Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.

Study Overview

• Status: Completed
• Conditions: HIV-1 Infection
• Intervention / Treatment: Drug: B/F/TAF Placebo; Drug: B/F/TAF; Drug: ABC/DTG/3TC Placebo; Drug: ABC/DTG/3TC

• Study Type: Interventional
• Enrollment (Actual): 631
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Ghent, Belgium, B-9000
    • UZ Gent
• Canada
  • Montreal, Canada, H2L 5B1
    • Clinique médicale l'Actuel
  • Montreal, Canada, H2X 2P4
    • McGill University Health Center
  • Montreal, Canada, H3A 1T1
    • Clinique OPUS Inc
  • Ottawa, Canada, K1H 8L6
    • Ottawa Hospital
  • Toronto, Canada, M4N 3M5
    • Sunnybrook Health Sciences Centre
  • Toronto, Canada, M5G 1K2
    • Maple Leaf Research
  • Vancouver, Canada, V6Z 2T1
    • Spectrum Health Care
  • Winnipeg, Canada, R3A 1R9
    • Winnipeg Regional Health Authority
• Dominican Republic
  • Santo Domingo, Dominican Republic, 10103
    • Instituto Dominicano de Estudios Virologicos IDEV
• France
  • Lyon cedex 04, France, 69317
    • Hopital de la Croix Rousse
  • Nice, France, 06200
    • CHU de Nice Archet I
  • PARIS cedex 10, France, 75475
    • Hopital Saint Louis
  • Paris, France, 75018
  • Paris, France, 75571
    • Hopital Saint Antoine
  • Tourcoing, France, 59208
    • Groupe Hospitalier Bichat Claude Bernard
• Germany
  • Berlin, Germany, 13353
    • zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn
  • Hamburg, Germany, 20146
    • ICH Study Center
• Italy
  • Bergamo, Italy, 24127
    • ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
  • Milano, Italy, 20127
    • Ospedale San Raffaele S.r.l. - PPDS
  • Roma, Italy
    • Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
• Puerto Rico
  • San Juan, Puerto Rico, 00935
    • University of Puerto Rico
  • San Juan, Puerto Rico, 00909
    • Hope Clinical Research
• Spain
  • Alicante, Spain, 3010
    • Hospital General Universitario de Alicante
  • Badalona, Spain, 08907
    • Hospital Universitario de Bellvitge
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Cordoba, Spain, 14004
    • C.H. Regional Reina Sofia - PPDS
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz - PPDS
  • Vigo, Spain, 36312
    • CHUVI - H.U. Alvaro Cunqueiro
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol
• United Kingdom
  • Birmingham, United Kingdom, B4 6DH
    • University Hospitals Birmingham NHS Foundation Trust
  • Brighton, United Kingdom, BN2 3EW
    • Brighton and Sussex University Hospitals NHS Trust
  • London, United Kingdom, NW3 2QG
    • Royal Free London NHS Foundation Trust
  • London, United Kingdom, SE5 9RJ
    • Kings College Hospital
  • London, United Kingdom, E1 1BB
    • Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
  • London, United Kingdom, WC1E 6JB
    • Mortimer Market Centre
  • London, United Kingdom, SW10 9TH
    • Chelsea and Westminster NHS Trust
  • Manchester, United Kingdom, M8 5RB
    • North Manchester General Hospital - PPDS
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-2050
      • University of Alabama At Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Spectrum Medical Group
    • Phoenix, Arizona, United States, 85015
      • Pueblo Family Physicians
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Medical Center
    • Los Angeles, California, United States, 90036
      • Ruane Clinical Research Group, Inc.
    • Los Angeles, California, United States, 90069
      • Anthony Martin Mills MD A Medical Corporation, DBA Mills Clinical Research
    • Oakland, California, United States, 94602
      • Alameda Health System- Highland Hospital
    • Sacramento, California, United States, 95817
      • University of California Davis
    • Sacramento, California, United States, 95825
      • Kaiser Permanente Medical Group
    • San Diego, California, United States, 92103
      • La Playa Medical Group
    • San Francisco, California, United States, 94118
      • Kaiser Permanente
    • San Leandro, California, United States, 94577
      • Kaiser Permanente
    • Torrance, California, United States, 90502
      • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Colorado
    • Denver, Colorado, United States, 80209
      • APEX Research
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Medical Faculty Associates
    • Washington, District of Columbia, United States, 20009
      • Whitman-Walker Institute
    • Washington, District of Columbia, United States, 20017
      • Providence Hospital - DC
    • Washington, District of Columbia, United States, 20036
      • Capital Medical Associates
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Therafirst Medical Center
    • Fort Lauderdale, Florida, United States, 33316
      • Gary J. Richmond, M.D., P.A.
    • Fort Pierce, Florida, United States, 34982
