Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa

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dc.contributor.authorShean, Karenen_ZA
dc.contributor.authorStreicher, Elizabethen_ZA
dc.contributor.authorPieterson, Elizeen_ZA
dc.contributor.authorSymons, Gregen_ZA
dc.contributor.authorvan Zyl Smit, Richarden_ZA
dc.contributor.authorTheron, Granten_ZA
dc.contributor.authorLehloenya, Rannakoeen_ZA
dc.contributor.authorPadanilam, Xavieren_ZA
dc.contributor.authorWilcox, Paulen_ZA
dc.contributor.authorVictor, Tommie Cen_ZA
dc.contributor.authorvan Helden Paulen_ZA
dc.contributor.authorGroubusch Martinen_ZA
dc.contributor.authorWarren, Robinen_ZA
dc.contributor.authorBadri, Motasimen_ZA
dc.contributor.authorDheda, Keertanen_ZA
dc.date.accessioned2016-01-11T06:51:42Z
dc.date.available2016-01-11T06:51:42Z
dc.date.issued2013en_ZA
dc.description.abstractBACKGROUND: Treatment-related outcomes in patients with extensively drug-resistant tuberculosis (XDR-TB) are poor. However, data about the type, frequency and severity of presumed drug-associated adverse events (AEs) and their association with treatment-related outcomes in patients with XDR-TB are scarce. METHODS: Case records of 115 South-African XDR-TB patients were retrospectively reviewed by a trained researcher. AEs were estimated and graded according to severity [grade 0 = none; grade 1-2 = mild to moderate; and grade 3-5 = severe (drug stopped, life-threatening or death)]. FINDINGS: 161 AEs were experienced by 67/115(58%) patients: 23/67(34%) required modification of treatment, the offending drug was discontinued in 19/67(28%), reactions were life-threatening in 2/67(3.0%), and 6/67(9.0%) died. ∼50% of the patients were still on treatment at the time of data capture. Sputum culture-conversion was less likely in those with severe (grade 3-5) vs. grade 0-2 AEs [2/27(7%) vs. 24/88(27%); p = 0.02]. The type, frequency and severity of AEs was similar in HIV-infected and uninfected patients. Capreomycin, which was empirically administered in most cases, was withdrawn in 14/104(14%) patients, implicated in (14/34) 41% of the total drug withdrawals, and was associated with all 6 deaths in the severe AE group (renal failure in five patients and hypokalemia in one patient). CONCLUSION: Drug-associated AEs occur commonly with XDR-TB treatment, are often severe, frequently interrupt therapy, and negatively impact on culture conversion outcomes. These preliminary data inform on the need for standardised strategies (including pre-treatment counselling, early detection, monitoring, and follow-up) and less toxic drugs to optimally manage patients with XDR-TB.en_ZA
dc.identifier.apacitationShean, K., Streicher, E., Pieterson, E., Symons, G., van Zyl Smit, R., Theron, G., ... Dheda, K. (2013). Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa. <i>PLoS One</i>, http://hdl.handle.net/11427/16256en_ZA
dc.identifier.chicagocitationShean, Karen, Elizabeth Streicher, Elize Pieterson, Greg Symons, Richard van Zyl Smit, Grant Theron, Rannakoe Lehloenya, et al "Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa." <i>PLoS One</i> (2013) http://hdl.handle.net/11427/16256en_ZA
dc.identifier.citationShean, K., Streicher, E., Pieterson, E., Symons, G., van Zyl Smit, R., Theron, G., ... & van Helden, P. (2013). Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa. PLoS ONE, 8, 63057. doi:10.1371/journal.pone.0063057en_ZA
dc.identifier.ris TY - Journal Article AU - Shean, Karen AU - Streicher, Elizabeth AU - Pieterson, Elize AU - Symons, Greg AU - van Zyl Smit, Richard AU - Theron, Grant AU - Lehloenya, Rannakoe AU - Padanilam, Xavier AU - Wilcox, Paul AU - Victor, Tommie C AU - van Helden Paul AU - Groubusch Martin AU - Warren, Robin AU - Badri, Motasim AU - Dheda, Keertan AB - BACKGROUND: Treatment-related outcomes in patients with extensively drug-resistant tuberculosis (XDR-TB) are poor. However, data about the type, frequency and severity of presumed drug-associated adverse events (AEs) and their association with treatment-related outcomes in patients with XDR-TB are scarce. METHODS: Case records of 115 South-African XDR-TB patients were retrospectively reviewed by a trained researcher. AEs were estimated and graded according to severity [grade 0 = none; grade 1-2 = mild to moderate; and grade 3-5 = severe (drug stopped, life-threatening or death)]. FINDINGS: 161 AEs were experienced by 67/115(58%) patients: 23/67(34%) required modification of treatment, the offending drug was discontinued in 19/67(28%), reactions were life-threatening in 2/67(3.0%), and 6/67(9.0%) died. ∼50% of the patients were still on treatment at the time of data capture. Sputum culture-conversion was less likely in those with severe (grade 3-5) vs. grade 0-2 AEs [2/27(7%) vs. 24/88(27%); p = 0.02]. The type, frequency and severity of AEs was similar in HIV-infected and uninfected patients. Capreomycin, which was empirically administered in most cases, was withdrawn in 14/104(14%) patients, implicated in (14/34) 41% of the total drug withdrawals, and was associated with all 6 deaths in the severe AE group (renal failure in five patients and hypokalemia in one patient). CONCLUSION: Drug-associated AEs occur commonly with XDR-TB treatment, are often severe, frequently interrupt therapy, and negatively impact on culture conversion outcomes. These preliminary data inform on the need for standardised strategies (including pre-treatment counselling, early detection, monitoring, and follow-up) and less toxic drugs to optimally manage patients with XDR-TB. DA - 2013 DB - OpenUCT DO - 10.1371/journal.pone.0063057 DP - University of Cape Town J1 - PLoS One LK - https://open.uct.ac.za PB - University of Cape Town PY - 2013 T1 - Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa TI - Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa UR - http://hdl.handle.net/11427/16256 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/16256
dc.identifier.urihttp://dx.doi.org/10.1371/journal.pone.0063057
dc.identifier.vancouvercitationShean K, Streicher E, Pieterson E, Symons G, van Zyl Smit R, Theron G, et al. Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa. PLoS One. 2013; http://hdl.handle.net/11427/16256.en_ZA
dc.language.isoengen_ZA
dc.publisherPublic Library of Scienceen_ZA
dc.publisher.departmentDivision of Pulmonologyen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.en_ZA
dc.rights.holder© 2013 Shean et alen_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/4.0en_ZA
dc.sourcePLoS Oneen_ZA
dc.source.urihttp://journals.plos.org/plosoneen_ZA
dc.subject.otherExtensively drug-resistant tuberculosisen_ZA
dc.subject.otherDrug therapyen_ZA
dc.subject.otherMulti-drug-resistant tuberculosisen_ZA
dc.subject.otherAdverse eventsen_ZA
dc.subject.otherHIVen_ZA
dc.subject.otherDrug interactionsen_ZA
dc.subject.otherRenal failureen_ZA
dc.subject.otherTuberculosisen_ZA
dc.titleDrug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africaen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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