Joy Saju, Poi Ming, Hughes Laura, Brady Michael T, Koletar Susan L, Para Michael F, Fan-Havard Patty
Department of Obstetrics and Gynecology, College of Medicine, Ohio State University, Columbus, OH 43210, USA.
Obstet Gynecol. 2005 Nov;106(5 Pt 1):1032-8. doi: 10.1097/01.AOG.0000180182.00072.e3.
Nevirapine-based therapy is associated with increased frequency of adverse events among women with CD4+ cell count of 250 cells/microL or greater. We evaluated the safety of nevirapine-based antiretroviral therapy in human immunodeficiency virus (HIV)-1-infected pregnant women.
We retrospectively evaluated 23 pregnancies managed with nevirapine-based regimens from July 2001 to April 2005. The incidence of adverse events was determined and analyzed by CD4+ cell count of either less than or greater than or equal to 250 cells/microL, and gestational age when nevirapine was initiated. Liver function abnormality was graded according to the National Institute of Allergy and Infectious Diseases Division of AIDS toxicity guidelines.
Five of 23 patients (21.7%) started nevirapine-based therapy after 27 weeks of gestation. All 3 cases of adverse events occurred in this group within 6 weeks of initiating therapy and with CD4+ cell count greater than 250 cells/microL. A significant difference was noted in the proportion of patients who developed toxicity while starting nevirapine in the third trimester (3/5, 60%; 95% confidence interval 14.66-94.73) compared with those starting nevirapine earlier in pregnancy (0/18, 0%; 95% confidence interval 0.0-18.53; P < .006). Two patients developed rash, eosinophilia, and liver function abnormality, with one developing clinical hepatitis and renal failure. A third patient had abnormal elevation of liver enzymes but was asymptomatic.
The incidence of adverse events with nevirapine may be lower than previously reported (13% versus 29%) and may be primarily noted with initiating the drug late in pregnancy. Further study of nevirapine in larger cohorts of HIV-infected pregnant women is warranted to determine the relationship between nevirapine hepatotoxicity and trimester use.
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基于奈韦拉平的治疗方案与CD4+细胞计数为250个/微升或更高的女性中不良事件发生率增加相关。我们评估了基于奈韦拉平的抗逆转录病毒疗法在感染人类免疫缺陷病毒（HIV）-1的孕妇中的安全性。
我们回顾性评估了2001年7月至2005年4月期间采用基于奈韦拉平方案治疗的23例妊娠情况。根据CD4+细胞计数低于或大于或等于250个/微升以及开始使用奈韦拉平的孕周，确定并分析不良事件的发生率。肝功能异常根据美国国立过敏与传染病研究所艾滋病司毒性指南进行分级。
23例患者中有5例（21.7%）在妊娠27周后开始基于奈韦拉平的治疗。所有3例不良事件均发生在该组开始治疗后的6周内，且CD4+细胞计数大于250个/微升。与孕期较早开始使用奈韦拉平的患者相比（0/18，0%；95%置信区间0.0 - 18.53），妊娠晚期开始使用奈韦拉平的患者发生毒性反应的比例有显著差异（3/5，60%；95%置信区间14.66 - 94.73；P <.006）。2例患者出现皮疹、嗜酸性粒细胞增多和肝功能异常，其中1例发展为临床肝炎和肾衰竭。第3例患者肝酶异常升高但无症状。
奈韦拉平不良事件的发生率可能低于先前报道（13%对29%），且可能主要在妊娠晚期开始使用该药物时出现。有必要在更大规模的感染HIV的孕妇队列中对奈韦拉平进行进一步研究，以确定奈韦拉平肝毒性与孕期使用之间的关系。
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