Background:  Nevirapine (NVP) is a potent anti-retroviral agent that has significantly impacted perinatal transmission of HIV worldwide. However recent reports of hepatotoxicity and liver-related deaths in selected populations has raised concern as to the use of this drug.

Methods:  All women who received nevirapine as part of their perinatal prophylaxis or medical management for their HIV infection during pregnancy were included in this study. Clinical, epidemiological, and laboratory results were recorded. Adverse events were analyzed.

Results:  A total of 125 women received NVP in the study period. The majority of women were Hispanic and 36 (29%) were black; 7 (6%) were co-infected with HCV and 18 (15%) with HBV. At baseline, median CD4 count was 395 cells/mm³ and 86 women (66%) had CD4 counts <500 cells/mm³; median HIV viral load was 4382 copies/mL with 57 (46%) women having <4000 copies/mL HIV RNA; 76 (63%) women received NVP within the first 24 weeks of pregnancy with a median length of NVP therapy of 13 weeks (range 1 to 38). Adverse events were graded using ACTG guidelines. One of 35 black (3%) and 13/86 (15%) non-black women experienced NVP liver related toxicity (p = 0.11, LFT grade 1 = 4; grade 2 =7; grade 3 = 3) and 11 other women had NVP associated rash (grade 1 = 10; grade 2 = 1). No difference was noted in incidence of toxicity (LFT or rash) by race or ethnicity. CD4 count did not predict LFT grades 0-3 (0: 425; 1: 250; 2: 422; 3: 321 cells/mL; p = 0.39). Additionally, no difference was noted in mean initial CD4 count between those with or without toxicity. (420 cells/mL for both, p = 0.99). However, those with CD4 >500 cells/ mm³ had more frequent toxicity than those with CD4 <500 cells/mm³, but this was not statistically significant (19%:  8/42 vs 11%: 9/82 p = 0.22). Toxicity happened more frequently within first 8 weeks of NVP use (7 out of 37, 19% vs 10 of 87, 11%, p = 0.27). In multivariate logistic analysis, no significant association was identified between toxicity and initial ethnicity (p = 0.22), CD4 (p = 0.14), HIV RNA level (p = 0.37) and length of NVP (per week increase: p = 0.71 or longer than 8 weeks: p = 0.48) after adjusting for initial AST and ALT levels.

Conclusions:  No statistically significant association between NVP side effects and ethnicity, CD4 levels, HIV RNA levels and length of NVP use were found.

Keywords: Nevirapine; Pregnancy; women