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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

Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2019

At a glance

  • Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary) ; Abacavir/dolutegravir/lamivudine
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 06 Nov 2019 Results published in the Gilead Sciences Media Release.
    • 06 Nov 2019 According to an Gilead Sciences media release, results from this study are being presented today at the 17th European AIDS Conference (EACS).
    • 14 Oct 2019 Results of pooled analysis from 8 phase III trials (CTP 4999, 55400,55093,195806,228352,229699,263351 and 263352 )published in the Clinical Infectious Diseases

Trial Overview

Outcome

Primary endpoint met - positive

Purpose

This non-inferiority phase III trial is evaluating 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.This trial includes an open-label extension phase.

Comments

According to a Gilead Sciences media release, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), has been approved in China for the treatment of HIV-1 infection, based on the results of 4 trials (1489, 1490, 1844 and 1878).

In March 2019, the Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.
In 2018, the drug has also been approved by the Hong Kong Department of Health, the U.S. Food and Drug Administration (FDA) and the European Commission.
The approval of Biktarvy is supported by data from four Phase 3 studies (Studies 1489, 1490, 1844 and 1878).

Primary Endpoints

Met on 30 May 2017

Proportion of Participants who Achieve HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

description: 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.
safety_issue: No
time_frame: Week 48 [1]

Other Endpoints

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

description: 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. time_frame: 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

time_frame: 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

description: 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. time_frame: 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

description: 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. time_frame: 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

time_frame: Week 144

Change From Baseline in log10 HIV-1 RNA at Week 48

time_frame: Baseline; Week 48

Change From Baseline in log10 HIV-1 RNA at Week 96

time_frame: Baseline; Week 96

Change From Baseline in log10 HIV-1 RNA at Week 144

time_frame: Baseline; Week 144

Change From Baseline in CD4+ Cell Count at Week 48

time_frame: Baseline; Week 48

Change From Baseline in CD4+ Cell Count at Week 96

time_frame: Baseline; Week 96

Change From Baseline in CD4+ Cell Count at Week 144

time_frame: Baseline; Week 144

Hip Bone Mineral Density (BMD) at Baseline

time_frame: Baseline

Percentage Change From Baseline in Hip BMD at Week 48

time_frame: Baseline; Week 48

Percentage Change From Baseline in Hip BMD at Week 96

time_frame: Baseline; Week 96

Percentage Change From Baseline in Hip BMD at Week 144

time_frame: Baseline; Week 144

Spine BMD at Baseline

time_frame: Baseline

Percentage Change From Baseline in Spine BMD at Week 48

time_frame: Baseline; Week 48

Percentage Change From Baseline in Spine BMD at Week 96

time_frame: Baseline; Week 96

Percentage Change From Baseline in Spine BMD at Week 144

time_frame: Baseline; Week 144

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label (OL) as Defined by Missing = Excluded and Missing = Failure Algorithm.

time_frame: OL Week 48

Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 OL as Defined by Missing = Excluded and Missing = Failure Algorithm.

time_frame: OL Week 96

Change From Baseline in CD4+ Cell Count at Week 48 OL

time_frame: OL Week 48

Change From Baseline in CD4+ Cell Count at Week 96 OL

time_frame: Baseline; OL Week 96 [2]

Diseases Treated

Indication Qualifiers Patient Segments
HIV-1 infections treatment first-line therapy

Biomarker

NCT Number Biomarker Name Biomarker Function
NCT02607930 CD4 Outcome Measure
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Subjects

  • Subject Type patients
  • Number

    Planned: 600

    Actual: 629

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient Inclusion Criteria

Key - Antiretroviral treatment naïve (≤ 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 RNA levels ≥ 500 copies/mL at screening - Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec) according to the Cockcroft-Gault formula - Negative screening test for human leukocyte antigen (HLA) -B*5701 allele provided by Gilead Sciences Key

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT02607930 ClinicalTrials.gov: US National Institutes of Health
EudraCT2015-004024-54 European Clinical Trials Database
GS-US380-1489 Gilead Sciences
Study 1489 -

