Exploring the Relationship Between UGT1A1 Genotypes in Maternal Blood and Infant Blood Samples and Bilirubin Levels in a Clinical Trial of Pregnant Women Treated with Boosted ATV

• Activity Number: 627
• Type: Contributed
• Date/Time: Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Wenhua Hu and Victoria Wirtz and Eric Vandeloise and Stjohn McGrath and Timothy Eley and Awny Farajallah and Shu-Pang Huang*+
• Companies: Bristol-Myers Squibb and Bristol-Myers Squibb and Bristol-Myers Squibb and Bristol-Myers Squibb and Bristol-Myers Squibb and Bristol-Myers Squibb and Bristol-Myers Squibb
• Keywords: Atazanavir ; Repeated Measures ; UGT1A1 genotypes ; Pregnant Women ; Bilirubin

Abstract

In a clinical trial to treat pregnant women with boosted atazanavir, 39 maternal blood samples were obtained for genotyping for UGT1A1 at study entry and 28 infant blood samples were obtained for genotyping for UGT1A1 from cord blood at delivery. Total bilirubin levels were measured from entry up to 8 weeks post delivery and for infants from birth until 6 weeks post delivery. Repeated measures modeling for total bilirubin was conducted separately for mother and infant. Results show that the association between UGT1A1 genotypes and bilirubin levels at baseline and delivery in pregnant women receiving boosted atazanavir were significant. The overall genotype-by-visit effect, however, in live-born infants was not significant. The Fisher exact test indicates a significant association between the UGT1A1 genotype and hyperbilirubinemia grades in pregnant women.