      • Midway Immunology and Research Center
    • Miami, Florida, United States, 33140
    • Miami, Florida, United States, 33133
      • AHF Kinder Medical Group
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center
    • Pensacola, Florida, United States, 32504
      • AIDS Healthcare Foundation-Miami Beach
    • Tampa, Florida, United States, 33614
      • St. Joseph's Comprehensive Research Institute
    • Vero Beach, Florida, United States, 32960
      • AIDS Research and Treatment Center of the Treasure Coast
    • West Palm Beach, Florida, United States, 33401
      • Triple O Research Institute PA
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
    • Atlanta, Georgia, United States, 30309
      • Atlanta Infectious Disease Group PC
    • Atlanta, Georgia, United States, 30312
      • AIDS Research Consortium of Atlanta Inc
    • Augusta, Georgia, United States, 30912
      • Augusta University
    • Decatur, Georgia, United States, 30033
      • Infectious Disease Specialists of Atlanta
    • Savannah, Georgia, United States, 31401
      • Chatham County Health Department
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana CTSI Clinical Research Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Sciences Center
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Berkley, Michigan, United States, 48072
      • Be Well Medical Center
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Kansas City Care Clinic
    • Saint Louis, Missouri, United States, 63108
      • Southampton Clinical Research Group, Inc.
    • Saint Louis, Missouri, United States, 63139
      • Southampton Healthcare Inc
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • Prime Healthcare Services - St Michael's LLC d/b/a Saint Michael's Medical Center
    • Somers Point, New Jersey, United States, 08244
      • South Jersey Infectious Disease
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
  • New York
    • Albany, New York, United States, 12208
      • Upstate Infectious Disease Associates
    • Bronx, New York, United States, 10467-2490
      • Montefiore Medical Center
    • Bronx, New York, United States, 10457
      • Bronx Care
    • Buffalo, New York, United States, 14215
      • Evergreen Health
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital-(Manhasset)
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • AIDS Research Consortium of Atlanta Inc
    • Charlotte, North Carolina, United States, 28209
      • ID Consultants PA
    • Greensboro, North Carolina, United States, 27401
    • Greenville, North Carolina, United States, 27858-4354
      • East Carolina University
    • Huntersville, North Carolina, United States, 28078
      • Rosedale Infectious Diseases
    • Winston-Salem, North Carolina, United States, 27157-1042
      • Wake Forest Baptist Medical Center - PPDS
  • Ohio
    • Akron, Ohio, United States, 44304
      • SUMMA Health System
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Research Institute
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Perelman Center for Advanced Medicine
    • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia FIGHT
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network
  • South Carolina
    • Columbia, South Carolina, United States, 29203-6840
      • Medical University of South Carolina PPDS
  • Texas
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research
    • Bellaire, Texas, United States, 77401
      • Saint Hope Foundation Inc
    • Dallas, Texas, United States, 75215
      • AIDS Arms Inc
    • Dallas, Texas, United States, 75246
      • North Texas Infectious Diseases Consultants PA
    • Dallas, Texas, United States, 75235
      • UT Southwestern Clinical Trials Office
    • Fort Worth, Texas, United States, 76104
    • Houston, Texas, United States, 77004
      • Therapeutic Concepts
    • Houston, Texas, United States, 77098
      • Research Access Network
    • Houston, Texas, United States, 77098
      • Gordon E Crofoot MD PA
    • Longview, Texas, United States, 75605
      • Diagnostic Clinic of Longview Center For Clinical Research (DCOL)
  • Washington
    • Seattle, Washington, United States, 98104
      • Peter Shalit MD
    • Spokane, Washington, United States, 99204
      • MultiCare Rockwood HIV Critical Care Clinic
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • The Medical College of Wisconsin, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
• Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening
• Adequate renal function: Estimated glomerular filtration rate ≥ 50 milliliter per minute (mL/min) (≥ 0.83 milliliter per second [mL/sec]) according to the Cockcroft-Gault formula
• Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by Gilead Sciences

