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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide 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 Dolutegravir + Emtricitabine/Tenofovir Alafenamide 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) ; Dolutegravir; Emtricitabine/tenofovir alafenamide
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms INFE 5305
  • 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 phase III study is designed to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults at Week 48.

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

Percentage of Participants Who Achieved 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.
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

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: Baseline, OL Week 48

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

time_frame: Baseline, OL Week 96

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

time_frame: Baseline; 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
NCT02607956 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: 645

  • Sex male & female
  • Age Group 27-46 years; adult

Patient Inclusion Criteria

Key - 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 RNA levels ≥ 500 copies/mL at screening - Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL/min (≥ 0.50 mL/sec) according to the Cockcroft-Gault formula Key

Patient Exclusion Criteria

- An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Decompensated cirrhosis (eg, 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial Details

Identifiers

Identifier Owner
NCT02607956 ClinicalTrials.gov: US National Institutes of Health
EudraCT2015-003988-10 European Clinical Trials Database
GS-US380-1490 Gilead Sciences
20692 United Kingdom Clinical Research Network
Study 1490 -

Organisations

  • Sponsors Gilead Sciences
  • Affiliations Gilead Sciences

Trial Dates

  • Initiation Dates

    Actual : 11 Nov 2015

  • Primary Completion Dates

    Planned : 01 Jun 2017

    Actual : 12 May 2017

  • End Dates

    Planned : 01 May 2021

Substudies/Extensions

Optional Pharmacokinetic (PK) Substudy: A PK substudy will be performed at the Week 4 or 8 visit in a subset of subjects (approximately n=30 evaluable) at selected study sites. The substudy will include intensive PK profiling in plasma. Optional Peripheral Blood Mononuclear cell (PBMC) Substudy: A 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. Optional 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 such as human leukocyte antigen (HLA). These samples will be collected at Day 1.
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 Australia; Belgium; Canada; Dominican Republic; England; France; Germany; Italy; Puerto Rico; Spain; United Kingdom; USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
Bictegravir/emtricitabine/tenofovir alafenamidePrimary Drug Oral Tablet
Dolutegravir Oral Tablet
Emtricitabine/tenofovir alafenamide Oral Tablet

Blinded Phase: DTG+F/TAF

DTG+F/TAF + B/F/TAF placebo for at least 144 weeks Drug: DTG (50 mg tablets administered orally, once daily, without regard to food) Other Name: Tivicay® Drug: F/TAF (200/25 mg tablets administered orally, once daily, without regard to food) Other Name: Descovy® Drug: B/F/TAF Placebo (Tablets administered orally, once daily, without regard to food)

Blinded Phase: B/F/TAF

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

Results

Therapeutic efficacy

Results from a phase III trial (Study 1490) demonstrated high efficacy and high barrier to resistance of bictegravir/emtricitabine/tenofovir alafenamide through 96 weeks. At week 96, non-inferiority was maintained from the primary endpoint measurement at week 48, with 84.1% (n=269/320) of patients taking bictegravir/emtricitabine/tenofovir alafenamide and 86.5% (n=281/325) of patients taking dolutegravir plus emtricitabine/tenofovir alafenamide achieving HIV-1 RNA levels less than 50 copies/mL (difference: -2.3%, 95% CI: -7.9% to 3.2%, p=0.41). Earlier, in the trial, it was reported that at week 48, 89% (286/320) of patients taking bictegravir/emtricitabine/tenofovir alafenamide (50/200/25mg) tablets and 92% (n=302/325) of patients taking dolutegravir plus emtricitabine/tenofovir alafenamide achieved the primary endpoint of HIV-1 RNA levels less than 50 copies/mL (difference: -3.5%, 95% CI: -7.9% to 1.0%, p=0.12). No patients in either treatment arm developed treatment-emergent resistance to any of the study drugs. Lipid changes were not significantly different between the two arms. The trial randomised 645 treatment-naïve adults with HIV to receive bictegravir/emtricitabine/tenofovir alafenamide or dolutegravir plus emtricitabine/tenofovir alafenamide [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 1490), bictegravir/emtricitabine/tenofovir alafenamide was well-tolerated with low discontinuations due to adverse events in both treatment arms (2% (n=6) versus 2% (n=5) [1 bictegravir/emtricitabine/tenofovir alafenamide and 4 dolutegravir plus emtricitabine/tenofovir alafenamide, after week 48]). The most commonly reported adverse events (all grades) were diarrhoea (18% versus 16%) and headache (16% versus 15%). There were fewer treatment-related adverse events (all grades) in the treatment arm, compared with dolutegravir plus emtricitabine/tenofovir alafenamide (20% versus 28%). Lipid changes were not significantly different between the two arms, and there were no renal discontinuations or cases of proximal renal tubulopathy. Earlier, it was reported that the most commonly reported adverse events with bictegravir/emtricitabine/tenofovir alafenamide and dolutegravir plus emtricitabine/tenofovir alafenamide were headache (13% versus 12%) and diarrhoea (12% versus 12%), respectively. There were no renal discontinuations or cases of proximal renal tubulopathy. Discontinuations due to adverse events were low in both treatment arms. The trial randomised 645 treatment-naïve adults with HIV to receive bictegravir/emtricitabine/tenofovir alafenamide or dolutegravir plus emtricitabine/tenofovir alafenamide [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(Rm) (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy- 30 October 2018. 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. 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
  8. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380?1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Internet-Doc 2017;.

