Perinatal safety outcomes with atazanavir and darunavir

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Atazanavir and darunavir, two HIV protease inhibitors (PIs) commonly used during pregnancy, have similar safety and activity profiles, according to study findings.

Investigators from Italian Group on Surveillance of Antiretroviral Treatment in Pregnancy led by Dr Marco Floridia at the National Centre for Global Health, Istituto Superiore di Sanità, Rome, compared pregnant women taking either atazanavir (n=409) or darunavir (n=91) to determine differences between the two therapies in terms of overall safety and pregnancy outcomes. The evaluated pregnancy outcomes included non-elective caesarean section, preterm delivery (<37 weeks), low birth weight, and neonatal gestational age-adjusted birthweight Z-score.

Based on the findings, there were no differences between the therapies with regard to discontinuation, pregnancy weight gain, alanine transaminase, total cholesterol, high-density lipoprotein (HDL) cholesterol, or low-density lipoprotein (LDL) cholesterol.
Patients treated with darunavir had greater median plasma triglyceride levels than patients treated with atazanavir at third trimester (235.5 vs 179 mg/dL; P =.032).

In addition, patients exposed to darunavir also had a higher median total cholesterol/HDL cholesterol ratio than atazanavir-treated patients (median 4.03 vs 3.27; P =.028).

Atazanavir was found to be associated with greater plasma bilirubin levels than darunavir (1.54 vs 0.32 mg/dL; P <.001). There were no significant differences between atazanavir and darunavir with regard to non-elective caesarean section (81.6% vs 83.6%; P =.961), preterm delivery (17.4% vs 18.9%; P =.755), low birth weight (20.4% vs 16.9%; P =.500), delivery complications (9.3% vs 5.6%; P =.488), or birth defects (5.8% vs 7.7%; P =.713).

The study investigators concluded that there was no difference in the risk of adverse pregnancy outcomes between the two PIs, a finding that supports current HIV treatment regimen recommendations.

The small number of participants in this study represents one of its main limitations. In addition, the non-randomisation of patients to treatment possibly precluded the elimination of selection bias during the prescribing process.

Due to the small number of differences between the two groups, many physicians prescribing HIV PIs to patients “might prefer either drug only in particular situations where the expected impact of treatment on lipid profile and bilirubin may be clinically relevant.”

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.

Authors
Marco Floridia, Masuelli G, Ravizza M, Tassis B, Cetin I, Sansone M, Degli Antoni A, Simonazzi G, Maccabruni A, Francisci D1, Frisina V, Liuzzi G, Dalzero S, Tamburrini E

Infectious Disease Advisor material
Journal of Antimicrobial Chemotherapy abstract


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