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A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

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Trial Profile

A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Dec 2021

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At a glance

  • Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary) ; Atazanavir; Atazanavir/cobicistat; Cobicistat; Cobicistat/darunavir; Darunavir; Emtricitabine/tenofovir disoproxil fumarate; Lamivudine/abacavir; Ritonavir
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 10 Dec 2021 Results of pooled analysis (n=1906) assessing virologic outcomes through 48 weeks of B/F/TAF treatment in individuals with pre-existing primary INSTI-R from 7 bictegravir/emtricitabine/tenofovir alafenamide studies (GS-US-380-1489/NCT02607930 and GS-US-380-1490/NCT02607956), (GS-US-380-1844/NCT02603120; GS-US-380-1878/NCT02603107; GS-US-380-4580/NCT03631732; GS-US-380-4030/NCT03110380 and GS-US-380-4449/NCT03405935), published in the JAIDS.
    • 29 Nov 2021 According to a Gilead Sciences media release, data from this study presented at the 18th European AIDS Conference (EACS 2021).
    • 30 Oct 2021 Results (n=2079) of pooled analysis assessing the safety and efficacy of switching adults with suppressed HIV to bictegravir/emtricitabine/tenofo - vir alafenamide (B/F/TAF) from 5 studies (Studies 1844, 1878, 4030, 4449, and 4580) presented at the 18th European AIDS Conference

Trial Overview

Outcome

Primary endpoint met - positive

Purpose

This phase III study is designed to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.

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 With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

description: The percentage of participants with 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 (non‐inferior efficacy of switching stably suppressed HIV‐1‐infected adults without known FTC/3TC resistance to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing boosted protease inhibitor (PI)‐based regimens)
time_frame: Week 48 [1]

Other Endpoints

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm

description: The percentage of participants with 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 to Week 48 [2]

Diseases Treated

Indication Qualifiers Patient Segments
HIV-1 infections treatment -

Biomarker

NCT Number Biomarker Name Biomarker Function
NCT02603107 T-cell surface antigen 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: 578

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

Patient Inclusion Criteria

Key - Currently receiving a once daily antiretroviral regimen consisting of ritonavir or cobicistat boosted ATV or DRV plus either FTC/TDF or ABC/3TC for ≥ 6 months preceding the screening visit - Adequate renal function: - Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec) according to the Cockcroft-Gault formula - Life expectancy ≥ 1 year - Currently on a stable regimen for ≥ 6 months preceding the screening visit with documented plasma HIV-1 RNA < 50 copies/mL for ≥ 6 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). Prior changes in antiretroviral regimen are only allowed due to tolerability issues or for regimen simplification. Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. (If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL [e.g., < 20 copies/mL], the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests) - Have no documented or suspected resistance to FTC, tenofovir, ABC or 3TC, including but not limited to the reverse transcriptase resistance mutations K65R and M184V/I - No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) Key

Patient Exclusion Criteria

- An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine based therapies) - Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance - A history of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study - Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 - Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with the dosing requirements - Any known allergies to the excipients of B/F/TAF FDC or ATV, RTV, DRV, COBI, FTC/TDF or ABC/3TC - Females who are pregnant (as confirmed by positive serum pregnancy test) - Females who are breastfeeding - Acute hepatitis in the 30 days prior to study entry - Chronic hepatitis B infection in individuals not on a TDF containing regimen, as determined by either: - Positive hepatitis B virus (HBV) surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit - Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit - Active tuberculosis infection Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial Details

Identifiers

Identifier Owner
NCT02603107 ClinicalTrials.gov: US National Institutes of Health
EudraCT2015-004011-20 European Clinical Trials Database
GS-US380-1878 Gilead Sciences
Study 380-1878 -
Study 1878 -

Organisations

  • Sponsors Gilead Sciences
  • Affiliations Gilead Sciences

Trial Dates

  • Initiation Dates

    Planned : 01 Nov 2015

    Actual : 20 Nov 2015

  • Primary Completion Dates

    Planned : 01 May 2017

    Actual : 15 May 2017

  • End Dates

    Planned : 01 Dec 2019

    Actual : 23 Dec 2019

Substudies/Extensions

Extension Phase: After Week 48, participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF for up to 96 additional weeks.