Organisations

  • Sponsors Gilead Sciences
  • Affiliations Gilead Sciences

Trial Dates

  • Initiation Dates

    Actual : 13 Nov 2015

  • Primary Completion Dates

    Planned : 01 May 2017

    Actual : 09 May 2017

  • End Dates

    Planned : 01 May 2021

Substudies/Extensions

An intensive pharmacokinetic (PK) substudy will be performed at the Weeks 4 or 8 visits in a subset of subjects (target n=30) at study sites able to conduct this testing. A pharmacogenomic substudy- For subjects who agree to participate and provide their additional specific consent, three blood samples will be obtained for the extraction of DNA for genomic testing and for potential genotyping to identify polymorphisms of drug metabolism enzymes including Uridine 5'-diphospho-glucuronosyltransferase (UGT1A1) and additional biomarker testing such as human leukocyte antigen (HLA). These samples will be collected at Day 1. A peripheral blood mononuclear cell (PBMC) substudy will be performed at Day 1 and Weeks 36, 84 and 132 in a subset of subjects (target n=50) at select study sites. The substudy will assess HIV-1, PBMC function for HIV disease progression, and how the immune system functions in the presence of HIV.
Beyond Week 144, study participants will have the option to receive Biktarvy in an open-label extension for up to 96 weeks.

Other Details

  • Design double-blind; multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location Belgium; Canada; Dominican Republic; England; France; Germany; Italy; Puerto Rico; Spain; United Kingdom; USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
Abacavir/dolutegravir/lamivudine Oral Tablet
Bictegravir/emtricitabine/tenofovir alafenamidePrimary Drug Oral Tablet

Blinded Phase: ABC/DTG/3TC

ABC/DTG/3TC + B/F/TAF placebo for at least 144 weeks Drug: ABC/DTG/3TC (600/50/300 mg tablets administered orally, once daily, without regard to food) Other Name: Triumeq® Drug: B/F/TAF Placebo (Tablets administered orally, once daily, without regard to food)

Blinded Phase: B/F/TAF

B/F/TAF + ABC/DTG/3TC placebo for at least 144 weeks Drug: B/F/TAF (50/200/25 mg tablets administered orally, once daily, without regard to food) Other Name: GS-9883/F/TAF, Biktarvy® Drug: ABC/DTG/3TC Placebo (Tablets administered orally, once daily, without regard to food)

Open-Label (OL) Phase

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 Name: GS-9883/F/TAF, Biktarvy®

Results

Therapeutic efficacy

Updated results from a phase III trial (Study 1489) in patients with HIV-1 infections showed that through 96 weeks of therapy bictegravir/emtricitabine/tenofovir alafenamide was statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine and non-inferiority was maintained from the primary endpoint measurement at week 48. At week 96, 87.9% (n = 276/314) of patients taking bictegravir/emtricitabine/tenofovir alafenamide (50/200/25mg) tablets and 89.8 % (n = 283/315) of patients taking abacavir/dolutegravir/lamivudine (600/50/300mg) achieved the primary endpoint of HIV-1 RNA levels less than 50 copies/mL (difference: -1.9%, 95 percent CI: -6.3 percent to 3.1%, p = 0.78). Significantly less median change in estimated glomerular filtration rate (eGFR) from baseline to week 96 was observed with bictegravir/emtricitabine/tenofovir alafenamide (-7.8 mL/min) compared with abacavir/dolutegravir/lamivudine (-9.6 mL/min) (p = 0.01). In both the treatment groups in changes from median changes in proteinuria were similar. Lipid changes were not significantly different between the two arms. Similar mean percent changes from baseline in spine and hip bone mineral density were observed in the bictegravir/emtricitabine/tenofovir alafenamide group and abacavir/dolutegravir/lamivudine group (spine: -0.71 vs. -0.22, p = 0.14; hip: -1.13 vs. -1.26, p = 0.59). The trial randomised 629 treatment-naïve adults with HIV to receive bictegravir/emtricitabine/tenofovir alafenamide or abacavir/dolutegravir/lamivudine [3] [4] .

Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) 50mg/200mg/25mg met the primary endpoint of non-inferiority in all four phase III studies, with comparable proportions of patients having HIV-1 RNA < 50 copies/mL (Studies 1489 and 1490) and HIV-1 RNA ≥ 50 copies/mL (Studies 1844 and 1878). One patient randomised to the protease inhibitor arm in Study 1878 developed an abacavir resistance mutation (L74V). No patients randomised to the bictegravir or dolutegravir arms developed treatment-emergent resistance [1] .

