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Single Pill Combinations in HIV Treatment
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Single Pill Combinations in HIV Treatment
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Which ART regimen would you start given the pt's problems with adherence?
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Case (continued)
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In era of universal ART in U.S., adherence is key
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Individual Level/Community Level
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CDC vital statistics
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What do you find is the greatest barrier to adherence in your patients?
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The Clinical Problem
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A New Era
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Which is your favorite SPC for HIV?
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Era of many options
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HIV = SPC dream state?
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What's the evidence SPCs aid adherence?
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What's the evidence in HIV?
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Few studies in HIV
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3 retrospective observational studies
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Which SPCs are available?
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Pros and cons of each
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Why cant you co-administer elvitegravir with cation-containing antacids?
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Next anticipated SPC
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Which were the 3 dolutegravir trials conducted in treatment naive patients?
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Patient populations DTG-SPC could be used Treatment naive
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Graphs: Dolutegrivir plus Abacavir-Lamivudine for the Treatment of HIV-1 Infection
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Patient populations DTG-SPC could be used Some treatment experienced
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What data does a company need to show to get a SPC approved?
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Bioequivalence data for SPC
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October 22, 2013: SPC filed with FDA for approval
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ABC/3tC + dolutegravir
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Summary of food considerations for SPCs
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What is the next likely SPC to be developed?
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Graph: Patients achieving a human immunodeficiency virus type 1 (HIV-1) RNA load of less than 50 copies/mL through week 48 of the study
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Multiple-dose pharmacokinetics of DRV 800mg with COBI 150mg (as single agents) versus RTV 100mg: GS-US-216-0115
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PIs co-formulated with cobicistat
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Algorithm: Use of an SPC for HIV
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Sign me up! or What did one cost-effectiveness study estimate as the cost-savings of switching Atripla to 3 drugs in U.S. when generics?
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Areas of Uncertainty
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Follow-up on Case
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Key Clinical Points
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Stop AIDS. Make the Promise.
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