Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead 
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 12 Diseases   4 Trials   4 Trials   242 News 


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  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Prezcobix (darunavir/cobicistat) / Gilead, J&J
    A RARE CASE OF VANISHING BILE DUCT SYNDROME IN A PATIENT WITH ADVANCED HIV/AIDS AND CMV HEPATITIS (Hall A, Poster Hall - Walter E. Washington Convention Center) -  Mar 14, 2024 - Abstract #DDW2024DDW_3799;    
    His home medications included darunavir, cobicistat, emtricitabine, and tenofovir alafenamide...Medications that are commonly implicated include penicillin and nevirapine...There is limited data on treatment options for VBDS; oftentimes, it is removal of the offending medication or treating the underlying infection and malignancy. In many cases of VBDS, ductopenia can become permanent, leading to progressive cholestasis, and ultimately cirrhosis.
  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
    Phase 4 DEFINE Switch Study to Manage InSTI-related Weight Gain: Metabolics and Biomarker Analysis (Poster hall) -  Mar 5, 2024 - Abstract #CROI2024CROI_403;    
    P4
    As previously reported, the primary Week 24 analysis found no significant difference in percent change in body weight from baseline when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) compared to continuing INSTI+tenofovir alafenamide (TAF)/emtricitabine (FTC).DEFINE (NCT04442737) is a randomized (1:1), prospective, 48-week, active-controlled, open-label, multicenter phase 4 study evaluating switching to D/C/F/TAF versus continuing INSTI+TAF/FTC in virologically suppressed adults with HIV-1 who had ?10% weight gain while on the INSTI-based regimen...Consistent with the minimal body weight changes observed through Week 24, metabolic and biomarker data remained relatively stable. Metabolic parameters in this high-BMI population did not improve following antiretroviral switch, highlighting that weight gain should be a pretreatment consideration.
  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment closed, Metastases:  The Late Presenter Treatment Optimisation Study (clinicaltrials.gov) -  Sep 28, 2023   
    P3,  N=447, Active, not recruiting, 
    Despite the availability of newer antiretroviral drugs and strategies in the management of HIV infection, including long-acting therapies, DRV/COBI/FTC/TAF is still considered an alternative regimen for the treatment of ART-na Recruiting --> Active, not recruiting
  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
    Enrollment closed, Trial completion date, Trial primary completion date:  Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza (clinicaltrials.gov) -  Sep 8, 2023   
    P4,  N=75, Active, not recruiting, 
    Recruiting --> Active, not recruiting Unknown status --> Active, not recruiting | Trial completion date: Apr 2022 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Sep 2023
  • ||||||||||  Dovato (dolutegravir/lamivudine) / ViiV Healthcare
    Journal:  Effectiveness and tolerability of dolutegravir/lamivudine for the treatment of HIV-1 infection in clinical practice. (Pubmed Central) -  Apr 26, 2023   
    Dolutegravir/lamivudine had the lowest healthcare costs of BIC/FTC/TAF, EVG/COBI/FTC/TAF, and DRV/COBI/FTC/TAF, and the lowest pharmacy costs of all regimens, in unadjusted and adjusted analyses and by treatment experience, supporting the economic benefits of DTG/3TC as an initial or switch regimen for HIV-1. In this large multicentre cohort, effectiveness and tolerability of dolutegravir/lamivudine were high among treatment-naive and treatment-experienced subjects.
  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Prezista (darunavir) / J&J, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment closed, Trial completion date, Trial primary completion date:  BIC-T&T: Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat' (clinicaltrials.gov) -  Apr 19, 2023   
    P3,  N=36, Active, not recruiting, 
    In this large multicentre cohort, effectiveness and tolerability of dolutegravir/lamivudine were high among treatment-naive and treatment-experienced subjects. Recruiting --> Active, not recruiting | Trial completion date: Jul 2022 --> Jul 2023 | Trial primary completion date: Jul 2022 --> Jul 2023
  • ||||||||||  methamphetamine / Generic mfg.
    A Rare Case of Pneumomediastinum and Extensive Subcutaneous Emphysema Following Methamphetamine Use: A Case Report (Walter E. Washington Convention Center, Area E, Hall C (Lower Level)) -  Mar 25, 2023 - Abstract #ATS2023ATS_8202;    
    Since the patient has had similar symptoms in the past, this may suggest the risk of recurrence and ultimately a more severe presentation. Physicians should have a high clinical suspicion of recreational drug use with spontaneous pneumomediastinum and subcutaneous emphysema in otherwise healthy young patients.
