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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

Trial Profile

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

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

Latest Information Update: 05 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

    • 01 Nov 2019 This trial has been completed in Spain, according to European Clinical Trials Database record.
    • 20 Aug 2019 Results of a detailed analyses of pre-existing resistance in the two BIC/FTC/TAF switch studies and efficacy at week 48, published in the Journal of Antimicrobial Chemotherapy
    • 09 Aug 2019 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).

Trial Overview

Outcome

Primary endpoint met - positive

Purpose

This phase III study is designed to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed HIV-1 infected adults.

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 with virologic failure (HIV-1 RNA ≥ 50 copies/mL) as defined by the modified US FDA snapshot algorithm

safety_issue: No
time_frame: Week 48 [1]

Other Endpoints

Percentage of Participants With HIV-1 RNA < 50 Copies/mL 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

Change From Baseline in CD4+ Cell Count at Week 48

time_frame: Baseline; Week 48

Spine Bone Mineral Density (BMD) at Baseline

time_frame: Baseline

Percentage Change From Baseline in Spine BMD at Week 48

time_frame: Baseline; Week 48

Hip Bone Mineral Density at Baseline

time_frame: Baseline

Percentage Change From Baseline in Hip BMD at Week 48

time_frame: Baseline; Week 48 [2]

Diseases Treated

Indication Qualifiers Patient Segments
HIV-1 infections treatment -

Biomarker

NCT Number Biomarker Name Biomarker Function
NCT02603120 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: 520

    Actual: 567

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

Patient Inclusion Criteria

Key - Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec) - Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit - HIV RNA < 50 copies/mL at the screening visit - Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). - Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC Key

Patient Exclusion Criteria

- Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance - Active tuberculosis infection - Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) - Females who are pregnant - Females who are breastfeeding - Acute hepatitis in the 30 days prior to study entry - Chronic Hepatitis B Virus (HBV) infection Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial Details

Identifiers

Identifier Owner
NCT02603120 ClinicalTrials.gov: US National Institutes of Health
EudraCT2015-004025-14 European Clinical Trials Database
GS-US380-1844 Gilead Sciences
Study 1844 -

Organisations

  • Sponsors Gilead Sciences
  • Affiliations Gilead Sciences

Trial Dates

  • Initiation Dates

    Planned : 01 Nov 2015

    Actual : 11 Nov 2015

  • Primary Completion Dates

    Planned : 01 Apr 2017

    Actual : 09 May 2017

  • End Dates

    Planned : 01 Jun 2020

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.

Other Details

  • Design double-blind; multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location Australia; Belgium; Canada; England; France; Germany; Italy; Japan; Puerto Rico; Spain; Sweden; 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 48 weeks Drug: ABC/DTG/3TC (600/50/300 mg FDC 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 48 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: ABC/DTG/3TC Placebo (Tablets administered orally once daily without regard to food)

Open-Label Phase

At the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF is demonstrated following review of unblinded data, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 96 weeks, or until the product becomes accessible to subjects through an access program, or until Gilead Sciences 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

In a phase III trial (Study 1844), at the primary endpoint of Week 48, switching to bictegravir/emtricitabine/tenofovir alafenamide was non-inferior to continuing ABC/DTG/3TC with 1.1% in the bictegravir/emtricitabine/tenofovir alafenamide arm and 0.4% in the ABC/DTG/3TC arm having HIV-1 RNA ≥50 c/mL (difference: 0.7%; 95% CI: -1.0% to 2.8%, p = 0.62). At week 48, no treatment-emergent resistance was detected, and no participants with pre-existing NRTI resistance mutations had HIV RNA >50 c/mL.The proportion of patients with HIV-1 RNA <50 c/mL was 93.6% and 95% in the bictegravir/emtricitabine/tenofovir alafenamide arm and ABC/DTG/3TC arm, respectively, according to FDA snapshot algorithm. The trial is designed to evaluate the efficacy and safety of switching from a regimen containing abacavir, dolutegravir and lamivudine (600/50/300mg) (ABC/DTG/3TC) to bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablet od in 565 virologically suppressed adults with HIV [3] .