An intensive pharmacokinetic (PK) substudy will be performed at the Weeks 4 or 8 visits in a subset of Treatment Group 1 subjects (target n=24) 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 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 multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location Australia; Belgium; Canada; Dominican Republic; England; France; Germany; Italy; Puerto Rico; Scotland; Spain; United Kingdom; USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
Atazanavir Oral Capsule
Atazanavir/cobicistat Oral Tablet
Bictegravir/emtricitabine/tenofovir alafenamidePrimary Drug Oral Tablet
Cobicistat Oral Tablet
Cobicistat/darunavir Oral Tablet
Darunavir Oral Tablet
Emtricitabine/tenofovir disoproxil fumarate Oral Tablet
Lamivudine/abacavir Oral Tablet
Ritonavir Oral Capsule

Stay on Baseline Regimen (SBR)

Randomized Phase: Participants remained on current antiretroviral (ARV) regimen consisting of ritonavir (RTV)-boosted or cobicistat (COBI)-boosted atazanavir (ATV) or darunavir (DRV), plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) for at least 48 weeks with food. Extension Phase: After Week 48, participants in countries where B/F/TAF is not available will be given the option to receive B/F/TAF for up to 96 additional weeks or until the product becomes accessible to participants through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first. Drug: RTV (100 mg capsule coadministered orally with ATV or DRV once daily with food) Drug: ATV (300 mg capsule administered orally once daily with food) Drug: DRV (800 mg tablet administered orally once daily with food) Drug: COBI (150 mg tablet coadministered orally with ATV or DRV once daily with food) Other Name: Tybost®, GS-9350 Drug: ATV/co (300/150 mg FDC tablet administered orally once daily with food) Other Name: Evotaz® Drug: DRV/co (800/150 mg FDC tablet administered orally once daily with food) Other Name: Prezcobix® Drug: FTC/TDF (200/300 mg FDC tablet administered orally once daily without regard to food) Other Name: Truvada® Drug: ABC/3TC (600/300 mg tablet administered orally once daily with or without regard to food) Drug: B/F/TAF (50/200/25 mg FDC tablet administered orally once daily without regard to food) Other Name: Biktarvy®

B/F/TAF

Randomized Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for at least 48 weeks, without regard to food. Extension Phase: After Week 48, participants in countries where B/F/TAF is not available will be given the option to receive B/F/TAF for up to 96 additional weeks or until the product becomes accessible to participants 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 tablet administered orally once daily without regard to food) Other Name: Biktarvy®

Results

Therapeutic efficacy

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 [3] [4] .

Results from 1844, 1878, 4030 and 4449 trials achieved its primary endpoint of HIV-1 RNA<50 copies/mL at week 48 with a proportion of 92 percent (129/140), showing that Biktarvy in older adults maintained high rates of virologic suppression [3] .

In the phase III Study 1878, bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was statistically non-inferior to regimens containing boosted protease inhibitor (bPI) with with 2% of patients in each group having HIV-1 RNA =50 c/mL (difference: 0.0%, 95% CI: -2.5% to 2.5%, p = 1.00); the proportion of patients with HIV-1 RNA <50 c/mL was 92% in the BIC/FTC/TAF arm and 89% in the bPI arm. No treatment emergent resistance was reported in the study arm. The study was conducted in 577 virologically suppressed adults with HIV taking regimens of boosted atazanavir (ATV) or darunavir (DRV) + abacavir/lamivudine (ABC/3TC) or FTC/tenofovir disoproxil fumarate (TDF) were randomized 1:1 to continue their bPI regimen or to switch to open-label coformulated BIC/FTC/TAF once daily [5] .

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

Results from 1844, 1878, 4030 and 4449 trials showed that biktarvy was generally well-tolerated; 11 patients experienced a grade 1 or 2 study drug-related adverse event (AE), four of which discontinued the study. No patient experienced a grade 3 or 4 drug-related AE or virologic failure. Most common AEs were nasopharyngitis and arthralgia (7 percent each) [3] .