Adverse events

In a phase III trial (Study 1489), in patients with HIV-1 infections, the fixed dose combination of bictegravir/emtricitabine/tenofovir alafenamide was well tolerated through week 96. The most commonly reported adverse events with bictegravir/emtricitabine/tenofovir alafenamide and abacavir/dolutegravir/lamivudine were nausea (11% vs. 24%), diarrhoea (15% vs. 16%) and headache (13% vs. 16%), respectively. Discontinuations due to adverse events were low in both groups with only 2% (n = 5) reported in abacavir/dolutegravir/lamivudine arm and none in the bictegravir/emtricitabine/tenofovir alafenamide arm. None of the patients randomised to either arm developed treatment-emergent resistance. There were no renal discontinuations and no cases of proximal renal tubulopathy or fanconi syndrome in the bictegravir/emtricitabine/tenofovir alafenamide treatment group. The trial randomised 629 treatment-naïve adults with HIV to receive bictegravir/emtricitabine/tenofovir alafenamide or abacavir/dolutegravir/lamivudine [3] [4] .

In four phase III studies (Studies 1489, 1490, 1844 and 1878), bictegravir/emtricitabine/tenofovir alafenamide 50mg/200mg/25mg was well tolerated. Treatment-emergent virological resistance was not seen. No patients discontinued study medication due to renal events and no cases of proximal renal tubulopathy or Fanconi syndrome were observed. Diarrhoea, nausea and headache were the most common adverse reactions [1] .

Publications

  1. Gilead Sciences. Gileads Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for the Treatment of HIV-1 Meets Primary Endpoint in Four Phase 3 Studies. Media-Rel 2017;.

    Media Release
  2. Gilead Sciences. Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy(R)(Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy. Media-Rel 2018;.

    Media Release
  3. Gilead Sciences. Gilead Announces Phase 3 Results for Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV. Media-Rel 2017;.

    Media Release
  4. White KL, 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. CROI-2018 2018; abstr. 532.

    Available from: URL: http://www.croiconference.org/sessions/pooled-week-48-efficacy-and-baseline-resistance-bftaf-treatment-naive-patients
  5. Gilead Sciences. Gileads Biktarvy Maintained High Efficacy With No Cases of Treatment-Emergent Resistance Through Three Years in Phase 3 HIV Clinical Trials. Media-Rel 2019;.

    Media Release
  6. Podzamczer D, Stellbrink H, Orkin C, Pozniak A, Arribas J, Koenig E, et al. B/F/TAF versus ABC/DTG/3TC or DTG + F/TAF in treatment?naive adults with high baseline viral load or low baseline CD4 count in two Phase III randomized, controlled clinical trials: Week 96 results. ICDTHI-2018 2018; abstr. P119.

    Available from: URL: https://onlinelibrary.wiley.com/doi/10.1002/jia2.25187
  7. Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, et al. Patient-reported outcomes among HIV-1-infected adults randomized to B/F/TAF versus DTG/ABC/3TC in two Phase 3 controlled clinical trials over 48 weeks. AIDS-2018 2018; abstr. TUPEB148.

    Available from: URL: http://programme.aids2018.org/Abstract/Abstract/4311
  8. Sax PE, Erlandson KM, Lake JE, McComsey GA, Orkin C, Esser S, et al. Weight Gain Following Initiation of Antiretroviral Therapy: Risk Factors in Randomized Comparative Clinical Trials. Clin-Infect-Dis 2019;.

    PubMed | CrossRef Fulltext
  9. Podzamczer D, Stellbrink H-J, Orkin C, Pozniak A, Arribas JR, Koenig E, et al. B/F/TAF versus ABC/DTG/3TC or DTG + F/TAF in treatment-naive adults with high baseline viral load or low baseline CD4 count in 2 Phase 3 randomized, controlled clinical trials. AIDS-2018 2018; abstr. THPEB038.

    Available from: URL: http://programme.aids2018.org/Abstract/Abstract/5126
  10. Acosta R, Willkom M, Martin R, Chang S, Liu X, Hedskog C, et al. Low-frequency resistance variants in ART-naive participants do not affect bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) triple therapy treatment outcome. IAS-2019 2019; abstr. MOPEB242.

