Perinatal Safety Outcomes With Atazanavir and Darunavir
Comparative safety information for 2 common protease inhibitors currently used in pregnancy was examined.
Atazanavir and darunavir, 2 HIV protease inhibitors (PIs) commonly used during pregnancy, have similar safety and activity profiles, according to study findings published in the Journal of Antimicrobial Chemotherapy.1
Investigators 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-randomization 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.”
Floridia M, Masuelli G, Ravizza M, et al; for 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 [published online December 13, 2017]. J Antimicrob Chemother. doi:10.1093/jac/dkx478