简要报告：在接受抗 HIV 治疗的孕妇中使用阿巴卡韦/拉米夫定和替诺福韦/恩曲他滨：一项观察性全国研究中的实验室和临床结局。

Brief Report: Abacavir/Lamivudine and Tenofovir/Emtricitabine in Pregnant Women With HIV: Laboratory and Clinical Outcomes in an Observational National Study.

机构信息

National Centre for Global Health, Istituto Superiore di Sanità, Rome, Italy.

I.N.M.I Lazzaro Spallanzani, Rome, Italy.

出版信息

J Acquir Immune Defic Syndr. 2018 May 1;78(1):99-104. doi: 10.1097/QAI.0000000000001640.

DOI:10.1097/QAI.0000000000001640

PMID:29406430

Abstract

BACKGROUND

Abacavir-lamivudine (ABC/3TC) and tenofovir-emtricitabine (TDF/FTC) represent in the guidelines of several countries, including Italy and United States, the preferred nucleoside/nucleotide backbones of antiretroviral regimens. We assessed their profile in pregnancy using data from a national observational study.

METHODS

Laboratory measures (CD4, HIV-RNA, lipid profile, glucose, hemoglobin, and alanine transferase) and pregnancy outcomes (preterm delivery, low birthweight, nonelective cesarean section, birthweight Z-score, congenital defects, HIV transmission, maternal weight gain, and pregnancy complications) were compared after prenatal exposure to ABC/3TC or TDF/FTC.

RESULTS

The study evaluated 913 pregnancies (ABC/3TC: 252; TDF/FTC: 661). At entry in pregnancy, women on TDF/FTC were older (33.6 vs. 32.4 years, P = 0.005), less frequently on treatment (66.9% vs. 80.2%, P < 0.001), and had lower CD4 counts (475/mm vs. 533/mm, P = 0.003) and higher plasma HIV-RNA levels (2.48 vs. 2.22 log10 copies/mL, P = 0.003). Women on ABC/3TC had more commonly hypertension/nephropathy (5.2% vs. 2.0%, P = 0.013). No major differences were observed in the main pregnancy outcomes and in rates of undetectable HIV-RNA at third trimester. In a subgroup analysis that evaluated at third trimester only cases with regular 3-drug treatment during pregnancy, women on TDF/FTC had lower hemoglobin levels (median: 11.1 vs. 11.8 g/dL, P = 0.002) and women on ABC/3TC had higher levels of total cholesterol (median: 230 vs. 216 mg/dL, P = 0.023) and low-density lipoprotein-cholesterol (133 vs. 111 mg/dL, P = 0.030).

CONCLUSIONS

In this study, use of TDF/FTC and ABC/3TC in pregnancy was associated with similar pregnancy outcomes and with some differences in laboratory measures that might guide physicians' prescriptions in mothers with hematologic or metabolic risk factors.

摘要

背景

阿巴卡韦-拉米夫定（ABC/3TC）和替诺福韦-恩曲他滨（TDF/FTC）是几种国家指南（包括意大利和美国）推荐的抗逆转录病毒方案中的首选核苷/核苷酸骨干药物。我们使用一项全国性观察性研究的数据来评估它们在妊娠中的应用情况。

方法

比较了在产前暴露于 ABC/3TC 或 TDF/FTC 后，实验室指标（CD4、HIV-RNA、血脂谱、血糖、血红蛋白和丙氨酸转氨酶）和妊娠结局（早产、低出生体重、非选择性剖宫产、出生体重 Z 评分、先天缺陷、HIV 传播、母体体重增加和妊娠并发症）。

结果

该研究评估了 913 例妊娠（ABC/3TC：252 例；TDF/FTC：661 例）。在妊娠开始时，使用 TDF/FTC 的女性年龄更大（33.6 岁 vs. 32.4 岁，P=0.005），接受治疗的频率更低（66.9% vs. 80.2%，P<0.001），CD4 计数更低（475/mm vs. 533/mm，P=0.003），血浆 HIV-RNA 水平更高（2.48 vs. 2.22 log10 拷贝/mL，P=0.003）。使用 ABC/3TC 的女性更常见高血压/肾病（5.2% vs. 2.0%，P=0.013）。在主要妊娠结局和第三孕期 HIV-RNA 未检出率方面，未观察到明显差异。在一项仅评估妊娠期间常规三药治疗的第三孕期的亚组分析中，使用 TDF/FTC 的女性血红蛋白水平较低（中位数：11.1 vs. 11.8 g/dL，P=0.002），使用 ABC/3TC 的女性总胆固醇水平较高（中位数：230 vs. 216 mg/dL，P=0.023）和低密度脂蛋白胆固醇（133 vs. 111 mg/dL，P=0.030）。