SAN FRANCISCO, CA—HIV Prophylaxis with lopinavir/ritonavir 12mg/kg twice daily was well tolerated in high-risk neonates without adverse drug events, according to study results presented at IDWeek 2013.

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Since 2011, the FDA has recommended against the use of lopinavir/ritonavir in neonates, especially pre-term neonates, due to serious adverse drug events. However, recent reports of a “cure” in a HIV-exposed infant involved the use of lopinavir/ritonavir for HIV prophylaxis. Sonia Vibhakar, PharmD, from The Ruth M. Rothstein CORE Center, Cook County Health and Hospitals System, Chicago, IL, and colleagues evaluated the efficacy and toxicity of antiretroviral therapy (ART) regimens used in neonates born to mothers that were HIV-positive.

The retrospective, single-center study defined high-risk delivery as neonates born to mothers with insufficient or no prenatal care, non-adherent to ART, diagnosed with HIV at labor/postpartum, or had a viral load >1000 copies/mL at delivery.

Study outcomes included rate of neonatal HIV seroconversion across various ART regimens and the rate of serious drug-related toxicity due to ART.

A total of 200 deliveries were considered, but only 49 deliveries were high-risk. Average gestation was 37.8 weeks; 10 were preterm (<36 weeks) and 14 infants had low birth weight (<2500g). Out of the 49 included deliveries, 5 neonates were administered nevirapine + zidovudine, 17 were administered lopinavir + zidovudine + lamivudine, and 27 were administered nevirapine + zidovudine + lamivudine.

The rate of seroconersion among high-risk neonates who received triple therapy with nevirapine + zidovudine + lamivudine (15%) was higher than in those receiving lopinavir/ritonavir + zidovudine + lamivudine (6%), though overall rates of seroconversion were low (12%) in this subset (P=0.41), researchers concluded.

“Overall, both lopinavir/ritonavir and nevirapine used in neonatal HIV prophylaxis were well-tolerated,” reported Dr. Vibhakar. “Its use for HIV prevention in neonates should be reconsidered.”