Cunningham Coleen K, Chaix Marie-Laure, Rekacewicz Claire, Britto Paula, Rouzioux Christine, Gelber Richard D, Dorenbaum Alejandro, Delfraissy Jean Francois, Bazin Brigitte, Mofenson Lynne, Sullivan John L
Department of Pediatrics, State University of New York Upstate Medical University, Syracuse, Syracuse, NY 13210, USA.
J Infect Dis. 2002 Jul 15;186(2):181-8. doi: 10.1086/341300. Epub 2002 Jun 26.
Pediatric AIDS Clinical Trials Group protocol 316 was an international, multicenter, placebo-controlled trial comparing single-dose oral nevirapine (200 mg to mother and 2 mg/kg to infant) with placebo in human immunodeficiency virus (HIV)-infected pregnant women receiving standard antiretroviral therapy. This substudy evaluated the emergence of nevirapine-resistance mutations at 6 weeks postpartum in a subgroup of participants. Maternal risk factors for the emergence of nevirapine-resistance mutations were evaluated. Mutations associated with nevirapine resistance were detectable at delivery, prior to receipt of study drug, in 5 (2.3%) of 217 women. Fourteen (15%; 95% confidence interval, 8%-23%) of 95 women who received intrapartum nevirapine developed a nevirapine-resistance mutation 6 weeks postpartum. The most common mutation was K103N, which was present in 10 women. The risk for development of a new nevirapine-resistance mutation did not correlate with CD4 cell count or HIV-1 RNA load at delivery or with type of antepartum antiretroviral therapy. The risk of nevirapine resistance should be considered when determining the risks or benefits of intrapartum nevirapine in women receiving antepartum antiretroviral therapy.
儿科艾滋病临床试验组316号方案是一项国际多中心、安慰剂对照试验，在接受标准抗逆转录病毒治疗的感染人类免疫缺陷病毒（HIV）的孕妇中，比较单剂量口服奈韦拉平（母亲200毫克，婴儿2毫克/千克）与安慰剂的效果。这项子研究评估了部分参与者产后6周时奈韦拉平耐药突变的出现情况。评估了奈韦拉平耐药突变出现的母体风险因素。在217名女性中，有5名（2.3%）在分娩时、接受研究药物之前就检测到了与奈韦拉平耐药相关的突变。95名在分娩时接受奈韦拉平治疗的女性中有14名（15%；95%置信区间为8%-23%）在产后6周出现了奈韦拉平耐药突变。最常见的突变是K103N，有10名女性出现该突变。新的奈韦拉平耐药突变的发生风险与分娩时的CD4细胞计数或HIV-1 RNA载量以及产前抗逆转录病毒治疗的类型无关。在确定产前接受抗逆转录病毒治疗的女性分娩时使用奈韦拉平的风险或益处时，应考虑奈韦拉平耐药的风险。
