Week 96 resistance analyses of the once‐daily, Single‐tablet Regimen (STR) Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in adults living with HIV‐1 from the phase 3 randomized AMBER and EMERALD trials

2020 ◽  
Author(s):  
Erkki Lathouwers ◽  
Shirley Weinsteiger ◽  
Bryan Baugh ◽  
Anne Ghys ◽  
John Jezorwski ◽  
...  
Keyword(s):  
Phase 3 ◽  
Once Daily ◽  
Single Tablet Regimen ◽  
Tenofovir Alafenamide ◽  
Living With Hiv ◽  
Hiv 1

scholarly journals Using a single tablet regimen of darunavir, cobicistat, emcitrabine, and tenofovir alafenamide in virally suppressed HIV-1 patients is an adequate treatment option for controlling HIV

2021 ◽  
Vol 7 (2) ◽  
Author(s):  
Priya Kathuria
Keyword(s):  
Protease Inhibitors ◽  
Treatment Option ◽  
Tenofovir Disoproxil Fumarate ◽  
Clinical Decision ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Adequate Treatment ◽  
Single Tablet Regimen ◽  
Tenofovir Alafenamide ◽  
Hiv 1

A clinical decision report using: Orkin C, Molina JM, Negredo E, et al. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018;5(1):e23-e34. https://doi.org/10.1016/S2352-3018(17)30179-0 for a patient with viriologically suppressed HIV-1.

scholarly journals Switching to a Bictegravir Single Tablet Regimen in Elderly People Living with HIV-1: Data Analysis from the BICTEL Cohort

Diagnostics ◽  
2021 ◽  
Vol 12 (1) ◽  
pp. 76
Author(s):  
Alessandro Lazzaro ◽  
Elio Gentilini Cacciola ◽  
Cristian Borrazzo ◽  
Giuseppe Pietro Innocenti ◽  
Eugenio Nelson Cavallari ◽  
...  
Keyword(s):  
T Cells ◽  
Real Life ◽  
Total Body Weight ◽  
P Value ◽  
People Living With Hiv ◽  
Single Tablet Regimen ◽  
Total Body ◽  
Tenofovir Alafenamide ◽  
Living With Hiv ◽  
Hiv 1

Bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) is a recommended once-daily single tablet regimen for the treatment of people living with HIV-1 (PLWH). We aimed to assess efficacy, safety and tolerability of BIC/FTC/TAF among PLWH, with a specific focus on people older than 55 years. Thus, we recruited an observational retrospective real-life cohort including all PLWH who underwent a therapeutic switch to BIC/FTC/TAF, independently from the provenience treatment regimen. After 48 weeks of follow-up, 147 PLWH were included and 93 were older than 55 years. PLWH with HIV-RNA < 37 copies/mL increased from 140 to 146 (p < 0.033). Among the overall population, we observed an increase in CD4+ T cells count by 30.1% (p-value < 0.001), in CD8+ T cells count by 7.1% (p-value = 0.004) and in CD4+/CD8+ ratio by 21.5% (p-value < 0.001). Lipidic profile was characterized by decreasing total cholesterol/HDL ratio by 8% (p-value < 0.001) and LDL by 6.8% (p-value = 0.007). Total body weight increased by 1.8% (p-value = 0.014) and BMI by 4.2% (p-value < 0.001), even remaining within the healthy range. Hepatic and renal profile were not altered by the switch, nor were adverse events and/or discontinuations events detected. In conclusion, BIC/FTC/TAF is effective, safe and well tolerated in real life and among PLWH older than 55.

