{"doi":"10.1093/cid/ciac707","title":"Rifapentine With and Without Moxifloxacin for Pulmonary Tuberculosis in People With Human Immunodeficiency Virus (S31/A5349)","abstract":"BACKGROUND: Tuberculosis (TB) Trials Consortium Study 31/AIDS Clinical Trials Group A5349, an international randomized open-label phase 3 noninferiority trial showed that a 4-month daily regimen substituting rifapentine for rifampin and moxifloxacin for ethambutol had noninferior efficacy and was safe for the treatment of drug-susceptible pulmonary TB (DS-PTB) compared with the standard 6-month regimen. We explored results among the prespecified subgroup of people with human immunodeficiency virus (HIV) (PWH). METHODS: PWH and CD4+ counts ≥100 cells/μL were eligible if they were receiving or about to initiate efavirenz-based antiretroviral therapy (ART). Primary endpoints of TB disease-free survival 12 months after randomization (efficacy) and ≥ grade 3 adverse events (AEs) on treatment (safety) were compared, using a 6.6% noninferiority margin for efficacy. Randomization was stratified by site, pulmonary cavitation, and HIV status. PWH were enrolled in a staged fashion to support cautious evaluation of drug-drug interactions between rifapentine and efavirenz. RESULTS: A total of 2516 participants from 13 countries in sub-Saharan Africa, Asia, and the Americas were enrolled. Among 194 (8%) microbiologically eligible PWH, the median CD4+ count was 344 cells/μL (interquartile range: 223-455). The rifapentine-moxifloxacin regimen was noninferior to control (absolute difference in unfavorable outcomes -7.4%; 95% confidence interval [CI] -20.8% to 6.0%); the rifapentine regimen was not noninferior to control (+7.5% [95% CI, -7.3% to +22.4%]). Fewer AEs were reported in rifapentine-based regimens (15%) than the control regimen (21%). CONCLUSIONS: In people with HIV-associated DS-PTB with CD4+ counts ≥100 cells/μL on efavirenz-based ART, the 4-month daily rifapentine-moxifloxacin regimen was noninferior to the 6-month control regimen and was safe. CLINICAL TRIALS REGISTRATION: NCT02410772.","journal":"Clinical Infectious Diseases","year":2022,"id":263449,"datarank":0.726035565066752,"base_score":2.639057329615259,"endowment":2.639057329615259,"self_citation_contribution":0.3958585994422889,"citation_network_contribution":0.3301769656244631,"self_endowment_contribution":0.3958585994422889,"citer_contribution":0.3301769656244631,"corpus_percentile":null,"corpus_rank":null,"citation_count":13,"citer_count":11,"citers_with_citation_signal":11,"citers_with_endowment":11,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9545,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02410772"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":82966,"name":"Patrick Phillips","orcid":"0000-0002-6336-7024","position":1,"is_corresponding":false},{"id":346871,"name":"Ekaterina V. Kurbatova","orcid":"0000-0003-4636-3731","position":2,"is_corresponding":false},{"id":346884,"name":"Andrew Vernon","orcid":"0000-0003-1105-8534","position":3,"is_corresponding":false},{"id":346870,"name":"Payam Nahid","orcid":"0000-0003-2811-1311","position":4,"is_corresponding":false},{"id":308897,"name":"Rodney Dawson","orcid":"0000-0001-9804-1588","position":5,"is_corresponding":false},{"id":346876,"name":"Kelly E. Dooley","orcid":"0000-0001-9013-5256","position":6,"is_corresponding":false},{"id":428505,"name":"Ian Sanne","orcid":"0000-0003-4921-5611","position":7,"is_corresponding":false},{"id":418028,"name":"Ziyaad Waja","orcid":"0000-0001-8717-9039","position":8,"is_corresponding":false},{"id":442631,"name":"Lerato Mohapi","orcid":null,"position":9,"is_corresponding":false},{"id":259564,"name":"Anthony T. Podany","orcid":"0000-0002-8371-0379","position":10,"is_corresponding":false},{"id":346881,"name":"Wadzanai Samaneka","orcid":"0000-0003-0215-9309","position":11,"is_corresponding":false},{"id":343028,"name":"Rada Savic","orcid":null,"position":12,"is_corresponding":false},{"id":346877,"name":"John L. Johnson","orcid":"0000-0003-1783-0476","position":13,"is_corresponding":false},{"id":921080,"name":"Grace Muzanyi","orcid":null,"position":14,"is_corresponding":false},{"id":503216,"name":"Umesh Lalloo","orcid":"0000-0002-5950-3118","position":15,"is_corresponding":false},{"id":784520,"name":"Kia Bryant","orcid":"0000-0003-0785-7800","position":16,"is_corresponding":false},{"id":346883,"name":"Erin Sizemore","orcid":"0000-0003-3232-0546","position":17,"is_corresponding":false},{"id":346882,"name":"Nigel Scott","orcid":"0000-0002-2132-793X","position":18,"is_corresponding":false},{"id":292878,"name":"Susan E. Dorman","orcid":"0000-0001-6882-9470","position":19,"is_corresponding":false},{"id":346887,"name":"Richard E. Chaisson","orcid":"0000-0003-4710-925X","position":20,"is_corresponding":false},{"id":346886,"name":"Susan Swindells","orcid":"0000-0001-5826-6037","position":21,"is_corresponding":false},{"id":346880,"name":"April C. Pettit","orcid":"0000-0001-8832-0866","position":0,"is_corresponding":true}],"reference_count":12,"raw_metadata":null,"created_at":"2026-07-19T00:26:33.413850Z","pmid":"36041016","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":[]}