    Available from: URL: http://programme.ias2019.org/Abstract/Abstract/3778
  11. Acosta RK, Willkom M, Martin R, Chang S, Wei X, Garner W, et al. Resistance Analysis of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients Through 48 Weeks. Antimicrob-Agents-Chemother 2019;.

    PubMed | CrossRef Fulltext
  12. 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. Internet-Doc 2017;.

    Available from: URL: http://link.adisinsight.com/Cx83H
  13. Rockstroh JK, Sax PE, Daar E, Walmsley S, Workowski K, Orkin C, et al. High Hbv and Hiv Suppression with Treatment of Hiv/Hbv Coinfection in B/F/Taf Studies. CROI-2018 2018; abstr. 618.

    Available from: URL: http://www.croiconference.org/sessions/high-hbv-and-hiv-suppression-treatment-hivhbv-coinfection-bftaf-studies
  14. 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-naIve or switch studies. AIDS-2018 2018; abstr. THPEB077.

    Available from: URL: http://programme.aids2018.org/Abstract/Abstract/11607
  15. Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, et al. 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-Patient-Centered-Outcome-Res 2018;.

    PubMed | CrossRef Fulltext
  16. Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, et al. A phase 3 randomized controlled clinical trial of bictegravir in a fixed dose combination, B/F/TAF, vs ABC/DTG/3TC in treatment-naive adults at week 48. IAS-2017 2017; abstr. MOAB0105LB.

    Available from: URL: http://programme.ias2017.org/Abstract/Abstract/5783
  17. Gilead Sciences. Gilead Presents New Data on Biktarvy(Rm) (Bictegravir, Emtricitabine and Tenofovir Alafenamide) and TAF-Based Regimens for the Treatment of HIV-1 in Children, Older Adults and Women. Media-Rel 2019;.

    Media Release
  18. Gupta SK, Mills A, Brinson C, Workowski K, Clarke A, Antinori A, et al. -- please add a title --. CROI-2019 2019; abstr. 502.

    Available from: URL: http://www.croiconference.org/sessions/96-week-efficacy-and-safety-bftaf-treatment-na%C3%AFve-adults-and-adults-%E2%89%A550-yrs

Authors

Author Total Publications First Author Last Author
Acosta R 2 2 -
Acosta RK 1 1 -
Andreatta K 1 - -
Antinori A 1 - -
Arribas J 1 - -
Arribas JR 3 - -
Asmuth DM 1 - -
Avihingsanon A 1 - -
Baumgarten A 2 - -
Brainard D 1 - -
Brainard DM 1 - -
Brar I 1 - -
Brinson C 1 - -
Brown TT 1 - -
Carter CC 1 - -
Chang S 3 - -
Cheng A 5 - 2
Clarke A 3 - -
Collins S 1 - -
Daar E 2 - -
Das M 1 - -
DeJesus E 2 - -
Erlandson KM 1 - -
Esser S 1 - -
Gallant J 1 1 -
Garner W 5 - -
Gilead Sciences 5 5 5
Girard P-M 1 - -
Graham H 1 - -
Gupta SK 1 1 -
Hedskog C 1 - -
Kityo C 1 - -
Koenig E 3 - -
Koethe JR 1 - 1
Kulkarni R 1 - -
Lake JE 1 - -
Laouri M 2 - -
Lazzarin A 1 - -
Liu X 1 - -
Lutz J 1 - -
Maggiolo F 3 - -
Majeed S 1 - -
Makadzange T 1 - -
Martin H 11 - 2
Martin R 3 - -
McComsey GA 1 - -
Melbourne K 1 - -
Mills A 2 - -
Molina J-M 1 - -
Orkin C 6 - -
Piontkowsky D 1 - -
Podzamczer D 3 2 -
Post FA 1 - -
Pozniak A 2 - -
Quirk E 8 - 5
Ramgopal M 2 - -
Rockstroh J 2 - -
Rockstroh JK 3 1 -
Romanova S 1 - -
Sax PE 2 1 -
SenGupta D 5 - -
Stellbrink H 1 - -
Stellbrink H-J 1 - -
Stellbrink HJ 1 - -
Stephens JL 1 - -
Tebas P 1 - -
Walmsley S 1 - -
Ward D 1 - -
Waters L 1 - -
Wei X 8 - -
White K 3 - 1
White KL 2 1 1
Willkom M 4 - -
Wohl D 4 2 -
Workowski K 2 - -
Yan M 1 - -
Yazdanpanah Y 1 - -
Zhong L 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Clinical Trials Mailbox

