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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Clinical and pharmacogenetic factors affecting neonatal bilirubinemia following atazanavir treatment of mothers during pregnancy
AIDS Research and Human Retroviruses, Volume 29, No. 10, Year 2013
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Description
A theoretical concern exists that atazanavir (ATV) use during pregnancy may exacerbate physiologic neonatal hyperbilirubinemia. The aim of this substudy was to evaluate patterns of neonatal bilirubin following ATV/ritonavir (RTV) treatment of pregnant mothers and clinical and pharmacogenetic factors that may correlate. The design involved a subanalysis of study AI424182, a multicenter, open-label, prospective, single-arm Phase I study. The study had two treatment arms: (1) ATV/RTV 300/100 mg once daily or (2) ATV/RTV 400/100 mg once daily, both in combination with zidovudine/lamivudine 300/150 mg twice daily. Total bilirubin was assessed at baseline, each visit, and delivery day for mothers and on days 1 (delivery day), 3, 5, and 7 and weeks 2 and 6 for neonates. Blood samples were obtained for UGT1A1 genotyping and ATV cord blood concentration. Bilirubin elevation of any grade occurred in 14/40 neonates (35%). All Grade 3 to 4 bilirubin abnormalities (n=7) occurred after day 14. The pattern of neonatal bilirubin levels reported was consistent with neonatal physiologic elevations of bilirubin. Little correlation was observed between either maternal bilirubin levels over the last 4 weeks of pregnancy (including delivery) or ATV cord concentration and neonatal bilirubin. There was a significant association between UGT1A1 genotype and bilirubin grade in the maternal population (p=0.0006) but not neonates (p=0.49). Neither neonatal UGT1A1 genotype nor cord blood ATV concentration is a good predictor of neonatal hyperbilirubinemia. ATV/RTV treatment of mothers does not appear to exacerbate neonatal physiologic hyperbilirubinemia. © 2013, Mary Ann Liebert, Inc.
Authors & Co-Authors
Eley, Timothy
United States, New York
Bristol-myers Squibb
Huang, Shu Pang
United States, New York
Bristol-myers Squibb
Conradie, Francesca M.
South Africa, Johannesburg
University of the Witwatersrand Faculty of Health Sciences
Zorrilla, Carmen D.
Puerto Rico, San Juan
University of Puerto Rico School of Medicine
Josipovic, Deirdre
South Africa, Johannesburg
University of the Witwatersrand
Botes, Mariëtte E.
South Africa, Pretoria
Scion Clinical Research
Osiyemi, Olayemi O.
United States, West Palm Beach
Triple o Research Institute pa
Hardy, Hélène
United States, New York
Bristol-myers Squibb
Bertz, Richard
United States, New York
Bristol-myers Squibb
McGrath, Donnie
United States, New York
Bristol-myers Squibb
Statistics
Citations: 10
Authors: 10
Affiliations: 6
Identifiers
Doi:
10.1089/aid.2013.0002
ISSN:
08892229
e-ISSN:
19318405
Research Areas
Genetics And Genomics
Maternal And Child Health
Sexual And Reproductive Health
Study Design
Cross Sectional Study
Cohort Study