In the phase III Study 1878, most commonly reported adverse events (all grades) in both, study and comparator arms included headache, diarrhoea, nasopharyngitis and upper respiratory tract infection. No renal adverse events leading to discontinuations or cases of proximal renal tubulopathy occurred with bictegravir, emtricitabine and tenofovir alafenamide BIC/FTC/TAF. The incidence of grade 3 or 4 adverse events was 4% (n = 13) for the BIC/FTC/TAF arm versus 6% (n = 18) for the bPI arm; the incidence of grade 3 or 4 laboratory abnormalities was 16% (n = 45) for the BIC/FTC/TAF arm versus 29% (n = 83) for the bPI arm. The study was conducted in 577 virologically suppressed adults with HIV taking regimens of boosted atazanavir (ATV) or darunavir (DRV) + abacavir/lamivudine (ABC/3TC) or FTC/tenofovir disoproxil fumarate (TDF) were randomized 1:1 to continue their bPI regimen or to switch to open-label co-formulated BIC/FTC/TAF once daily. BIC/FTC/TAF was generally well-tolerated with minimal changes to estimated glomerular filtration rate (eGFR), lipids and weight through 96 weeks. The most common drug-related adverse event was headache (2%) [5] .

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. New Findings on Gileads Biktarvy(Rm) Presented at AIDS 2020: Virtual Include Positive Switch Data in Older Adults. Media-Rel 2020;.

    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. Gilead Sciences. Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens. Media-Rel 2017;.

    Media Release

  5. Acosta R, Andreatta K, D?Antoni M, Collins S, Martin H, White K. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. ICDTHI-2020 2020; abstr. P124.

    Available from: URL: http://www.hivglasgow.org/

  6. Ramgopal M, Maggiolo F, Ward D, Lebouche B, Rizzardini G, Molina J?, et al. Pooled analysis of 4 international trials of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults aged > 65 or older demonstrating safety and efficacy: Week 48 Results. AIDS-2020 2020; abstr. OAB0403.

    Available from: URL: https://onlinelibrary.wiley.com/doi/10.1002/jia2.25547

  7. 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

  8. Gilead Sciences. Clinical and Patient-Reported Outcomes in People Living With HIV on Biktarvy(Rm) in Observational BICSTaR Study Demonstrate Consistent Efficacy Profile in Real-World Setting. Media-Rel 2021;.

    Media Release

  9. Daar E, DeJesus E, Ruane P, Crofoot G, Oguchi G, Creticos C, et al. Phase 3 Randomized, Controlled Trial of Switching to Fixed-dose Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) from Boosted Protease Inhibitor-based Regimens in Virologically Suppressed Adults: Week 48 Results. IDW-2017 2017; abstr. LB-4.

    Available from: URL: https://idsa.confex.com/idsa/2017/webprogram/Paper67504.html

  10. Andreatta K, Chang S, Delaney M, Willkom M, Martin R, Graham H, et al. Long- term efficacy of bictegravir/ emtricitabine/tenofovir alafenamide after switch from boosted protease inhibitor- based regimens including in those with preexisting resistance and viral blips. EACS-2021 2021; abstr. PE1/19.

    Available from: URL: https://eacs-conference2021.com/

  11. Andreatta K, Acosta R, D'Antoni ML, Porter DP, Chang S, Martin R, et al. Sustained viral suppression among participants with pre-existing M184V/I who switched to bictegravir/emtricitabine/tenofovir alafenamide. EACS-2019 2019; abstr. PE13/21.

    Available from: URL: http://www.professionalabstracts.com/eacs2019/iplanner/#/list

  12. Andreatta K, Acosta R, D'Antoni ML, Liu H, Chang S, Martin R, et al. Prevalence and risk factors of preexisting TAMs in clinical trial participants and sustained viral suppression after switching to bictegravir/emtricitabine/tenofovir alafenamide. EACS-2021 2021; abstr. PE1/6.

    Available from: URL: https://eacs-conference2021.com/

  13. Thompson M, Brar I, Brinson C, Creticos C, Hagins D, Koenig E, et al. Tenofovir Alafenamide vs Tenofovir Df in Women: Pooled Analysis of 7 Clinical Trials. CROI-2019 2019; abstr. 519.

