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External Validation of the Bilirubin-Atazanavir Nomogram for Assessment of Atazanavir Plasma Exposure in HIV-1-Infected Patients.

Journal article
Authors Dinko Rekić
Daniel Röshammar
Martin Bergstrand
Joel Tärning
Andrea Calcagno
Antonio D'Avolio
Vidar Ormaasen
Marie Vigan
Aurélie Barrail-Tran
Michael Ashton
Magnus Gisslén
Angela Abelö
Published in The AAPS journal
Volume 15
Issue 2
Pages 308-15
ISSN 1550-7416
Publication year 2013
Published at Institute of Neuroscience and Physiology, Department of Pharmacology
Institute of Biomedicine, Department of Infectious Medicine
Pages 308-15
Language en
Links dx.doi.org/10.1208/s12248-012-9440-...
https://gup.ub.gu.se/file/103059
Keywords HIV, atazanavir, bilirubin, nomogram
Subject categories Biostatistics, Basic Medicine, Pharmacy, Pharmacology, Clinical pharmacology, Pharmaceutical pharmacology, Toxicology, Infectious Medicine

Abstract

Atazanavir increases plasma bilirubin levels in a concentration-dependent manner. Due to less costly and readily available assays, bilirubin has been proposed as a marker of atazanavir exposure. In this work, a previously developed nomogram for detection of suboptimal atazanavir exposure is validated against external patient populations. The bilirubin nomogram was validated against 311 matching bilirubin and atazanavir samples from 166 HIV-1-infected Norwegian, French, and Italian patients on a ritonavir-boosted regimen. In addition, the nomogram was evaluated in 56 Italian patients on an unboosted regimen. The predictive properties of the nomogram were validated against observed atazanavir plasma concentrations. The use of the nomogram to detect non-adherence was also investigated by simulation. The bilirubin nomogram predicted suboptimal exposure in the patient populations on a ritonavir-boosted regimen with a negative predictive value of 97% (95% CI 95-100). The bilirubin nomogram and monitoring of atazanavir concentrations had similar predictive properties for detecting non-adherence based on simulations. Although both methods performed adequately during a period of non-adherence, they had lower predictive power to detect past non-adherence episodes. Using the bilirubin nomogram for detection of suboptimal atazanavir exposure in patients on a ritonavir-boosted regimen is a rapid and cost-effective alternative to routine measurements of the actual atazanavir exposure in plasma. Its application may be useful in clinical settings if atazanavir concentrations are not available.

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