Nevirapine toxicity in a cohort of HIV-1-infected pregnant women.

ABSTRACT

OBJECTIVE: The purpose of this study was to complete an evaluation of nevirapine (NVP) toxicity in a cohort of HIV+ pregnant women. STUDY DESIGN: This was a retrospective study of 611 women followed from January 1996 to December 2003. All women who used NVP for > 7 days were included. Multivariate logistic regression was used to test independent association of CD4 and hepatitis C virus (HCV) infection related to the outcome of toxic effects of NVP. RESULTS: One hundred ninety-seven women were exposed to NVP for > 7 days, and toxicity occurred in 11 (5.6%), leading to drug discontinuation in 7 patients. One case of Stevens-Johnson syndrome occurred. No serious liver toxicity occurred except for 1 grade 4 cholestasis. Median CD4 was 344 in women without toxicities and 298 in women with toxicities. HCV was the only significant factor associated to toxicity by logistic regression (odds ratio [OR] 15.61, P = .001). CONCLUSION: NVP toxicities occurred in a very small fraction of patients and were not associated with fatalities.