    Available from: URL: http://www.croiconference.org/sessions/tenofovir-alafenamide-vs-tenofovir-df-women-pooled-analysis-7-clinical-trials

  14. Andreatta K, Acosta R, D?Antoni M, Porter D, Chang S, Mar-tin R, et al. Sustained viral suppression after switch to bictegravir/ emtricitabine/tenofovir alafenamide among clinical trial par- ticipants with preexisting M184V/I. ICDTHI-2020 2020; abstr. P123.

    Available from: URL: http://www.hivglasgow.org/

  15. Andreatta K, Haubrich R, Willkom M, Martin R, Chang S, Acosta R, et al. High prevalence of previously undocumented baseline M184V/I does not affect virologic outcome in virologically-suppressed patients switching to bictegravir/emtricitabine/tenofovir alafenamide from a boosted protease inhibitor-based regimen. ICDTHI-2018 2018; abstr. P298.

    Available from: URL: https://onlinelibrary.wiley.com/doi/10.1002/jia2.25187

  16. 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

  17. Rockstroh J, Molina J, Post F, Fox J, Koenig E, Daar E, et al. Long-term follow-up after a switch to bictegravir, emtric- itabine, tenofovir alafenamide, from a boosted protease inhibitor-based regimen. ICDTHI-2020 2020; abstr. P036.

    Available from: URL: http://www.hivglasgow.org/

  18. 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

  19. 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

  20. 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

  21. D'Antoni ML, Andreatta K, Acosta R, Martin H, Chang S, Martin R, et al. Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Efficacy in Participants with Pre-existing Primary Integrase Inhibitor Resistance Through 48 Weeks of Phase 3 Clinical Trials. J-Acquir-Immune-Defic-Syndr 2021;.

    PubMed | CrossRef Fulltext

  22. 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 7 2 -
Andreatta K 14 9 -
Arribas JR 1 - -
Avihingsanon A 1 - -
Brainard D 1 - -
Brar I 1 - -
Brinson C 2 - -
Chang S 10 - -
Cheng A 2 - -
Collins S 5 - -
Creticos C 3 - -
Crofoot G 2 - -
D'Antoni ML 3 1 -
D?Antoni M 2 - -
Daar E 3 1 -
Das M 1 - 1
DeJesus E 4 - -
Delaney M 1 - -
Fox J 1 - -
Gallant J 3 - -
Garner W 1 - -
Gilead Sciences 5 5 5
Graham H 11 - -
Guo S 1 - -
Hagins D 1 - -
Haubrich R 1 - -
Kityo C 1 - -
Koenig E 3 - -
Lebouche B 1 - -
Liu A 1 - -
Liu H 3 - -
Liu Y 1 - -
Liu Y-P 3 - -
Liu YP 1 - -
Maggiolo F 2 - -
Makadzange T 1 - -
Mar-tin R 1 - -
Martin H 15 - 2
Martin R 9 - -
Martorell C 1 - -
McNicholl I 3 - -
Molina J 1 - -
Molina J-M 2 - -
Molina J? 1 - -
Mussini C 1 - -
Oguchi G 2 - -
Orkin C 2 - -
Pikora C 2 - -
Piontkowsky D 1 - -
Porter D 1 - -
Porter DP 1 - -
Post F 1 - -
Quirk E 6 - 3
Ramgopal M 1 1 -
Rizzardini G 1 - -
Rockstroh J 2 1 -
Rockstroh JK 2 1 -
Romanova S 1 - -
Ruane P 2 - -
Sax PE 1 - -
SenGupta D 2 - -
Temme LL 1 - -
Thompson M 1 1 -
Walmsley S 1 - -
Wang H 1 - -
Ward D 1 - -
Waters L 1 - -
Wei L 2 - -
Wei X 2 - -
White K 4 - 3
White KL 8 - 8
Willkom M 9 - -
Wohl D 1 - -
Workowski K 1 - -
Yazdanpanah Y 1 - -

