Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead 
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 0 Diseases   10 Trials   10 Trials   41 News 


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  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    [VIRTUAL] Long-term analysis of B/F/TAF in treatment-naïve adults living with HIV through four years of follow-up () -  May 27, 2021 - Abstract #IASHIV2021IAS_HIV_1252;    
    Week (W) 48 primary and W96 and W144 secondary endpoint results of the blinded phase from two studies established non-inferiority of B/F/TAF to dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) and DTG+F/TAF in treatment-naïve PWH. Through 4 years of follow-up, B/F/TAF resulted in high rates of virologic suppression with no treatment-emergent resistance, and a low frequency of AEs and few drug discontinuations.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    [VIRTUAL] Achievement of undetectable HIV-1 RNA in the B/F/TAF treatment-naïve clinical trials () -  May 27, 2021 - Abstract #IASHIV2021IAS_HIV_1229;    
    Consistent TND was associated with several factors, including lower baseline VL, higher baseline CD4 cell count, and high adherence. These data can be used to design studies with enhanced frequency of TND outcomes, which could aid cure research.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Vemlidy (tenofovir alafenamide) / Gilead
    [VIRTUAL] Does weight gain on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B) lead to metabolic syndrome? () -  May 27, 2021 - Abstract #IASHIV2021IAS_HIV_922;    
    Despite '¥10% weight gain from baseline over a median of 88.9 weeks, we did not see an increase in metabolic syndrome in this group compared to those with less weight gain. We may need more patients with longer follow up to answer this very important question.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    [VIRTUAL] Patterns of weight gain in Bictegravir/Emtricitabine/Tenofovir alafenamide (B) () -  May 27, 2021 - Abstract #IASHIV2021IAS_HIV_828;    
    Weight gain is now being recognized as an adverse effect of antiretroviral therapy, our study shows that 15 % of our patients who started on B gained '¥ 10 % of their baseline weight, mostly within the first 48 weeks, moreover 15% of the patients who gained excessive weight were poorly adherent to therapy. Clearly more prospective studies on weight gain with its consequences are needed in PLWH.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    [VIRTUAL] Switch to BIC/FTC/TAF in virally suppressed PLWH: efficacy and tolerability () -  May 27, 2021 - Abstract #IASHIV2021IAS_HIV_779;    
    BACKGROUND: Since bictegravir (BIC)/emtricitabine (FTC)/tenofovir alafenamide (TAF) authorization from the Italian Medicines Agency in June 2019, our institute has established a prearranged switch from elvitegravir/cobicistat (EVG/c)-based regimens in virally suppressed PLWH and, based on a case-by-case indication, from other regimens. In a large sample of suppressed PLWH followed in a real-life setting, 1-year TF of BIC/FTC/TAF was low (7%) with 2% of VF, suggesting that the switch is effective and safe.
  • ||||||||||  bersacapavir (JNJ-56136379) / J&J
    Enrollment open:  A Study of JNJ-56136379 in Healthy Participants (clinicaltrials.gov) -  May 20, 2021   
    P1,  N=21, Recruiting, 
    No abstract available Not yet recruiting --> Recruiting
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    New trial:  ASAP: Antiretroviral Speed Access Program (clinicaltrials.gov) -  May 20, 2021   
    P,  N=75, Recruiting, 
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults (clinicaltrials.gov) -  May 11, 2021   
    P4,  N=30, Completed, 
    The interstudy differences in selected populations and control regimens may lead to the high heterogeneity of the meta-analysis. Recruiting --> Completed | N=200 --> 30 | Trial completion date: Oct 2021 --> Sep 2020 | Trial primary completion date: Sep 2021 --> Aug 2020
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Trial completion date, Trial primary completion date:  (mo)BETTA Trial in Transwomen for Optimization of ART (clinicaltrials.gov) -  Apr 28, 2021   
    P4,  N=48, Recruiting, 
    Trial completion date: Aug 2022 --> Aug 2023 Trial completion date: Apr 2020 --> May 2022 | Trial primary completion date: Apr 2020 --> May 2022
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Trial completion date, Trial primary completion date:  B/F/TAF Switch Study for HIV-HBV Coinfection (clinicaltrials.gov) -  Apr 22, 2021   
    P4,  N=60, Recruiting, 
    Trial completion date: Feb 2022 --> Jun 2022 | Trial primary completion date: Feb 2022 --> Jun 2022 Trial completion date: Jun 2022 --> Oct 2022 | Trial primary completion date: Oct 2021 --> Jan 2022
  • ||||||||||  bersacapavir (JNJ-56136379) / J&J
    New P1 trial:  A Study of JNJ-56136379 in Healthy Participants (clinicaltrials.gov) -  Apr 20, 2021   
    P1,  N=21, Not yet recruiting, 
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Clinical, Journal:  Failure to Biktarvy® and development of resistance mutations in an antiretroviral-experienced patient. (Pubmed Central) -  Apr 7, 2021   
    After two months under antiretroviral therapy (ART), acute neurologic deterioration with epilepsy, right hemiparesis and dysphagia occurred, leading to nasogastric nutrition. Virological failure was confirmed with 4.01 HIV RNA Log copies/mL and R263K and M184V resistance mutations were detected.
  • ||||||||||  Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    New P4 trial:  Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND) (clinicaltrials.gov) -  Apr 1, 2021   
    P4,  N=40, Not yet recruiting,