Bussmann Hermann, Wester C William, Wester Carolyn N, Lekoko Bright, Okezie Okechukwu, Thomas Ann Muir, DeGruttola S M Victor, Makhema Joseph, Essex Max, Marlink Richard G
Harvard School of Public Health AIDS Initiative, Boston, MA 02115, USA.
J Acquir Immune Defic Syndr. 2007 Jul 1;45(3):269-73. doi: 10.1097/QAI.0b013e318050d683.
Millions of HIV-infected women in developing countries are in need of safe and highly effective antiretroviral therapy. Pregnancy rates are usually high in developing countries, and efavirenz (EFV) use in women of childbearing age is of concern because of its potential teratogenicity.
As part of a prospective study comparing 6 initial highly active antiretroviral therapy (HAART) regimens, 3 of which contained EFV, pregnancy and birth outcomes were evaluated among female participants enrolled in a randomized clinical trial in Botswana. Before enrollment, all female participants indicated a willingness to avoid pregnancy for the 3-year duration of the study. Monthly urine pregnancy testing and regular contraceptive education and counseling were given to all women on study.
Four hundred fifty-one (69.4%) of 650 enrolled study participants were female and experienced 71 pregnancies, for a rate of 7.9 per 100 person-years during the study. The mean time from HAART initiation to time of first pregnancy was 385 days. The median birth weight of babies was 2950 g (interquartile range: 2700-3250 g); the gender of babies (24 female and 15 male) and occurrence of early pregnancy loss (42%) and stillbirths (3%) did not differ between EFV- and non-EFV-exposed pregnancies (P=0.7). First-trimester EFV exposure occurred in 38 (53.5%) of the 71 pregnancies; 22 (57.9%) of these 38 pregnancies resulted in live births. One infant (4.5%) of the 22 EFV-exposed live births had a congenital abnormality with right limb shortening that was assessed to be unrelated to EFV exposure.
The restoration of health and longevity in many HAART-treated women is often accompanied by childbearing, as evidenced by the large fraction of women in our cohort who became pregnant despite their initial statements of intent to avoid pregnancy. Of 22 first-trimester EFV-exposed live births, 1 neonate was found to have a major congenital abnormality; however, this defect was unrelated to EFV exposure. The small sample size is insufficient to estimate accurately the underlying risk of congenital malformation after exposure to EFV in early pregnancy, underscoring the importance of reporting to the existing international Antiretroviral Pregnancy Registry. In addition to accessing safe and effective HAART regimens, HIV-infected women require access to comprehensive family planning services, including contraception and procreation counseling.
发展中国家数以百万计的感染艾滋病毒的妇女需要安全且高效的抗逆转录病毒疗法。发展中国家的怀孕率通常较高，由于依非韦伦（EFV）具有潜在致畸性，育龄妇女使用该药物令人担忧。
作为一项比较6种初始高效抗逆转录病毒疗法（HAART）方案（其中3种含有EFV）的前瞻性研究的一部分，在博茨瓦纳一项随机临床试验的女性参与者中评估了怀孕和分娩结局。在入组前，所有女性参与者均表示愿意在研究的3年期间内避免怀孕。对所有参与研究的女性进行每月一次的尿妊娠试验以及定期的避孕教育和咨询。
650名入组研究参与者中有451名（69.4%）为女性，共经历了71次怀孕，研究期间的怀孕率为每100人年7.9次。从开始HAART到首次怀孕的平均时间为385天。婴儿的出生体重中位数为2950克（四分位间距：2700 - 3250克）；暴露于EFV的怀孕和未暴露于EFV的怀孕之间，婴儿性别（24名女性和15名男性）、早期妊娠丢失发生率（42%）和死产率（3%）没有差异（P = 0.7）。71次怀孕中有38次（53.5%）在孕早期暴露于EFV；这38次怀孕中有22次（57.9%）分娩活婴。在22例孕早期暴露于EFV的活产婴儿中，有1例（4.5%）出现先天性异常，表现为右肢缩短，经评估与EFV暴露无关。
许多接受HAART治疗的女性恢复健康并延长寿命后往往会生育，我们队列中的很大一部分女性尽管最初表示打算避免怀孕但仍怀孕，这证明了这一点。在22例孕早期暴露于EFV的活产婴儿中，发现1例新生儿有严重先天性异常；然而，这种缺陷与EFV暴露无关。小样本量不足以准确估计孕早期暴露于EFV后先天性畸形的潜在风险，这突出了向现有的国际抗逆转录病毒妊娠登记处报告的重要性。除了获得安全有效的HAART方案外，感染艾滋病毒的女性还需要获得全面的计划生育服务，包括避孕和生育咨询。
