孕期阿巴卡韦和拉米夫定暴露与非缺陷性不良妊娠结局：来自抗逆转录病毒妊娠登记处的数据。

Abacavir and lamivudine exposures during pregnancy and non-defect adverse pregnancy outcomes: data from the antiretroviral pregnancy registry.

作者信息

Vannappagari Vani, Koram Nana, Albano Jessica, Tilson Hugh, Gee Conway

机构信息

*Epidemiology and Real world Evidence, ViiV Healthcare, Research Triangle Park, NC; †Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC; ‡INC Research, Post Approval and Strategic Services, Raleigh, NC; and §INC Research, Biostatistics, Wilmington, NC.

出版信息

J Acquir Immune Defic Syndr. 2015 Mar 1;68(3):359-64. doi: 10.1097/QAI.0000000000000465.

DOI:10.1097/QAI.0000000000000465

PMID:25469525

Abstract

BACKGROUND

The antiretroviral (ARV) pregnancy registry, an international voluntary registry, provides information on teratogenicity and non-defect adverse pregnancy outcomes.

METHODS

We analyzed ARV pregnancy registry prospective singleton pregnancies, estimating frequencies of and risk for nondefect adverse outcomes among HIV-infected women. Prenatal exposures to abacavir (ABC)-containing regimens vs. non-ABC ARV regimens, and lamivudine (3TC)-containing regimens vs. non-3TC regimens were compared.

RESULTS

Of 2006 outcomes with prenatal ABC exposure, 95.6% were live births; 4.4% were spontaneous/induced abortions and stillbirths. Of live births, 16.2% had low birth weight (LBW); 11.9% were preterm births. Relative risks comparing exposure to ABC vs. non-ABC ARV regimens were spontaneous abortions 0.92 [95% confidence interval (CI): 0.66 to 1.27], induced abortions 0.84 (95% CI: 0.59 to 1.21), stillbirths 0.59 (95% CI: 0.35 to 1.00), preterm births 0.96 (95% CI: 0.84 to 1.09), and LBW 1.00 (95% CI: 0.90 to 1.13). Of 11,211 outcomes with prenatal 3TC exposure, 95.3% were live births; 4.7% were spontaneous/induced abortions and stillbirths. Of live births, 16.2% had LBW; 11.9% were preterm births. The relative risks comparing exposure to 3TC vs. non-3TC ARV regimens were spontaneous abortions 0.63 (95% CI: 0.50 to 0.80), induced abortions 0.54 (95% CI: 0.43 to 0.69), stillbirths 1.25 (95% CI: 0.86 to 1.80), preterm births 0.86 (95% CI: 0.77 to 0.95), and LBW 1.02 (95% CI: 0.93 to 1.12).

CONCLUSIONS

ABC-containing and non-ABC ARV regimens have similar risks for non-birth defect adverse pregnancy outcomes. 3TC-containing regimens have lower risk for spontaneous abortions, induced abortions, and preterm births compared with non-3TC ARV regimens, whereas both regimens had similar prevalence and risks for stillbirths and LBW.

摘要

背景

抗逆转录病毒（ARV）妊娠登记处是一个国际自愿登记处，提供有关致畸性和无缺陷不良妊娠结局的信息。

方法

我们分析了ARV妊娠登记处的前瞻性单胎妊娠，估计了HIV感染女性中无缺陷不良结局的频率和风险。比较了产前暴露于含阿巴卡韦（ABC）方案与不含ABC的ARV方案，以及含拉米夫定（3TC）方案与不含3TC方案的情况。

结果

在2006例有产前ABC暴露的结局中，95.6%为活产；4.4%为自然流产/人工流产和死产。在活产中，16.2%出生体重低（LBW）；11.9%为早产。比较暴露于ABC与不含ABC的ARV方案的相对风险为自然流产0.92[95%置信区间（CI）：0.66至1.27]，人工流产0.84（95%CI：0.59至1.21），死产0.59（95%CI：0.35至1.00），早产0.96（95%CI：0.84至1.09），以及LBW 1.00（95%CI：0.90至1.13）。在11211例有产前3TC暴露的结局中，95.3%为活产；4.7%为自然流产/人工流产和死产。在活产中，16.2%出生体重低；11.9%为早产。比较暴露于3TC与不含3TC的ARV方案的相对风险为自然流产0.63（95%CI：0.50至0.80），人工流产0.54（95%CI：0.43至0.69），死产1.25（95%CI：0.86至1.80），早产0.86（95%CI：0.77至0.95），以及LBW 1.02（95%CI：0.93至1.12）。