Key Exclusion Criteria:

• An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening (refer to study protocol)
• Decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding)
• Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
• Females who are pregnant (as confirmed by positive serum pregnancy test)
• Females who are breastfeeding
• Chronic Hepatitis B Virus (HBV) infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B/F/TAF; B/F/TAF + ABC/DTG/3TC placebo administered without regard to food for at least 144 weeks.	Drug: B/F/TAF; 50/200/25 mg tablets administered orally, once daily, without regard to food; Other Names: Biktarvy®; GS-9883/F/TAF; Drug: ABC/DTG/3TC Placebo; Tablets administered orally, once daily
Active Comparator: ABC/DTG/3TC; ABC/DTG/3TC + B/F/TAF placebo administered without regard to food for at least 144 weeks.	Drug: B/F/TAF Placebo; Tablets administered orally, once daily; Drug: ABC/DTG/3TC; 600/50/300 milligrams (mg) tablets administered orally, once daily; Other Names: Triumeq®
Experimental: Open-label Phase B/F/TAF to B/F/TAF; After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.	Drug: B/F/TAF; 50/200/25 mg tablets administered orally, once daily, without regard to food; Other Names: Biktarvy®; GS-9883/F/TAF
Experimental: Open-label Phase ABC/DTG/3TC to B/F/TAF; After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.	Drug: B/F/TAF; 50/200/25 mg tablets administered orally, once daily, without regard to food; Other Names: Biktarvy®; GS-9883/F/TAF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in CD4+ Cell Count at Week 48		Baseline, Week 48
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 96
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 144
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm	The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm	The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 96
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm	The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 144
Change From Baseline in log10 HIV-1 RNA at Week 48		Baseline, Week 48
Change From Baseline in log10 HIV-1 RNA at Week 96		Baseline, Week 96
Change From Baseline in log10 HIV-1 RNA at Week 144		Baseline, Week 144
Change From Baseline in CD4+ Cell Count at Week 96		Baseline, Week 96
Change From Baseline in CD4+ Cell Count at Week 144		Baseline, Week 144
Change From Baseline in CD4+ Cell Count at Week 48 Open-Label		Baseline, open-label Week 48
Change From Baseline in CD4+ Cell Count at Week 96 Open-Label		Baseline, open-label Week 96
Percentage Change From Baseline in Hip BMD at Week 48		Baseline, Week 48
Percentage Change From Baseline in Hip BMD at Week 96		Baseline, Week 96
Percentage Change From Baseline in Hip BMD at Week 144		Baseline, Week 144
Percentage Change From Baseline in Spine BMD at Week 48		Baseline, Week 48
Percentage Change From Baseline in Spine BMD at Week 96		Baseline, Week 96
Percentage Change From Baseline in Spine BMD at Week 144		Baseline, Week 144
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm	The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit.	Baseline, open-label Week 48
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm	The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.	Baseline, open-label Week 48
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm	The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit.	Baseline, open-label Week 96
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm	The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.	Baseline, open-label Week 96

