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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).
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Authors

Mayor MeshTerms

Infant, Low Birth Weight

Pregnancy Outcome

Keywords
Journal Title the new england journal of medicine
Publication Year Start

 



PMID- 29694825
OWN - NLM
STAT- MEDLINE
DCOM- 20180509
LR  - 20180516
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 378
IP  - 17
DP  - 2018 Apr 26
TI  - Birth Outcomes for Pregnant Women with HIV Using Tenofovir-Emtricitabine.
PG  - 1593-1603
LID - 10.1056/NEJMoa1701666 [doi]
AB  - BACKGROUND: 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.).
FAU - Rough, Kathryn
AU  - Rough K
AD  - From the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and
      Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research
      (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division
      of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham
      and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of
      Pediatrics, Northwestern University Feinberg School of Medicine, Chicago
      (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David
      Geffen School of Medicine at the University of California, Los Angeles, Los
      Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of
      Colorado School of Medicine, Aurora (E.B.).
FAU - Seage, George R 3rd
AU  - Seage GR 3rd
AD  - From the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and
      Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research
      (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division
      of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham
      and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of
      Pediatrics, Northwestern University Feinberg School of Medicine, Chicago
      (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David
      Geffen School of Medicine at the University of California, Los Angeles, Los
      Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of
      Colorado School of Medicine, Aurora (E.B.).
FAU - Williams, Paige L
AU  - Williams PL
AD  - From the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and
      Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research
      (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division
      of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham
      and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of
      Pediatrics, Northwestern University Feinberg School of Medicine, Chicago
      (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David
      Geffen School of Medicine at the University of California, Los Angeles, Los
      Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of
      Colorado School of Medicine, Aurora (E.B.).
FAU - Hernandez-Diaz, Sonia
AU  - Hernandez-Diaz S
AD  - From the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and
      Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research
      (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division
      of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham
      and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of
      Pediatrics, Northwestern University Feinberg School of Medicine, Chicago
      (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David
      Geffen School of Medicine at the University of California, Los Angeles, Los
      Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of
      Colorado School of Medicine, Aurora (E.B.).
FAU - Huo, Yanling
AU  - Huo Y
AD  - From the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and
      Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research
      (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division
      of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham
      and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of
      Pediatrics, Northwestern University Feinberg School of Medicine, Chicago
      (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David
      Geffen School of Medicine at the University of California, Los Angeles, Los
      Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of
      Colorado School of Medicine, Aurora (E.B.).
FAU - Chadwick, Ellen G
AU  - Chadwick EG
AD  - From the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and
      Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research
      (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division
      of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham
      and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of
      Pediatrics, Northwestern University Feinberg School of Medicine, Chicago
      (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David
      Geffen School of Medicine at the University of California, Los Angeles, Los
      Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of
      Colorado School of Medicine, Aurora (E.B.).
FAU - Currier, Judith S
AU  - Currier JS
AD  - From the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and
      Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research
      (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division
      of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham
      and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of
      Pediatrics, Northwestern University Feinberg School of Medicine, Chicago
      (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David
      Geffen School of Medicine at the University of California, Los Angeles, Los
      Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of
      Colorado School of Medicine, Aurora (E.B.).
FAU - Hoffman, Risa M
AU  - Hoffman RM
AD  - From the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and
      Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research
      (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division
      of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham
      and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of
      Pediatrics, Northwestern University Feinberg School of Medicine, Chicago
      (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David
      Geffen School of Medicine at the University of California, Los Angeles, Los
      Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of
      Colorado School of Medicine, Aurora (E.B.).
FAU - Barr, Emily
AU  - Barr E
AD  - From the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and
      Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research
      (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division
      of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham
      and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of
      Pediatrics, Northwestern University Feinberg School of Medicine, Chicago
      (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David
      Geffen School of Medicine at the University of California, Los Angeles, Los
      Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of
      Colorado School of Medicine, Aurora (E.B.).
FAU - Shapiro, David E
AU  - Shapiro DE
AD  - From the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and
      Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research
      (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division
      of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham
      and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of
      Pediatrics, Northwestern University Feinberg School of Medicine, Chicago
      (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David
      Geffen School of Medicine at the University of California, Los Angeles, Los
      Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of
      Colorado School of Medicine, Aurora (E.B.).
FAU - Patel, Kunjal
AU  - Patel K
AD  - From the Departments of Epidemiology (K.R., G.R.S., P.L.W., S.H.-D., K.P.) and
      Biostatistics (P.L.W., D.E.S.) and the Center for Biostatistics and AIDS Research
      (Y.H., D.E.S., K.P.), Harvard T.H. Chan School of Public Health, and the Division
      of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham
      and Women's Hospital and Harvard Medical School (K.R.), Boston; the Department of
      Pediatrics, Northwestern University Feinberg School of Medicine, Chicago
      (E.G.C.); the Department of Medicine and Division of Infectious Diseases, David
      Geffen School of Medicine at the University of California, Los Angeles, Los
      Angeles (J.S.C., R.M.H.); and the Department of Pediatrics, University of
      Colorado School of Medicine, Aurora (E.B.).
CN  - PHACS and the IMPAACT P1025 Study Teams
LA  - eng
GR  - U01 HD052104/HD/NICHD NIH HHS/United States
GR  - UM1 AI068632/AI/NIAID NIH HHS/United States
GR  - UM1 AI068616/AI/NIAID NIH HHS/United States
GR  - U01 HD052102/HD/NICHD NIH HHS/United States
GR  - T32 AI007433/AI/NIAID NIH HHS/United States
GR  - UM1 AI106716/AI/NIAID NIH HHS/United States
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (Anti-HIV Agents)
RN  - 2494G1JF75 (Lopinavir)
RN  - 2T8Q726O95 (Lamivudine)
RN  - 4B9XT59T7S (Zidovudine)
RN  - 99YXE507IL (Tenofovir)
RN  - G70B4ETF4S (Emtricitabine)
RN  - O3J8G9O825 (Ritonavir)
SB  - AIM
SB  - IM
MH  - Adult
MH  - Anti-HIV Agents/adverse effects/*therapeutic use
MH  - Cohort Studies
MH  - Disease Transmission, Infectious/prevention & control
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination/adverse effects
MH  - Emtricitabine/adverse effects/*therapeutic use
MH  - Female
MH  - HIV Infections/*drug therapy
MH  - Humans
MH  - *Infant, Low Birth Weight
MH  - Infant, Newborn
MH  - Lamivudine/therapeutic use
MH  - Lopinavir/adverse effects/therapeutic use
MH  - Pregnancy
MH  - Pregnancy Complications, Infectious/*drug therapy
MH  - *Pregnancy Outcome
MH  - Premature Birth/*epidemiology
MH  - Risk
MH  - Ritonavir/therapeutic use
MH  - Tenofovir/adverse effects/*therapeutic use
MH  - Zidovudine/therapeutic use
EDAT- 2018/04/26 06:00
MHDA- 2018/05/10 06:00
CRDT- 2018/04/26 06:00
PHST- 2018/04/26 06:00 [entrez]
PHST- 2018/04/26 06:00 [pubmed]
PHST- 2018/05/10 06:00 [medline]
AID - 10.1056/NEJMoa1701666 [doi]
PST - ppublish
SO  - N Engl J Med. 2018 Apr 26;378(17):1593-1603. doi: 10.1056/NEJMoa1701666.