In a long term, open-label follow-up of phase III GS-US-380-1844 and GS-US380-1878 trial for two year post 48 week primary endpoints in adults who switched to Biktarvy from abacavir, dolutegravir and lamivudine (600/50/300mg) (ABC/DTG/3TC) or a boosted protease inhibitor (PI)-based regimen, overall, 98% patients displayed higher virologic suppression (n=561/570) whereas 97% (155/159) population with preexisting drug resistance to nucleoside reverse transcriptase inhibitors (NRTIs) also showed virologic suppression. Moreover 95% (42/44) subjects who were with archieved M184V/I also exhibited virologic suppression. Moreover, in a phase III GS-US-380-4030 in patients who switched from DTG+F/TAF or DTG+F/TDF to DTG+F/TAF or Biktarvy for 48 weeks, 99% (557/562) of all patients with any post-baseline visit and 99% (220/222) of patients with resistance to any class of anti-retroviral therapy, including those with archived M184V/I (79/81; 98 percent) had undetectable viral load (HIV-1 RNA <50 copies/mL) with no emergent drug resistance [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 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] .

In a phase III trial (Study 1844), patients in the bictegravir/emtricitabine/tenofovir alafenamide arm showed a lower incidence of study drug-related adverse events (AEs) versus the ABC/DTG/3TC arm (8%vs 16%, p = 0.006; all grades), which were primarily mild or moderate in severity. The difference between groups was primarily driven by numerically more drug-related gastrointestinal (flatulence, nausea, diarrhoea) and neuropsychiatric (abnormal dreams and insomnia) AEs in the ABC/DTG/3TC arm. Headache (3% in both arms) was the most common study drug-related AE observed. AEs in few patients led to premature trial discontinuation (2% vs 1%). No patients in either treatment arm developed treatment-emergent resistance through Week 48. No renal AEs leading to discontinuations or cases of proximal renal tubulopathy were reported in either treatment arms. Lipid profiles were unchanged after switching to bictegravir/emtricitabine/tenofovir alafenamide from ABC/DTG/3TC and bone mineral density changes from baseline were the same between arms, at Week 48. The trial is designed to evaluate the efficacy and safety of switching from a regimen containing abacavir, dolutegravir and lamivudine (600/50/300mg) (ABC/DTG/3TC) to bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablet od in virologically suppressed adults with HIV [3] .

Pharmacodynamics

Preclinical studies: in guinea-pig brain membrane, R 84760 had a 5-17 higher affinity for the κ-opioid receptor than enadoline and U 50488H. In rabbit vas deferens assay, R 85760 demonstrated a 2.5-210 times more potent κ-agonist activity than enadoline and U 50488H. In the phenylquinolone writhing test in mice, subcutaneously administered R 84760 produced an antinociceptive effect with 5-360 times higher potency than those of enadoline and U 50488H, and 40-850 times higher than those of morphine, pentazocine and butorphanol. Orally administered R 84760 demonstrated 20-2080 times higher potency than the above reference drugs. It did not develop tolerance to antinociception in contrast to morphine.

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 Presents Results from Phase 3 Study Evaluating Patients Who Switched to Biktarvy(R) (Bictegravir, Emtricitabine and Tenofovir Alafenamide) from Regimen Containing Abacavir, Dolutegravir and Lamivudine. Media-Rel 2018;.

    Media Release
  3. Gilead Sciences. Gilead Presents Data on Biktarvy(Rm) (Bictegravir, Emtricitabine and Tenofovir Alafenamide) in Virologically Suppressed Adults, Including Those With Pre-Existing NRTI Resistance. Media-Rel 2019;.

    Media Release
  4. 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
  5. Andreatta K, Martin R, Chang S, Willkom M, Wei L, Graham H, et al. Previously undocumented preexisting resistance and maintenance of virologic suppression in HIV-1 RNA-suppressed patients switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF). IAS-2019 2019; abstr. MOPEB243.

    Available from: URL: http://programme.ias2019.org/Abstract/Abstract/721
  6. Molina J-M, Ward D, Brar I, Mills A, Stellbrink H-J, Lopez-Cortes L, et al. Switch to Bictegravir/F/Taf from Dtg and Abc/3Tc. CROI-2018 2018; abstr. 22.

    Available from: URL: http://www.croiconference.org/sessions/switch-bictegravirftaf-dtg-and-abc3tc
  7. Andreatta K, Willkom M, Martin R, Chang S, Martin H, Graham H, et al. Resistance Analyses of Bictegravir/Emtricitabine/Tenofovir Alafenamide Switch Studies. CROI-2018 2018; abstr. 506.

