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首页> 外文期刊>AIDS Research and Human Retroviruses >Clinical and pharmacogenetic factors affecting neonatal bilirubinemia following atazanavir treatment of mothers during pregnancy
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Clinical and pharmacogenetic factors affecting neonatal bilirubinemia following atazanavir treatment of mothers during pregnancy

机译：阿扎那韦治疗孕妇后影响新生儿胆红素血症的临床和药物遗传学因素

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A theoretical concern exists that atazanavir (ATV) use during pregnancy may exacerbate physiologic neonatal hyperbilirubinemia. The aim of this substudy was to evaluate patterns of neonatal bilirubin following ATV/ritonavir (RTV) treatment of pregnant mothers and clinical and pharmacogenetic factors that may correlate. The design involved a subanalysis of study AI424182, a multicenter, open-label, prospective, single-arm Phase I study. The study had two treatment arms: (1) ATV/RTV 300/100 mg once daily or (2) ATV/RTV 400/100 mg once daily, both in combination with zidovudine/lamivudine 300/150 mg twice daily. Total bilirubin was assessed at baseline, each visit, and delivery day for mothers and on days 1 (delivery day), 3, 5, and 7 and weeks 2 and 6 for neonates. Blood samples were obtained for UGT1A1 genotyping and ATV cord blood concentration. Bilirubin elevation of any grade occurred in 14/40 neonates (35%). All Grade 3 to 4 bilirubin abnormalities (n=7) occurred after day 14. The pattern of neonatal bilirubin levels reported was consistent with neonatal physiologic elevations of bilirubin. Little correlation was observed between either maternal bilirubin levels over the last 4 weeks of pregnancy (including delivery) or ATV cord concentration and neonatal bilirubin. There was a significant association between UGT1A1 genotype and bilirubin grade in the maternal population (p=0.0006) but not neonates (p=0.49). Neither neonatal UGT1A1 genotype nor cord blood ATV concentration is a good predictor of neonatal hyperbilirubinemia. ATV/RTV treatment of mothers does not appear to exacerbate neonatal physiologic hyperbilirubinemia.
机译：从理论上讲，怀孕期间使用阿扎那韦（ATV）可能会加剧新生儿生理性高胆红素血症。本子研究的目的是评估ATV /利托那韦（RTV）治疗孕妇后的新生儿胆红素模式，以及可能相关的临床和药理遗传因素。设计涉及研究AI424182的子分析，AI424182是一项多中心，开放标签，前瞻性单臂I期研究。该研究有两个治疗方案：（1）每天一次ATV / RTV 300/100 mg或（2）每天一次ATV / RTV 400/100 mg，均与齐多夫定/拉米夫定300/150 mg每日两次联合使用。评估母亲在基线，每次就诊和分娩时的总胆红素水平，在新生儿的第1天（分娩日），第3、5和7天以及第2和6周评估总胆红素。获得血样用于UGT1A1基因分型和ATV脐带血浓度。 14/40新生儿（35％）发生任何级别的胆红素升高。第3天至第4级所有胆红素异常（n = 7）均在第14天后发生。报道的新生儿胆红素水平与新生儿生理性胆红素升高一致。孕妇在妊娠的最后4周（包括分娩）中胆红素水平或ATV脐带浓度与新生儿胆红素之间几乎没有相关性。在孕产妇人群中，UGT1A1基因型与胆红素等级之间存在显着相关性（p = 0.0006），而在新生儿中则没有（p = 0.49）。新生儿UGT1A1基因型和脐血ATV浓度均不能很好地预测新生儿高胆红素血症。母亲的ATV / RTV治疗似乎并未加剧新生儿生理性高胆红素血症。

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