Palombi Leonardo, Pirillo Maria F, Marchei Emilia, Jere Haswell, Sagno Jean-Baptiste, Luhanga Richard, Floridia Marco, Andreotti Mauro, Galluzzo Clementina Maria, Pichini Simona, Mwenda Ruben, Mancinelli Sandro, Marazzi Maria Cristina, Vella Stefano, Liotta Giuseppe, Giuliano Marina
Department of Biomedicine and Prevention, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy.
Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy.
J Antimicrob Chemother. 2016 Apr;71(4):1027-30. doi: 10.1093/jac/dkv435. Epub 2015 Dec 17.
To evaluate antiretroviral drug concentrations in mothers and infants enrolled under the Option B-Plus approach for the prevention of HIV mother-to-child transmission in Malawi and to assess the maternal virological response after 1 year of treatment.
Forty-seven women and 25 children were studied. Mothers were administered during pregnancy a combination of tenofovir, lamivudine and efavirenz and continued it during breastfeeding (up to 2 years) and thereafter. Drug concentrations were evaluated in mothers (plasma and breast milk) at 1 and 12 months post-partum and in infants (plasma) at 6 and 12 months of age. Drug concentrations were determined using an LC-MS/MS validated methodology.
In breast milk, tenofovir concentrations were very low (breast milk/maternal plasma ratio = 0.08), while lamivudine was concentrated (breast milk/plasma ratio = 3) and efavirenz levels were 80% of those found in plasma. In infants, median levels at 6 months were 24 ng/mL tenofovir, 2.5 ng/mL lamivudine and 86.4 ng/mL efavirenz. At month 12, median levels were below the limit of quantification for the three drugs. No correlation was found between drug concentrations and laboratory parameters or indices of growth. HIV-RNA >1000 copies/mL was seen at month 1 in 15% of the women and at month 12 in 8.5%. Resistance was found in half of the women with detectable viral load.
Breastfeeding infants under Option B-Plus are exposed to low concentrations of antiretroviral drugs. With this strategy, mothers had a good virological response 1 year after delivery.
评估在马拉维采用B+方案预防艾滋病毒母婴传播的母亲和婴儿体内抗逆转录病毒药物浓度，并评估治疗1年后母亲的病毒学反应。
对47名妇女和25名儿童进行了研究。母亲在怀孕期间服用替诺福韦、拉米夫定和依非韦伦的组合药物，并在母乳喂养期间（长达2年）及之后继续服用。在产后1个月和12个月对母亲（血浆和母乳）以及婴儿6个月和12个月时（血浆）的药物浓度进行评估。使用经过验证的液相色谱-串联质谱法测定药物浓度。
母乳中，替诺福韦浓度非常低（母乳/母体血浆比值=0.08），而拉米夫定有浓缩（母乳/血浆比值=3），依非韦伦水平为血浆中水平的80%。婴儿6个月时，替诺福韦中位数水平为24 ng/mL，拉米夫定为2.5 ng/mL，依非韦伦为86.4 ng/mL。在12个月时，三种药物的中位数水平均低于定量下限。未发现药物浓度与实验室参数或生长指标之间存在相关性。15%的妇女在第1个月时HIV-RNA>1000拷贝/mL，8.5%的妇女在第12个月时出现该情况。在病毒载量可检测的妇女中，有一半发现耐药。
采用B+方案时，母乳喂养的婴儿接触到低浓度的抗逆转录病毒药物。采用该策略，母亲在分娩1年后有良好的病毒学反应。