  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date:  microRNAs in HIV and Obesity (clinicaltrials.gov) -  Mar 17, 2023   
    P4,  N=30, Recruiting, 
    Physicians should have a high clinical suspicion of recreational drug use with spontaneous pneumomediastinum and subcutaneous emphysema in otherwise healthy young patients. Not yet recruiting --> Recruiting | Trial completion date: Jul 2024 --> Mar 2025 | Initiation date: Jul 2022 --> Mar 2023 | Trial primary completion date: Jul 2024 --> Mar 2025
  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Prezista (darunavir) / J&J
    Journal:  Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-na (Pubmed Central) -  Mar 14, 2023   
    Not yet recruiting --> Recruiting | Trial completion date: Jul 2024 --> Mar 2025 | Initiation date: Jul 2022 --> Mar 2023 | Trial primary completion date: Jul 2024 --> Mar 2025 D/C/F/TAF may be a suitable treatment option for individuals with HIV-1 and NPCs.
  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Trial completion date, Trial primary completion date, Metastases:  The Late Presenter Treatment Optimisation Study (clinicaltrials.gov) -  Jan 10, 2023   
    P3,  N=440, Recruiting, 
    D/C/F/TAF may be a suitable treatment option for individuals with HIV-1 and NPCs. Trial completion date: Jan 2024 --> May 2024 | Trial primary completion date: Dec 2022 --> May 2024
  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Prezcobix (darunavir/cobicistat) / Gilead, J&J
    The Immunoprotective Effect of the Human Immunodeficiency Virus in Delaying the Development of Inflammatory Bowel Disease () -  Dec 9, 2022 - Abstract #AIBD2022AIBD_211;    
    The presence of HIV and IBD presenting together is a rare clinical phenomenon with only a handful of reports in the literature. By reviewing the pathophysiological and clinical manifestations when these 2 diseases are present concurrently, we use our patient as a model example to describe how HIV can be protective in the development and exacerbation of IBD.
  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Descovy (emtricitabine/tenofovir alafenamide) / Gilead
    Long-term efficacy and resistance analyses of D/C/F/TAF in the phase III AMBER and EMERALD studies: post 96-week data () -  Oct 4, 2022 - Abstract #HIVGlasgow2022HIV_Glasgow_346;    
    Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2023 --> Aug 2023  In AMBER (treatment-naïve adults) and EMERALD (treatment-experienced, virologically suppressed adults), long-term D/C/F/TAF treatment was considered efficacious with a high genetic barrier to resistance development.
  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    New P4 trial:  microRNAs in HIV and Obesity (clinicaltrials.gov) -  Jul 19, 2022   
    P4,  N=30, Not yet recruiting, 
  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Trial completion date, Trial primary completion date, Metastases:  The Late Presenter Treatment Optimisation Study (clinicaltrials.gov) -  Apr 26, 2022   
    P3,  N=440, Recruiting, 
    In conclusion, in treatment-naïve and virologically suppressed patients, incidences and prevalences of D/C/F/TAF-related gastrointestinal AEOIs were low and tended to present early. Trial completion date: Dec 2021 --> Jan 2024 | Trial primary completion date: Jun 2021 --> Dec 2022
  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Adherence:  Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita) (clinicaltrials.gov) -  Dec 20, 2021   
    P4,  N=1, Terminated, 
    This supports the use of a once-daily, single-tablet regimen of D/C/F/TAF 800/150/200/10 mg for the treatment of HIV-1-infected subjects. N=30 --> 1 | Trial completion date: Jun 2021 --> Dec 2021 | Not yet recruiting --> Terminated | Trial primary completion date: Jan 2021 --> Dec 2021; Lack of eligible enrollees/ Halted by Primary Sponsor
  • ||||||||||  bictegravir (GS-9883) / Gilead
    Clinical, Review, Journal, Adverse events:  Comparative safety review of recommended, first-line single-tablet regimens in patients with HIV. (Pubmed Central) -  Nov 5, 2021   
    Integrase inhibitors (InsTIs)-based regimens have few interruptions for adverse events and few drug-related adverse events, with tenofovir alafenamide/emtricitabine/dolutegravir and lamivudine/dolutegravir being the most tolerable ones. However, neuropsychiatric adverse events and metabolic issues could prompt the alternative use of darunavir or doravirine-based combinations, even if a superior safety profile of these combinations over InSTIs has yet to be demonstrated.
  • ||||||||||  Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Prezista (darunavir) / J&J
    Journal:  Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis. (Pubmed Central) -  Oct 27, 2021   
    P3
    However, neuropsychiatric adverse events and metabolic issues could prompt the alternative use of darunavir or doravirine-based combinations, even if a superior safety profile of these combinations over InSTIs has yet to be demonstrated. High rates of viral suppression during acute/early infection were achieved with D/C/F/TAF rapid initiation, no treatment-emergent resistant mutations were observed, and D/C/F/TAF was safe and well tolerated.