Safety and Effectiveness of 3 Novel All-Oral Shortened Regimens for Rifampicin- or Multidrug-Resistant Tuberculosis in Kazakhstan
Rashitov M. Franke M.F. Trevisi L. Bekbolatova G. Shalimova J. Eshmetov G. Bektasov S. LaHood A. Arlyapova N. Osso E. Yedilbayev A. Korotych O. Ciobanu A. Skrahina A. Mitnick C.D. Seung K.J. Algozhin Y. Rich M.L.
15 October 2024Oxford University Press
Clinical Infectious Diseases
2024#79Issue 41046 - 1053 pp.
Background. In 2019, the World Health Organization called for operational research on all-oral shortened regimens for multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB). We report safety and effectiveness of three 9-month all-oral regimens containing bedaquiline (Bdq), linezolid (Lzd), and levofloxacin (Lfx) and reinforced with cycloserine (Cs) and clofazimine (Cfz), delamanid (Dlm) and pyrazinamide (Z), or Dlm and Cfz. Methods. We conducted a prospective cohort study of patients initiating treatment for pulmonary MDR/RR-TB under operational research conditions at public health facilities in Kazakhstan. Participants were screened monthly for adverse events. Participants with baseline resistance were excluded from the study and treated with a longer regimen. We analyzed clinically relevant adverse events of special interest in all participants and sputum culture conversion and end-of-treatment outcomes among individuals who were not excluded. Results. Of 510 participants, 41% were women, the median age was 37 years (25th–75th percentile: 28–49), 18% had a body mass index <18.5 kg/m2, and 51% had cavitary disease. A total of 399 (78%) initiated Bdq-Lzd-Lfx-Cs-Cfz, 83 (16%) started Bdq-Lzd-Lfx-Dlm-Z, and 28 (5%) initiated Bdq-Lzd-Lfx-Dlm-Cfz. Fifty-eight individuals (11%) were excluded from the study, most commonly due to identification of baseline drug resistance (n = 52; 90%). Among the remaining 452 participants, treatment success frequencies were 92% (95% CI: 89–95%), 89% (95% CI: 80–94%), and 100% (95% CI: 86–100%) for regimens with Cs/Cfz, Dlm/Z, and Dlm/Cfz, respectively. Clinically relevant adverse events of special interest were uncommon. Conclusions. All regimens demonstrated excellent safety and effectiveness, expanding the potential treatment options for patients, providers, and programs.
bedaquiline , culture conversion , fluoroquinolone , linezolid , operational research
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Partners In Health Kazakhstan, Almaty, Kazakhstan
Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, United States
Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States
Atyrau Regional Center of Phthisiopulmonology, Atreyu, Kazakhstan
Karaganda Regional Center of Phthisiopulmonology, Karaganda, Kazakhstan
Turkistan Regional Center of Phthisiopulmonology, Turkistan, Kazakhstan
National Scientific Center of Phthisiopulmonology, Almaty, Kazakhstan
Partners In Health, Boston, MA, United States
World Health Organization, Regional Office for Europe, Copenhagen, Denmark
The Republican Scientific and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus
Division of Global Health Equity, Brigham and Women’s Hospital, Boston, MA, United States
Partners In Health Kazakhstan
Department of Global Health and Social Medicine
Department of Epidemiology
Atyrau Regional Center of Phthisiopulmonology
Karaganda Regional Center of Phthisiopulmonology
Turkistan Regional Center of Phthisiopulmonology
National Scientific Center of Phthisiopulmonology
Partners In Health
World Health Organization
The Republican Scientific and Practical Centre for Pulmonology and Tuberculosis
Division of Global Health Equity
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