title: Maternal Lopinavir/Ritonavir Is Associated with Fewer Adverse Events in Infants than Nelfinavir or Atazanavir.
abstract: Combination antiretroviral therapy (cART) is successfully used for prevention of perinatal HIV transmission. To investigate safety, we compared adverse events (AE) among infants exposed to different maternal cART regimens. We reviewed 158 HIV-uninfected infants born between 1997 and 2009, using logistic regression to model grade ≥1 AE and grade ≥3 AE as a function of maternal cART and confounding variables (preterm, C-section, illicit drug use, race, ethnicity, infant antiretrovirals, and maternal viremia). Frequently used cART regimens included zidovudine (63%), lamivudine (80%), ritonavir-boosted lopinavir (37%), nelfinavir (26%), and atazanavir (10%). At birth, anemia occurred in 13/140 infants (9%), neutropenia in 27/107 (25%), thrombocytopenia in 5/133 (4%), and liver enzyme elevation in 21/130 (16%). Corresponding rates of AE at 4 weeks were 59/141 (42%), 54/130 (42%), 3/137 (2%), and 3/104 (3%), respectively. Serious AE (grade ≥ 3) exceeded 2% only for neutropenia (13% at birth; 9% at 4 weeks). Compared with infants exposed to maternal lopinavir/ritonavir, infants exposed to nelfinavir and atazanavir had a 5-fold and 4-fold higher incidence of AE at birth, respectively. In conclusion, hematologic and hepatic AE were frequent, but rarely serious. In this predominantly protease inhibitor-treated population, lopinavir/ritonavir was associated with the lowest rate of infant AE.
authors.affiliation: Division of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO 80045, USA.
authors.forename: Christiana
authors.identifier: 0000-0002-4611-6477
authors.initials: C
authors.lastname: Smith
authors.affiliation: Division of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO 80045, USA; Department of Medicine, University of Colorado School of Medicine, Aurora, CO 80045, USA; Department of Pathology, University of Colorado School of Medicine, Aurora, CO 80045, USA.
authors.forename: Adriana
authors.initials: A
authors.lastname: Weinberg
authors.affiliation: Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, CO 80045, USA.
authors.forename: Jeri E
authors.initials: JE
authors.lastname: Forster
authors.affiliation: Division of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO 80045, USA; Department of Medicine, University of Colorado School of Medicine, Aurora, CO 80045, USA.
authors.forename: Myron J
authors.initials: MJ
authors.lastname: Levin
authors.affiliation: Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, CO 80045, USA; Denver Health Medical Center, Denver, CO 80204, USA.
authors.forename: Jill
authors.initials: J
authors.lastname: Davies
authors.affiliation: Children's Hospital Colorado, Aurora, CO 80045, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Pappas
authors.affiliation: Children's Hospital Colorado, Aurora, CO 80045, USA.
authors.forename: Kay
authors.initials: K
authors.lastname: Kinzie
authors.affiliation: Division of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO 80045, USA.
authors.forename: Emily
authors.initials: E
authors.lastname: Barr
authors.affiliation: Division of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO 80045, USA.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Paul
authors.affiliation: Division of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO 80045, USA.
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: McFarland
mesh_terms: D000069446:Atazanavir Sulfate / Q000009:adverse effects*; D004359:Drug Therapy, Combination; D005260:Female; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000139:chemically induced*; D061466:Lopinavir / Q000009:adverse effects*; D008297:Male; D019888:Nelfinavir / Q000009:adverse effects*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011297:Prenatal Exposure Delayed Effects / Q000139:chemically induced; D012189:Retrospective Studies; D019438:Ritonavir / Q000009:adverse effects*
chemical_list: D017320:HIV Protease Inhibitors; D061466:Lopinavir; D000069446:Atazanavir Sulfate; D019888:Nelfinavir; D019438:Ritonavir