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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Hyperbilirubinemia during atazanavir treatment in 2,404 patients in the italian atazanavir expanded access program and master cohorts
Infection, Volume 37, No. 3, Year 2009
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Description
Background: : Although the mechanism of atazanavir (ATV)-related hyperbilirubinemia is well identified, its prevalence, risk factors, and association with transaminase flares have rarely been assessed in a large population from the "real life" setting. Methods: : Prospectively collected data on 2,404 patients from the Italian MASTER Cohort and the Italian ATV expanded access program database were examined. Uni- and multivariable Cox proportional hazards regression models were conducted to identify risk factors for grade ≤ III hyperbilirubinemia during the administration of ATV. The risk of increased levels of serum alanine aminotranferase (ALT) was compared between patients with or without grade ≤ III hyperbilirubinemia in a Cox regression analysis stratified by hepatitis C virus (HCV) serostatus. Results: : Grade III and IV hyperbilirubinemia were observed in 1,072 (44.6%) and 174 (7.2%) of the patients, respectively. Higher CD4+ T-cell counts, abnormal bilirubinemia at baseline, and ritonavir co-administration were associated with a higher risk of developing grade ≤ III hyperbilirubinemia. In contrast, female gender, clinical class C, and non-nucleoside reverse transcriptase co-administration appeared to be protective. Higher bilirubinemia at baseline and the use of ritonavir were associated with a higher risk of grade IV hyperbilirubinemia. The occurrence of grade ≤ III hyperbilirubinemia was not associated with severe hepatotoxicity (hazard ratio 1.00, 95% confidence interval 0.64-1.57; p = 0.997). Conclusions: : Hyperbilrubinemia is a common side effect of an ATV pharmacotherapeutic regimen. However, grade IV increase in bilirubin was rarely found. In most cases, ATV hyperbilirubinemia appeared to be an innocent phenomenon as far as the risk of a subsequent increase in liver enzyme level is concerned. © 2009 Springer.
Authors & Co-Authors
Torti, Carlo
Italy, Brescia
Università Degli Studi Di Brescia
Lapadula, Giuseppe
Italy, Brescia
Università Degli Studi Di Brescia
Antinori, Andrea
Italy, Rome
Irccs Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
Quirino, Tiziana
Italy, Varese
Azienda Ospedaliera Ospedale Di Circolo e Fondazione Macchi Di Varese
Maserati, Renato
Italy, Pavia
Fondazione Irccs Policlinico San Matteo
Maggiolo, Franco
Italy, Bergamo
Ospedali Riuniti Di Bergamo
De Luca, Andrea
Italy, Rome
Università Cattolica Del Sacro Cuore, Campus Di Roma
Lazzarin, Adriano
Italy, Milan
Irccs Ospedale San Raffaele
Di Perri, Giovanni
Italy, Turin
Università Degli Studi Di Torino
Rizzardini, Giuliano
Italy, Milan
Ospedale Luigi Sacco - Polo Universitario
Carosi, Giaampiero
Italy, Brescia
Università Degli Studi Di Brescia
Statistics
Citations: 46
Authors: 11
Affiliations: 11
Identifiers
Doi:
10.1007/s15010-008-8010-6
ISSN:
03008126
Research Areas
Environmental
Health System And Policy
Infectious Diseases
Study Design
Cross Sectional Study
Cohort Study
Study Approach
Quantitative
Participants Gender
Female