410. Successful Use of Lopinavir/ritonavir for Prophylaxis in Neonates Born to High Risk Mothers with HIV
Session: Poster Abstract Session: Pediatric HIV
Thursday, October 3, 2013
Room: The Moscone Center: Poster Hall C
  • ID Week Poster FINAL.pdf (154.0 kB)
  • Background:

    Recent reports of a “cure” in a HIV exposed infant involved Lopinavir/ritonavir (LPV/r). As of 2011, the FDA recommends avoiding LPV/r in neonates, especially in preterm infants, due to serious adverse drug events (ADEs). Prior to this guidance, our institution recommended 2-weeks of LPV/r (12 mg/kg/twice daily) with lamivudine for babies born to high risk mothers with HIV. All babies received a total of 6 weeks of zidovudine. Herein we discuss the use of LPV/r in high risk infants.


    Neonates born to HIV positive mothers from Jan 2008 – Dec 2012 and referred to the Ruth M Rothstein CORE Center in Chicago, IL were identified retrospectively. High risk defined as mothers with insufficient prenatal care, non-adherence to ART, HIV diagnosis at labor/postpartum, or a viral load >1000 at delivery.  Demographic data and maternal and neonatal ART were documented.    


    During the study period, 181 babies were born to HIV-infected women, 41 met criteria for high-risk. 40/41 received triple ART; 15 with LPV/r and 25 nevirapine.  Average gestation 38 weeks; 8 were preterm (≤36 weeks). Average birth weight 2740 grams; 13 were low (< 2500 grams). One serious ADE occurred in a 29week gestation baby involving an overdose of LPV/r due to a medication error. The infant received 80 times the recommended dose of LPV/r, leading to metabolic acidosis and alcohol poisoning, however, no cardiac toxicity was documented.  Subsequently this neonate seroconverted.  At 1 year after the ADE, she is well and without apparent sequelae from the overdose. Five seroconversions occurred; 1 in the LPV/r (above mentioned infant) and 4 in the nevirapine (P=0.41), but 3 of the 5, including baby above, were likely infected in utero due to positive PCR or viral load at birth. However, overall rate of seroconversion in the neonates was low, with none occurring in those with a low risk. 


    A life threatening ADE occurred in one neonate as a result of a significant medication error leading to drug overdose of LPV/r.  Overall, LPV/r dosed at 12 mg/kg twice daily was tolerated without ADEs, even in preterm infants. LPV/r was effective in preventing perinatal transmission in high risk births in this small cohort and further consideration of this agent for HIV prevention in neonates should be considered.

    Sonia Vibhakar, PharmD, The Ruth M. Rothstein CORE Center, Cook County Health and Hospitals System, Chicago, IL, Zahra Kassamali, PharmD, University of Illinois, Chicago, Chicago, IL, Pamela Haerr, RN, BS, CPNP, Ruth M. Rothstein CORE Center, Chicago, IL and Mariam Aziz, MD, Rush University Medical Center, Chicago, chicago, IL


    S. Vibhakar, None

    Z. Kassamali, None

    P. Haerr, None

    M. Aziz, None

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