{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Chang VK"],"funding":["NIAID NIH HHS"],"pagination":["9400"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11526018"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["15(1)"],"pubmed_abstract":["The Phase 3 randomized controlled trial, TBTC Study 31/ACTG A5349 (NCT02410772) demonstrated that a 4-month rifapentine-moxifloxacin regimen for drug-susceptible pulmonary tuberculosis was safe and effective. The primary efficacy outcome was 12-month tuberculosis disease free survival, while the primary safety outcome was the proportion of grade 3 or higher adverse events during the treatment period. We conducted an analysis of demographic, clinical, microbiologic, radiographic, and pharmacokinetic data and identified risk factors for unfavorable outcomes and adverse events. Among participants receiving the rifapentine-moxifloxacin regimen, low rifapentine exposure is the strongest driver of tuberculosis-related unfavorable outcomes (HR 0.65 for every 100 µg∙h/mL increase, 95%CI 0.54-0.77)"],"journal":["Nature communications"],"pubmed_title":["Risk-stratified treatment for drug-susceptible pulmonary tuberculosis."],"pmcid":["PMC11526018"],"funding_grant_id":["UM1 AI106701","UM1 AI068634","K24 AI150349","UM1 AI068636","R01 AI135124","UM1 AI069518","K08 AI141740","UM1 AI069496"],"pubmed_authors":["Kumwenda J","Akol JP","Reichler M","Elskamp M","Jeffries C","Gurupira W","Hedges K","Carr W","Leon M","Chang KC","Kizza HM","Ssaku E","Tameris M","Rassool M","Yuan Y","Nguyen HV","Bennet J","Diacon A","Gotuzzo E","Velasquez GE","Mohapi L","Kosashunhanan N","Swindells S","Camblart M","Leung CC","Henderson C","Lalloo UG","Grosset JH","Potani C","Moro R","Quintero M","Hosseinipour M","Vernon A","Okeyo E","Mponda K","Fagley M","Chaisson RE","Nguyen HTT","Kurbatova EV","Hiemstra A","Tuler L","Sims J","Nguyen HTM","Jaffer M","Dorman SE","Cowan L","Tuberculosis Trials Consortium","Hott A","Luabeya AKK","Peddareddy L","Luu LT","Weiner M","Klein K","Sekitoleko I","Musodza Y","Pillay S","Pettit AC","Samuel G","Whitworth W","Gaikwad S","Mitchell E","Mwelase N","Luetkemeyer A","Pavon P","Peters D","Mangan J","Lokhande R","Neverkar N","Engle M","Jindani A","Escada R","Sadowski C","AIDS Clinical Trial Group","Majoro K","Rabuogi P","Mazurek G","Tsikhutsu I","Guy E","de Melo MG","Sizemore EE","Carter C","Nahid P","Nsubuga P","Mendoza A","Xaba M","Marquez C","Nhung NV","Duque R","Johnson JL","Hendricks B","Hosey L","Cornelissen L","Dawson R","Royal G","Mogashoa N","Dunn M","Louis MJJ","Jean CP","Savic RM","Coughlin K","Chang VK","Schwalb A","Harrison T","Joseph Y","Ouma SG","Munyanga C","Dooley KE","DeCausey B","Kleinhans C","Merrifield C","Sawe F","Lama JR","Borisov A","Willby M","Burton D","Mercy C","Siika A","Diacon AH","Hatherill M","Apollon A","Alves Lira RC","Burns S","Imperial MZ","Ricaldi J","Posey J","Podany AT","Brown N","Campbell J","Sugandhavesa P","Gonzales P","Gatechompol S","Burzynski J","Mukwekwerere P","Nuermberger EL","Bryant KE","Avihingsanon A","Phillips PPJ"],"additional_accession":[]},"is_claimable":false,"name":"Risk-stratified treatment for drug-susceptible pulmonary tuberculosis.","description":"The Phase 3 randomized controlled trial, TBTC Study 31/ACTG A5349 (NCT02410772) demonstrated that a 4-month rifapentine-moxifloxacin regimen for drug-susceptible pulmonary tuberculosis was safe and effective. The primary efficacy outcome was 12-month tuberculosis disease free survival, while the primary safety outcome was the proportion of grade 3 or higher adverse events during the treatment period. We conducted an analysis of demographic, clinical, microbiologic, radiographic, and pharmacokinetic data and identified risk factors for unfavorable outcomes and adverse events. Among participants receiving the rifapentine-moxifloxacin regimen, low rifapentine exposure is the strongest driver of tuberculosis-related unfavorable outcomes (HR 0.65 for every 100 µg∙h/mL increase, 95%CI 0.54-0.77)","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Oct","modification":"2026-06-01T09:55:16.063Z","creation":"2025-04-06T09:32:18.155Z"},"accession":"S-EPMC11526018","cross_references":{"pubmed":["39477924"],"doi":["10.1038/s41467-024-53273-7"]}}