Treatment initiation or switch to BIC/FTC/TAF - real-world safety and efficacy data from two HIV centers in Romania

Oana Săndulescu; Mădălina Irimia; Otilia Elisabeta Benea; Mariana Mărdărescu; Liliana Lucia Preoțescu; Carmen Mihaela Dorobăț; Isabela Ioana Loghin; Irina Cristina Nicolau; Raluca Elena Jipa; Ramona Ștefania Popescu; Cristina Loredana Benea; Alina Cozma; Ioana Andreea Dărămuș; Victor Daniel Miron; Liviu Jany Prisăcariu; Adriana Florina Bahnă; Irina Nistor; Oana Manuela Secrieru; Silvas George; Andreea Bîrcă; Loredana Dobrea; Alexandra-Ștefana Șogorescu; Ioana Viziteu; Anca Streinu-Cercel

doi:10.18683/germs.2021.1286

Treatment initiation or switch to BIC/FTC/TAF - real-world safety and efficacy data from two HIV centers in Romania

Germs. 2021 Dec 29;11(4):512-522. doi: 10.18683/germs.2021.1286. eCollection 2021 Dec.

Authors

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

Affiliations

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.

Keywords: BIC/FTC/TAF; PLWH; Romania; real-world.

GERMS.