Stavudine toxicity in adult longer-term ART patients in Blantyre, Malawi

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dc.contributor.authorvan Oosterhout, Joep Jen_ZA
dc.contributor.authorMallewa, Janeen_ZA
dc.contributor.authorKaunda, Symonen_ZA
dc.contributor.authorChagoma, Newtonen_ZA
dc.contributor.authorNjalale, Yassinen_ZA
dc.contributor.authorKampira, Elizabethen_ZA
dc.contributor.authorMukaka, Mavutoen_ZA
dc.contributor.authorHeyderman, Robert Sen_ZA
dc.date.accessioned2015-11-23T12:34:40Z
dc.date.available2015-11-23T12:34:40Z
dc.date.issued2012en_ZA
dc.description.abstractBACKGROUND: Stavudine is an effective and inexpensive antiretroviral drug, but no longer recommended by WHO for first-line antiretroviral regimens in resource-limited settings due to toxicity concerns. Because of the high cost of alternative drugs, it has not been feasible to replace stavudine in most adults in the Malawi ART programme. We aimed to provide policy makers with a detailed picture of stavudine toxicities in Malawians on longer-term ART, in order to facilitate prioritization of stavudine replacement among other measures to improve the quality of ART programmes. METHODS: Prospective cohort of Malawian adults who had just completed one year of stavudine containing ART in an urban clinic, studying peripheral neuropathy, lipodystrophy, diabetes mellitus, high lactate syndromes, pancreatitis and dyslipidemia during 12 months follow up. Stavudine dosage was 30 mg irrespective of weight. Cox regression was used to determine associations with incident toxicities. RESULTS: 253 patients were enrolled, median age 36 years, 62.5% females. Prevalence rates (95%-confidence interval) of toxicities after one year on stavudine were: peripheral neuropathy 21.3% (16.5-26.9), lipodystrophy 14.7% (2.4-8.1), high lactate syndromes 0.0% (0-1.4), diabetes mellitus 0.8% (0-2.8), pancreatitis 0.0% (0-1.5). Incidence rates per 100 person-years (95%-confidence interval) during the second year on stavudine were: peripheral neuropathy 19.8 (14.3-26.6), lipodystrophy 11.4 (7.5-16.3), high lactate syndromes 2.1 (0.7-4.9), diabetes mellitus 0.4 (0.0-1.4), pancreatitis 0.0 (0.0-0.2). Prevalence of hypercholesterolemia and hypertriglyceridemia increased from 12.1% to 21.1% and from 29.5% to 37.6% respectively between 12 and 24 months. 5.5% stopped stavudine, 1.3% died and 4.0% defaulted during follow up. Higher age was an independent risk factor for incident peripheral neuropathy and lipodystrophy. CONCLUSION: Stavudine associated toxicities continued to accumulate during the second year of ART, especially peripheral neuropathy and lipodystrophy and more so at increasing age. Our findings support investments for replacing stavudine in first-line regimens in sub-Saharan Africa.en_ZA
dc.identifier.apacitationvan Oosterhout, J. J., Mallewa, J., Kaunda, S., Chagoma, N., Njalale, Y., Kampira, E., ... Heyderman, R. S. (2012). Stavudine toxicity in adult longer-term ART patients in Blantyre, Malawi. <i>PLoS One</i>, http://hdl.handle.net/11427/15317en_ZA
dc.identifier.chicagocitationvan Oosterhout, Joep J, Jane Mallewa, Symon Kaunda, Newton Chagoma, Yassin Njalale, Elizabeth Kampira, Mavuto Mukaka, and Robert S Heyderman "Stavudine toxicity in adult longer-term ART patients in Blantyre, Malawi." <i>PLoS One</i> (2012) http://hdl.handle.net/11427/15317en_ZA
dc.identifier.citationvan Oosterhout, J. J., Mallewa, J., Kaunda, S., Chagoma, N., Njalale, Y., Kampira, E., ... & Heyderman, R. S. (2012). Stavudine toxicity in adult longer-term ART patients in Blantyre, Malawi. PLoS One, 7(7), e42029. doi:10.1371/journal.pone.0042029en_ZA
