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Your search keyword '"Jezorwski, John"' showing total 4 results
Start Over Author "Jezorwski, John" Publisher lippincott williams & wilkins
4 results on '"Jezorwski, John"'

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

Author

Orkin, Chloe, Eron, Joseph J., Rockstroh, Jürgen, Podzamczer Palter, Daniel, Esser, Stefan, Vandekerckhove, Linos, Van Landuyt, Erika, Lathouwers, Erkki, Hufkens, Veerle, Jezorwski, John, Opsomer, Magda, and AMBER study group

Subjects
Male, 0301 basic medicine, efficacy, Medizin, HIV Infections, Gastroenterology, 0302 clinical medicine, Medicine and Health Sciences, ART-naive, Emtricitabine, Immunology and Allergy, tenofovir alafenamide, 030212 general & internal medicine, Darunavir, Emtricitabine tenofovir alafenamide, Alanine, Cobicistat, Antiretrovirals, Viral Load, OPEN-LABEL, Drug Combinations, Treatment Outcome, Infectious Diseases, INITIAL TREATMENT, Female, Viral load, Tablets, medicine.drug, HIV infections, Adult, safety, TENOFOVIR DISOPROXIL FUMARATE, DARUNAVIR, medicine.medical_specialty, Anti-HIV Agents, Darunavir/Cobicistat, Immunology, RITONAVIR, Tenofovir alafenamide, single-tablet regimen, 03 medical and health sciences, ADHERENCE, Double-Blind Method, Internal medicine, INFECTION ANALYSIS, medicine, Humans, Protease Inhibitors, Tenofovir, emtricitabine, business.industry, Adenine, ADULTS, cobicistat, Antiretroviral agents, 030104 developmental biology, HIV-1, Ritonavir, Infeccions per VIH, business
Abstract

Background: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in AMBER (NCT02431247). Methods: Treatment-naive, HIV-1-positive adults [screening plasma viral load >= 1000 copies/ml; CD4(+) cell count >50 cells/mu l) were randomized (1 : 1) to D/C/F/TAF (N = 362) or D/C plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) (N = 363) over at least 48 weeks. After week 48, patients could continue on or switch to D/C/F/TAF in an open-label extension phase until week 96. Results: At week 96, D/C/F/TAF exposure was 626 patient-years (D/C/F/TAF arm) and 109 patient-years (control arm post switch), week 96 virologic suppression (viral load = 50 copies/ml; FDA-Snapshot) was 5.5% (20/362) and 4.4% (16/363), respectively. No darunavir, primary protease inhibitor or tenofovir resistance-associated mutations (RAMs) were observed post baseline. In one patient in each arm, an M184I and/or V RAM was detected. Few adverse event-related discontinuations (3% D/C/F/TAF

Published
2020

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

Author

Orkin C, Eron JJ, Rockstroh J, Podzamczer D, Esser S, Vandekerckhove L, Van Landuyt E, Lathouwers E, Hufkens V, Jezorwski J, and Opsomer M

Subjects
Adenine analogs & derivatives, Adult, Alanine, Anti-HIV Agents therapeutic use, Cobicistat therapeutic use, Darunavir therapeutic use, Double-Blind Method, Drug Combinations, Emtricitabine therapeutic use, Female, Humans, Male, Protease Inhibitors therapeutic use, Tenofovir therapeutic use, Treatment Outcome, Viral Load drug effects, Anti-HIV Agents administration & dosage, HIV Infections drug therapy, HIV Infections virology, HIV-1 drug effects, Protease Inhibitors administration & dosage, Tablets
Abstract

Background: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in AMBER (NCT02431247)., Methods: Treatment-naive, HIV-1-positive adults [screening plasma viral load ≥1000 copies/ml; CD4 cell count >50 cells/μl) were randomized (1 : 1) to D/C/F/TAF (N = 362) or D/C plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) (N = 363) over at least 48 weeks. After week 48, patients could continue on or switch to D/C/F/TAF in an open-label extension phase until week 96., Results: At week 96, D/C/F/TAF exposure was 626 patient-years (D/C/F/TAF arm) and 109 patient-years (control arm post switch), week 96 virologic suppression (viral load <50 copies/ml; FDA-Snapshot, from baseline) was 85.1% (308/362) (D/C/F/TAF) and 83.7% (304/363) (control). Week 96 virologic failure (viral load ≥50 copies/ml; FDA-Snapshot) was 5.5% (20/362) and 4.4% (16/363), respectively. No darunavir, primary protease inhibitor or tenofovir resistance-associated mutations (RAMs) were observed post baseline. In one patient in each arm, an M184I and/or V RAM was detected. Few adverse event-related discontinuations (3% D/C/F/TAF; <1% control post switch) and no deaths occurred on D/C/F/TAF. Improved renal and bone parameters were maintained in the D/C/F/TAF arm and observed in the control arm post switch. Increases in total-cholesterol/high-density-lipoprotein--cholesterol rtio at week 96 were +0.25 versus baseline (D/C/F/TAF) and +0.24 versus switch (control)., Conclusion: At week 96, D/C/F/TAF resulted in high virologic response and low virologic failure rates, with no resistance development to darunavir or TAF/TDF. Bone, renal and lipid safety were consistent with known D/C/F/TAF component profiles. Control arm safety post switch was consistent with the D/C/F/TAF arm. AMBER week 96 results confirm the efficacy, high barrier to resistance and bone/renal safety benefits of D/C/F/TAF for treatment-naive patients.

Published
2020
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