Disease Epidemiology and Research (V. Cox) and the Department of Medicine (H. McIlleron), University of Cape Town, and the Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine (S.W.) - both in Cape Town, South Africa; the Institute of Tropical Medicine, Antwerp, Belgium (B. C. J.); Médecins Sans Frontières, Geneva (G.F., N.L.); Médecins Sans Frontières, Yerevan, Armenia (O.K.); the National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia (N.K.); Partners In Health (M.K.) and Jhpiego Lesotho (L.O.) - both in Maseru; Socios En Salud Sucursal Peru (L.L., S.M.-T., J.R., E.S.-G., D.E.V.-V.), Hospital Nacional Sergio E. Bernales, Centro de Investigacion en Enfermedades Neumologicas (E.S.-G.), Hospital Nacional Dos de Mayo (E.T.), Universidad Nacional Mayor de San Marcos (E.T.), and Hospital Nacional Hipólito Unanue (D.E.V.-V.) - all in Lima; Global Health and Social Medicine, Harvard Medical School (L.L., K.J.S., M.L.R., C.D.M.), Partners In Health (L.L., K.J.S., M.L.R., C.D.M.), the Division of Global Health Equity, Brigham and Women's Hospital (K.J.S., M.L.R., C.D.M.), the Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, (L.T.), and Harvard T.H. Chan School of Public Health (L.T.) - all in Boston; and the Indus Hospital and Health Network, Karachi, Pakistan (H. Mushtaque, N.S.).

The New England Journal of Medicine
|January 29, 2025
PubMed
Summary

New all-oral regimens show noninferior efficacy for treating rifampin-resistant tuberculosis. These shortened treatment options offer comparable outcomes to standard therapy with similar safety profiles.

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Area of Science:

  • Infectious Diseases
  • Clinical Trials
  • Pharmacology

Background:

  • Historically, treatment for rifampin-resistant tuberculosis (TB) suffered from limited options and weak evidence.
  • Advances in TB drug development and increased funding have enabled rigorous trials of new treatment strategies.

Purpose of the Study:

  • To evaluate the noninferiority of five novel 9-month, all-oral regimens compared to standard therapy for fluoroquinolone-susceptible, rifampin-resistant TB.
  • To assess the efficacy and safety of shortened, all-oral treatment regimens.

Main Methods:

  • A phase 3, multinational, open-label, randomized controlled noninferiority trial was conducted.
  • Participants received standard therapy or one of five oral regimens containing bedaquiline, delamanid, linezolid, levofloxacin/moxifloxacin, clofazimine, and pyrazinamide.
  • Bayesian response-adaptive randomization was used, with favorable outcome at week 73 as the primary endpoint.

Main Results:

  • In the modified intention-to-treat analysis, 80.7% of patients on standard therapy achieved favorable outcomes.
  • Three novel regimens (BCLLfxZ, BLMZ, BDLLfxZ) demonstrated noninferior efficacy compared to standard therapy.
  • Adverse event rates were similar across regimens, with notable hepatotoxicity observed in 11.7% of all participants.

Conclusions:

  • Consistent findings across analyses support the noninferior efficacy of three all-oral, shortened regimens for rifampin-resistant TB.
  • These findings pave the way for improved treatment options for patients with this challenging form of tuberculosis.