{"doi":"10.1093/cid/ciae305","title":"Safety and Effectiveness of 3 Novel All-Oral Shortened Regimens for Rifampicin- or Multidrug-Resistant Tuberculosis in Kazakhstan","abstract":"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.","journal":"Clinical Infectious Diseases","year":2024,"id":429493,"datarank":0.5422670986374707,"base_score":2.1972245773362196,"endowment":2.1972245773362196,"self_citation_contribution":0.32958368660043297,"citation_network_contribution":0.2126834120370377,"self_endowment_contribution":0.32958368660043297,"citer_contribution":0.2126834120370377,"corpus_percentile":null,"corpus_rank":null,"citation_count":8,"citer_count":6,"citers_with_citation_signal":3,"citers_with_endowment":3,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.956,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT05871489"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":376978,"name":"Molly F. Franke","orcid":"0000-0002-4890-5728","position":1,"is_corresponding":false},{"id":394133,"name":"Letizia Trevisi","orcid":null,"position":2,"is_corresponding":false},{"id":1232173,"name":"Gulzhanat Bekbolatova","orcid":null,"position":3,"is_corresponding":false},{"id":1232174,"name":"Julia Shalimova","orcid":null,"position":4,"is_corresponding":false},{"id":1232175,"name":"Gafurzhan Eshmetov","orcid":null,"position":5,"is_corresponding":false},{"id":1120183,"name":"Sagit Bektasov","orcid":null,"position":6,"is_corresponding":false},{"id":1079699,"name":"Allison LaHood","orcid":"0000-0001-8415-133X","position":7,"is_corresponding":false},{"id":1232176,"name":"Nataliya Arlyapova","orcid":null,"position":8,"is_corresponding":false},{"id":1232177,"name":"Elna Osso","orcid":null,"position":9,"is_corresponding":false},{"id":1231627,"name":"Askar Yedilbayev","orcid":"0000-0001-8557-5046","position":10,"is_corresponding":false},{"id":1232178,"name":"Oleksandr Korotych","orcid":null,"position":11,"is_corresponding":false},{"id":1232179,"name":"Anisoara Ciobanu","orcid":null,"position":12,"is_corresponding":false},{"id":817966,"name":"Alena Skrahina","orcid":"0000-0002-1460-0272","position":13,"is_corresponding":false},{"id":765792,"name":"Carole D. Mitnick","orcid":"0000-0002-3455-658X","position":14,"is_corresponding":false},{"id":1079702,"name":"Kwonjune J. Seung","orcid":"0000-0003-0417-4625","position":15,"is_corresponding":false},{"id":1232180,"name":"Yerkebulan Algozhin","orcid":null,"position":16,"is_corresponding":false},{"id":1079698,"name":"Michael Rich","orcid":"0000-0003-4333-4695","position":17,"is_corresponding":false},{"id":1232172,"name":"Makhmujan Rashitov","orcid":null,"position":0,"is_corresponding":true}],"reference_count":18,"raw_metadata":null,"created_at":"2026-07-19T01:59:06.668462Z","pmid":"38833593","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}