Persistence of Nevirapine Exposure During the Postpartum Period After Intrapartum Single-Dose Nevirapine in Addition to Zidovudine Prophylaxis for the Prevention of Mother-to-Child Transmission of HIV-1

Persistence of Nevirapine Exposure During the Postpartum Period After Intrapartum Single-Dose Nevirapine in Addition to Zidovudine Prophylaxis for the Prevention of Mother-to-Child Transmission of HIV-1
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产时单剂量奈韦拉平加齐多夫定预防后,产后期间奈韦拉平的持续暴露,以预防 HIV-1 母婴传播

DOI:
10.1097/01.qai.0000149791.37205.b1
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发表时间:
2005
期刊:
JAIDS Journal of Acquired Immune Deficiency Syndromes
影响因子:
--
通讯作者:
M. Mirochnick
M. Mirochnick
中科院分区:
--
文献类型:
--
作者:
T. Cressey;G. Jourdain;M. Lallemant;S. Kunkeaw;J. B. Jackson;P. Musoke;E. Capparelli;M. Mirochnick

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目的:测定产后单次服用奈韦拉平(NVP)预防母婴传播的血浆浓度。方法:血浆样本在分娩和产后第8天至45天期间获得的艾滋病毒感染的泰国妇女谁收到分娩期间NVP剂量在围产期艾滋病毒预防临床试验-2(PHPT-2),以预防围产期艾滋病毒传播。将这些数据与来自2项NVP I期研究的NVP浓度数据合并进行群体分析。结果:给药后8 - 14天,中位NVP水平降至68 ng/mL(范围:<50-228,n = 43),15 - 21天降至51 ng/mL(范围:<50-166,n = 25)。在产后第二周和第三周,NVP水平分别低于23%和44%的样本的定量限。在21 - 45天之间,没有样品具有可定量的NVP浓度。来自人群分析的模拟预测,NVP浓度福尔斯在11天时在5%的女性中降至10 ng/mL以下,在17.5天时在50%的女性中降至10 ng/mL以下,在28天时在95%的女性中降至10 ng/mL以下。结论:显着的NVP浓度保持长达20天,这些泰国妇女。为确保在NVP浓度降至非抑制水平之前保持覆盖率,应考虑在分娩后1个月额外进行抗逆转录病毒治疗,以防止耐药病毒的出现。
Objective:To determine nevirapine (NVP) plasma levels during the postpartum period after a single intrapartum NVP dose for the prevention of mother-to-child transmission. Methods:Plasma samples at delivery and during days 8 to 45 postpartum were obtained from HIV-infected Thai women who received an intrapartum NVP dose in the Perinatal HIV Prevention Clinical Trial-2 (PHPT-2) for the prevention of perinatal HIV transmission. These data were combined with NVP concentration data from 2 phase 1 studies of NVP for a population analysis. Results:The median NVP level fell to 68 ng/mL (range: <50-228, n = 43) 8 to 14 days after dosing and to 51 ng/mL (range: <50-166, n = 25) between 15 and 21 days. During the second and third weeks postpartum, NVP levels were below the limit of quantitation in 23% and 44% of samples, respectively. Between 21 and 45 days, no sample had a quantifiable NVP concentration. A simulation derived from the population analysis predicts that NVP concentration falls to less than 10 ng/mL in 5% of women by 11 days, in 50% of women by 17.5 days, and in 95% of women by 28 days. Conclusions:Significant NVP concentrations remained for up to 20 days in these Thai women. To ensure that coverage is maintained until NVP concentrations fall to nonsuppressive levels, 1 month of additional antiretroviral treatment after delivery should be considered to prevent the emergence of resistant viruses.