Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study)
Objectives: No previous studies specifically explored the switch from efavirenz to bictegravir (BIC)-containing three-drug antiretroviral regimens. This study aimed to evaluate the efficacy and safety outcomes of a treatment switch from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/...
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| Language: | English |
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Elsevier
2025-09-01
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| Series: | International Journal of Infectious Diseases |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971225001857 |
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| author | Roberta Gagliardini Marta Camici Simone Lanini Rita Bellagamba Sandrine Ottou Maria Maddalena Plazzi Alessandra Vergori Valentina Mazzotta Annalisa Mondi Marisa Fusto Jessica Paulicelli Massimo Tempestilli Carmela Pinnetti Elisabetta Grilli Ilaria Mastrorosa Federico De Zottis Giulia Del Duca Andrea Antinori |
| author_facet | Roberta Gagliardini Marta Camici Simone Lanini Rita Bellagamba Sandrine Ottou Maria Maddalena Plazzi Alessandra Vergori Valentina Mazzotta Annalisa Mondi Marisa Fusto Jessica Paulicelli Massimo Tempestilli Carmela Pinnetti Elisabetta Grilli Ilaria Mastrorosa Federico De Zottis Giulia Del Duca Andrea Antinori |
| author_sort | Roberta Gagliardini |
| collection | DOAJ |
| description | Objectives: No previous studies specifically explored the switch from efavirenz to bictegravir (BIC)-containing three-drug antiretroviral regimens. This study aimed to evaluate the efficacy and safety outcomes of a treatment switch from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) given once daily (OD) or on alternate days (ATAD) to BIC/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in virologically suppressed people with HIV (PWH). Methods: A pilot, single-arm, prospective study was conducted. Results: Overall, 234 PWH were enrolled. 217 of 234 (92.7%, 95% confidence interval [CI], 88.6-95.7%) participants had HIV-RNA <40 cp/ml at 48 weeks. Virological failure occurred in three participants, none with documented resistance, and all resuppressed without antiretroviral therapy change. After 48 weeks, a slight increase in cluster of differentiation (CD)4 cell count was observed from the baseline (+ 59 cells/mmc, 95% CI, 31; 86, P <0.001), but not in CD4/CD8 ratio. A slight increase in creatinine (mean change +0.11 mg/dl, 95% CI 0.10; 0.13, P <0.001) and a decrease in total cholesterol (mean change −8 mg/dl, 95% CI −14; −3, P = 0.001) were also observed. Conclusions: Our data showed that BIC/FTC/TAF demonstrated high virologic and immunologic efficacy and an excellent safety profile. |
| format | Article |
| id | doaj-art-eeee9d3a49764366ad45d479e86e43c3 |
| institution | Kabale University |
| issn | 1201-9712 |
| language | English |
| publishDate | 2025-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj-art-eeee9d3a49764366ad45d479e86e43c32025-08-20T03:57:31ZengElsevierInternational Journal of Infectious Diseases1201-97122025-09-0115810796110.1016/j.ijid.2025.107961Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study)Roberta Gagliardini0Marta Camici1Simone Lanini2Rita Bellagamba3Sandrine Ottou4Maria Maddalena Plazzi5Alessandra Vergori6Valentina Mazzotta7Annalisa Mondi8Marisa Fusto9Jessica Paulicelli10Massimo Tempestilli11Carmela Pinnetti12Elisabetta Grilli13Ilaria Mastrorosa14Federico De Zottis15Giulia Del Duca16Andrea Antinori17Viral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, Italy; Corresponding author:Infectious Diseases Division, Department of Medicine, University of Udine and Azienda Sanitaria Universitaria Friuli Centrale, Udine, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyCellular Immunology and Pharmacology Laboratory, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyViral Immunodeficiencies Unit, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS, Roma, ItalyObjectives: No previous studies specifically explored the switch from efavirenz to bictegravir (BIC)-containing three-drug antiretroviral regimens. This study aimed to evaluate the efficacy and safety outcomes of a treatment switch from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) given once daily (OD) or on alternate days (ATAD) to BIC/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in virologically suppressed people with HIV (PWH). Methods: A pilot, single-arm, prospective study was conducted. Results: Overall, 234 PWH were enrolled. 217 of 234 (92.7%, 95% confidence interval [CI], 88.6-95.7%) participants had HIV-RNA <40 cp/ml at 48 weeks. Virological failure occurred in three participants, none with documented resistance, and all resuppressed without antiretroviral therapy change. After 48 weeks, a slight increase in cluster of differentiation (CD)4 cell count was observed from the baseline (+ 59 cells/mmc, 95% CI, 31; 86, P <0.001), but not in CD4/CD8 ratio. A slight increase in creatinine (mean change +0.11 mg/dl, 95% CI 0.10; 0.13, P <0.001) and a decrease in total cholesterol (mean change −8 mg/dl, 95% CI −14; −3, P = 0.001) were also observed. Conclusions: Our data showed that BIC/FTC/TAF demonstrated high virologic and immunologic efficacy and an excellent safety profile.http://www.sciencedirect.com/science/article/pii/S1201971225001857ART optimizationIntegrase strand transfer inhibitorAntiretroviral therapyART-experiencedBictegravirEFV-based regimen |
| spellingShingle | Roberta Gagliardini Marta Camici Simone Lanini Rita Bellagamba Sandrine Ottou Maria Maddalena Plazzi Alessandra Vergori Valentina Mazzotta Annalisa Mondi Marisa Fusto Jessica Paulicelli Massimo Tempestilli Carmela Pinnetti Elisabetta Grilli Ilaria Mastrorosa Federico De Zottis Giulia Del Duca Andrea Antinori Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study) International Journal of Infectious Diseases ART optimization Integrase strand transfer inhibitor Antiretroviral therapy ART-experienced Bictegravir EFV-based regimen |
| title | Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study) |
| title_full | Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study) |
| title_fullStr | Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study) |
| title_full_unstemmed | Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study) |
| title_short | Switching to bictegravir/emtricitabine/tenofovir alafenamide from efavirenz/emtricitabine/tenofovir disoproxil in virologically suppressed people with HIV: findings from a non-randomized clinical trial (EBONY study) |
| title_sort | switching to bictegravir emtricitabine tenofovir alafenamide from efavirenz emtricitabine tenofovir disoproxil in virologically suppressed people with hiv findings from a non randomized clinical trial ebony study |
| topic | ART optimization Integrase strand transfer inhibitor Antiretroviral therapy ART-experienced Bictegravir EFV-based regimen |
| url | http://www.sciencedirect.com/science/article/pii/S1201971225001857 |
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