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All Rights ReservedA randomized clinical trial evaluating therapeutic drug monitoring (TDM) for protease inhibitor-based regimens in antiretroviral-experienced HIV-in...
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2011 Jul-A12(4):201-14. doi: 10.1310/HCT.A randomized clinical trial evaluating therapeutic drug monitoring (TDM) for protease inhibitor-based regimens in antiretroviral-experienced HIV-infected individuals: week 48 results of the A5146 study.1, , , , , , .1Beth Israel Deaconess Medical Center, Boston, MA, USA. malbrech@bidmc.harvard.eduAbstractBACKGROUND: We devised an open-label, randomized trial to evaluate whether therapeutic drug monitoring (TDM) of protease inhibitors (PIs) and dose escalation based upon a normalized inhibitory quotient (NIQ), which integrates PI trough concentration and drug resistance, could improve virologic outcome in PI-experienced patients with treatment failure. Secondary analyses through 48 weeks are presented.METHODS: Eligible HIV-infected subjects with a screening viral load of ≥ 1000 copies/mL initiated a new PI-based regimen at entry and had NIQ performed at week 2. Subjects with an NIQ ≤1 were randomized at week 4 to a standard-of-care (SOC) arm or TDM arm featuring PI dose escalation.RESULTS: One hundred and eighty-three subjects were randomized. There was no significant treatment difference in change from randomization to week 48 in HIV-1 RNA [ P = .13, median (25th, 75th percentile log10 copies/mL change): -0.03 (-0.74, 0.62) with TDM and 0.11 (-2.3, 0.82) with SOC]. In subgroup analysis, patients with ≥ 0.69 active PIs benefited from TDM compared to those with &0.69 active PIs ( P = .05).CONCLUSIONS: While the TDM strategy of PI dose escalation did not improve virologic response at week 48 overall, in subgroup analysis, TDM favorably impacted virologic outcome in subjects taking PI-based regimens with moderate antiviral activity.PMID:
[PubMed - indexed for MEDLINE] PMCID: PMC3328407 Study design and disposition of patients. TDM = therapeutic drug monitoring and protease inhibitor (PI) SOC =
OBS = observational arm. NIQ = normalized ITT = intent -to-treat.HIV Clin Trials. ;12(4):201-214.Figure 2A. Time to premature discontinuation of scheduled clinic evaluations. Kaplan-Meier curve of time to premature study discontinuation. Solid line represents standard of care (SOC) hatched line represents therapeutic drug monitoring (TDM) horizontal axis displays week since randomization to Step 2; vertical axis displays proportion of subjects on study.Figure 2B. Time to first permanent discontinuation of protease inhibitor (PI) in the initial regimen. Kaplan-Meier curve of time to permanent discontinuation of first PI. Solid line represents standard of care (SOC) hatched line represents therapeutic drug monitoring (TDM) horizontal axis displays week since randomization to Step 2; vertical axis displays proportion of subjects on PIs.HIV Clin Trials. ;12(4):201-214.Median change in plasma HIV-1 RNA from Step 2 randomization. Symbols represent median log10 vertical lines represent interquartile range. Solid line represents standard of care (SOC) dotted line represents therapeutic drug monitoring (TDM) dashed line represents observational (OBS) horizontal axis vertical axis displays median change in log10 HIV-1 RNA.HIV Clin Trials. ;12(4):201-214.Publication TypesMeSH TermsSubstancesGrant SupportFull Text SourcesMedicalMiscellaneous
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3.货品不支持在线交易Discordant associations between SLCO1B1 521T→C and plasma levels of ritonavir-boosted protease inhibitors in AIDS clinical trials group study A5146.
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FormatSummarySummary (text)AbstractAbstract (text)MEDLINEXMLPMID ListChoose DestinationFileClipboardCollectionsE-mailOrderMy BibliographyCitation managerFormatSummary (text)Abstract (text)MEDLINEXMLPMID ListCSVCreate File1 selected item: FormatSummarySummary (text)AbstractAbstract (text)MEDLINEXMLPMID ListMeSH and Other DataE-mailSubjectAdditional textE-mailAdd to ClipboardAdd to CollectionsOrder articlesAdd to My BibliographyGenerate a file for use with external citation management software.Create File
):209-16. doi: 10.1097/FTD.0b013ead.Discordant associations between SLCO1B1 521T→C and plasma levels of ritonavir-boosted protease inhibitors in AIDS clinical trials group study A5146.1, , , , , , , , .1Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts, USA.AbstractOBJECTIVE: Among HIV-positive patients prescribed ritonavir-boosted lopinavir, SLCO1B1 521T→C (rs4149056) is associated with increased plasma lopinavir exposure. Protease inhibitors (PIs) are also substrates for cytochrome P450 (CYP) 3A and ABCB1, which are induced by NR1I2. We characterized relationships between ABCB1, CYP3A4, CYP3A5, NR1I2, and SLCO1B1 polymorphisms and trough PI concentrations among AIDS Clinical Trials Group study A5146 participants.METHODS: At study entry, subjects with virologic failure on PI-containing regimens initiated new ritonavir-boosted PI regimens. We studied associations between week 2 PI plasma trough concentrations and 143 polymorphisms in these genes, including 4 targeted polymorphisms.RESULTS: Among 275 subjects with both drug concentrations and genetic data, allelic frequencies of SLCO1B1 521T→C were 15%, 1%, and 8% in whites, blacks, and Hispanics, respectively. Further analyses were limited to 268 white, black, or Hispanic subjects who initiated ritonavir-boosted lopinavir (n = 98), fosamprenavir (n = 69), or saquinavir (n = 99). Of targeted polymorphisms, SLCO1B1 521T→C tended to be associated with higher lopinavir concentrations, with a 1.38-fold increase in the mean per C allele (95% confidence interval, 0.97-1.96; n = 98; P = 0.07). With fosamprenavir, SLCO1B1 521T→C was associated with lower amprenavir concentrations, with a 35% decrease in the mean per C allele (geometric mean ratio 0.65; 95% confidence interval, 0.44-0.94; n = 69; adjusted P = 0.02). There was no significant association with saquinavir concentrations, and none of the remaining 139 exploratory polymorphisms were statistically significant after correcting for multiple comparisons.CONCLUSIONS: With ritonavir-boosted PIs, a SLCO1B1 polymorphism that predicts higher lopinavir trough concentrations seems to predict lower amprenavir trough concentrations. The mechanism underlying this discordant association is uncertain.PMID:
[PubMed - indexed for MEDLINE] PMCID: PMC3603284 Each subject contributed a single datapoint to the figure within each drug. Horizontal lines represent medians.Ther Drug Monit. ):209-216.Each subject contributed a single datapoint to the figure within each drug. Horizontal lines represent medians.Ther Drug Monit. ):209-216.Publication TypesMeSH TermsSubstancesGrant SupportFull Text SourcesMedicalMiscellaneous
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