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dc.contributor.authorTweed, Conor D.
dc.contributor.authorCrook, Angela M.
dc.contributor.authorDawson, Rodney
dc.contributor.authorDiacon, Andreas H.
dc.contributor.authorMcHugh, Timothy D.
dc.contributor.authorMendel, Carl M.
dc.contributor.authorMeredith, Sarah K.
dc.contributor.authorMohapi, Lerato
dc.contributor.authorMurphy, Michael E.
dc.contributor.authorNunn, Andrew J.
dc.contributor.authorPhillips, Patrick P. J.
dc.contributor.authorSingh, Kasha P.
dc.contributor.authorSpigelman, Melvin
dc.contributor.authorGillespie, Stephen H.
dc.date.accessioned2019-08-19T10:30:02Z
dc.date.available2019-08-19T10:30:02Z
dc.date.issued2019-08-14
dc.identifier.citationTweed , C D , Crook , A M , Dawson , R , Diacon , A H , McHugh , T D , Mendel , C M , Meredith , S K , Mohapi , L , Murphy , M E , Nunn , A J , Phillips , P P J , Singh , K P , Spigelman , M & Gillespie , S H 2019 , ' Toxicity related to standard TB therapy for pulmonary tuberculosis and treatment outcomes in the REMoxTB study according to HIV status ' , BMC Pulmonary Medicine , vol. 19 , 152 . https://doi.org/10.1186/s12890-019-0907-6en
dc.identifier.issn1471-2466
dc.identifier.otherPURE: 260661536
dc.identifier.otherPURE UUID: 9525cf62-d375-4748-bbbf-682474b6d4bd
dc.identifier.otherRIS: urn:A3D584073D30FEE2D9C540B2FC007945
dc.identifier.otherRIS: Tweed2019
dc.identifier.otherORCID: /0000-0001-6537-7712/work/60887775
dc.identifier.otherScopus: 85071044376
dc.identifier.urihttp://hdl.handle.net/10023/18334
dc.descriptionSupported by the Global Alliance for TB Drug Development with support from the Bill and Melinda Gates Foundation, the European and Developing Countries Clinical Trials Partnership (grant IP.2007.32011.011), U.S. Agency for International Development, U.K. Department for International Development, Directorate General for International Cooperation of the Netherlands, Irish Aid, Australia Department of Foreign Affairs and Trade, and National Institutes of Health, AIDS Clinical Trials Group and by grants from the National Institute of Allergy and Infectious Diseases (NIAID) (UM1AI068634, UM1 AI068636, and UM1AI106701) and by NIAID grants to the University of KwaZulu Natal, South Africa, AIDS Clinical Trials Group (ACTG) site 31422 (1U01AI069469); to the Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, South Africa, ACTG site 12301 (1U01AI069453); and to the Durban International Clinical Trials Unit, South Africa, ACTG site 11201 (1U01AI069426); Bayer Healthcare for the donation of moxifloxacin; and Sanofi for the donation of rifampin.en
dc.description.abstractBackground:  The phase III REMoxTB study prospectively enrolled HIV-positive (with CD4+ count > 250 cells, not on anti-retroviral therapy) and HIV-negative patients. We investigated the incidence of adverse events and cure rates according to HIV status for patients receiving standard TB therapy in the trial. Methods:  Forty-two HIV-positive cases were matched to 220 HIV-negative controls by age, gender, ethnicity, and trial site using coarsened exact matching. Grade 3 and 4 adverse events (AEs) were summarised by MedDRA System Organ Class. Kaplan-Meier curves for time to first grade 3 or 4 AE were constructed according to HIV status with hazard ratios calculated. Patients were considered cured if they were culture negative 18 months after commencing therapy with ≥2 consecutive negative culture results. Results:  Twenty of 42 (47.6%) HIV-positive and 34 of 220 (15.5%) HIV-negative patients experienced ≥1 grade 3 or 4 AE, respectively. The majority of these were hepatobiliary disorders that accounted for 12 of 40 (30.0%) events occurring in 6 of 42 (14.3%) HIV-positive patients and for 15 of 60 (25.0%) events occurring in 9 of 220 (4.1%) HIV-negative patients. The median time to first grade 3 or 4 AE was 54 days (IQR 15.5–59.0) for HIV-positive and 29.5 days (IQR 9.0–119.0) for HIV-negative patients, respectively. The hazard ratio for experiencing a grade 3 or 4 AE among HIV-positive patients was 3.25 (95% CI 1.87–5.66, p < 0.01). Cure rates were similar, with 38 of 42 (90.5%) HIV-positive and 195 of 220 (88.6%) HIV-negative patients (p = 0.73) cured at 18 months. Conclusions: HIV-positive patients receiving standard TB therapy in the REMoxTB study were at greater risk of adverse events during treatment but cure rates were similar when compared to a matched sample of HIV-negative patients.
dc.format.extent9
dc.language.isoeng
dc.relation.ispartofBMC Pulmonary Medicineen
dc.rightsCopyright © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en
dc.subjectTuberculosisen
dc.subjectClinical trialsen
dc.subjectHIVen
dc.subjectAdverse eventsen
dc.subjectRA0421 Public health. Hygiene. Preventive Medicineen
dc.subjectE-DASen
dc.subject.lccRA0421en
dc.titleToxicity related to standard TB therapy for pulmonary tuberculosis and treatment outcomes in the REMoxTB study according to HIV statusen
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews.School of Medicineen
dc.contributor.institutionUniversity of St Andrews.Sir James Mackenzie Institute for Early Diagnosisen
dc.contributor.institutionUniversity of St Andrews.Centre for Biophotonicsen
dc.contributor.institutionUniversity of St Andrews.Biomedical Sciences Research Complexen
dc.contributor.institutionUniversity of St Andrews.Infection and Global Health Divisionen
dc.contributor.institutionUniversity of St Andrews.Global Health Implementation Groupen
dc.contributor.institutionUniversity of St Andrews.Gillespie Groupen
dc.contributor.institutionUniversity of St Andrews.Infection Groupen
dc.identifier.doihttps://doi.org/10.1186/s12890-019-0907-6
dc.description.statusPeer revieweden


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