Trial Centres

Investigators

Download Data (CSV)
Investigator Centre Name Trial Centre Country
Gilead Study Director Gilead Sciences USA
Gilead Study Team
GS-US-380-1878@gilead.com
show details 		Gilead Sciences USA
Hiba Graham, PharmD Gilead Sciences USA
Marshall Fordyce, MD Gilead Sciences USA

+ Lead investigator

Centres

Download Data (CSV)
Centre Name Location Trial Centre Country
- Annandale, Virginia USA
- Atlanta, Georgia USA
- Augusta, Georgia USA
- Aurora, Colorado USA
- Austin, Texas USA
- Berkley, Michigan USA
- Berlin Germany
- Birmingham United-Kingdom
- Bonn Germany
- Boston, Massachusetts USA
- Brighton United-Kingdom
- Bronx, New York USA
- Brussels Belgium
- Buffalo, New York USA
- Chapel Hill, North Carolina USA
- Charlotte, North Carolina USA
- Chicago, Illinois USA
- Columbia, South Carolina USA
- Düsseldorf, Nordrhein-Westfalen Germany
- Dallas, Texas USA
- Darlinghurst, New South Wales Australia
- DeLand, Florida USA
- Durham, North Carolina USA
- Edinburgh United-Kingdom
- Essen Germany
- Fitzroy, Victoria Australia
- Fort Lauderdale, Florida USA
- Fort Pierce, Florida USA
- Frankfurt Germany
- Ghent Belgium
- Greenville, North Carolina USA
- Hamburg Germany
- Honolulu, Hawaii USA
- Houston, Texas USA
- Huntersville, North Carolina USA
- Köln Germany
- Kansas City, Kansas USA
- Kansas City, Missouri USA
- Liverpool United-Kingdom
- London United-Kingdom
- Longview, Texas USA
- Los Angeles, California USA
- Louisville, Kentucky USA
- Lyon France
- Málaga Spain
- München Germany
- Macon, Georgia USA
- Madrid Spain
- Manchester United-Kingdom
- Melbourne, Victoria Australia
- Memphis, Tennessee USA
- Miami, Florida USA
- Milano Italy
- Minneapolis, Minnesota USA
- Montreal, Quebec Canada
- Munchen Germany
- Nantes France
- New Orleans, Louisiana USA
- Newport Beach, California USA
- Nice France
- Oakland, California USA
- Orlando, Florida USA
- Paris France
- Pensacola, Florida USA
- Philadelphia, Pennsylvania USA
- Phoenix, Arizona USA
- Ponce Puerto-Rico
- Prahran, Victoria Australia
- Rio Piedras Puerto-Rico
- 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
- Santo Domingo Dominican-Republic
- Seattle, Washington USA
- Spokane, Washington USA
- Springfield, Massachusetts USA
- Sydney, New South Wales Australia
- Tampa, Florida USA
- Toronto, Ontario Canada
- Torrance, California USA
- Tourcoing France
- Tours France
- Vancouver, British Columbia Canada
- Vero Beach, Florida USA
- Washington, District of Columbia USA
- West Palm Beach, Florida USA
- Wilton Manors, Florida USA
Gilead Sciences
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Gilead Sciences
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 USA
Gilead Sciences
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Gilead Sciences International Ltd.
Clinical Trials Mailbox
Flowers Building, Granta Park
Abington, Cambridge
Post code:CB21 6GT
Telephone number:+441223897284
clinical.trials@gilead.com

