Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead 
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  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment open, Phase classification, Trial initiation date:  B-HASTE: Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV (clinicaltrials.gov) -  Dec 19, 2020   
    P4,  N=100, Recruiting, 
    Not yet recruiting --> Recruiting | Phase classification: PN/A --> P4 | Initiation date: Mar 2020 --> Dec 2020
  • ||||||||||  bictegravir (GS-9883) / Gilead
    PK/PD data, Journal:  Pharmacokinetics of Co-encapsulated Antiretrovirals with Ingestible Sensors. (Pubmed Central) -  Dec 18, 2020   
    To assess the safety and impact, if any, coencapsulation might have on ARV concentrations, we evaluated the pharmacokinetics of ARVs coencapsulated with an ingestible sensor for eight commonly used fixed-dose combination ARVs: emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF); FTC/tenofovir alafenamide (TAF); efavirenz (EFV)/FTC/TDF; abacavir (ABC)/lamivudine (3TC); dolutegravir (DTG)/ABC/3TC; rilpivirine (RPV)/TAF/FTC; elvitegravir (EVG)/cobicistat (COBI)/FTC/TAF; and bictegravir (BIC)/FTC/TAF...In a subsequent evaluation of FTC/TDF and BIC/FTC/TAF using a crossover design, the geometric mean ratio (GMR) between the coencapsulated and the unencapsulated formulations for FTC/TDF were the following: FTC, 84.6% (90% confidence interval [CI] 66.6-107.4) for AUC and 77.5% (60.1-99.9) for Cmax...The observed deviation in FTC/TDF (Truvada) may be due to participant characteristics, fasted/fed conditions, and/or random variation and may warrant further investigations with a larger sample size. These findings provide assurance for use of co-encapsulated ARVs for future HIV treatment-adherence research.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Trial completion date, Trial primary completion date:  B/F/TAF Switch Study for HIV-HBV Coinfection (clinicaltrials.gov) -  Nov 3, 2020   
    P4,  N=60, Recruiting, 
    Trial primary completion date: Jan 2022 --> Jul 2022 Trial completion date: Jan 2022 --> Jun 2022 | Trial primary completion date: Feb 2021 --> Oct 2021
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment open:  Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant (clinicaltrials.gov) -  Oct 28, 2020   
    P4,  N=24, Recruiting, 
    Trial completion date: Jan 2022 --> Jun 2022 | Trial primary completion date: Feb 2021 --> Oct 2021 Not yet recruiting --> Recruiting
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment open, IO biomarker:  A Test and Treat Strategy in New HIV Diagnosis. (clinicaltrials.gov) -  Oct 7, 2020   
    P3,  N=100, Recruiting, 
    Active, not recruiting --> Completed Not yet recruiting --> Recruiting
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Trial completion, Enrollment change:  Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM (clinicaltrials.gov) -  Sep 28, 2020   
    P4,  N=27, Completed, 
    Enrolling by invitation --> Completed | Trial completion date: Feb 2020 --> Oct 2020 | Trial primary completion date: Feb 2020 --> Sep 2020 Recruiting --> Completed | N=56 --> 27
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Phase classification:  Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant (clinicaltrials.gov) -  Sep 23, 2020   
    P4,  N=24, Not yet recruiting, 
    These results indicate that BIC/FTC/TAF is an effective treatment option for suppressed patients, including those with evidence of archived NRTI resistance. Phase classification: P3 --> P4
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    [VIRTUAL] Real‐world experience using bictegravir/emtricitabine/tenofovir‐alafenamide (B/F/TAF) in a Scottish HIV cohort () -  Sep 21, 2020 - Abstract #HIVGlasgow2020HIV-Glasgow_197;    
    Thirteen of 109 (12%) patients started on B/F/TAF were subsequently stopped due to adverse effects, of which neuropsychiatric side‐effects were by far most common. These results show real‐world cohorts may have greater discontinuation rates due to side‐effects compared to the trial cohorts [1,2], and suggest Biktarvy may have comparable incidence of neuropsychiatric side‐effects to dolutegravir‐based regimens [5].
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    [VIRTUAL] Long‐term follow‐up after a switch to bictegravir, emtricitabine, tenofovir alafenamide, from a boosted protease inhibitor‐based regimen () -  Sep 21, 2020 - Abstract #HIVGlasgow2020HIV-Glasgow_192;    
    Virologically suppressed (HIV‐1 RNA < 50 copies/mL) PLWH on boosted ATV or DRV plus either F/tenofovir disoproxil fumarate or abacavir/lamivudine for ≥6 months prior to screening were randomized 1:1 to B/F/TAF or to stay on baseline PI regimen (SBR)... Long‐term follow‐up of PLWH switching to B/F/TAF from a boosted PI regimen demonstrates continued high rates of virologic suppression with no emergent resistance and was safe and well tolerated through a maximum of 156 weeks.
  • ||||||||||  Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    [VIRTUAL] Persistence of antiretroviral therapy regimens among veterans with HIV newly initiating treatment in the US () -  Sep 21, 2020 - Abstract #HIVGlasgow2020HIV-Glasgow_188;    
    Among US veterans with HIV, STR initiators were significantly less likely to discontinue first‐line therapy compared to MTR initiators. Veterans who initiated a BIC/FTC/TAF regimen had a lower risk of discontinuation compared to MTRs and other STRs included in the study.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    [VIRTUAL] Syphilitic Hepatitis Mimicking Primary Biliary Cholangitis: An Atypical Presentation of Syphilis () -  Sep 15, 2020 - Abstract #ACG2020ACG_2964;    
    Case Description/ 26 y/o homosexual male with PMH HIV (on Biktarvy and Bactrim) presented with nausea, vomiting, epigastric pain, and fevers for 5 days...Our patient had a high titer of AMA-M2, which turned negative after treatment. Liver biopsy shows mild chronic portal inflammation Liver Biopsy: Negative Warthin-starry stain
  • ||||||||||  bictegravir (GS-9883) / Gilead
    [VIRTUAL] Initiation of Antiretroviral Therapy Leading to Idiopathic Terminal Ileal Ulceration () -  Sep 15, 2020 - Abstract #ACG2020ACG_1852;    
    Three weeks after presentation, ART (bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate) was started, after which he developed abdominal pain, diarrhea, and low-grade fevers...Two weeks after ART initiation, all symptoms improved and he was discharged on ART, atovaquone, and valacyclovir...It is possible that ART initiation caused his GI symptoms and the terminal ileum ulceration was found incidentally. In patients such as ours, follow-up is advised for up to 6-8 months with repeat colonoscopy to monitor for progression to IBD, which may be more likely in patients with symptomatic ITIUs.
  • ||||||||||  bictegravir (GS-9883) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    P4 data, Journal, Adverse events:  Short-term Adverse Events With BIC/FTC/TAF: Postmarketing Study. (Pubmed Central) -  Sep 12, 2020   
    The paucity of real-world data prompted this retrospective, observational evaluation of discontinuation rates, adverse effects, and virologic control. In a Southern US, predominantly African American overweight population, we found optimal virologic control and low discontinuation rates, with 4% discontinuing BIC/FTC/TAF due to rash, low platelets, loss of appetite, and insomnia.