Atazanavir and darunavir in pregnant women with HIV

Evaluation of laboratory and clinical outcomes from an observational national study

on behalf of The Italian Group on Surveillance of Antiretroviral Treatment in Pregnancy

Research output: Contribution to journalArticle

Abstract

Background: Atazanavir and darunavir represent the main HIV PIs recommended in pregnancy, but comparativedata in pregnant women are limited.We assessed the safety and activity profile of these two drugs in pregnancyusing data from a national observational study.Methods: Women with atazanavir or darunavir exposure in pregnancy were evaluated for laboratory measuresand main pregnancy outcomes (e.g. preterm delivery, low birthweight, non-elective caesarean section and neonatalgestational age-adjusted birthweight Z-score).Results: Final analysis included 500 pregnancies with either atazanavir (n"409) or darunavir (n"91) exposure.No differences in pregnancy outcomes, weight gain in pregnancy, drug discontinuations, undetectable HIV-RNA,haemoglobin, ALT, total cholesterol, HDL cholesterol and LDL cholesterol were observed between the twogroups. At third trimester, exposure to darunavir was associated with higher levels of plasma triglycerides(median 235.5 versus 179 mg/dL; P"0.032) and a higher total cholesterol/HDL cholesterol ratio (median 4.03versus 3.27; P"0.028) and exposure to atazanavir was associated with higher levels of plasma bilirubin (1.54versus 0.32 mg/dL; P<0.001).Conclusions: In this observational study, the two main HIV PIs currently recommended by perinatal guidelinesshowed similar safety and activity in pregnancy, with no evidence of differences between the two drugs in termsof main pregnancy outcomes. Based on the minor differences observed in laboratory measures, prescribingphysicians might prefer either drug in some particular situations where the different impacts of treatment onlipid profile and bilirubin may have clinical relevance.

Original languageEnglish
Pages (from-to)1025-1030
Number of pages6
JournalJournal of Antimicrobial Chemotherapy
Volume73
Issue number4
DOIs
Publication statusPublished - Apr 1 2018

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Observational Studies
Pregnant Women
HIV
Pregnancy
Pregnancy Outcome
Bilirubin
Pharmaceutical Preparations
HDL Cholesterol
Cholesterol
Safety
Third Pregnancy Trimester
Cesarean Section
LDL Cholesterol
Weight Gain
Hemoglobins
Triglycerides
Atazanavir Sulfate
Darunavir
RNA
Therapeutics

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

Cite this

Atazanavir and darunavir in pregnant women with HIV : Evaluation of laboratory and clinical outcomes from an observational national study. / on behalf of The Italian Group on Surveillance of Antiretroviral Treatment in Pregnancy.

In: Journal of Antimicrobial Chemotherapy, Vol. 73, No. 4, 01.04.2018, p. 1025-1030.

Research output: Contribution to journalArticle

on behalf of The Italian Group on Surveillance of Antiretroviral Treatment in Pregnancy. / Atazanavir and darunavir in pregnant women with HIV : Evaluation of laboratory and clinical outcomes from an observational national study. In: Journal of Antimicrobial Chemotherapy. 2018 ; Vol. 73, No. 4. pp. 1025-1030.
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abstract = "Background: Atazanavir and darunavir represent the main HIV PIs recommended in pregnancy, but comparativedata in pregnant women are limited.We assessed the safety and activity profile of these two drugs in pregnancyusing data from a national observational study.Methods: Women with atazanavir or darunavir exposure in pregnancy were evaluated for laboratory measuresand main pregnancy outcomes (e.g. preterm delivery, low birthweight, non-elective caesarean section and neonatalgestational age-adjusted birthweight Z-score).Results: Final analysis included 500 pregnancies with either atazanavir (n{"}409) or darunavir (n{"}91) exposure.No differences in pregnancy outcomes, weight gain in pregnancy, drug discontinuations, undetectable HIV-RNA,haemoglobin, ALT, total cholesterol, HDL cholesterol and LDL cholesterol were observed between the twogroups. At third trimester, exposure to darunavir was associated with higher levels of plasma triglycerides(median 235.5 versus 179 mg/dL; P{"}0.032) and a higher total cholesterol/HDL cholesterol ratio (median 4.03versus 3.27; P{"}0.028) and exposure to atazanavir was associated with higher levels of plasma bilirubin (1.54versus 0.32 mg/dL; P<0.001).Conclusions: In this observational study, the two main HIV PIs currently recommended by perinatal guidelinesshowed similar safety and activity in pregnancy, with no evidence of differences between the two drugs in termsof main pregnancy outcomes. Based on the minor differences observed in laboratory measures, prescribingphysicians might prefer either drug in some particular situations where the different impacts of treatment onlipid profile and bilirubin may have clinical relevance.",
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T1 - Atazanavir and darunavir in pregnant women with HIV

T2 - Evaluation of laboratory and clinical outcomes from an observational national study

AU - on behalf of The Italian Group on Surveillance of Antiretroviral Treatment in Pregnancy

AU - Floridia, M.

