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. 2023 Aug 9;18(8):e0289132.
doi: 10.1371/journal.pone.0289132. eCollection 2023.

Real-life safety of Emtricitabine/Tenofovir Alafenamide/Bictegravir

Nicola Squillace  1 , Elena Ricci  2 , Paolo Maggi  3 , Lucia Taramasso  4 , Barbara Menzaghi  5 , Giuseppe Vittorio De Socio  6 , Stefania Piconi  7 , Benedetto Maurizio Celesia  8 , Giancarlo Orofino  9 , Eleonora Sarchi  10 , Giovanni Francesco Pellicanò  11 , Filomena Simeone  3 , Laura Valsecchi  12 , Alessandra Bandera  13 , Giovanni Cenderello  14 , Letizia Attala  15 , Goffredo Angioni  16 , Katia Falasca  17 , Antonio Cascio  18 , Olivia Bargiacchi  19 , Antonio Di Biagio  4 , Paolo Bonfanti  1   20 ; CISAI Study Group
Affiliations

Real-life safety of Emtricitabine/Tenofovir Alafenamide/Bictegravir

Nicola Squillace et al. PLoS One. .

Abstract

Introduction: Integrase strand transfer inhibitors (INSTI) are one of the most prescribed drug classes for the treatment of HIV infection worldwide. Emtricitabine/Tenofovir Alafenamide/ Bictegravir (FTC/TAF/BIC) has been evaluated in randomized clinical trials; few studies have verified tolerability and safety in clinical practice. Our aim was to investigate the metabolic and hepatic safety in a real-life setting of FTC/TAF/BIC.

Materials and methods: Consecutive people living with HIV infection (PLWH) enrolled in the SCOLTA project, switching to or initiating their first antiretroviral treatment with FTC/TAF/BIC were included. PLWH with HBV co-infection were excluded. Metabolic and hepatic variables were collected at T0 and T1, were defined as baseline and 6-month follow-up respectively, and their modifications were analysed using the paired t-test and the analysis of variance.

Results: Five hundred and thirty-nine PLWH with at least one follow-up visit were included in the analysis. Mean age was 48 years (±12.1), 74% were male, 16.1% were naïve to antiretrovirals (ART). At T1, ART-experienced PLWH showed a significant reduction of total cholesterol (TC) and triglycerides, and a slight increase in blood glucose (BG) and ALT. On the contrary, in ART-naïve PLWH blood lipids significantly increased, although with an unaffected TC/high density lipoprotein (HDL)-c ratio, while alanine aminotransferase (ALT) decreased significantly, mainly in those with altered baseline level. The treatment interruptions were 45 (8.4%) over the whole observation period, 13 (2.4%) due to AEs. The most frequent AEs were related to the central nervous system (6 events of depression, insomnia, headache, agitation) and 3 PLWH discontinued the regimen because of grade 1-2 weight gain.

Conclusions: In ART-experienced PLWH switching to FTC/TAF/BIC a significant improvement of lipid profile occurred but with significant BG and ALT variation without clinical relevance. In ART-naïve PLWH, blood lipids increased even though lipid profile did not worsen, and a trend towards normalization of liver enzymes was suggested. FTC/TAF/BIC is well tolerated in the real life setting.

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Conflict of interest statement

“The following authors served as consultant or advisory board and/or received speaker’s fees and/or received research grants for their institutions, outside the present work: PM and GFP from Gilead Science, ViiV Healthcare, Janssen and Merck Sharp & Dohme, PB from Gilead Science, ViiV Healthcare, Janssen, Merck Sharp & Dohme and Pfizer. ADB from Gilead Science, ViiV Healthcare and Janssen. RB from Gilead Science, ViiV Healthcare, and Merck Sharp & Dohme. AC from Gilead Science, Janssen, Merck Sharp & Dohme; NS from ViiV Healthcare, Janssen and Gilead Sciences; LT from ViiV Healthcare and Gilead Science; GVDS from ViiV Healthcare. All remaining authors have no potential conflicts of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.”

Figures

Fig 1
Fig 1. Flow chart of the treatment interruptions.
See this image and copyright information in PMC

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