Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention
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Date
2016
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Massachusetts Medical Society
Abstract
BACKGROUND
Randomized-trial data on the risks and benefits of antiretroviral therapy (ART) as compared
with zidovudine and single-dose nevirapine to prevent transmission of the human immunodeficiency virus (HIV) in HIV-infected pregnant women with high CD4 counts are lackingMETHODS
We randomly assigned HIV-infected women at 14 or more weeks of gestation with CD4
counts of at least 350 cells per cubic millimeter to zidovudine and single-dose nevirapine
plus a 1-to-2-week postpartum “tail” of tenofovir and emtricitabine (zidovudine alone);
zidovudine, lamivudine, and lopinavir–ritonavir (zidovudine-based ART); or tenofovir,
emtricitabine, and lopinavir–ritonavir (tenofovir-based ART). The primary outcomes
were HIV transmission at 1 week of age in the infant and maternal and infant safetyRESULTS
The median CD4 count was 530 cells per cubic millimeter among 3490 primarily black
African HIV-infected women enrolled at a median of 26 weeks of gestation (interquartile
range, 21 to 30). The rate of transmission was significantly lower with ART than with zidovudine alone (0.5% in the combined ART groups vs. 1.8%; difference, −1.3 percentage
points; repeated confidence interval, −2.1 to −0.4). However, the rate of maternal grade 2
to 4 adverse events was significantly higher with zidovudine-based ART than with zidovudine alone (21.1% vs. 17.3%, P=0.008), and the rate of grade 2 to 4 abnormal blood
chemical values was higher with tenofovir-based ART than with zidovudine alone (2.9% vs.
0.8%, P=0.03). Adverse events did not differ significantly between the ART groups
(P>0.99). A birth weight of less than 2500 g was more frequent with zidovudine-based ART
than with zidovudine alone (23.0% vs. 12.0%, P<0.001) and was more frequent with tenofovir-based ART than with zidovudine alone (16.9% vs. 8.9%, P=0.004); preterm delivery
before 37 weeks was more frequent with zidovudine-based ART than with zidovudine alone
(20.5% vs. 13.1%, P<0.001). Tenofovir-based ART was associated with higher rates than
zidovudine-based ART of very preterm delivery before 34 weeks (6.0% vs. 2.6%, P=0.04)
and early infant death (4.4% vs. 0.6%, P=0.001), but there were no significant differences
between tenofovir-based ART and zidovudine alone (P=0.10 and P=0.43). The rate of HIVfree survival was highest among infants whose mothers received zidovudine-based ART.CONCLUSIONS
Antenatal ART resulted in significantly lower rates of early HIV transmission than zidovudine
alone but a higher risk of adverse maternal and neonatal outcomes. (Funded by the National
Institutes of Health; PROMISE ClinicalTrials.gov numbers, NCT01061151 and NCT01253538.)
Description
Keywords
Antiretroviral Therapy, HIV Prevention, Benefits and Risks
Citation
Fowler, M. G., Qin, M., Fiscus, S. A., Currier, J. S., Flynn, P. M., Chipato, T., ... & Mofenson, L. M. (2016). Benefits and risks of antiretroviral therapy for perinatal HIV prevention. New England Journal of Medicine, 375(18), 1726-1737.