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HIV medication linked to adrenal dysfunction in newborns of HIV-infected mothers
Simon A. JAMA. 2011;doi:10.1001/jama.2011.915.
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Mothers who have HIV and were treated before and after birth with the protease inhibitor lopinavir-ritonavir were more likely to have infants with adrenal dysfunction compared with a zidovudine-based regimen, according to a preliminary report published online this week.
Albane Simon, MD, of the Hospital Necker-Enfants Maiades, Assistance Publique-Hopitaux de Paris, and colleagues looked at mother-child pairs in the Paris area who were enrolled in the French Perinatal Cohort Study between December 2004 and September 2008. They evaluated 50 HIV-1 uninfected children who received lopinavir-ritonavir (Kaletra, Abbott Laboratories) just after birth, and 108 who received standard prophylaxis: zidovudine alone (n=100); zidovudine and lamivudine (n=6); or zidovudine and nevirapine (n=2).
Among the 50 newborns treated with lopinavir-ritonavir, 14% had abnormally high hydroxyprogesterone results from dried blood spots (>16.5 ng/mL at term or >23.1 ng/mL preterm) vs. none of the controls. For children born at term, five of 42 newborns treated with lopinavir-ritonavir vs. zero of 93 controls had values of more than 16.5 ng/mL.
The median (midpoint) 17-hydroxyprogesterone (17OHP) value for term newborns treated with lopinavir-ritonavir was 9.9 ng/mL vs. 3.7 ng/mL in controls. The difference observed in median 17OHP values between treated newborns and controls was higher in children also exposed in utero (11.5 ng/mL vs. 3.7 ng/mL) than not exposed in utero (6.9 ng/mL vs. 3.3 ng/mL).
Consistent with the findings for 17OHP, the dehydroepiandrosterone sulfate values were significantly higher only in cases also exposed in utero to ritonavir-boosted protease inhibitor.
“Our findings of the association between lopinavir-ritonavir and transient adrenal dysfunction in HIV-1 uninfected newborns suggest that lopinavir-ritonavir and, more generally, ritonavir-boosting, should be used with caution, if at all, in premature infants … if this drug regimen is administered to full-term infants, it should be used under electrolyte monitoring,” the researchers concluded. “Whether more prolonged exposure of HIV-1-infected or -uninfected infants via breast milk is associated with endocrine disruption should be carefully investigated, and the apparent risk associated with prenatal ritonavir exposure also merits further evaluation.”
Disclosure: Dr. Warszawski reports having obtained a research grant from Abbott Laboratories for another study; Dr. Polak reports receiving support for educational presentations and grant support from Pfizer, Ipsen and Sandoz-SAS Laboratories; Dr. Blance reports receiving support for travel to meetings from Abbott Laboratories and honoraria for lectures and development of educational presentations from Astellas, Boehringer Ingelheim, GlaxoSmithKline and Tibotec Laboratories. No other relevant financial disclosures were reported.
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