AU - Masuelli, G.

AU - Ravizza, M.

AU - Tassis, B.

AU - Cetin, I.

AU - Sansone, M.

AU - Antoni, A. Degli

AU - Simonazzi, G.

AU - Maccabruni, A.

AU - Francisci, D.

AU - Frisina, V.

AU - Liuzzi, G.

AU - Dalzero, S.

AU - Tamburrini, E.

AU - Floridia, M.

AU - Ravizza, M.

AU - Tamburrini, E.

AU - Ravizza, M.

AU - Tamburrini, E.

AU - Di Lorenzo, F.

AU - Sterrantino, G.

AU - Meli, M.

AU - Campolmi, I.

AU - Vichi, F.

AU - Del Pin, B.

AU - Marocco, R.

AU - Mastroianni, C.

AU - S.Mercurio, V.

AU - Maccabruni, A.

AU - Zanaboni, D.

AU - Guaraldi, G.

AU - Nardini, G.

AU - Molinari, A.

AU - Sabbatini, F.

AU - Grossi, P.

AU - Maso, G.

AU - Spinillo, A.

AU - Roccio, M.

AU - Capone, A.

AU - Pinnetti, C.

AU - Liuzzi, G.

AU - Pirillo, M. F.

AU - Amici, R.

AU - Galluzzo, C. M.

AU - Baroncelli, S.

AU - Floridia, M.

AU - Villani, P.

AU - Cusato, M.

AU - Parazzini, F.

AU - Vella, S.

PY - 2018/4/1

Y1 - 2018/4/1

N2 - Background: Atazanavir and darunavir represent the main HIV PIs recommended in pregnancy, but comparativedata in pregnant women are limited.We assessed the safety and activity profile of these two drugs in pregnancyusing data from a national observational study.Methods: Women with atazanavir or darunavir exposure in pregnancy were evaluated for laboratory measuresand main pregnancy outcomes (e.g. preterm delivery, low birthweight, non-elective caesarean section and neonatalgestational age-adjusted birthweight Z-score).Results: Final analysis included 500 pregnancies with either atazanavir (n"409) or darunavir (n"91) exposure.No differences in pregnancy outcomes, weight gain in pregnancy, drug discontinuations, undetectable HIV-RNA,haemoglobin, ALT, total cholesterol, HDL cholesterol and LDL cholesterol were observed between the twogroups. At third trimester, exposure to darunavir was associated with higher levels of plasma triglycerides(median 235.5 versus 179 mg/dL; P"0.032) and a higher total cholesterol/HDL cholesterol ratio (median 4.03versus 3.27; P"0.028) and exposure to atazanavir was associated with higher levels of plasma bilirubin (1.54versus 0.32 mg/dL; P<0.001).Conclusions: In this observational study, the two main HIV PIs currently recommended by perinatal guidelinesshowed similar safety and activity in pregnancy, with no evidence of differences between the two drugs in termsof main pregnancy outcomes. Based on the minor differences observed in laboratory measures, prescribingphysicians might prefer either drug in some particular situations where the different impacts of treatment onlipid profile and bilirubin may have clinical relevance.

AB - Background: Atazanavir and darunavir represent the main HIV PIs recommended in pregnancy, but comparativedata in pregnant women are limited.We assessed the safety and activity profile of these two drugs in pregnancyusing data from a national observational study.Methods: Women with atazanavir or darunavir exposure in pregnancy were evaluated for laboratory measuresand main pregnancy outcomes (e.g. preterm delivery, low birthweight, non-elective caesarean section and neonatalgestational age-adjusted birthweight Z-score).Results: Final analysis included 500 pregnancies with either atazanavir (n"409) or darunavir (n"91) exposure.No differences in pregnancy outcomes, weight gain in pregnancy, drug discontinuations, undetectable HIV-RNA,haemoglobin, ALT, total cholesterol, HDL cholesterol and LDL cholesterol were observed between the twogroups. At third trimester, exposure to darunavir was associated with higher levels of plasma triglycerides(median 235.5 versus 179 mg/dL; P"0.032) and a higher total cholesterol/HDL cholesterol ratio (median 4.03versus 3.27; P"0.028) and exposure to atazanavir was associated with higher levels of plasma bilirubin (1.54versus 0.32 mg/dL; P<0.001).Conclusions: In this observational study, the two main HIV PIs currently recommended by perinatal guidelinesshowed similar safety and activity in pregnancy, with no evidence of differences between the two drugs in termsof main pregnancy outcomes. Based on the minor differences observed in laboratory measures, prescribingphysicians might prefer either drug in some particular situations where the different impacts of treatment onlipid profile and bilirubin may have clinical relevance.

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U2 - 10.1093/jac/dkx478

DO - 10.1093/jac/dkx478

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SP - 1025

EP - 1030

JO - Journal of Antimicrobial Chemotherapy

JF - Journal of Antimicrobial Chemotherapy

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