    Available from: URL: http://www.croiconference.org/sessions/resistance-analyses-bictegraviremtricitabinetenofovir-alafenamide-switch-studies
  8. Andreatta K, Willkom M, Martin R, Chang S, Liu H, Liu Y-P, et al. Long-Term B/F/Taf Switch Efficacy in Patients with Archived Preexisting Resistance. CROI-2019 2019; abstr. 552.

    Available from: URL: http://www.croiconference.org/sessions/long-term-bftaf-switch-efficacy-patients-archived-preexisting-resistance
  9. 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
  10. 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
  11. 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
  12. Andreatta K, Willkom M, Martin R, Chang S, Wei L, Liu H, et al. Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I. J-Antimicrob-Chemother 2019;.

    PubMed | CrossRef Fulltext

Authors

Author Total Publications First Author Last Author
Acosta R 1 1 -
Andreatta K 6 4 -
Arribas JR 1 - -
Avihingsanon A 1 - -
Brar I 1 - -
Brinson C 1 - -
Chang S 4 - -
Cheng A 2 - -
Clarke A 2 - -
Custodio JM 1 - -
Daar E 1 - -
DeJesus E 2 - -
Garner W 3 - -
Gilead Sciences 3 3 3
Graham H 5 - -
Kityo C 1 - -
Laouri M 2 - -
Liu H 3 - -
Liu Y-P 1 - -
Liu YP 1 - -
Lopez-Cortes L 1 - -
Maggiolo F 3 - -
Makadzange T 1 - -
Martin H 9 - -
Martin R 4 - -
Mills A 1 - -
Molina J-M 2 1 -
Orkin C 2 - -
Piontkowsky D 1 - -
Podzamczer D 1 - -
Quirk E 7 - 5
Rockstroh J 1 - -
Rockstroh JK 1 1 -
Romanova S 1 - -
Ruane P 1 - -
Sax PE 1 - -
SenGupta D 1 - -
Stellbrink H-J 1 - -
Walmsley S 1 - -
Ward D 1 - -
Wei L 2 - -
Wei X 2 - -
White K 1 - -
White KL 4 - 4
Willkom M 5 - -
Wohl D 3 2 -
Workowski K 1 - -
Yazdanpanah Y 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
-
Szwarcberg J, MD Gilead Sciences
-

Centres

Centre Name Location Trial Centre Country
- Augusta, Georgia USA
- Austin, Texas USA
- Badalona Spain
- Barcelona Spain
- Berkley, Michigan USA
- Berlin Germany
- Beverly Hills, California USA
- Bonn Germany
- Boston, Massachusetts USA
- Brighton United-Kingdom
- Bronx, New York USA
- Buffalo, New York USA
- Charlotte, North Carolina USA
- Chicago, Illinois USA
- Cincinnati, Ohio USA
- Columbia, South Carolina USA
- Cordoba Spain
- Dallas, Texas USA
- Decatur, Georgia USA
- DeLand, Florida USA
- Detroit, Michigan USA
- Essen Germany
- Fort Lauderdale, Florida USA
- Fort Pierce, Florida USA
- Frankfurt am Main Germany
- Ghent Belgium
- Greenville, North Carolina USA
- Hamburg Germany
- Honolulu, Hawaii USA
- Houston, Texas USA
- Huntersville, North Carolina USA
- Kansas City, Missouri USA
- Longview, Texas USA
- Los Angeles, California USA
- Louisville, Kentucky USA
- München Germany
- Macon, Georgia USA
- Madrid Spain
- Manchester United-Kingdom
- Miami, Florida USA
- Miami Beach, Florida USA
- Minneapolis, Minnesota USA
- Montreal, Quebec Canada
- Munich Germany
- Nantes France
- New Orleans, Louisiana USA
- New York, New York USA
- Newark, New Jersey USA
- NICE Cedex 03 France
- Oakland, California USA
- Orlando, Florida USA
- Palm Springs, California USA
- Paris France
- Paris cedex 20 France
- Pensacola, Florida USA
- Philadelphia, Pennsylvania USA
- Phoenix, Arizona USA
- Roma Italy
- Sacramento, California USA
- Saint Louis, Missouri USA
- San Juan Puerto-Rico
- San Leandro, California USA
- Santa Fe, New Mexico USA
- Santiago de Compostela Spain
- Savannah, Georgia USA
- Seattle, Washington USA
- Sevilla Spain
- Spokane, Washington USA
- Springfield, Massachusetts USA
- Sydney, New South Wales Australia
- Tampa, Florida USA
- Vancouver, British Columbia Canada
- Vero Beach, Florida USA
- Washington, District of Columbia USA
- West Palm Beach, Florida USA
- Wilton Manors, Florida USA
- Winnipeg, Manitoba Canada
Gilead Sciences
Gilead Study Team
GS-US-380-1844@gilead.com
show details
-
-
Gilead Sciences International Ltd. Abington United-Kingdom

