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Clinical significance of hyperbilirubinemia in the CASTLE study
© Uy et al; licensee BioMed Central Ltd. 2010
Published: 8 November 2010
Purpose of the study
While unconjugated hyperbilirubinemia is associated with the use of ritonavir-boosted atazanavir (ATV/r), the nature of the hyperbilirubinemia over time and its clinical significance has not been well-characterized in controlled studies. The purpose of this study is to describe the patterns and clinical significance of hyperbilirubinemia in patients treated with ATV/r in the CASTLE study.
CASTLE was a randomized, 96-week study to assess the efficacy and safety of ATV/r vs. lopinavir/r, each with tenofovir/emtricitabine, in treatment-naïve patients. This analysis included only ATV/r patients. The proportions of patients with hyperbilirubinemia (grades 3-4 total bilirubin elevation) were tabulated for each study visit. The impact of hyperbilirubinemia on symptoms (jaundice or scleral icterus), ASL/ALT elevations, quality of life (MOS-HIV physical and mental summary scores), and adherence (MACS adherence questionnaire) were described.
Summary of results
Patients without hyperbilirubinemia
Patients with hyperbilirubinemia
MOS-HIV Physical Summary Score Categories at Week 96
MOS-HIV Mental Summary Score Categories at Week 96
Adherence Through Week 96
Hyperbilirubinemia, while common in patients on ATV/r at any time through 96 weeks in the CASTLE study, was less frequent at any single time point and not associated with related symptoms in most patients. The presence of hyperbilirubinemia did not affect AST/ALT elevations, quality of life, or adherence. These data suggest that hyperbilirubinemia observed with ATV/r does not impact clinical outcomes.
This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.