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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

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

Latest Information Update: 09 Oct 2019

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

    • 06 Oct 2019 This trial has been completed in Spain, according to European Clinical Trials Database.
    • 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 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 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 Jul 2020

Substudies/Extensions

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

Current antiretroviral regimen

Randomized Phase: Participants will remain on current antiretroviral regimen consisting of ritonavir boosted ATV (RTV+ATV), ritonavir boosted DRV (RTV+DRV), cobicistat boosted ATV (COBI+ATV or ATV/co), or cobicistat boosted DRV (COBI+DRV or DRV/co) plus either FTC/TDF or ABC/3TC for at least 48 weeks. 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. 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: Participants will switch to B/F/TAF FDC and continue treatment for at least 48 weeks. 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. 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] .

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 [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 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 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 [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 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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
  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 2 1 -
Andreatta K 7 5 -
Arribas JR 1 - -
Avihingsanon A 1 - -
Brar I 1 - -
Brinson C 1 - -
Chang S 5 - -
Cheng A 2 - -
Creticos C 2 - -
Crofoot G 1 - -
Daar E 2 1 -
Das M 1 - 1
DeJesus E 3 - -
Garner W 1 - -
Gilead Sciences 3 3 3
Graham H 7 - -
Guo S 1 - -
Hagins D 1 - -
Haubrich R 1 - -
Kityo C 1 - -
Koenig E 2 - -
Liu H 2 - -
Liu Y 1 - -
Liu Y-P 3 - -
Liu YP 1 - -
Maggiolo F 1 - -
Makadzange T 1 - -
Martin H 7 - -
Martin R 5 - -
Martorell C 1 - -
Molina J-M 2 - -
Mussini C 1 - -
Oguchi G 1 - -
Orkin C 2 - -
Piontkowsky D 1 - -
Quirk E 6 - 3
Rockstroh J 1 - -
Rockstroh JK 2 1 -
Romanova S 1 - -
Ruane P 1 - -
Sax PE 1 - -
SenGupta D 2 - -
Temme LL 1 - -
Thompson M 1 1 -
Walmsley S 1 - -
Waters L 1 - -
Wei L 2 - -
Wei X 2 - -
White K 2 - 1
White KL 4 - 4
Willkom M 6 - -
Wohl D 1 - -
Workowski K 1 - -
Yazdanpanah Y 1 - -

Trial Centres

Investigators

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

Centres

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

Trial History

Event Date Event Type Comment
09 Oct 2019 Other trial event Last checked against European Clinical Trials Database record. Updated 09 Oct 2019
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
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 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
31 Aug 2018 Biomarker Update Biomarkers information updated Updated 05 May 2016
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

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