Tenofovir Diphosphate Concentrations in Dried Blood Spots From Pregnant and Postpartum Adolescent and Young Women Receiving Daily Observed Pre-exposure Prophylaxis in Sub-Saharan Africa.
Tenofovir Diphosphate Concentrations in Dried Blood Spots From Pregnant and Postpartum Adolescent and Young Women Receiving Daily Observed Pre-exposure Prophylaxis in Sub-Saharan Africa.
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DOI：
10.1093/cid/ciaa1872
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发表时间：
2021-10-05
期刊：
影响因子：
--
通讯作者：
IMPAACT 2009 Team
中科院分区：
文献类型：
--
作者：
Stranix-Chibanda L;Anderson PL;Kacanek D;Hosek S;Huang S;Nematadzira TG;Taulo F;Korutaro V;Nakabiito C;Masenya M;Lypen K;Brown E;Ibrahim ME;Yager J;Wiesner L;Johnston B;Amico KR;Rooney JF;Chakhtoura N;Spiegel HML;Chi BH;IMPAACT 2009 Team
干血斑（DBS）中的细胞内替诺福韦二磷酸（TFV-DP）浓度用于监测累积暴露前预防（PrEP）依从性。我们评估了TFV-DP在妊娠和产后青春期女孩和年轻女性（AGYW）中每日口服PrEP（恩曲他滨200 mg/二磷酸替诺福韦酯300 mg）后的DBS中的作用。在撒哈拉以南非洲，年龄在16-24岁的AGYW的妊娠（14-24周妊娠，n = 20）和产后（6-12周产后，n =20）组中，直接观察PrEP给药12周。 通过经验证的液相色谱-串联质谱法测定每周DBS TFV-DP。采用Wilcoxon检验比较组间第12周TFV-DP分布。拟合群体药代动力学模型以估计稳态浓度并创建依从性类别的基准。评估了TFV-DP的基线相关性。中位年龄为20（IQR，19-22）岁。在3360次给药中，直接观察到3352次（>99%）。TFV-DP的中位（IQR）半衰期在妊娠期为10（7-12）天，产后为17（14-21）天，分别在5周和8周达到稳态。妊娠期观察到的中位（IQR）稳态TFV-DP为965 fmol/punch（691-1166），产后为1406 fmol/punch（1053-1859）（P =.006）。 妊娠期模型稳态TFV-DP中位数为881 fmol/punch（667-1105），产后为1438 fmol/punch（1178-1919）。在汇总分析中，基线肌酐清除率与观察到的TFV-DP浓度相关。非洲AGYW的TFV-DP在妊娠期比产后低约三分之一。这些特定人群的基准可用于指导怀孕/产后非洲妇女的PrEP依从性支持。NCT 03386578在接受每日暴露前预防的非洲少女和年轻女性中，直接观察给药12周后，妊娠期间干血斑中二磷酸替诺福韦的浓度比产后低约三分之一。我们建议使用特定人群的基准来支持依从性。
Intracellular tenofovir diphosphate (TFV-DP) concentration in dried blood spots (DBSs) is used to monitor cumulative pre-exposure prophylaxis (PrEP) adherence. We evaluated TFV-DP in DBSs following daily oral PrEP (emtricitabine 200 mg/tenofovir diphosphate 300 mg) among pregnant and postpartum adolescent girls and young women (AGYW). Directly observed PrEP was administered for 12 weeks in a pregnancy (14–24 weeks’ gestation, n = 20) and postpartum (6–12 weeks postpartum, n = 20) group of AGYW aged 16–24 years in sub-Saharan Africa. Weekly DBS TFV-DP was measured by validated liquid chromatography–tandem mass spectrometry assay. Week 12 TFV-DP distributions were compared between groups with Wilcoxon test. Population pharmacokinetic models were fit to estimate steady-state concentrations and create benchmarks for adherence categories. Baseline correlates of TFV-DP were evaluated. Median age was 20 (IQR, 19–22) years. Of 3360 doses, 3352 (>99%) were directly observed. TFV-DP median (IQR) half-life was 10 (7–12) days in pregnancy and 17 (14–21) days postpartum, with steady state achieved by 5 and 8 weeks, respectively. Observed median (IQR) steady-state TFV-DP was 965 fmol/punch (691–1166) in pregnancy versus 1406 fmol/punch (1053–1859) postpartum (P = .006). Modeled median steady-state TFV-DP was 881 fmol/punch (667–1105) in pregnancy versus 1438 fmol/punch (1178–1919) postpartum. In pooled analysis, baseline creatinine clearance was associated with observed TFV-DP concentrations. TFV-DP in African AGYW was approximately one-third lower in pregnancy than postpartum. These Population-specific benchmarks can be used to guide PrEP adherence support in pregnant/postpartum African women. NCT03386578 Concentrations of tenofovir diphosphate in dried blood spots were approximately one-third lower during pregnancy than postpartum after 12 weeks of directly observed dosing among African adolescent girls and young women on daily pre-exposure prophylaxis. We recommend population-specific benchmarks for adherence support.
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影响因子：
3.7
作者：
Montgomery MC;Oldenburg CE;Nunn AS;Mena L;Anderson P;Liegler T;Mayer KH;Patel R;Almonte A;Chan PA
通讯作者：
Chan PA
影响因子：
5.6
作者：
Blumenthal, Jill;Pasipanodya, Elizabeth C.;Moore, David J.
通讯作者：
Moore, David J.
DOI：
10.1016/j.jpba.2016.01.038
发表时间：
2016-04-15
影响因子：
3.4
作者：
Zheng JH;Rower C;McAllister K;Castillo-Mancilla J;Klein B;Meditz A;Guida LA;Kiser JJ;Bushman LR;Anderson PL
通讯作者：
Anderson PL
影响因子：
7.2
作者：
Pettker, Christian M.;Goldberg, James D.;Copel, Joshua A.
通讯作者：
Copel, Joshua A.
DOI：
10.1097/qad.0000000000001922
发表时间：
2018-08-24
期刊：
AIDS (London, England)
影响因子：
--
作者：
Pyra M;Anderson PL;Hendrix CW;Heffron R;Mugwanya K;Haberer JE;Thomas KK;Celum C;Donnell D;Marzinke MA;Bukusi EA;Mugo NR;Asiimwe S;Katabira E;Baeten JM;Partners Demonstration Study Team
通讯作者：
Partners Demonstration Study Team