show details 		Abington, Cambridge United-Kingdom

+ Lead Centre

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Trial History

Event Date Event Type Comment
10 Dec 2021 Results Results of pooled analysis (n=1906) assessing virologic outcomes through 48 weeks of B/F/TAF treatment in individuals with pre-existing primary INSTI-R from 7 bictegravir/emtricitabine/tenofovir alafenamide studies (GS-US-380-1489/NCT02607930 and GS-US-380-1490/NCT02607956), (GS-US-380-1844/NCT02603120; GS-US-380-1878/NCT02603107; GS-US-380-4580/NCT03631732; GS-US-380-4030/NCT03110380 and GS-US-380-4449/NCT03405935), published in the JAIDS. Updated 22 Dec 2021
29 Nov 2021 Results According to a Gilead Sciences media release, data from this study presented at the 18th European AIDS Conference (EACS 2021). Updated 08 Nov 2021
30 Oct 2021 Results Results (n=2079) of pooled analysis assessing the safety and efficacy of switching adults with suppressed HIV to bictegravir/emtricitabine/tenofo - vir alafenamide (B/F/TAF) from 5 studies (Studies 1844, 1878, 4030, 4449, and 4580) presented at the 18th European AIDS Conference Updated 29 Dec 2021
30 Oct 2021 Results Results assessing long term efficacy of bictegravir-emtricitabine/tenofovir alafenamide after switch from boosted protease inhibitor-based regimens including in those with preexisting resistance and viral blips, presented at the 18th European AIDS Conference. Updated 28 Dec 2021
29 Oct 2021 Results Results published in Gilead Sciences media release. Updated 08 Nov 2021
30 Dec 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 30 Dec 2020
29 Dec 2020 Biomarker Update Biomarkers information updated Updated 06 Nov 2021
18 Dec 2020 Other trial event Last checked against European Clinical Trials Database record. Updated 18 Dec 2020
08 Oct 2020 Results Results of outcomes from an open-label extension on B/F/TAF presented at the 15th International Congress on Drug Therapy and HIV Infection Updated 26 Nov 2020
08 Oct 2020 Results Results of pooled analysis from following clinical studies: GS-US380-1844, GS-US380-1878, GS-US380-4030, GS-US380-4580, GS-US380-1474 and GS-US380-4449 presented at the 15th International Congress on Drug Therapy and HIV Infection Updated 11 Nov 2020
08 Oct 2020 Results Results of an analysis of bictegravir/emtricitabine/tenofovir alafenamide assessing efficacy against HIV-1 subtype F from five clinical studies: GS-US-380-1489, GS-US-380-1490, GS-US-380-1844, GS-US-380-1878 and GS-US-380-4449 presented at the 15th International Congress on Drug Therapy and HIV Infection Updated 11 Nov 2020
05 Oct 2020 Results According to a Gilead Sciences media release, results of the open-label extension period through week 156 were presented at HIV Glasgow 2020. Updated 07 Oct 2020
10 Jul 2020 Results Results (n=140) of pooled analysis from four clinical studies: GS-US380-1844, GS-US1878, GS-US4030 and GS-US4449 assessing safety and efficacy through week 48 presented at the 23rd International AIDS Conference Updated 31 Jul 2020
04 Jul 2020 Results According to a Gilead Sciences media release, pooled analysis results from this and other three trials (1844, 4030 and 4449) will be presented at the 23rd International AIDS Conference (AIDS 2020: Virtual). Updated 08 Jul 2020
04 Jul 2020 Results Pooled analysis results from this and other three trials (1844, 4030 and 4449)presented in a Gilead Sciences media release. Updated 08 Jul 2020
01 Jul 2020 Other trial event According to a Gilead Sciences media release, pooled analysis results from this and other three trials (1844, 4030 and 4449) will be presented at the 23rd International AIDS Conference (AIDS 2020: Virtual). Updated 08 Jul 2020
17 Jan 2020 Other trial event This trial has been completed in Belgium , according to European Clinical Trials Database Updated 17 Jan 2020
14 Jan 2020 Status change - completed Status changed from active, no longer recruiting to completed. Updated 29 Jan 2020
02 Dec 2019 Completion date Planned End Date changed from 1 Jul 2020 to 1 Dec 2019. Updated 11 Dec 2019
09 Nov 2019 Results Results of pooled analysis investigating the prevalence of pre-existing M184V/I and impact on virologic outcomes presented at the 17th European AIDS Conference Updated 27 Jan 2020
06 Oct 2019 Other trial event This trial has been completed in Spain, according to European Clinical Trials Database. Updated 09 Oct 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 Results of a pooled analysis of 7 randomized, double-blind clinical trials assessing the efficacy and safety of TAF vs. TDF for ART initiation or switch in women, presented at the 26th Conference on Retroviruses and Opportunistic Infections Updated 06 May 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
06 Feb 2019 Other trial event This trial has been completed in Germany, according to European Clinical Trials Database. Updated 11 Feb 2019
21 Nov 2018 Completion date Planned End Date changed from 1 Jul 2019 to 1 Jul 2020. Updated 19 Dec 2018
31 Oct 2018 Results Results of a retrospective analysis assessing the pre-existing M184V/I resistance substitutions and impact on virologic outcomes, presented at the 14th International Congress on Drug Therapy and HIV Infection. Updated 03 Jan 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
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
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 (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
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
08 Oct 2017 Results Results assessing efficcay,safety and tolerability of 48 weeks results presented at the IDWeek 2017. Updated 25 Oct 2017
04 Oct 2017 Results Results presented in a Gilead Sciences media release. Updated 06 Oct 2017
04 Oct 2017 Results Results from this trial are being presented at IDWeek 2017, according to a Gilead Sciences media release. Updated 06 Oct 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 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
22 May 2017 Completion date Planned End Date changed from 1 May 2019 to 1 Jul 2019. Updated 31 May 2017
27 Dec 2016 Completion date Planned End Date changed from 1 May 2018 to 1 May 2019. Updated 30 Dec 2016
12 Jul 2016 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 14 Jul 2016
21 Mar 2016 Completion date Planned End Date changed from 1 May 2019 to 1 May 2018, according to ClinicalTrials.gov record. Updated 29 Mar 2016
21 Mar 2016 Other trial event Planned primary completion date changed from 1 Jul 2017 to 1 May 2017, according to ClinicalTrials.gov record. Updated 29 Mar 2016
04 Mar 2016 Other trial event New source identified and integrated European Clinical Trials Database (EudraCT2015-004011-20). Updated 04 Mar 2016
22 Feb 2016 Completion date Planned End Date changed from 1 Apr 2019 to 1 May 2019 according to ClinicalTrials.gov record. Updated 04 Mar 2016
22 Feb 2016 Other trial event Planned primary completion date changed from 1 Apr 2017 to 1 Jul 2017 according to ClinicalTrials.gov record. Updated 04 Mar 2016
27 Nov 2015 Status change - recruiting Status changed from not yet recruiting to recruiting, according to ClinicalTrials.gov record. Updated 03 Dec 2015
17 Nov 2015 New trial record New trial record Updated 17 Nov 2015