Flowers Building, Granta Park
Abington, Cambridge
Postcode: CB21 6GT
United Kingdom
Fax: +441223897284
clinical.trials@gilead.com
show details
Gilead Sciences International Ltd. United-Kingdom
Gilead Study Director Gilead Sciences USA
Hal Martin, MD, MPH Gilead Sciences USA

Centres

Centre Name Location Trial Centre Country
- Akron, Ohio USA
- Albany, New York USA
- Alicante Spain
- Atlanta, Georgia USA
- Augusta, Georgia USA
- Austin, Texas USA
- Badalona Spain
- Badalona, Barcelona Spain
- Barcelona Spain
- Bellaire, Texas USA
- Bergamo Italy
- Berkley, Michigan USA
- Berlin Germany
- Birmingham United-Kingdom
- Birmingham, Alabama USA
- Bonn Germany
- Brighton United-Kingdom
- Bronx, New York USA
- Brussels Belgium
- Buffalo, New York USA
- Chapel Hill, North Carolina USA
- Charlotte, North Carolina USA
- Cincinnati, Ohio USA
- Cleveland, Ohio USA
- Columbia, South Carolina USA
- Columbus, Ohio USA
- Cordoba Spain
- Dallas, Texas USA
- Decatur, Georgia USA
- Denver, Colorado USA
- Detroit, Michigan USA
- Fort Lauderdale, Florida USA
- Fort Pierce, Florida USA
- Fort Worth, Texas USA
- Ghent Belgium
- Greensboro, North Carolina USA
- Greenville, North Carolina USA
- Hamburg Germany
- Houston, Texas USA
- Huntersville, North Carolina USA
- Indianapolis, Indiana USA
- Kansas City, Missouri USA
- London United-Kingdom
- Longview, Texas USA
- Los Angeles, California USA
- Lyon cedex 04 France
- Madrid Spain
- Manchester United-Kingdom
- Manhasset, New York USA
- Miami, Florida USA
- Milano Italy
- Milwaukee, Wisconsin USA
- Minneapolis, Minnesota USA
- Montreal Canada
- New Orleans, Louisiana USA
- Newark, New Jersey USA
- Nice France
- Oakland, California USA
- Orlando, Florida USA
- Ottawa Canada
- Paris France
- PARIS cedex 10 France
- Paris cedex 12 France
- Pensacola, Florida USA
- Philadelphia, Pennsylvania USA
- Phoenix, Arizona USA
- Pittsburgh, Pennsylvania USA
- Roma Italy
- Sacramento, California USA
- Saint Louis, Missouri USA
- San Diego, California USA
- San Francisco, California USA
- San Juan Puerto-Rico
- San Leandro, California USA
- Santa Fe, New Mexico USA
- Santo Domingo Dominican-Republic
- Savannah, Georgia USA
- Seattle, Washington USA
- Somers Point, New Jersey USA
- Spokane, Washington USA
- Springfield, Massachusetts USA
- Tampa, Florida USA
- Toronto Canada
- Torrance, California USA
- Tourcoing France
- Vancouver Canada
- Vero Beach, Florida USA
- Vigo Spain
- Washington, District of Columbia USA
- West Palm Beach, Florida USA
- Winnipeg Canada
- Winston-Salem, North Carolina USA
Gilead Sciences
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-
Gilead Sciences
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USA
Gilead Sciences International Ltd. Abington, Cambridge United-Kingdom

