MOPEB238
Share
 
Title
A Phase 3b, multicenter, open-label study switching from an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide(E/C/F/TAF) or a Tenofovir disoproxil fumarate containing regimen to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in virologically-suppressed, HIV-1 infected subjects aged ≥65 years
Presenter
Jean-Michel Molina
Authors
F. Maggiolo1, G. Rizzardini2, J.-M. Molina3, F. Pulido4, S. De Wit5, L. Vandekerckhove6, J. Berenguer7, C. Blair8, S. Chuck8, D. Piotkowsky8, H. Martin8, I. McNicholl8, R. Haubrich8, J. Gallant8
Institutions
1Division of Infectious Diseases, ASST Papa Giovanni XXIII, Bergamo, Italy, 2Division of Infectious Diseases, Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy, 3Saint Louis Hospital, University Paris Diderot, Department of Infectious Diseases, Paris, France, 4Unidad VIH, Hospital Universitario 12 de Octubre, imas12, UCM, Madrid, Spain, 5St Pierre University Hospital, Université Libre de Bruxelles, Brussels, Belgium, 6University Hospital, Ghent, Belgium, 7Infectious Diseases, Hospital General Universitario Gregorio Marañón (IiSGM), Madrid, Spain, 8Gilead Sciences Inc., Foster City, United States

Background: As the proportion of older people living with HIV is increasing, it is important to study the long-term safety and efficacy of antiretroviral therapy in older individuals. B/F/TAF is a small single tablet regimen with few drug-drug interactions and a high barrier to resistance; it contains TAF resulting in less renal and bone toxicity than TDF-based regimens. We evaluated the efficacy and safety of switching participants 65 years and older to B/F/TAF from E/C/F/TAF or a TDF-containing regimen at 24 weeks. This study will follow participants for a total of 96 weeks.
Methods: Virologically suppressed(HIV-1 RNA < 50 copies/mL) participants >65 years old who were currently receiving either E/C/F/TAF or a TDF-based regimen were switched to open-label B/F/TAF. Primary endpoint was HIV-1 RNA < 50 copies/mL at Week(W) 24 as defined by the Food and Drug Administration(FDA) Snapshot algorithm.
Results: Of 86 participants, mean age was 70 years(range 65-80), 13% were female, and 99% were White; 91% (78/86) of participants were receiving E/C/F/TAF at baseline.
At W24, HIV RNA < 50 copies/mL was 98% for B/F/TAF; 2 participants had no virologic data in window and there were no virologic failures. No Grade 3-4 study-drug related adverse events(AEs) were observed. Three AEs led to premature study drug discontinuation; one was study-drug related(Table). There were no discontinuations of B/F/TAF due to a renal or bone AEs. Median change from baseline in total fasting cholesterol, LDL, HDL, triglycerides and total cholesterol:HDL were -14, -7, -3, -17 mg/dL and -0.1, respectively. Median change from baseline in eGFR was -4.5 mL/min. Median percent change in urine beta-2-microglobulin:creatinine and urine retinol binding protein:creatinine ratios were 20.8 and -15.6, respectively.
Conclusions: Through W24, high rates of virologic suppression were maintained in older participants who switched to B/F/TAF. The safety and efficacy data support the switch to B/F/TAF in virologically suppressed HIV-infected individuals aged ≥ 65 years.


Adverse EventsB/F/TAF (N=86), % (n)
Any Grades 3-4 Study Drug-Related AEs0
Grades 3 or 4 Laboratory AEs6% (5)
Any Study Drug-Related Serious AE0
AEs Leading to Study Drug Discontinuation3.5% (3)*
AEs Leading to Study Drug Discontinuation (drug-related)1% (1)?
* 1) abdominal discomfort , 2) alcohol withdrawal, 3) benzodiazepine withdrawal 
? abdominal discomfort (grade 2) 
[Adverse Events]