Risk of nevirapine-associated Stevens-Johnson syndrome among HIV-infected pregnant women: The Medunsa National Pharmacovigilance Centre, 2007 - 2012

Abstract

Background. Stevens-Johnson syndrome (SJS) is an acute life-threatening condition often elicited by drugs. The government's indecisiveness in deciding to stop the use of nevirapine (NVP) in HIV-infected pregnant women owing to the increase of SJS among this population group in South Africa prompted this investigation. 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 with SJS (cases) taking NVP-containing regimens were matched with women without SJS (controls) taking NVP-containing regimens. 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,). 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.

Severe Delayed Cutaneous and Systemic Reactions to Drugs: A Global Perspective on the Science and Art of Current Practice

“…Almost all of the published data, mainly case reports, has been on SJS/TEN. It is not clear if pregnancy itself predisposes the mother to SCAR although one small study in South Africa suggested that pregnancy is a risk factor for SJS in HIV-infected women taking nevirapine (123). There are a handful of published reports of maternal SJS/TEN affecting the unborn fetus (124).…”

Bibliometric analysis of literature on toxic epidermal necrolysis and Stevens-Johnson syndrome: 1940 – 2015

“…Other causes of SJS and TEN include certain infections [15]. For unclear reasons, it was found that patients with human immune deficiency virus (HIV) have higher risk of developing SJS and TEN compared to un-infected people [7, 16–21]. Other infections such as Mycoplasma pneumoniae infections and herpes simplex viral infections were linked to SJS and TEN even without previous exposure to medications [22–27].…”

Stevens Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Nevirapine among HIV-Infected Pregnant Women: Five Cases

“…Nevirapine toxicity is common [6,7]. Control studies have reported that pregnancy is a risk factor for TEN/SJS when HIV-positive women are treated with a combination of nevirapine with an odds ratio of 14.28 (p=0.006), a 95% confidence interval (1.54-131.82) [8]. All women had taken antiretroviral triple therapy as part of mother-child prevention of HIV transmission with an average CD4 cell count at 416/ mm 3 , viral load was not available.…”