Raltegravir once daily or twice daily in previously untreated patients with HIV-1: a randomised, active-controlled, phase 3 non-inferiority trial

2011 ◽  
Vol 11 (12) ◽  
pp. 907-915 ◽  
Author(s):  
Joseph J Eron ◽  
Jürgen K Rockstroh ◽  
Jacques Reynes ◽  
Jaime Andrade-Villanueva ◽  
Jose Valdez Ramalho-Madruga ◽  
...  
Keyword(s):  
Phase 3 ◽  
Once Daily ◽  
Hiv 1

scholarly journals Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients

AIDS ◽  
2020 ◽  
Vol 34 (5) ◽  
pp. 707-718 ◽  
Author(s):  
Chloe Orkin ◽  
Joseph J. Eron ◽  
Jürgen Rockstroh ◽  
Daniel Podzamczer ◽  
Stefan Esser ◽  
...  
Keyword(s):  
Phase 3 ◽  
Treatment Naïve ◽  
Tenofovir Alafenamide ◽  
Hiv 1

scholarly journals 2509. Pooled Resistance Analyses of Darunavir (DRV) Once Daily (QD) Regimens and Formulations Across 10 Clinical Studies of Treatment-Naïve (TN) and Treatment-Experienced (TE) Patients with Human Immunodeficiency Virus (HIV)-1 Infection

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S870-S871 ◽  
Author(s):  
Erkki Lathouwers ◽  
Sareh Seyedkazemi ◽  
Donghan Luo ◽  
Kimberley Brown ◽  
Sandra De Meyer ◽  
...  
Keyword(s):  
Clinical Studies ◽  
Virologic Failure ◽  
Transcriptase Inhibitor ◽  
Resistance Testing ◽  
Resistance Development ◽  
Single Tablet Regimen ◽  
Treatment Naïve ◽  
Tenofovir Alafenamide ◽  
Hiv 1 ◽  
Phenotypic Susceptibility

Abstract Background DRV has demonstrated high efficacy and barrier to resistance development across diverse populations, from TN to heavily TE patients. We evaluated resistance data from 10 clinical studies of different DRV 800 mg QD–based antiretroviral regimens and formulations. Methods The analysis included patients from 10 phase 2/3 studies (48–192 weeks in duration) of ritonavir- and cobicistat-boosted DRV 800 mg QD–based regimens in TN and virologically failing or suppressed TE patients with HIV-1 (table). Three were phase 3 studies of the DRV/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg single-tablet regimen (STR). Post-baseline resistance was evaluated in patients experiencing protocol-defined virologic failure (PDVF); definitions and criteria for resistance testing varied slightly among studies. Resistance-associated mutations (RAMs) were based on respective International Antiviral Society–USA mutation lists over time. Results Of the 3,635 patients evaluated, 250 met PDVF criteria and 205 had post-baseline genotypes/phenotypes. Overall, 4 (0.1%) patients developed (or had identified [switch studies]) ≥1 DRV and/or primary protease inhibitor (PI) RAM (table), and only 1 (< 0.1%, ODIN) patient lost DRV phenotypic susceptibility; this TE patient had prior VF with lopinavir. Among those who used a nucleos(t)ide reverse transcriptase inhibitor (NRTI) backbone (mostly emtricitabine [FTC] + tenofovir [TFV]), 12 (0.4%) patients had ≥1 NRTI RAM, including 10 with M184I/V associated with FTC resistance. No TFV RAMs were observed. Among patients receiving D/C/F/TAF (n = 1,949), none had post-baseline DRV, primary PI, or TFV RAMs; only 2 (0.1%) patients developed an FTC RAM. Conclusion Across a large, diverse population using DRV 800 mg QD–based regimens and formulations, resistance development remains rare; 0.1% of patients had ≥1 DRV and/or primary PI RAM post-baseline. Among 3 trials of the D/C/F/TAF STR, no patients developed a DRV or primary PI RAM. After > 10 years of investigating DRV 800 mg QD–based regimens in clinical trials, loss of phenotypic susceptibility to DRV has never been observed in TN or TE virologically suppressed patients and was only once observed in a TE patient with prior VF on multiple antiretrovirals, including a PI. Disclosures All authors: No reported disclosures.

Sign in / Sign up

Export Citation Format

Share Document