    Available from: URL: http://link.adisinsight.com/g2X7Z
  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. Stellbrink H, Arribas J, Stephens J, Albrecht H, Sax P, Maggiolo F, et al. Phase III randomized, controlled clinical trial of bictegravir coformulated with FTC/TAF in a fixed?dose combination (B/F/TAF) versus dolutegravir (DTG) + F/TAF in treatment?naive HIV?1 positive adults: Week 96. ICDTHI-2018 2018; abstr. O211.

    Available from: URL: https://onlinelibrary.wiley.com/doi/10.1002/jia2.25187
  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. 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
  16. 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
  17. Sax PE, Pozniak A, Arribas J, Koenig E, Dejesus E, Stellbrink H-J, et al. Phase 3 randomized, controlled clinical trial of bictegravir coformulated with FTC/TAF in a fixed-dose combination (B/F/TAF) vs dolutegravir (DTG) + F/TAF in treatment-naive HIV-1 positive adults: week 48 results. IAS-2017 2017; abstr. TUPDB0201LB.

    Available from: URL: http://programme.ias2017.org/Abstract/Abstract/5793

Authors

Author Total Publications First Author Last Author
Acosta R 2 2 -
Acosta RK 1 1 -
Albrecht H 1 - -
Andreatta K 1 - -
Antinori A 2 - -
Arribas J 3 - -
Arribas JR 3 - -
Asmuth DM 1 - -
Avihingsanon A 1 - -
Baumgarten A 2 - -
Brainard D 1 - -
Brainard DM 1 - -
Brinson C 1 - -
Brown TT 1 - -
Carter CC 1 - -
Chang S 3 - -
Cheng A 6 - 2
Clarke A 1 - -
Collins S 2 - -
Creticos C 1 - -
Daar E 1 - -
Das M 1 - -
DeJesus E 3 - -
Erlandson KM 1 - -
Esser S 1 - -
Garner W 4 - -
Gilead Sciences 5 5 5
Graham H 1 - -
Gupta SK 1 1 -
Hedskog C 1 - -
Kityo C 1 - -
Koenig E 4 - -
Koethe JR 1 - 1
Kulkarni R 1 - -
Lake JE 1 - -
Liu X 1 - -
Lutz J 1 - -
Maggiolo F 2 - -
Majeed S 1 - -
Makadzange T 1 - -
Martin H 10 - 3
Martin R 3 - -
Martorell C 1 - -
McComsey GA 1 - -
Melbourne K 1 - -
Mills A 1 - -
Molina J-M 1 - -
Orkin C 5 - -
Piontkowsky D 1 - -
Podzamczer D 2 2 -
Post FA 1 - -
Pozniak A 3 - -
Quirk E 6 - 3
Ramgopal M 2 - -
Reynes J 1 - -
Rockstroh J 1 - -
Rockstroh JK 3 1 -
Romanova S 1 - -
Sax P 1 - -
Sax PE 3 2 -
Sengupta D 6 - -
Slim J 1 - -
Stellbrink H 2 1 -
Stellbrink H-J 2 - -
Stellbrink HJ 1 - -
Stephens J 1 - -
Stephens JL 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 1 - -
Workowski K 3 - -
Yan M 1 - -
Yazdanpanah Y 1 - -
Zhong L 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Devi SenGupta, MD Gilead Sciences
-
Gilead Study Director Gilead Sciences
-

