- |||||||||| 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, HEOR, Real-world evidence, Real-world: Comparing Real-World Healthcare Costs Associated with Single-Tablet Regimens for HIV-1: The 2-Drug Regimen Dolutegravir/Lamivudine vs. Standard 3- or 4-Drug Regimens. (Pubmed Central) - Aug 8, 2023 Unknown status --> Active, not recruiting | Trial completion date: Apr 2022 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Sep 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.
- |||||||||| 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, Prezista (darunavir) / J&J, Descovy (emtricitabine/tenofovir alafenamide) / Gilead
Clinical, P3 data, Journal: Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment (ART)-naïve and -experienced, virologically-suppressed adults living with HIV-1. (Pubmed Central) - Feb 26, 2022 P3 We could not demonstrate the noninferiority of D/C/F/TAF relative to DTG/ABC/3TC as initial antiretroviral therapy, although both regimens were similarly well tolerated. D/C/F/TAF was effective with a high barrier to resistance and bone/renal safety benefits, regardless of demographic or clinical characteristics for treatment-naïve and treatment-experienced, virologically-suppressed adults.
- |||||||||| Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) / J&J, Gilead, Prezcobix (darunavir/cobicistat) / Gilead, J&J, Descovy (emtricitabine/tenofovir alafenamide) / Gilead
Clinical, PK/PD data, Journal: Population Pharmacokinetic Analysis of Darunavir and Tenofovir Alafenamide in HIV-1-Infected Patients on the Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen (AMBER and EMERALD Studies). (Pubmed Central) - Jan 11, 2022 P3 Additionally, our findings demonstrate that in patients with low plasma concentrations, there is no risk of decreased virologic response or virologic rebound. 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.
- |||||||||| 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.
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