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

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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.date.updated2019-08-18T03:29:47Z
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.description.versionPublisher's version
dc.format.extent9 pagesen_ZA
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.language.isoen_ZAen_ZA
dc.publisherBMC (part of Springer Nature)en_ZA
dc.rights.holderAuthors retain copyrighten_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
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