Centres

Centre Name Location Trial Centre Country
- Albany, New York USA
- Alicante Spain
- Annandale, Virginia USA
- Antwerp Belgium
- Atlanta, Georgia USA
- Austin, Texas USA
- Badalona Spain
- Baltimore, Maryland USA
- Bellaire, Texas USA
- Bergamo Italy
- Berkley, Michigan USA
- Berlin Germany
- Beverly Hills, California USA
- Birmingham United-Kingdom
- Boston, Massachusetts USA
- Bronx, New York USA
- Carlton, Victoria Australia
- Chapel Hill, North Carolina USA
- Charlotte, North Carolina USA
- Chicago, Illinois USA
- Cincinnati, Ohio USA
- Clayton, Victoria Australia
- Columbia, South Carolina USA
- Düsseldorf Germany
- Dallas, Texas USA
- Decatur, Georgia USA
- DeLand, Florida USA
- Denver, Colorado USA
- Detroit, Michigan USA
- Essen Germany
- Fort Lauderdale, Florida USA
- Fort Pierce, Florida USA
- Fort Worth, Texas USA
- Frankfurt Germany
- Ghent Belgium
- Greensboro, North Carolina USA
- Greenville, North Carolina USA
- Hamburg Germany
- Hillsborough, New Jersey USA
- Houston, Texas USA
- Huntersville, North Carolina USA
- Indianapolis, Indiana USA
- Köln Germany
- Kansas City, Missouri USA
- London United-Kingdom
- Longview, Texas USA
- Los Angeles, California USA
- München Germany
- Macon, Georgia USA
- Madrid Spain
- Malaga Spain
- Manchester United-Kingdom
- Manhasset, New York USA
- Melbourne, Victoria Australia
- Miami, Florida USA
- Miami Beach, Florida USA
- Milano Italy
- Montpellier France
- Montreal Canada
- New York, New York USA
- Newark, New Jersey USA
- Nice France
- Oakland Park, Florida USA
- Orlando, Florida USA
- Ottawa Canada
- Pensacola, Florida USA
- Philadelphia, Pennsylvania USA
- Phoenix, Arizona USA
- Pittsburgh, Pennsylvania USA
- Prahran, Victoria Australia
- Roma Italy
- Sacramento, California USA
- Saint Louis, Missouri USA
- San Francisco, California USA
- San Juan Puerto-Rico
- San Leandro, California USA
- Santo Domingo Dominican-Republic
- Savannah, Georgia USA
- Seattle, Washington USA
- Spokane, Washington USA
- Springfield, Massachusetts USA
- Sydney, New South Wales Australia
- Tampa, Florida USA
- Toronto Canada
- Tourcoing France
- Vigo Spain
- Washington, District of Columbia USA
- West Palm Beach, Florida USA
- Winnipeg Canada
- Winston-Salem, North Carolina USA
Gilead Sciences
-
-
Gilead Sciences
-
-
Gilead Sciences, Inc.
-
USA

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
31 May 2019 Other trial event Last checked against European Clinical Trials Database record. Updated 31 May 2019
09 May 2019 Completion date Planned End Date changed from 1 Apr 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
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
31 Oct 2018 Results Week-96 results presented at the 14th International Congress on Drug Therapy and HIV Infection Updated 24 Dec 2018
30 Oct 2018 Other trial event 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
30 Oct 2018 Results According to Gilead Sciences media release, 96 week results from this study were presented at the 2018 HIV Glasgow conference in Glasgow Updated 12 Feb 2019
30 Oct 2018 Results Results (96 week ) presented in a Gilead Sciences media release. Updated 12 Feb 2019
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 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
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
03 May 2018 Completion date Planned End Date changed from 1 Apr 2019 to 1 Apr 2020. Updated 08 Jun 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 assessing 48-week efficacy and safety of the trial, presented at the 9th International AIDS Society Conference on HIV Science.. Updated 01 Sep 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, 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
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
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
24 Nov 2016 Completion date Planned End Date changed from 1 May 2018 to 1 Apr 2019. Updated 29 May 2017
21 Jun 2016 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 28 Jun 2016
05 May 2016 Completion date Planned End Date changed from 1 Jan 2019 to 1 May 2018. Updated 11 May 2016
28 Apr 2016 Other trial event New source identified and integrated (European Clinical Trials Database; EudraCT2015-003988-10). Updated 28 Apr 2016
13 Feb 2016 Other trial event New source identified and integrated (United Kingdom Clinical Research Network; 20692). Updated 13 Feb 2016
20 Nov 2015 New trial record New trial record Updated 20 Nov 2015

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