Trial History

Event Date Event Type Comment
06 Nov 2019 Results Results published in the Gilead Sciences Media Release. Updated 13 Nov 2019
06 Nov 2019 Results According to an Gilead Sciences media release, results from this study are being presented today at the 17th European AIDS Conference (EACS). Updated 13 Nov 2019
14 Oct 2019 Results Results of pooled analysis from 8 phase III trials (CTP 4999, 55400,55093,195806,228352,229699,263351 and 263352 )published in the Clinical Infectious Diseases Updated 22 Oct 2019
09 Aug 2019 Other trial event According to a Gilead Sciences media release, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), has been approved in China for the treatment of HIV-1 infection, based on the results of 4 trials (1489, 1490, 1844 and 1878). Updated 13 Aug 2019
01 Aug 2019 Other trial event Last checked against Clinicaltrials.gov record. Updated 01 Aug 2019
24 Jul 2019 Results Results assessing low-frequency resistance variants in ART-naive participants from studies 1489 and 1490 presented at the 10th International AIDS Society Conference on HIV Science Updated 03 Oct 2019
17 Jul 2019 Completion date Planned End Date changed from 1 Aug 2021 to 1 May 2021. Updated 01 Aug 2019
07 Jun 2019 Other trial event Last checked against European Clinical Trials Database record. Updated 07 Jun 2019
09 May 2019 Completion date Planned End Date changed from 1 Aug 2020 to 1 Aug 2021. Updated 23 May 2019
26 Mar 2019 Other trial event According to a Gilead Sciences media release, the Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. The approval of Biktarvy is supported by data from four Phase 3 studies (Studies 1489, 1490, 1844 and 1878). Updated 01 Apr 2019
07 Mar 2019 Results Results comparing the long-term safety and efficacy of B/F/TAF vs dolutegravir (DTG)-containing regimens in treatment-naive adults and the subset aged ≥50 y, in a pooled analysis from two phase 3 studies at Week 96, presented at the 26th Conference on Retroviruses and Opportunistic Infections Updated 03 May 2019
06 Mar 2019 Results Post-hoc analysis results using data from two phase 3 studies (Studies 1489 and 1490) evaluating Biktarvy in treatment-naive adults aged 50 and older (n=96/634), at Week 96 were presented in a Gilead Sciences media release. Updated 13 Mar 2019
25 Feb 2019 Results Results of the resistance analysis of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients Through 48 Weeks in Studies 1489 and 1490, published in the Antimicrobial Agents and Chemotherapy Updated 01 Mar 2019
30 Nov 2018 Completion date Planned End Date changed from 1 Apr 2020 to 1 Aug 2020. Updated 27 Dec 2018
31 Oct 2018 Results Results of a pooled analysis of Study 1489 and Study 1490 assessing Bictegravir/emtricitabine/tenofovir-alafenamide in treatment-naive adults with high baseline viral load or low baseline CD4 count, presented at the 14th International Congress on Drug Therapy and HIV Infection Updated 27 Dec 2018
30 Oct 2018 Results According to a Gilead Sciences media release, pooled analysis data from studies 1489 and 1490 with high viral loads (HIV-1 RNA > 100,000 c/mL) or low CD4 counts (CD4 < 200 cells/µL) are presented at the 2018 HIV Glasgow conference. Updated 12 Feb 2019
03 Oct 2018 Other trial event According to a Gilead Sciences media release, 96 week data from this trial will be presented during a late-breaking abstract session at the IDWeek 2018 conference. Additional data that demonstrate the long-term utility of Biktarvy will be presented at upcoming scientific conferences. Updated 27 Nov 2018
03 Oct 2018 Results 96-week results presented in the Gilead Sciences media release. Updated 10 Oct 2018
03 Oct 2018 Other trial event According to Gilead Sciences media release,Based on the data from four phase III trials (Studies 1489, 1490, 1844 and 1878),that the Hong Kong Department of Health has approved Biktarvy,a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults. Hong Kong is the first market in Asia to approve Biktarvy. Updated 09 Oct 2018
31 Aug 2018 Biomarker Update Biomarkers information updated Updated 05 May 2016
27 Jul 2018 Results Results from NCT02603120 and NCT02607930 presented at the 22nd International AIDS Conference Updated 10 Sep 2018
27 Jul 2018 Results Results of a pooled analysis of 1489 and 1490 studies assessing Bictegravir/emtricitabine/tenofovir-alafenamide in treatment-naive adults with high baseline viral load or low baseline CD4 count, presented at the 22nd International AIDS Conference Updated 30 Aug 2018
27 Jul 2018 Results Results of pooled data from five trials (GS-US-380-1489, GS-US-380-1490, GS-US-380-1844, GS-US-380-1878 and GS-US-380-1961 ) were presented at the 22nd International AIDS Conference. Updated 29 Aug 2018
