1028 - Long-term Follow-up After a Switch to Bictegravir, Emtracitabine, Tenofovir Alafenamide from Dolutegravir, Abacavir, Lamivudine

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Presenting Author(s)

Indira Brar

Associate Clinical Professor Wayne State School of Medicine
Henry Ford Hospital
Detroit, Michigan
Disclosure: Gilead (Speaker's Bureau)janssen (Speaker's Bureau)ViiV (Speaker's Bureau)

Co-Author(s)

PR

Peter Ruane

HIV Specialist
Ruane Clinical Research Group
Los Angeles, CA
Disclosure: AbbVie (Consultant, Grant/Research Support, Speaker's Bureau)Bristol-Myers Squibb (Grant/Research Support)Gilead Sciences Inc. (Consultant, Grant/Research Support, Scientific Research Study Investigator, Shareholder, Speaker's Bureau)Idenix (Consultant)Janssen (Grant/Research Support, Speaker's Bureau)Viiv Healthcare (Grant/Research Support)
DW

Douglas Ward

Physician
Dupont Circle Physicians Group, Washington, DC, USA
Washington, District of Columbia
Disclosure: Gilead Sciences Inc. (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker's Bureau)Merck (Advisor or Review Panel member)Viiv Healthcare (Advisor or Review Panel member, Speaker's Bureau)
JM

Jean-Michel Molina

Pr. Jean-michel Molina
UNiversity of Paris CIte
Paris, Ile-de-France, France
Disclosure: Bristol-Myers Squibb (Advisor or Review Panel member)Gilead Sciences Inc. (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member)Janssen (Advisor or Review Panel member)Merck (Advisor or Review Panel member)Teva (Advisor or Review Panel member)Viiv Healthcare (Advisor or Review Panel member)
Anthony Mills

Chief Executive Officer/ Principal Investigator
Men’s Health Foundation/ Mills Clinical Research
Los Angeles, CA
Disclosure: Gilead (Grant/Research Support, Advisor or Review Panel member)Janssen Pharmaceutica (Grant/Research Support, Advisor or Review Panel member)Merck (Grant/Research Support, Advisor or Review Panel member)Shionogi (Grant/Research Support)ViiV Healthcare (Grant/Research Support, Advisor or Review Panel member)
MB

Mezgebe Berhe

Practicing Physician
North Texas Infectious Diseases Consultants
Dallas, Texas
Disclosure: Gilead Sciences Inc. (Grant/Research Support, Scientific Research Study Investigator)
CB

Cynthia Brinson

Medical Director
Central Texas Clinical Research
Austin, Texas
Disclosure: Gilead (Advisor or Review Panel member, Speaker's Bureau)ViiV Healthcare (Advisor or Review Panel member, Speaker's Bureau)
MR

Moti Rampogal

Physician
Midway Immunology and Research Center
Fort Pierce, Florida
Disclosure: Gilead Sciences (Consultant, Research Grant or Support, Speaker's Bureau)Janssen (Consultant, Research Grant or Support, Speaker's Bureau)Merck (Consultant, Research Grant or Support)ViiV Healthcare (Consultant, Research Grant or Support, Speaker's Bureau)
PB

Paul Benson

HIV Specialist
Be Well Medical Center
Berkley, MI
Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
KH

Keith Henry

Staff MD
Hennepin County Medical Center
Minneapolis, Minnesota
Disclosure: Gilead (Research Grant or Support, Paid to institution)GSK/ViiV (Research Grant or Support, Paid to institution)Janssen (Research Grant or Support, Paid to institution)Merck (Research Grant or Support, Paid to institution)
HH

Hailin Huang

Manager, Biostatistics
Gilead Sciences Inc.
Foster City, California
Disclosure: Gilead Sciences Inc. (Employee, Shareholder)
Kristen Andreatta

Research Scientist
Gilead Sciences, Inc.
Foster City, CA
Disclosure: Gilead Sciences (Employee, Shareholder)
HM

Hal Martin

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

Background: Bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) is a guidelines-recommended single-tablet regimen (STR) for people living with HIV-1 (PLWH). Week (W) 48 primary endpoint results of this phase 3 study switching to B/F/TAF from dolutegravir (DTG), abacavir (ABC) and lamivudine (3TC) established the safety and efficacy of B/F/TAF. Here we report outcomes from an open-label (OL) extension of B/F/TAF.

Methods: Adults virologically suppressed on DTG, ABC, and 3TC were randomized 1:1 to switch to B/F/TAF once daily or continue their current regimen as a STR in a double blind (DB) manner. Unblinding occurred after the W48 primary endpoint, then participants received B/F/TAF in an OL extension while transitioning off the study. All participants who received B/F/TAF in the DB or OL phases are included in analyses. Efficacy was assessed as the proportion with HIV-1 RNA < 50 copies/mL at each study visit using missing=excluded (M=E) analysis, efficacy in in subgroups with pre-existing resistance was assessed using last observation carried forward. Safety was assessed by adverse events (AEs) and laboratory results.

Results: 563 participants were randomized and treated (282 B/F/TAF, 281 ABC/DTG/3TC); 524 (93%) completed the DB phase and received OL B/F/TAF; a total of 547 participants received B/F/TAF in DB and/or OL phases: 11% women, 21% Black, median age 47 yrs (range 21, 71). The median duration of B/F/TAF was 96 weeks (IQR 49-119). HIV-1 RNA < 50 c/mL was maintained in 99-100% at all timepoints (M=E) through a maximum of 168 weeks, including high efficacy in those with archived resistance (Table 1). No participant developed resistance to B/F/TAF. Study drug-related AEs occurred in 7% on B/F/TAF; most were grade 1; the most common was headache (1.6%). 7 (1%) participants had an AE leading to premature study drug discontinuation, only 1, headache, occurred in the OL phase. Estimated GFR and lipids were mostly stable with slightly increased LDL at W96; weight changes are noted at W48 and W96. (Table 2).Table 1.

Table 2.

Conclusion: Extended follow-up to the study of switching to B/F/TAF from DTG/ABC/3TC, demonstrates continued high rates of virologic suppression with no resistance and excellent safety and tolerability of B/F/TAF through a maximum of 168 weeks for treatment of PLWH.