References

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    Media Release

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    Available from: URL: http://clinicaltrials.gov

  3. Gilead Sciences. New Findings on Gileads Biktarvy(Rm) Presented at AIDS 2020: Virtual Include Positive Switch Data in Older Adults. Media-Rel 2020;.

    Media Release

  4. 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;.

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  5. Gilead Sciences. Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens. Media-Rel 2017;.

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  6. Gilead Sciences. Gilead Sciences Demonstrates Commitment to Scientific Innovation In HIV With New Prevention, Treatment and Cure Research Data Presented At AIDS 2020: Virtual. Media-Rel 2020;.

    Media Release

  7. Gilead Sciences. European CHMP Adopts Positive Opinion for Gileads Biktarvy(R) (Bictegravir, Emtricitabine, Tenofovir Alafenamide). Media-Rel 2018;.

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  8. Acosta R, Andreatta K, D?Antoni M, Collins S, Martin H, White K. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. ICDTHI-2020 2020; abstr. P124.

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  13. 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.

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  16. Daar E, DeJesus E, Ruane P, Crofoot G, Oguchi G, Creticos C, et al. Phase 3 Randomized, Controlled Trial of Switching to Fixed-dose Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) from Boosted Protease Inhibitor-based Regimens in Virologically Suppressed Adults: Week 48 Results. IDW-2017 2017; abstr. LB-4.

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  35. 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;.

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  36. Gilead Sciences. European Commission Grants Marketing Authorization for Gilead's Biktarvy(R) (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection. Media-Rel 2018;.

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  37. Gilead Sciences. Hong Kong Department of Health Approves Biktarvy(R) (bictegravir, emtricitabine, tenofovir alafenamide). Media-Rel 2018;.

    Media Release
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