29 Jun 2018 Results Results from NCT02607930 and NCT02603120 trials published in The Patient - Patient-Centered Outcomes Research Updated 25 Jul 2018
25 Jun 2018 Completion date Planned End Date changed from 1 Apr 2019 to 1 Apr 2020. Updated 30 Jul 2018
25 Jun 2018 Other trial event According to a Gilead Sciences media release, the European Commission has granted Marketing Authorization for Biktarvy (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. The approval is based on four phase III trials (Studies 1489, 1490, 1844 and 1878). Updated 04 Jul 2018
27 Apr 2018 Other trial event The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the companys Marketing Authorization Application (MAA) for Biktarvy for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir. A European Commission decision is expected in mid-2018. Updated 03 May 2018
07 Mar 2018 Results Results of pooled efficacy analyses through week 48 and the effect of baseline resistance on treatment response of study 1489 and study 1490 presented at the 25th Conference on Retroviruses and Opportunistic Infections. Updated 24 Apr 2018
07 Mar 2018 Results Results from studies 1489, 1490, 1878 and 1844 presented at the 25th Conference on Retroviruses and Opportunistic Infections Updated 20 Apr 2018
08 Feb 2018 Other trial event According to a Gilead Sciences media release, Gilead plans to present data from this studies at scientific conferences in 2018. Updated 09 Feb 2018
08 Feb 2018 Other trial event According to a Gilead Sciences media release, based on the data from four phase III trials (Studies 1489, 1490, 1844 and 1878), the U.S. Food and Drug Administration (FDA) has approved Biktarvy, an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults. Updated 09 Feb 2018
31 Aug 2017 Results Results published in The Lancet. Updated 04 Sep 2017
10 Aug 2017 Other trial event According to a Gilead Sciences media release, the US FDA has granted priority review for the company's NDA for BIC/FTC/TAF, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018. Updated 16 Aug 2017
26 Jul 2017 Results Results presented at the 9th International AIDS Society Conference on HIV Science. Updated 31 Aug 2017
24 Jul 2017 Results Results published in the Gilead Sciences Media Release. Updated 27 Jul 2017
13 Jul 2017 Other trial event According to a Gilead Sciences media release, 48-week data from this and another phase 3 trial investigating BIC/FTC/TAF compared to regimens containing DTG in treatment-naive adult patients will be presented at the International AIDS Society Conference on HIV Science (IAS 2017). Updated 17 Jul 2017
13 Jul 2017 Other trial event The company's MAA for BIC/FTC/TAF has been fully validated and is now under evaluation by the European Medicines Agency (EMA), according to a Gilead Sciences media release. The MAA was supported by data from this and 3 other phase III trials. Updated 17 Jul 2017
12 Jun 2017 Other trial event According to a Gilead Sciences media release, based on the data from four phase III trials (Studies 1489, 1490, 1844 and 1878), the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults. Updated 16 Jun 2017
12 Jun 2017 Other trial event According to a Gilead Sciences media release, the company plans to submit a marketing authorization application for BIC/FTC/TAF in the European Union in the third quarter of 2017. Updated 16 Jun 2017
30 May 2017 Other trial event Gilead plans to submit data from this trial for presentations at scientific conferences in 2017, as reported in a media release. Updated 02 Jun 2017
30 May 2017 Results Results published in the Gilead Sciences Media Release Updated 02 Jun 2017
30 May 2017 Other trial event According to a Gilead Sciences media release, based on the data from this and other three Phase III trials (Studies 1489, 1490, 1844 and 1878) company is planning U.S. NDA Submission in Q2 2017 and EU MAA Filing in Q3 2017. Updated 02 Jun 2017
30 May 2017 Endpoint met Primary endpoint has been met. (Proportion of Participants who Achieve HIV-1 RNA 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm), as reported in a Gilead Sciences media release. Updated 02 Jun 2017
23 Nov 2016 Completion date Planned End Date changed from 1 May 2018 to 1 Apr 2019. Updated 29 Nov 2016
23 Nov 2016 Other trial event Planned primary completion date changed from 1 Jun 2017 to 1 May 2017. Updated 29 Nov 2016
23 Jun 2016 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 27 Jun 2016
26 Apr 2016 Completion date Planned End Date changed from 1 Jan 2019 to 1 May 2018. Updated 02 May 2016
26 Apr 2016 Other trial event New source identified and integrated (European Clinical Trials Database; EudraCT2015-004024-54). Updated 26 Apr 2016
20 Nov 2015 New trial record New trial record Updated 20 Nov 2015

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