Birth outcomes for pregnant women with HIV using tenofovir–Emtricitabine

for the PHACS and the IMPAACT P1025 Study Teams

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

In a previous trial of antiretroviral therapy (ART) involving pregnant women with human immunodeficiency virus (HIV) infection, those randomly assigned to receive tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF–FTC–LPV/r) had infants at greater risk for very premature birth and death within 14 days after delivery than those assigned to receive zidovudine, lamivudine, and ritonavir-boosted lopinavir (ZDV–3TC–LPV/r). METHODS Using data from two U.S.-based cohort studies, we compared the risk of adverse birth outcomes among infants with in utero exposure to ZDV–3TC–LPV/r, TDF–FTC–LPV/r, or TDF–FTC with ritonavir-boosted atazanavir (ATV/r). We evaluated the risk of preterm birth (<37 completed weeks of gestation), very preterm birth (<34 completed weeks), low birth weight (<2500 g), and very low birth weight (<1500 g). Risk ratios with 95% confidence intervals were estimated with the use of modified Poisson models to adjust for confounding. RESULTS There were 4646 birth outcomes. Few infants or fetuses were exposed to TDF–FTC–LPV/r (128 [2.8%]) as the initial ART regimen during gestation, in contrast with TDF–FTC–ATV/r (539 [11.6%]) and ZDV–3TC–LPV/r (954 [20.5%]). As compared with women receiving ZDV–3TC–LPV/r, women receiving TDF–FTC–LPV/r had a similar risk of preterm birth (risk ratio, 0.90; 95% confidence interval [CI], 0.60 to 1.33) and low birth weight (risk ratio, 1.13; 95% CI, 0.78 to 1.64). As compared to women receiving TDF–FTC–ATV/r, women receiving TDF–FTC–LPV/r had a similar or slightly higher risk of preterm birth (risk ratio, 1.14; 95% CI, 0.75 to 1.72) and low birth weight (risk ratio, 1.45; 95% CI, 0.96 to 2.17). There were no significant differences between regimens in the risk of very preterm birth or very low birth weight. CONCLUSIONS The risk of adverse birth outcomes was not higher with TDF–FTC–LPV/r than with ZDV–3TC–LPV/r or TDF–FTC–ATV/r among HIV-infected women and their infants in the United States, although power was limited for some comparisons. (Funded by the National Institutes of Health and others).

Original languageEnglish (US)
Pages (from-to)1593-1603
Number of pages11
JournalNew England Journal of Medicine
Volume378
Issue number17
DOIs
StatePublished - Apr 26 2018

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Premature Birth
Pregnant Women
HIV
Parturition
Ritonavir
Odds Ratio
Confidence Intervals
Low Birth Weight Infant
Lopinavir
Very Low Birth Weight Infant
Tenofovir
Pregnancy
Premature Mortality
Lamivudine
Zidovudine
National Institutes of Health (U.S.)
Virus Diseases
Fetus
Cohort Studies
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

for the PHACS and the IMPAACT P1025 Study Teams. / Birth outcomes for pregnant women with HIV using tenofovir–Emtricitabine. In: New England Journal of Medicine. 2018 ; Vol. 378, No. 17. pp. 1593-1603.
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title = "Birth outcomes for pregnant women with HIV using tenofovir–Emtricitabine",
abstract = "In a previous trial of antiretroviral therapy (ART) involving pregnant women with human immunodeficiency virus (HIV) infection, those randomly assigned to receive tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF–FTC–LPV/r) had infants at greater risk for very premature birth and death within 14 days after delivery than those assigned to receive zidovudine, lamivudine, and ritonavir-boosted lopinavir (ZDV–3TC–LPV/r). METHODS Using data from two U.S.-based cohort studies, we compared the risk of adverse birth outcomes among infants with in utero exposure to ZDV–3TC–LPV/r, TDF–FTC–LPV/r, or TDF–FTC with ritonavir-boosted atazanavir (ATV/r). We evaluated the risk of preterm birth (<37 completed weeks of gestation), very preterm birth (<34 completed weeks), low birth weight (<2500 g), and very low birth weight (<1500 g). Risk ratios with 95{\%} confidence intervals were estimated with the use of modified Poisson models to adjust for confounding. RESULTS There were 4646 birth outcomes. Few infants or fetuses were exposed to TDF–FTC–LPV/r (128 [2.8{\%}]) as the initial ART regimen during gestation, in contrast with TDF–FTC–ATV/r (539 [11.6{\%}]) and ZDV–3TC–LPV/r (954 [20.5{\%}]). As compared with women receiving ZDV–3TC–LPV/r, women receiving TDF–FTC–LPV/r had a similar risk of preterm birth (risk ratio, 0.90; 95{\%} confidence interval [CI], 0.60 to 1.33) and low birth weight (risk ratio, 1.13; 95{\%} CI, 0.78 to 1.64). As compared to women receiving TDF–FTC–ATV/r, women receiving TDF–FTC–LPV/r had a similar or slightly higher risk of preterm birth (risk ratio, 1.14; 95{\%} CI, 0.75 to 1.72) and low birth weight (risk ratio, 1.45; 95{\%} CI, 0.96 to 2.17). There were no significant differences between regimens in the risk of very preterm birth or very low birth weight. CONCLUSIONS The risk of adverse birth outcomes was not higher with TDF–FTC–LPV/r than with ZDV–3TC–LPV/r or TDF–FTC–ATV/r among HIV-infected women and their infants in the United States, although power was limited for some comparisons. (Funded by the National Institutes of Health and others).",
author = "{for the PHACS and the IMPAACT P1025 Study Teams} and Kathryn Rough and Seage, {George R.} and Williams, {Paige L.} and Sonia Hernandez-Diaz and Yanling Huo and Ellen Chadwick and Currier, {Judith S.} and Hoffman, {Risa M.} and Emily Barr and Shapiro, {David E.} and Kunjal Patel",
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Birth outcomes for pregnant women with HIV using tenofovir–Emtricitabine. / for the PHACS and the IMPAACT P1025 Study Teams.

