Potential associations between atazanavir exposure and clinical outcome: A pharmacokinetic sub-study from the MODAt randomized trial

E Colella, D Cattaneo, L Galli, S Baldelli, E Clementi, M Galli, A Lazzarin, A Castagna, S Rusconi, V Spagnuolo

Research output: Contribution to journalArticle

Abstract

The 96-week results of the Monotherapy Once a Day with Atazanavir/r (MODAt) study [NCT01511809] showed an inferior virological efficacy of atazanavir (ATV)/ritonavir monotherapy versus triple therapy, which was promptly retrieved by the reintroduction of nucleoside/nucleotide inhibitors of reverse transcriptase [N(n)RTIs]. We aimed to identify potential relationships between ATV exposure and clinical outcome in HIV-1 subjects treated with ATV/ritonavir monotherapy [ATV/r 300/100 mg] versus ATV/ritonavir triple therapy [ATV/r 300/100 mg+2NRTIs]. A chromatographic method coupled with tandem mass spectrometry was applied to analyze ATV plasma concentrations in a pharmacokinetic sub-study from the MODAt trial. Mixed linear models were used to examine the ATV plasma concentration trend during follow-up and to assess the association between ATV plasma concentrations trajectories with the study arm or the occurrence of treatment failure or drug-related adverse events or the grading of baseline total bilirubin (
Original languageEnglish
Pages (from-to)106-111
Number of pages6
JournalNew Microbiologica
Volume41
Issue number2
Publication statusPublished - 2018

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Pharmacokinetics
Ritonavir
Atazanavir Sulfate
Reverse Transcriptase Inhibitors
Tandem Mass Spectrometry
Drug-Related Side Effects and Adverse Reactions
Treatment Failure
Bilirubin
Nucleosides
HIV-1
Linear Models
Nucleotides
Therapeutics

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Colella, E., Cattaneo, D., Galli, L., Baldelli, S., Clementi, E., Galli, M., ... Spagnuolo, V. (2018). Potential associations between atazanavir exposure and clinical outcome: A pharmacokinetic sub-study from the MODAt randomized trial. New Microbiologica, 41(2), 106-111.

Potential associations between atazanavir exposure and clinical outcome: A pharmacokinetic sub-study from the MODAt randomized trial. / Colella, E; Cattaneo, D; Galli, L; Baldelli, S; Clementi, E; Galli, M; Lazzarin, A; Castagna, A; Rusconi, S; Spagnuolo, V.

In: New Microbiologica, Vol. 41, No. 2, 2018, p. 106-111.

Research output: Contribution to journalArticle

Colella, E, Cattaneo, D, Galli, L, Baldelli, S, Clementi, E, Galli, M, Lazzarin, A, Castagna, A, Rusconi, S & Spagnuolo, V 2018, 'Potential associations between atazanavir exposure and clinical outcome: A pharmacokinetic sub-study from the MODAt randomized trial', New Microbiologica, vol. 41, no. 2, pp. 106-111.
Colella, E ; Cattaneo, D ; Galli, L ; Baldelli, S ; Clementi, E ; Galli, M ; Lazzarin, A ; Castagna, A ; Rusconi, S ; Spagnuolo, V. / Potential associations between atazanavir exposure and clinical outcome: A pharmacokinetic sub-study from the MODAt randomized trial. In: New Microbiologica. 2018 ; Vol. 41, No. 2. pp. 106-111.
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