Safety and Effectiveness of 3 Novel All-Oral Shortened Regimens for Rifampicin- or Multidrug-Resistant Tuberculosis in Kazakhstan.

Autor:	Rashitov, Makhmujan, Franke, Molly F, Trevisi, Letizia, Bekbolatova, Gulzhanat, Shalimova, Julia, Eshmetov, Gafurzhan, Bektasov, Sagit, LaHood, Allison, Arlyapova, Nataliya, Osso, Elna, Yedilbayev, Askar, Korotych, Oleksandr, Ciobanu, Anisoara, Skrahina, Alena, Mitnick, Carole D, Seung, Kwonjune J, Algozhin, Yerkebulan, Rich, Michael L
Předmět:	ANTIBIOTICS HETEROCYCLIC compounds PYRAZINAMIDE COMBINATION drug therapy PATIENT safety RESEARCH funding FLUOROQUINOLONES ORAL drug administration TREATMENT effectiveness TREATMENT duration DESCRIPTIVE statistics ANTITUBERCULAR agents QUINOLONE antibacterial agents LONGITUDINAL method LINEZOLID CONFIDENCE intervals RIFAMPIN
Zdroj:	Clinical Infectious Diseases; 10/15/2024, Vol. 79 Issue 4, p1046-1053, 8p
Abstrakt:	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. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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