Collaborators and Investigators

• Sponsor: Gilead Sciences

Publications and helpful links

General Publications

• Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31.
• Acosta RK, Willkom M, Martin R, Chang S, Wei X, Garner W, Lutz J, Majeed S, SenGupta D, Martin H, Quirk E, White KL. Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks. Antimicrob Agents Chemother. 2019 Apr 25;63(5):e02533-18. doi: 10.1128/AAC.02533-18. Print 2019 May.
• Acosta R, Willkom M, Martin R, Chang S, Liu X, Hedskog C, et al. Low-frequency resistance variants in art-naïve participants do not affect bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) triple therapy outcome. [Poster MOPEB242]. 10th IAS Conference on HIV Science (IAS 2019); 2019 July 21-24; Mexico City, Mexico.
• Acosta R, White K, Garner W, Wei X, Andreatta K, Willkom M, et al. HIV-1 subtype (B or non-B) had no impact on the efficacy of B/F/TAF or resistance development in five phase 3 treatment-naïve or switch studies. [Poster THPEB077]. 22nd International AIDS Conference; 2018 July 23-27; Amsterdam, Netherlands.
• White K, Kulkarni R, Willkom M, Martin R, Chang S, Wei X, et al. Pooled week 48 efficacy and baseline resistance: B/F/TAF in treatment-naive patients. [Poster 532]. Conference on Retroviruses and Opportunistic Infections; 2018 March 4-7; Boston, USA.
• Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.
• Wohl DA, Yazdanpanah Y, Baumgarten A, Clarke A, Thompson MA, Brinson C, Hagins D, Ramgopal MN, Antinori A, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e355-e363. doi: 10.1016/S2352-3018(19)30077-3. Epub 2019 May 5.
• Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. HIV Viral Blips in Adults Treated with INSTI-Based Regimens Through 144 Weeks. [Poster 540]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts.
• Mills A, Gupta SK, Brinson C, Workowski K, Clarke A, Antinori A, Stephens JL, et al. 144-Week Efficacy and Safety of B/F/TAF in Treatment-Naive Adults Age ≥50 Years. [Poster 477]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts.
• Orkin C, DeJesus E, Sax PE, Arribas JR, Gupta SK, Martorell C, Stephens JL, Stellbrink HJ, Wohl D, Maggiolo F, Thompson MA, Podzamczer D, Hagins D, Flamm JA, Brinson C, Clarke A, Huang H, Acosta R, Brainard DM, Collins SE, Martin H; GS-US-380-1489; GS-US-380-1490 study investigators. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020 Jun;7(6):e389-e400. doi: 10.1016/S2352-3018(20)30099-0.
• Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. [Poster P124]. HIV Drug Therapy 2020 (HIV Glasgow 2020); 2020 October 5-8; Glasgow, United Kingdom.
• Acosta R, Chen G, Chang S, Martin R, Wang X, Huang H, et al. HIV with Transmitted Drug Resistance Is Durably Suppressed by B/F/TAF at Week 144. [Poster 430]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.
• Acosta RK, Chen GQ, Chang S, Martin R, Wang X, Huang H, Brainard D, Collins SE, Martin H, White KL. Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naive participants. J Antimicrob Chemother. 2021 Jul 15;76(8):2153-2157. doi: 10.1093/jac/dkab115.
• Workowski K, Orkin C, Sax P, Hagins D, Koenig E, Stephens JL, et al. Four-Year Outcomes of B/F/TAF in Treatment-Naïve Adults [Poster 415]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.
• Acosta R, Chen G, Qin L, Wang X, Huang H, Hindman J, et al. Achievement of Undetectable HIV-1 RNA in the B/F/TAF Treatment-Naïve Clinical Trials. [Poster PEB150]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.
• Acosta R, Chen G, Huang H, Liu H, White K. Unreturned Pill Bottles in the 1489 and 1490 Clinical Trials: An Important Measure of Poor Adherence That Is Often Ignored in Pill Count Calculations. [Poster 902]. IDWeek 2021; 2021 September 29-October 3; Virtual.
• Arribas J, Orkin C, Maggiolo F, Antinori A, Lazzarin A, Yasdanpanah, et al. Long-term Analysis of B/F/TAF in Treatment-Naïve Adults Living With HIV Through Four Years of Follow-up. [PEB151]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.
• Ramgopal M, Maggiolo F, Ward D, Leboucche B, Rizzardini G, Molina JM, et al. Pooled Analysis of 4 International Trials of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged ≥ 65 Years Demonstrating Safety and Efficacy: Week 48 Results. [Oral OAB0403].AIDS 2020; 2020 July 6-10; Virtual.
• Daar E, Orkin C, Sax P, Stephens J, Koenig E, Clarke A, et al. Incidence of Metabolic Complications Among Treatment-naïve Adults Living With HIV-1 Randomized to B/F/TAF, DTG/ABC/3TC or DTG + F/TAF After 3 Years. [Oral 69]. IDWeek 2021; 2021 September 29-October 3; Virtual.
• Pozniak A, et al. Outcomes 48 Weeks After Switching From DTG/ABC/3TC or DTG + F/TAF to B/F/TAF. [PE2/68]. 18th European AIDS Conference (EAC 2021), 2021 October 27-30; London, United Kingdom.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2015
• Primary Completion (Actual): May 9, 2017
• Study Completion (Actual): July 2, 2021

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (Estimate): November 18, 2015

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: HIV
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Lamivudine; Triumeq
• Other Study ID Numbers: GS-US-380-1489; 2015-004024-54 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
• IPD Sharing Time Frame: 18 months after study completion
• IPD Sharing Access Criteria: A secured external environment with username, password, and RSA code.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No