- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date: Biktarvy in Treatment-Na (clinicaltrials.gov) - Mar 18, 2021 P4, N=250, Not yet recruiting, Potential risks for DDIs/contraindications vary by ART, with the lowest potential seen in unboosted integrase strand transfer inhibitor-based regimens, including raltegravir + emtricitabine/tenofovir alafenamide fumarate, followed by three dolutegravir-based regimens. Trial completion date: Oct 2021 --> Mar 2023
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
[VIRTUAL] 4-YEAR OUTCOMES OF B/F/TAF IN TREATMENT-NAIVE ADULTS () - Mar 18, 2021 - Abstract #CROI2021CROI_624; Similar outcomes were demonstrated in participants who switched from DTG-containing regimens to B/F/TAF. These results confirm long term safety and efficacy of B/F/TAF.
- |||||||||| [VIRTUAL] EFFECTIVENESS OF RECOMMENDED 3-DRUG REGIMENS FOR TREATING ADVANCED HIV INFECTION () - Mar 18, 2021 - Abstract #CROI2021CROI_615;
The effectiveness of one of the newest 3-drug regimen (3DR), bictegravir/ emtricitabine/tenofovir alafenamide (B/F/TAF), was therefore compared to other 3DRs that included boosted darunavir (bDRV), dolutegravir (DTG) or elvitegravir/cobicistat (EVG/c) among ART-naïve PLWH with CD4 count <200 cells/μL. Among PLWH with advanced HIV infection initiating ART, those on B/F/TAF appeared less likely to discontinue their regimen compared to other 3DRs (unadjusted) and were numerically more likely to achieve virologic suppression compared to bDRV but did not differ from those on DTG or EVG/cbased 3DR (adjusted).
- |||||||||| Vocabria (cabotegravir oral) / ViiV Healthcare, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
Trial completion date, Head-to-Head: SOLAR: A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY (clinicaltrials.gov) - Mar 12, 2021 P3, N=654, Recruiting, BIC concentrations were significantly decreased with concurrent use of 1HP among PLWH with LTBI. Trial completion date: Mar 2023 --> Jun 2023
- |||||||||| medroxyprogesterone injection / Generic mfg.
Trial completion date, Trial primary completion date: BONE:STAR: BONE: STAR (Switching to TAF Based Anti-Retroviral Therapy) Study (clinicaltrials.gov) - Mar 2, 2021 P4, N=330, Recruiting, Trial completion date: Jun 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Jun 2021 Trial completion date: Jun 2022 --> Jun 2023 | Trial primary completion date: Jun 2022 --> Jun 2023
- |||||||||| bictegravir (GS-9883) / Gilead
Journal: Fulminant diffuse cerebral toxoplasmosis as the first manifestation of HIV infection. (Pubmed Central) - Feb 23, 2021 Dexamethasone was initiated and he developed rigours...He was then initiated on Biktarvy 50 mg/200 mg/25 mg, one tablet daily, which contains 50 mg of bictegravir, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide...This case highlights missed opportunities to request HIV serology and raises awareness that cerebral toxoplasmosis can occur as the first manifestation of HIV. Prompt diagnosis and early initiation of antiretroviral therapy reduces morbidity and mortality in this patient cohort.
- |||||||||| tenofovir disoproxil fumarate / Generic mfg.
