142nd APHA Annual Meeting and Exposition

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304590
Simplification of PI+RTV+TVD to STB Maintains HIV Suppression and is Well-Tolerated

142nd APHA Annual Meeting and Exposition (November 15 - November 19, 2014): http://www.apha.org/events-and-meetings/annual
Monday, November 17, 2014 : 12:45 PM - 1:00 PM

Doug Cunningham, DO , Pueblo Family Physicians, Phoenix, AZ
Jose Arribas, MD , Hospital La Paz, Madrid, Spain
Jason Hindman, PharmD, MBA , Gilead Sciences, Foster City, CA
Will Garner, PhD , Gilead Sciences, Foster City, CA
Thai Nguyen, MD , Gilead Sciences, Foster City, CA
Background: We report week (W) 48 results of a randomized, open-label, Phase 3b trial of a switch to the single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF (STB) from ritonavir-boosted protease inhibitor (PI+RTV) plus emtricitabine/tenofovir DF (TVD).

Methods: Virologically suppressed subjects on PI+RTV+TVD for ≥ 6 months were randomized to switch to STB or remain on their baseline PI regimen. Eligibility criteria included CrCl ≥ 70 mL/min, no resistance to FTC and TDF, exposure to ≤2 prior ARV regimens, and no history of virologic failure. Primary endpoint was the proportion of subjects who maintained HIV-1 RNA < 50 c/mL at W48 by FDA snapshot. If noninferiority was established, then superiority would be tested.

Results: 433 subjects were randomized and treated (293 STB; 140 PI). Baseline characteristics were similar between groups. At W48, 94% of STB subjects maintained HIV-1 RNA < 50 c/mL compared to 87% on PI (difference 6.7%, 95% CI +0.4% to +13.7%; p=0.025). Rates of virologic failure were low (0.7% STB vs 1.4% PI) with no emergent resistance. There were no AEs with a ≥5% difference in percentages between groups. Grade 3 or 4 adverse events (AEs) were low and similar. The median CrCl (mL/min) changes were -7.5 and 0.4, respectively, with no cases of proximal renal tubulopathy. Median fasting triglycerides for STB significantly decreased from baseline compared to PI (-16 vs +3 mg/dL; p =0.001).

Conclusion: Switching to STB compared to continuing PI+RTV+TVD resulted in significantly higher rates of virologic suppression without emergence of resistance and was well-tolerated.

Learning Areas:

Basic medical science applied in public health
Chronic disease management and prevention
Clinical medicine applied in public health
Other professions or practice related to public health
Public health or related research

Learning Objectives:
Describe the efficacy, safety and patient benefits of switching from a PI-based regimen to the single-tablet-regimen of STRIBILD (STB) in pts with HIV-1 infection.

Keyword(s): HIV/AIDS, Treatment

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: STB does not currently have a "switch" indication in the FDA label, however this data is being submitted to request this label change.

Qualified on the content I am responsible for because: I was a study investigator for "study 115," aka the switch from a PI+RTV+TVD based regiment to Stribild. With over 28 years of experience treating HIV patients, Iíve also been active in tackling issues related to the HIV standard of care and health-plan reimbursements.
Any relevant financial relationships? Yes

Name of Organization Clinical/Research Area Type of relationship
Gilead Sciences HIV Advisory Committee/Board, Consultant and Speaker's bureau and teaching engagements
Abbott/AbbVie HIV Advisory Committee/Board
ViiV HIV Advisory Committee/Board and Speaker's bureau and teaching engagements
Bristol-Myers Squibb HIV Advisory Committee/Board

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.