Trial History

Event Date Event Type Comment
05 Nov 2019 Other trial event Last checked against European Clinical Trials Database record. Updated 05 Nov 2019
01 Nov 2019 Other trial event This trial has been completed in Spain, according to European Clinical Trials Database record. Updated 05 Nov 2019
20 Aug 2019 Results Results of a detailed analyses of pre-existing resistance in the two BIC/FTC/TAF switch studies and efficacy at week 48, published in the Journal of Antimicrobial Chemotherapy Updated 23 Aug 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
24 Jul 2019 Results Results (n=510) who switched to Bictegravir/Emtricitabine/Tenofovir Alafenamide had high rates of virologic suppression in two open label extension studies (1844 and 1878), presented at the 10th International AIDS Society Conference on HIV Science. Updated 03 Oct 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 Resistance analyses and virologic outcomes data from studies 1878 and 1844 were presented at the 26th Conference on Retroviruses and Opportunistic Infections. Updated 03 May 2019
06 Mar 2019 Results According to a Gilead Sciences media release, results of retrospective analysis assessing the long-term Biktarvy switch efficacy in patients with archived pre-existing resistance from two phase 3 Biktarvy switch studies (Studies 1844 and 1878), were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle. Updated 13 Mar 2019
06 Mar 2019 Results Results of retrospective analysis assessing the long-term Biktarvy switch efficacy in patients with archived pre-existing resistance from two phase 3 Biktarvy switch studies (Studies 1844 and 1878) presented in a Gilead Sciences media release. Updated 13 Mar 2019
30 Jan 2019 Other trial event This trial has been completed in Germany. Updated 04 Feb 2019
19 Dec 2018 Other trial event Last checked against ClinicalTrials.gov record. Updated 19 Dec 2018
21 Nov 2018 Completion date Planned End Date changed from 1 Jul 2019 to 1 Jun 2020. Updated 19 Dec 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 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 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 from studies 1489, 1490, 1878 and 1844 presented at the 25th Conference on Retroviruses and Opportunistic Infections Updated 20 Apr 2018
07 Mar 2018 Results Results assessing safety and efficacy presented at the 25th Conference on Retroviruses and Opportunistic Infections Updated 18 Apr 2018
07 Mar 2018 Results Results (n=572), of an integrated resistance analysis from 2 phase 3 clinical trials (Study 1878 and study 1844) presented at the 25th Conference on Retroviruses and Opportunistic Infections Updated 18 Apr 2018
05 Mar 2018 Other trial event According to a Gilead Sciences media release, Jean-Michel Molina is lead study investigator. Updated 08 Mar 2018
05 Mar 2018 Results According to a Gilead Sciences media release, data from this trial were presented at the 2018 Conference on Retroviruses and Opportunistic Infections (CROI). Updated 08 Mar 2018
05 Mar 2018 Results 48-week results published in the Gilead Sciences Media Release Updated 08 Mar 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
17 Nov 2017 Completion date Planned End Date changed from 1 Jun 2019 to 1 Jul 2019. Updated 23 Nov 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
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 with virologic failure (HIV-1 RNA 50 copies/mL) as defined by the modified US FDA snapshot algorithm, as reported in a Gilead Sciences media release. Updated 02 Jun 2017
19 May 2017 Completion date Planned End Date changed from 1 Apr 2019 to 1 Jun 2019. Updated 26 May 2017
27 Jul 2016 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 02 Aug 2016
02 Mar 2016 Other trial event New source identified and integrated (EU Clinical Trials Register;EudraCT2015-004025-14). Updated 09 Mar 2016
01 Dec 2015 Status change - recruiting Status changed from not yet recruiting to recruiting, as reported by ClinicalTrials.gov. Updated 05 Dec 2015
17 Nov 2015 New trial record New trial record Updated 17 Nov 2015

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