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Single Pill Combinations in HIV Treatment
Slide 1.
Single Pill Combinations in HIV Treatment
Slide 1.
Outline
Slide 2.
Case
Slide 3.
Which ART regimen would you start given the pt's problems with adherence?
Slide 4.
Case (continued)
Slide 5.
Adherence
Slide 6.
In era of universal ART in U.S., adherence is key
Slide 7.
Individual Level/Community Level
Slide 8.
CDC vital statistics
Slide 9.
What do you find is the greatest barrier to adherence in your patients?
Slide 10.
The Clinical Problem
Slide 11.
A New Era
Slide 12.
Which is your favorite SPC for HIV?
Slide 13.
Era of many options
Slide 14.
HIV = SPC dream state?
Slide 15.
What's the evidence SPCs aid adherence?
Slide 16.
What's the evidence in HIV?
Slide 17.
Few studies in HIV
Slide 18.
3 retrospective observational studies
Slide 19.
Which SPCs are available?
Slide 20.
Pros and cons of each
Slide 21.
Complera
Slide 22.
STRIBILD
Slide 	23.
Why cant you co-administer elvitegravir with cation-containing antacids?
Slide 24.
Next anticipated SPC
Slide 25.
Which were the 3 dolutegravir trials conducted in treatment naive patients?
Slide 26.
Patient populations DTG-SPC could be used Treatment naive
Slide 27.
Graphs: Dolutegrivir plus Abacavir-Lamivudine for the Treatment of HIV-1 Infection
Slide 28.
Patient populations DTG-SPC could be used Some treatment experienced
Slide 29.
What data does a company need to show to get a SPC approved?
Slide 30.
Bioequivalence data for SPC
Slide 31.
October 22, 2013: SPC filed with FDA for approval
Slide 32.
ABC/3tC + dolutegravir
Slide 33.
Summary of food considerations for SPCs
Slide 34.
What is the next likely SPC to be developed?
Slide 36.
TAF/FTC/ELV/Cobi
Slide 36.
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
Slide 37.
Multiple-dose pharmacokinetics of DRV 800mg with COBI 150mg (as single agents) versus RTV 100mg: GS-US-216-0115
Slide 38.
PIs co-formulated with cobicistat
Slide 39.
Algorithm: Use of an SPC for HIV
Slide 40.
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?
Slide 41.
Areas of Uncertainty
Slide 42.
Follow-up on Case
Slide 43.
Key Clinical Points
Slide 44.
Stop AIDS. Make the Promise.
Slide 45.