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Atazanavir and darunavir in pregnant women with HIV: evaluation of laboratory and clinical outcomes from an observational national study.

Atazanavir and darunavir in pregnant women with HIV: evaluation of laboratory and clinical outcomes from an observational national study.
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Floridia M, Masuelli G, Ravizza M, Tassis B, Cetin I, Sansone M, Degli Antoni A, Simonazzi G, Maccabruni A, Francisci D, Frisina V, Liuzzi G, Dalzero S, Tamburrini E, ,


Floridia M, Masuelli G, Ravizza M, Tassis B, Cetin I, Sansone M, Degli Antoni A, Simonazzi G, Maccabruni A, Francisci D, Frisina V, Liuzzi G, Dalzero S, Tamburrini E, , (click to view)

Floridia M, Masuelli G, Ravizza M, Tassis B, Cetin I, Sansone M, Degli Antoni A, Simonazzi G, Maccabruni A, Francisci D, Frisina V, Liuzzi G, Dalzero S, Tamburrini E, ,

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The Journal of antimicrobial chemotherapy 2017 12 13() doi 10.1093/jac/dkx478

Abstract
Background
Atazanavir and darunavir represent the main HIV PIs recommended in pregnancy, but comparative data in pregnant women are limited. We assessed the safety and activity profile of these two drugs in pregnancy using data from a national observational study.

Methods
Women with atazanavir or darunavir exposure in pregnancy were evaluated for laboratory measures and main pregnancy outcomes (e.g. preterm delivery, low birthweight, non-elective caesarean section and neonatal gestational 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 two groups. 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 4.03 versus 3.27; P = 0.028) and exposure to atazanavir was associated with higher levels of plasma bilirubin (1.54 versus 0.32 mg/dL; P < 0.001). Conclusions
In this observational study, the two main HIV PIs currently recommended by perinatal guidelines showed similar safety and activity in pregnancy, with no evidence of differences between the two drugs in terms of main pregnancy outcomes. Based on the minor differences observed in laboratory measures, prescribing physicians might prefer either drug in some particular situations where the different impacts of treatment on lipid profile and bilirubin may have clinical relevance.

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