Risk of nevirapine-associated Stevens-Johnson syndrome among HIV-infected pregnant women: The Medunsa National Pharmacovigilance Centre, 2007 - 2012
Objectives. To investigate if pregnancy is a risk factor for SJS among HIV-infected women taking NVP-containing regimens and registered within the Medunsa National Pharmacovigilance Centre database.
Methods. A matched case-control study with 5:1 matching was conducted. Women taking NVP-containing regimens with SJS (cases) were matched with women taking NVP-containing regimens without SJS (controls). Controls were randomly selected and matched to cases by hospital, age, treatment duration and CD4 count. Conditional logistic regression was used to determine if pregnancy was a risk factor for SJS.
Results. Six SJS cases were identified and 30 controls selected. The median age of both cases and controls was 29 years and the average CD4 counts were 237 and 234 cells/µl respectively. Subjects were on NVP treatment for 18 - 31 days before the onset of SJS. Controls did not develop SJS after treatment of between 1 and 365 days. Pregnancy increased the chances of developing SJS 14-fold (OR 14.28, p=0.006, 95% CI 1.54 - 131.82).
Conclusions. NVP-containing ARV regimens taken during pregnancy increase the risk of developing SJS. Healthcare workers are advised to offer informed consent to patients and recommend effective contraception methods if NVP treatment is considered. In the light of our findings, further studies of the association between NVP, pregnancy and SJS are necessary before general conclusions can be reached.
Nomathemba Dube, Medunsa National Pharmacovigilance Centre, Medunsa Campus, University of Limpopo, Ga-Rankuwa; AIDS Unit, National Institute for Communicable Diseases, National Health Laboratory Services, Pretoria
E Adewusi, Medunsa National Pharmacovigilance Centre, Medunsa Campus, University of Limpopo
R Summers, Department of Pharmacy, Faculty of Health Sciences, Medunsa Campus, University of Limpopo; Medunsa National Pharmacovigilance Centre, Medunsa Campus, University of Limpopo
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Date published: 2013-01-25
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