Mirochnick Mark, Dorenbaum Alejandro, Blanchard Suzette, Cunningham Coleen K, Gelber Richard D, Mofenson Lynne, Culnane Mary, Sullivan John L
Boston University School of Medicine, Boston Medical Center, 91 Concord Street, 6th Floor, Boston, MA 02118, USA.
J Acquir Immune Defic Syndr. 2003 Jun 1;33(2):153-6. doi: 10.1097/00126334-200306010-00006.
To evaluate cord blood and predose nevirapine concentrations in infants exposed to the two-dose intrapartum neonatal nevirapine regimen.
The authors obtained plasma samples for nevirapine assay from cord blood and just prior to the 48-hours to 72-hours after birth neonatal nevirapine dose from a subset of infants participating in PACTG 316, a randomized, placebo-controlled trial of the two-dose intrapartum neonatal nevirapine regimen added to standard antiretroviral therapy.
Nevirapine concentrations were measured in 109 cord blood samples and 149 predose samples. Cord blood nevirapine concentrations were below the target concentration of 100 ng/mL (10-times the in vitro IC(50) of nevirapine against wild-type HIV) in eight (7%) of 109 infants (95% confidence interval [CI], 3%-14%); the concentrations in six of these infants were below the assay limit of quantitation. Predose infant nevirapine concentrations were below 100 ng/mL in 23 (15%) of 149 infants (95% CI, 10%-22%); the concentrations in 13 of these infants were below the assay limit of quantitation. Lower predose nevirapine concentrations were associated with lower cord blood concentrations and a shorter interval between maternal dosing and delivery. All but one of the infants with predose nevirapine concentrations below the assay limit of quantitation were born less than 2 hours after maternal dosing.
Infants born less than 2 hours after maternal nevirapine dosing during labor should receive a dose of nevirapine immediately after birth in addition to the standard infant dose at 48 to 72 hours.
评估接受两剂分娩期新生儿奈韦拉平方案的婴儿的脐带血和给药前奈韦拉平浓度。
作者从参与PACTG 316的部分婴儿中获取血浆样本用于奈韦拉平检测，PACTG 316是一项随机、安慰剂对照试验，在标准抗逆转录病毒治疗基础上加用两剂分娩期新生儿奈韦拉平方案。样本分别来自脐带血以及出生后48至72小时新生儿奈韦拉平给药前。
对109份脐带血样本和149份给药前样本进行了奈韦拉平浓度检测。109名婴儿中有8名（7%）的脐带血奈韦拉平浓度低于目标浓度100 ng/mL（奈韦拉平对野生型HIV的体外半数抑制浓度的10倍）（95%置信区间[CI]，3%-14%）；其中6名婴儿的浓度低于检测定量下限。149名婴儿中有23名（15%）给药前奈韦拉平浓度低于100 ng/mL（95% CI，10%-22%）；其中13名婴儿的浓度低于检测定量下限。给药前奈韦拉平浓度较低与脐带血浓度较低以及母亲给药与分娩之间的间隔较短有关。给药前奈韦拉平浓度低于检测定量下限的婴儿中，除1名外，均在母亲给药后不到2小时出生。
分娩期间母亲服用奈韦拉平后不到2小时出生的婴儿，除在48至72小时给予标准婴儿剂量外，出生后应立即给予一剂奈韦拉平。
