Oana Săndulescu1, Mădălina Irimia2, Otilia Elisabeta Benea1, Mariana Mărdărescu3, Liliana Lucia Preoțescu1, Carmen Mihaela Dorobăț4, Isabela Ioana Loghin5, Irina Cristina Nicolau6, Raluca Elena Jipa7, Ramona Ștefania Popescu1, Cristina Loredana Benea2, Alina Cozma2, Ioana Andreea Dărămuș8, Victor Daniel Miron9, Liviu Jany Prisăcariu6, Adriana Florina Bahnă6, Irina Nistor6, Oana Manuela Secrieru6, Silvas George6, Andreea Bîrcă2, Loredana Dobrea2, Alexandra-Ștefana Șogorescu2, Ioana Viziteu10, Anca Streinu-Cercel1. 1. MD, PhD, Carol Davila University of Medicine and Pharmacy Bucharest, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania. 2. MD, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania. 3. MD, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No.1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania. 4. MD, PhD, HIV/AIDS Department, Clinical Infectious Diseases Hospital "Sf Parascheva", 2 Octav Botez Street, Iaşi, 700116, Romania. 5. MD, University of Medicine and Pharmacy "Grigore T. Popa" Iași, HIV/AIDS Department, Clinical Infectious Diseases Hospital "Sf Parascheva", 2 Octav Botez Street, Iaşi, 700116, Romania. 6. MD, HIV/AIDS Department, Clinical Infectious Diseases Hospital "Sf Parascheva", 2 Octav Botez Street, Iaşi, 700116, Romania. 7. MD, Carol Davila University of Medicine and Pharmacy Bucharest, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania. 8. MD, PhDc, Carol Davila University of Medicine and Pharmacy Bucharest, National Institute for Infectious Diseases "Prof. Dr. Matei Balș", No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania. 9. MD, PhDc, Carol Davila University of Medicine and Pharmacy Bucharest, No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania. 10. Medical student, Carol Davila University of Medicine and Pharmacy Bucharest, No. 1 Dr Calistrat Grozovici street, Bucharest, 021105, Romania.
Abstract
INTRODUCTION: Development of highly active antiretroviral therapy marked an important step forward in the management of people living with HIV and fixed dose combinations are now available to be used as modern antiretroviral regimens. The single-tablet regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was recently approved in Europe and included in international guidelines and recommendations. It became available in Romania in early 2021. We present the real-world results from a retrospective analysis of patients initiating BIC/FTC/TAF in two HIV centers in Romania. METHODS: This retrospective analysis included patients treated with BIC/FTC/TAF (first-line or switch) in two HIV centers in Romania, one in Bucharest and one in Iași. We collected data on baseline patient characteristics, reasons for initiation of BIC/FTC/TAF and preliminary clinical and laboratory efficacy, safety and tolerability data. All assessments had been performed according to local practice. Statistical analyses were mostly descriptive and association analysis was performed to assess changes in laboratory parameters from baseline to data cut-off (October 2021). RESULTS: In total, 122 patients were initiated on BIC/FTC/TAF in routine clinical practice from February to October 2021 in the two HIV centers, either as first-line or switch. The majority of patients were male (71%). The median age at baseline was 35.0 years (IQR 32.0-50.8 years). Overall, 91 patients (75%) were treatment-experienced and the most frequent reason for switch was treatment simplification (79%). The mean ± standard deviation follow-up duration on treatment with BIC/FTC/TAF was 101.6 ± 64.2 days until the cut-off date for this analysis. We found no significant changes in lipid values, blood glucose or liver enzymes, coupled with a significant decrease in viral load (p=0.001). A low number of adverse events occurred during the treatment period (n=4): two cases of fatigue and two gastrointestinal reactions. No patient discontinued BIC/FTC/TAF and the overall tolerability was good. CONCLUSIONS: The insights of the first report on BIC/FTC/TAF use in routine clinical practice in Romania provide an overview of effectiveness and safety to local clinicians treating this patient population. GERMS.
INTRODUCTION: Development of highly active antiretroviral therapy marked an important step forward in the management of people living with HIV and fixed dose combinations are now available to be used as modern antiretroviral regimens. The single-tablet regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was recently approved in Europe and included in international guidelines and recommendations. It became available in Romania in early 2021. We present the real-world results from a retrospective analysis of patients initiating BIC/FTC/TAF in two HIV centers in Romania. METHODS: This retrospective analysis included patients treated with BIC/FTC/TAF (first-line or switch) in two HIV centers in Romania, one in Bucharest and one in Iași. We collected data on baseline patient characteristics, reasons for initiation of BIC/FTC/TAF and preliminary clinical and laboratory efficacy, safety and tolerability data. All assessments had been performed according to local practice. Statistical analyses were mostly descriptive and association analysis was performed to assess changes in laboratory parameters from baseline to data cut-off (October 2021). RESULTS: In total, 122 patients were initiated on BIC/FTC/TAF in routine clinical practice from February to October 2021 in the two HIV centers, either as first-line or switch. The majority of patients were male (71%). The median age at baseline was 35.0 years (IQR 32.0-50.8 years). Overall, 91 patients (75%) were treatment-experienced and the most frequent reason for switch was treatment simplification (79%). The mean ± standard deviation follow-up duration on treatment with BIC/FTC/TAF was 101.6 ± 64.2 days until the cut-off date for this analysis. We found no significant changes in lipid values, blood glucose or liver enzymes, coupled with a significant decrease in viral load (p=0.001). A low number of adverse events occurred during the treatment period (n=4): two cases of fatigue and two gastrointestinal reactions. No patient discontinued BIC/FTC/TAF and the overall tolerability was good. CONCLUSIONS: The insights of the first report on BIC/FTC/TAF use in routine clinical practice in Romania provide an overview of effectiveness and safety to local clinicians treating this patient population. GERMS.
Authors: Paul E Sax; Edwin DeJesus; Anthony Mills; Andrew Zolopa; Calvin Cohen; David Wohl; Joel E Gallant; Hui C Liu; Lijie Zhong; Kitty Yale; Kirsten White; Brian P Kearney; Javier Szwarcberg; Erin Quirk; Andrew K Cheng Journal: Lancet Date: 2012-06-30 Impact factor: 79.321
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Authors: Paul E Sax; Anton Pozniak; M Luisa Montes; Ellen Koenig; Edwin DeJesus; Hans-Jürgen Stellbrink; Andrea Antinori; Kimberly Workowski; Jihad Slim; Jacques Reynes; Will Garner; Joseph Custodio; Kirsten White; Devi SenGupta; Andrew Cheng; Erin Quirk Journal: Lancet Date: 2017-08-31 Impact factor: 79.321
Authors: Franco Maggiolo; Giuliano Rizzardini; Jean-Michel Molina; Federico Pulido; Stephane De Wit; Linos Vandekerckhove; Juan Berenguer; Michelle L D'Antoni; Christiana Blair; Susan K Chuck; David Piontkowsky; Hal Martin; Richard Haubrich; Ian R McNicholl; Joel Gallant Journal: Infect Dis Ther Date: 2021-03-09