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Toxicity related to standard TB therapy for pulmonary tuberculosis and treatment outcomes in the REMoxTB study according to HIV status

dc.contributor.authorTweed, Conor D.en_ZA
dc.contributor.authorCrook, Angela M.en_ZA
dc.contributor.authorDawson, Rodneyen_ZA
dc.contributor.authorDiacon, Andreas H.en_ZA
dc.contributor.authorMcHugh, Timothy D.en_ZA
dc.contributor.authorMendel, Carl M.en_ZA
dc.contributor.authorMeredith, Sarah K.en_ZA
dc.contributor.authorMohapi, Leratoen_ZA
dc.contributor.authorMurphy, Michael E.en_ZA
dc.contributor.authorNunn, Andrew J.en_ZA
dc.contributor.authorPhillips, Patrick P. J.en_ZA
dc.contributor.authorSingh, Kasha P.en_ZA
dc.contributor.authorSpigelman, Melvinen_ZA
dc.contributor.authorGillespie, Stephen H.en_ZA
dc.date.accessioned2019-08-19T05:29:59Z
dc.date.available2019-08-19T05:29:59Z
dc.date.issued2019-08-14
dc.identifier.citationTweed, C. D., et al 2019. Toxicity related to standard TB therapy for pulmonary tuberculosis and treatment outcomes in the REMoxTB study according to HIV status. BMC Pulmonary Medicine, 19:152, doi:10.1186/s12890-019-0907-6
dc.identifier.issn1471-2466 (online)
dc.identifier.otherdoi:10.1186/s12890-019-0907-6
dc.identifier.urihttp://hdl.handle.net/10019.1/106367
dc.descriptionCITATION: Tweed, C. D., et al 2019. Toxicity related to standard TB therapy for pulmonary tuberculosis and treatment outcomes in the REMoxTB study according to HIV status. BMC Pulmonary Medicine, 19:152, doi:10.1186/s12890-019-0907-6.
dc.descriptionThe original publication is available at https://bmcpulmmed.biomedcentral.com
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%) HIVnegative 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.description.urihttps://bmcpulmmed.biomedcentral.com
dc.format.extent9 pagesen_ZA
dc.language.isoen_ZAen_ZA
dc.publisherBMC (part of Springer Nature)en_ZA
dc.subjectTuberculosisen_ZA
dc.subjectPulmonary tuberculosisen_ZA
dc.subjectHIV infectionsen_ZA
dc.subjectClinical trials of drugsen_ZA
dc.titleToxicity related to standard TB therapy for pulmonary tuberculosis and treatment outcomes in the REMoxTB study according to HIV statusen_ZA
dc.typeArticleen_ZA
dc.date.updated2019-08-18T03:29:47Z
dc.description.versionPublisher's version
dc.rights.holderAuthors retain copyrighten_ZA


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