In: New England Journal of Medicine, Vol. 378, No. 17, 26.04.2018, p. 1593-1603.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Birth outcomes for pregnant women with HIV using tenofovir–Emtricitabine

AU - for the PHACS and the IMPAACT P1025 Study Teams

AU - Rough, Kathryn

AU - Seage, George R.

AU - Williams, Paige L.

AU - Hernandez-Diaz, Sonia

AU - Huo, Yanling

AU - Chadwick, Ellen

AU - Currier, Judith S.

AU - Hoffman, Risa M.

AU - Barr, Emily

AU - Shapiro, David E.

AU - Patel, Kunjal

PY - 2018/4/26

Y1 - 2018/4/26

N2 - In a previous trial of antiretroviral therapy (ART) involving pregnant women with human immunodeficiency virus (HIV) infection, those randomly assigned to receive tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF–FTC–LPV/r) had infants at greater risk for very premature birth and death within 14 days after delivery than those assigned to receive zidovudine, lamivudine, and ritonavir-boosted lopinavir (ZDV–3TC–LPV/r). METHODS Using data from two U.S.-based cohort studies, we compared the risk of adverse birth outcomes among infants with in utero exposure to ZDV–3TC–LPV/r, TDF–FTC–LPV/r, or TDF–FTC with ritonavir-boosted atazanavir (ATV/r). We evaluated the risk of preterm birth (<37 completed weeks of gestation), very preterm birth (<34 completed weeks), low birth weight (<2500 g), and very low birth weight (<1500 g). Risk ratios with 95% confidence intervals were estimated with the use of modified Poisson models to adjust for confounding. RESULTS There were 4646 birth outcomes. Few infants or fetuses were exposed to TDF–FTC–LPV/r (128 [2.8%]) as the initial ART regimen during gestation, in contrast with TDF–FTC–ATV/r (539 [11.6%]) and ZDV–3TC–LPV/r (954 [20.5%]). As compared with women receiving ZDV–3TC–LPV/r, women receiving TDF–FTC–LPV/r had a similar risk of preterm birth (risk ratio, 0.90; 95% confidence interval [CI], 0.60 to 1.33) and low birth weight (risk ratio, 1.13; 95% CI, 0.78 to 1.64). As compared to women receiving TDF–FTC–ATV/r, women receiving TDF–FTC–LPV/r had a similar or slightly higher risk of preterm birth (risk ratio, 1.14; 95% CI, 0.75 to 1.72) and low birth weight (risk ratio, 1.45; 95% CI, 0.96 to 2.17). There were no significant differences between regimens in the risk of very preterm birth or very low birth weight. CONCLUSIONS The risk of adverse birth outcomes was not higher with TDF–FTC–LPV/r than with ZDV–3TC–LPV/r or TDF–FTC–ATV/r among HIV-infected women and their infants in the United States, although power was limited for some comparisons. (Funded by the National Institutes of Health and others).

AB - In a previous trial of antiretroviral therapy (ART) involving pregnant women with human immunodeficiency virus (HIV) infection, those randomly assigned to receive tenofovir, emtricitabine, and ritonavir-boosted lopinavir (TDF–FTC–LPV/r) had infants at greater risk for very premature birth and death within 14 days after delivery than those assigned to receive zidovudine, lamivudine, and ritonavir-boosted lopinavir (ZDV–3TC–LPV/r). METHODS Using data from two U.S.-based cohort studies, we compared the risk of adverse birth outcomes among infants with in utero exposure to ZDV–3TC–LPV/r, TDF–FTC–LPV/r, or TDF–FTC with ritonavir-boosted atazanavir (ATV/r). We evaluated the risk of preterm birth (<37 completed weeks of gestation), very preterm birth (<34 completed weeks), low birth weight (<2500 g), and very low birth weight (<1500 g). Risk ratios with 95% confidence intervals were estimated with the use of modified Poisson models to adjust for confounding. RESULTS There were 4646 birth outcomes. Few infants or fetuses were exposed to TDF–FTC–LPV/r (128 [2.8%]) as the initial ART regimen during gestation, in contrast with TDF–FTC–ATV/r (539 [11.6%]) and ZDV–3TC–LPV/r (954 [20.5%]). As compared with women receiving ZDV–3TC–LPV/r, women receiving TDF–FTC–LPV/r had a similar risk of preterm birth (risk ratio, 0.90; 95% confidence interval [CI], 0.60 to 1.33) and low birth weight (risk ratio, 1.13; 95% CI, 0.78 to 1.64). As compared to women receiving TDF–FTC–ATV/r, women receiving TDF–FTC–LPV/r had a similar or slightly higher risk of preterm birth (risk ratio, 1.14; 95% CI, 0.75 to 1.72) and low birth weight (risk ratio, 1.45; 95% CI, 0.96 to 2.17). There were no significant differences between regimens in the risk of very preterm birth or very low birth weight. CONCLUSIONS The risk of adverse birth outcomes was not higher with TDF–FTC–LPV/r than with ZDV–3TC–LPV/r or TDF–FTC–ATV/r among HIV-infected women and their infants in the United States, although power was limited for some comparisons. (Funded by the National Institutes of Health and others).

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DO - 10.1056/NEJMoa1701666

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