1002 - A Daily Single Tablet Regimen (STR) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Virologically-Suppressed Adults Living with HIV and End Stage Renal Disease on Chronic Hemodialysis

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Presenting Author(s)

Joseph J. Eron

Professor
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina
Disclosure: Gilead Sciences (Consultant, Research Grant or Support)Janssen (Consultant, Research Grant or Support)Merck (Consultant)ViiV Healthcare (Consultant, Research Grant or Support)

Co-Author(s)

AW

Aimee Wilkin

Professor, Infectious Diseases
Wake Forest University
Winston-Salem, North Carolina
Disclosure: Gilead Sciences Inc. (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member)GlaxoSmithKline (Grant/Research Support)Janssen (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member)Pfizer (Grant/Research Support)
Moti Ramgopal

Medical Director
Midway Specialty Care Center
Fort Pierce, Florida
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Olayemi Osiyemi

President
Triple O Research Institute
West Palm Beach, Florida
Disclosure: GlaxoSmithKline (Advisor or Review Panel member, Speaker's Bureau)ViiV Healthcare (Advisor or Review Panel member, Speaker's Bureau)
Mehri McKellar

Associate Professor of Medicine
Duke University Hospital
DURHAM, North Carolina
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Jihad Slim

Medical Director
Saint Michael’s Medical Center, Newark, NJ, USA
Newark, New Jersey
Disclosure: Abbvie (Speaker's Bureau)Gilead (Speaker's Bureau)Jansen (Speaker's Bureau)Merck (Speaker's Bureau)ViiV (Speaker's Bureau)
DA

David Asmuth

Professor of Medicine
University of California Davis,
Sacramento, California
Disclosure: Gilead Sciences Inc. (Scientific Research Study Investigator)
ED

Edwin DeJesus

Medical Director
Orlando Immunology Center, University of Central Florida College of Medicine
Orlando, FL
Disclosure: Gilead Sciences (Advisor or Review Panel member)
PG

Polina German

Executive Director, Clinical Pharmacology
Gilead Sciences, Inc.
Foster City, California
Disclosure: Gilead Sciences (Employee)
CB

Christiana Blair

Director
Gilead Sciences Inc.
Foster City, California
Disclosure: Gilead Sciences (Employee, Shareholder)
CC

Christoph C. Carter

Director, Clinical Research (MD)
Gilead Sciences
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
Diana M. Brainard

SVP, Therapeutic Area Head, Virology
Gilead Sciences Inc.
Foster City, CA
Disclosure: Gilead Sciences (Employee)
SC

Sean E. Collins

Senior Director
Gilead Sciences
Foster CIty, California
Disclosure: Gilead Sciences (Employee)
HM

Hal Martin

Exec Director, Virology Clinical Research
Gilead Sciences
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)

Background: Treatment for people living with HIV (PLWH) and end stage renal disease (ESRD) on hemodialysis (HD) has previously required complex dose-adjusted regimens. We evaluated a daily regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) and established this treatment as effective and safe, showing that daily TAF resulted in lower plasma tenofovir exposure than a historical comparison of once weekly tenofovir disoproxil fumarate in patients with ESRD on HD. After week (W) 96, participants transitioned to daily B/F/TAF to assess whether efficacy and safety would be maintained on this STR that is guidelines-recommended for PLWH with eGFR > 30 mL/min.

Methods: Virologically suppressed adult PLWH with ESRD on chronic HD who completed W96 on E/C/F/TAF enrolled in the B/F/TAF extension for 48 weeks. Efficacy was assessed as the proportion of participants with virologic suppression (HIV RNA < 50 copies/mL). Safety was assessed throughout the study, PK was assessed using sparse sampling at W4, 24 and 48.

Results: 55 enrolled, 36 completed E/C/F/TAF, 10 entered the B/F/TAF extension. The median age was 55 yrs (range 34-63); median time on HD was 4 yrs (range 2-16). All ten participants on B/F/TAF had HIV-1 RNA < 50 c/mL (95% CI 69%, 100%) at W48. All participants had at least 1 adverse event (AE); most were grade 1 or 2 in severity. One participant had a grade 3 AE and 3 had serious AEs; none were considered related to study drug by the investigator. One participant had AEs attributed to study drug (malaise grade 1 and nausea grade 2), which resolved and did not lead to discontinuation of study drug. There were no clinically relevant changes in fasting lipids. In participants with evaluable data (n=2-5 per timepoint), mean bictegravir trough concentrations were lower compared to PLWH not on HD but remained 4- to 7-fold higher than the established protein-adjusted 95% effective concentration (paEC₉₅) of 162 ng/mL against wild-type virus.

Conclusion: A once daily regimen of B/F/TAF maintained virologic suppression in PLWH on chronic HD. B/F/TAF was well-tolerated with no discontinuations. B/F/TAF may be an effective, safe and convenient once daily STR and ameliorate the need for dose adjustment in appropriate PLWH who require chronic HD.