Evaluation of the adverse effects of nevirapine in HIV-infected pregnant women in a South Brazilian University Hospital

PURPOSE: The aim of this article is to evaluate the use of nevirapine HIV-infected pregnant women in our service. METHODS: a retrospective study was performed between January 2003 and December 2006 analysing all women prescribed nevirapine in pregnancy. Exclusion criteria included: (1) women who started nevirapine before pregnancy, (2) patients with abnormal baseline liver enzymes, and (3) women with incomplete liver biochemistry data. Evaluated parameters included age, weeks of exposure to nevirapine, gestational age in the begginning of medication, weeks of follow-up, viral load, CD4 cells count and serum aminotransferase levels. The incidence of adverse hepatic and/or cutaneous effects was determined and correlated to the CD4 cells count. Statistical analysis were performed using Fisher's exact test and t-Student test when appropriate, with a statistical significance level of p= 0,05. RESULTS: one hundred fifty-seven women met the inclusion criteria. Thirtyone (19.7%) presented cutaneous and/or hepatic toxicity. Skin rash accounted for 77.4% of toxicities and liver function abnormalities were noted in 22.6% of women exhibiting toxicities. Grade 1, 2 and 3 hepatotoxicities were observed in 0.6, 2.5 and 1.3%, respectively. Baseline CD4 counts, viral loads and transaminases were similar in pregnant women with nevirapine adverse effects and those without reaction. Median absolute CD4 cell counts were 465.4 and 416.6 cells/mu L in women with and without side effects, respectively (p= 0.3). All patients who experienced hepatotoxicity had pretreatment CD4 counts superior to 250 cells/mu L. CONCLUSIONS: The incidence of adverse events with nevirapine in our study was high, but most of them were cutaneous. There was no correlation between high CD4 counts and adverse events when analysing both cutaneous and hepatic reactions; nevertheless, hepatotoxicity occurred only in pregnant women with CD4 counts >= 250 cells/mu L.