title: Severe antiretroviral-associated skin reactions in South African patients: a case series and case-control analysis.
abstract: Severe skin reactions may complicate combination antiretroviral therapy (cART). Nevirapine is known to be associated with severe skin reactions, but there are conflicting data on risk factors in African patients. We reviewed cases of severe skin reactions admitted to a tertiary hospital in Cape Town, South Africa. We identified associations with severe skin reactions in patients on cART.
  
  
  
  We described severe skin reaction cases in patients taking cART admitted to Groote Schuur Hospital in Cape Town, South Africa, between 2006 and 2012. We included those patients who developed a severe skin reaction within 120 days of cART initiation in a case-control analysis. We identified control patients matched on date of cART initiation and primary care facility by linkage with the Western Cape electronic provincial HIV database. We conducted a conditional (fixed effects) logistic regression modelling.
  
  
  
  We identified 169 severe skin reactions in patients on cART. The most common presentations were Stevens Johnson syndrome/toxic epidermal necrolysis (49%) and drug hypersensitivity syndrome (36%). One hundred forty-one patients were female, of which 27 were pregnant. Median duration of hospitalization was 12 days (interquartile range 8 to 19) and six patients died. We included 91 cases and 361 matched controls in the analysis. Severe skin reaction was associated with nevirapine exposure, adjusted odds ratio of 7.6 (95%CI 3.7 to 15.7) and with pregnancy, adjusted odds ratio 3.7 (95%CI 1.3 to 10.8) compared with men.
  
  
  
  Severe skin reactions resulted in prolonged admission to hospital in this setting. We found that nevirapine use and pregnancy are independently associated with severe skin reaction. Copyright © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Annemie
authors.initials: A
authors.lastname: Stewart
authors.affiliation: Division of Dermatology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Rannakoe
authors.initials: R
authors.lastname: Lehloenya
authors.affiliation: School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.|Health Impact Assessment Directorate, Department of Health, Provincial Government of the Western Cape, Cape Town, South Africa.|Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Andrew
authors.initials: A
authors.lastname: Boulle
authors.affiliation: School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Renee
authors.initials: R
authors.lastname: de Waal
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Gary
authors.initials: G
authors.lastname: Maartens
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa. karen.cohen@uct.ac.za.
authors.forename: Karen
authors.initials: K
authors.lastname: Cohen
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects*; D016022:Case-Control Studies; D003875:Drug Eruptions / Q000453:epidemiology / Q000209:etiology* / Q000503:physiopathology; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D016015:Logistic Models; D008297:Male; D019829:Nevirapine / Q000008:administration & dosage / Q000009:adverse effects*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000821:virology; D012189:Retrospective Studies; D012307:Risk Factors; D012737:Sex Factors; D013019:South Africa; D013262:Stevens-Johnson Syndrome / Q000453:epidemiology / Q000209:etiology*
chemical_list: D019380:Anti-HIV Agents; D019829:Nevirapine
keywords: HIV/AIDS; adverse drug reaction; antiretroviral; case-control; pharmacoepidemiology; pregnancy; risk factor; skin reaction