[VIRTUAL] A Rare Case of Nephrogenic Diabetes Insipidus From Tenofovir (On-Demand) - Feb 2, 2021 - Abstract #ENDO2021ENDO_1536; This case illustrates the importance of monitoring patients on tenofovir for signs of renal [tubular] dysfunction. In a polyuric patient on tenofovir, there should be a high index of suspicion for nephrogenic diabetes insipidus.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Clinical, Journal: Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment-Experienced Patients. (Pubmed Central) - Jan 30, 2021 After adjusting for demographics, baseline ART, and CM categories, switching to BIC/FTC/TAF led to significant DDI score reductions in patients receiving CMs for cardiovascular disease, neurologic/psychiatric disorders, chronic pain, inflammation, gastrointestinal/urologic conditions, and conditions requiring hormonal therapy. Treatment-experienced PWH eligible to switch their ART may experience significant declines in number and severity of DDIs if switched to BIC/FTC/TAF.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial primary completion date: SOLUBIC: Bioequivalence of Solid/Crushed/Dissolved Forms of Biktarvy (clinicaltrials.gov) - Jan 27, 2021 P1, N=18, Recruiting, Treatment-experienced PWH eligible to switch their ART may experience significant declines in number and severity of DDIs if switched to BIC/FTC/TAF. Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, NN1213 / Novo Nordisk
Trial completion date: Early ART to Limit Infection and Establishment of Reservoir (clinicaltrials.gov) - Jan 25, 2021 P2, N=195, Active, not recruiting, Trial primary completion date: Dec 2020 --> Dec 2021 Trial completion date: May 2021 --> Sep 2023
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
Trial completion date, Trial primary completion date: Effects of Biktarvy on CFR in Stable HIV Patients (clinicaltrials.gov) - Jan 6, 2021 P3, N=30, Recruiting, Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Dec 2021 --> Apr 2022 Trial completion date: Nov 2020 --> Nov 2021 | Trial primary completion date: Nov 2020 --> Nov 2021
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Descovy (emtricitabine/tenofovir alafenamide) / Gilead
[VIRTUAL] Effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (BIC/TAF/FTC) use in older African-American patients: a retrospective chart review. () - Dec 26, 2020 - Abstract #ASHP2020ASHP_3779; These include patient demographics; HIV-1 RNA and CD4 cell count at baseline and weeks 12, 24, and 48; past exposure to antiretroviral therapy; HIV risk factors and disease status; creatinine clearance, weight, BMI, lipid panel, and liver function tests at baseline and weeks 12, 24, 48. The electronic chart will also be assessed to determine if the patient experienced any adverse effects, during the duration of data collection, that were caused by BIC/TAF/FTC, using the Common Terminology Criteria for Adverse Events grading system.
- |||||||||| bictegravir (GS-9883) / Gilead, Pifeltro (doravirine) / Merck (MSD), Tivicay (dolutegravir) / ViiV Healthcare
[VIRTUAL] Dolutegravir/Doravirine: A dual-therapy, nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) sparing HIV antiretroviral regimen in a patient with declining renal function () - Dec 26, 2020 - Abstract #ASHP2020ASHP_2590; The patient was prescribed a regimen of efavirenz/tenofovir DF/emtricitabine (Atripla) upon referral to the specialty clinic. On his first visit he was initiated on bictegravir/tenofovir alafenamide/emtricitabine (Biktarvy) but was switched to a regimen consisting of doravirine 100mg, dolutegravir 50mg, and lamivudine 50mg in January of 2019 because of his declining kidney function...The patient was on esomeprazole, a PPI, for management of severe GERD with esophageal damage (Schatzki’s ring), thus ruling out Juluca as an option...As of February 2020, his CD4 count was 707 and as of June 2020, the patient’s viral loads have remained consistently suppressed at 12 months on a two-drug combination of doravirine and dolutegravir.
- |||||||||| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Vemlidy (tenofovir alafenamide) / Gilead
Clinical, Journal: Crushed bictegravir/emtricitabine/tenofovir alafenamide in a human immunodeficiency virus-positive patient with esophageal cancer. (Pubmed Central) - Dec 20, 2020 On his first visit he was initiated on bictegravir/tenofovir alafenamide/emtricitabine (Biktarvy) but was switched to a regimen consisting of doravirine 100mg, dolutegravir 50mg, and lamivudine 50mg in January of 2019 because of his declining kidney function...The patient was on esomeprazole, a PPI, for management of severe GERD with esophageal damage (Schatzki’s ring), thus ruling out Juluca as an option...As of February 2020, his CD4 count was 707 and as of June 2020, the patient’s viral loads have remained consistently suppressed at 12 months on a two-drug combination of doravirine and dolutegravir. No abstract available
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