dc.identifier.ris TY - Journal Article AU - van Oosterhout, Joep J AU - Mallewa, Jane AU - Kaunda, Symon AU - Chagoma, Newton AU - Njalale, Yassin AU - Kampira, Elizabeth AU - Mukaka, Mavuto AU - Heyderman, Robert S AB - BACKGROUND: Stavudine is an effective and inexpensive antiretroviral drug, but no longer recommended by WHO for first-line antiretroviral regimens in resource-limited settings due to toxicity concerns. Because of the high cost of alternative drugs, it has not been feasible to replace stavudine in most adults in the Malawi ART programme. We aimed to provide policy makers with a detailed picture of stavudine toxicities in Malawians on longer-term ART, in order to facilitate prioritization of stavudine replacement among other measures to improve the quality of ART programmes. METHODS: Prospective cohort of Malawian adults who had just completed one year of stavudine containing ART in an urban clinic, studying peripheral neuropathy, lipodystrophy, diabetes mellitus, high lactate syndromes, pancreatitis and dyslipidemia during 12 months follow up. Stavudine dosage was 30 mg irrespective of weight. Cox regression was used to determine associations with incident toxicities. RESULTS: 253 patients were enrolled, median age 36 years, 62.5% females. Prevalence rates (95%-confidence interval) of toxicities after one year on stavudine were: peripheral neuropathy 21.3% (16.5-26.9), lipodystrophy 14.7% (2.4-8.1), high lactate syndromes 0.0% (0-1.4), diabetes mellitus 0.8% (0-2.8), pancreatitis 0.0% (0-1.5). Incidence rates per 100 person-years (95%-confidence interval) during the second year on stavudine were: peripheral neuropathy 19.8 (14.3-26.6), lipodystrophy 11.4 (7.5-16.3), high lactate syndromes 2.1 (0.7-4.9), diabetes mellitus 0.4 (0.0-1.4), pancreatitis 0.0 (0.0-0.2). Prevalence of hypercholesterolemia and hypertriglyceridemia increased from 12.1% to 21.1% and from 29.5% to 37.6% respectively between 12 and 24 months. 5.5% stopped stavudine, 1.3% died and 4.0% defaulted during follow up. Higher age was an independent risk factor for incident peripheral neuropathy and lipodystrophy. CONCLUSION: Stavudine associated toxicities continued to accumulate during the second year of ART, especially peripheral neuropathy and lipodystrophy and more so at increasing age. Our findings support investments for replacing stavudine in first-line regimens in sub-Saharan Africa. DA - 2012 DB - OpenUCT DO - 10.1371/journal.pone.0042029 DP - University of Cape Town J1 - PLoS One LK - https://open.uct.ac.za PB - University of Cape Town PY - 2012 T1 - Stavudine toxicity in adult longer-term ART patients in Blantyre, Malawi TI - Stavudine toxicity in adult longer-term ART patients in Blantyre, Malawi UR - http://hdl.handle.net/11427/15317 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/15317
dc.identifier.urihttp://dx.doi.org/10.1371/journal.pone.0042029
dc.identifier.vancouvercitationvan Oosterhout JJ, Mallewa J, Kaunda S, Chagoma N, Njalale Y, Kampira E, et al. Stavudine toxicity in adult longer-term ART patients in Blantyre, Malawi. PLoS One. 2012; http://hdl.handle.net/11427/15317.en_ZA
dc.language.isoengen_ZA
dc.publisherPublic Library of Scienceen_ZA
dc.publisher.departmentDivision of Human Geneticsen_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© van Oosterhout 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.otherToxicityen_ZA
dc.subject.otherAntiretroviral therapyen_ZA
dc.subject.otherLipodystrophyen_ZA
dc.subject.otherPeripheral neuropathyen_ZA
dc.subject.otherPancreatitisen_ZA
dc.subject.otherAdultsen_ZA
dc.subject.otherDiabetes mellitusen_ZA
dc.subject.otherTuberculosisen_ZA
dc.titleStavudine toxicity in adult longer-term ART patients in Blantyre, Malawien_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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