Use of Tenofovir Alafenamide/Emtricitabine/Elvitegravir-Cobicistat in HIV-Naive Patients with Advanced Disease: GENIS Study

Objective: The primary endpoint of the study was to determine the proportion of patients with HIV RNA < 50 copies/mL at 48 weeks. Design: Phase IV, multicentric, open-label, single-arm clinical trial of participants recruited in 2018−2019 to evaluate the efficacy and safety of tenofovir alafenami...

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Published in:Journal of clinical medicine 2022-08, Vol.11 (17), p.4994
Main Authors: Perez Stachowski, Javier, Rial Crestelo, David, Moreno Zamora, Ana, Cabello, Noemi, Ryan, Pablo, Espinosa Aguilera, Nuria, Bisbal, Otilia, Vivancos Gallego, Maria Jesus, Nuñez, Maria Jose, Troya, Jesus, Dominguez, Montserrat, Sierra, Julian Olalla
Format: Article
Language:English
Subjects:
Acquired immune deficiency syndrome
AIDS
Antiretroviral drugs
Body mass index
Cholesterol
Clinical medicine
Clinical trials
Drug dosages
High density lipoprotein
HIV
Human immunodeficiency virus
Laboratories
Lipids
Lymphocytes
Mortality
Mutation
Patients
Triglycerides
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Summary:Objective: The primary endpoint of the study was to determine the proportion of patients with HIV RNA < 50 copies/mL at 48 weeks. Design: Phase IV, multicentric, open-label, single-arm clinical trial of participants recruited in 2018−2019 to evaluate the efficacy and safety of tenofovir alafenamide/emtricitabine/elvitegravir-cobicistat (TAF/FTC/EVG-c) as first-line treatment in HIV-1 infected naïve participants with advanced disease. Methods: Adverse events were graded according to the Division of AIDS scale version 2.0. Quantitative variables were recorded as median and interquartile range, and qualitative variables as absolute number and percentage. T-Student or Wilcoxon tests were used to analyze intragroup differences of the continuous variables. Results: Fifty participants were recruited with a baseline median CD4 lymphocyte count of 116 cells/µL and a viral load of 218,938 copies/mL. The proportion of patients with viral load
ISSN:2077-0383
2077-0383
DOI:10.3390/jcm11174994