Real-life safety of Emtricitabine/Tenofovir Alafenamide/Bictegravir

被引:7
作者
Squillace, Nicola [1 ]
Ricci, Elena [2 ]
Maggi, Paolo [3 ]
Taramasso, Lucia [4 ]
Menzaghi, Barbara [5 ]
De Socio, Giuseppe Vittorio [6 ]
Piconi, Stefania [7 ]
Maurizio Celesia, Benedetto [8 ]
Orofino, Giancarlo [9 ]
Sarchi, Eleonora [10 ]
Pellicano, Giovanni Francesco [11 ]
Simeone, Filomena [3 ]
Valsecchi, Laura [12 ]
Bandera, Alessandra [13 ]
Cenderello, Giovanni [14 ]
Attala, Letizia [15 ]
Angioni, Goffredo [16 ]
Falasca, Katia [17 ]
Cascio, Antonio [18 ]
Bargiacchi, Olivia [19 ]
Di Biagio, Antonio [4 ]
Bonfanti, Paolo [1 ,20 ]
机构
[1] Fdn IRCCS San Gerardo Tintori, Infect Dis Unit, Monza, Italy
[2] Fdn ASIA Onlus, Buccinasco, MI, Italy
[3] AORN St Anna & San Sebastiano, Infect Dis Unit, Caserta, Italy
[4] Univ Genoa, Infect Dis Clin, San Martino Hosp, Genoa, Italy
[5] ASST Valle Olona, Unit Infect Dis, Busto Arsizio, VA, Italy
[6] Santa Maria Hosp, Unit Infect Dis, Perugia, Italy
[7] A Manzoni Hosp, Unit Infect Dis, Lecce, Italy
[8] Garibaldi Hosp, Unit Infect Dis, Catania, Italy
[9] ASL Citta Torino, Div Infect & Trop Dis 1, Turin, Italy
[10] S Antonio & Biagio & Cesare Arrigo Hosp, Infect Dis Unit, Alessandria, Italy
[11] Univ Messina, G Martino Hosp, Infect Dis, Messina, Italy
[12] ASST Fatebenefratelli Sacco, Dept Infect Dis 1, Milan, Italy
[13] Fdn IRCCS Ca Granda Osped Maggiore Policlin, Infect Dis Unit, Milan, Italy
[14] Sanremo Hosp, Infect Dis Dept, San Remo, Italy
[15] Santa Maria Annunziata Hosp, Unit Infect Dis, SOC USLCENTRO FIRENZE 1, Florence, Italy
[16] SS Trinita Hosp, Infect Dis Unit, Cagliari, Italy
[17] Univ G dAnnunzio, Dept Med & Sci Aging, Clin Infect Dis, Chieti Pescara, Chieti, Italy
[18] Univ Palermo, Dept Hlth Promot Mother & Child Care, Unit Infect Dis, Internal Med & Med Specialties, Palermo, Italy
[19] Osped Maggiore La Carita, Unit Infect Dis, Novara, Italy
[20] Univ Milano Bicocca, Dept Med, Milan, MI, Italy
来源
PLOS ONE | 2023年 / 18卷 / 08期
关键词
TENOFOVIR ALAFENAMIDE; INSULIN-RESISTANCE; ANTIRETROVIRALS; BICTEGRAVIR; MULTICENTER; REGIMENS; PHASE-3;
D O I
10.1371/journal.pone.0289132
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
IntroductionIntegrase 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 methodsConsecutive 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.ResultsFive hundred and thirty-nine PLWH with at least one follow-up visit were included in the analysis. Mean age was 48 years (& PLUSMN;12.1), 74% were male, 16.1% were naive 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-naive 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.ConclusionsIn 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-naive 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.
引用
收藏
页数:12
相关论文
共 22 条
[1]  
Adults HPoAGf., 2022, Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV
[2]   Real-life experience with bictegravir/emtricitabine/tenofovir alafenamide in a large reference clinical centre [J].
Ambrosioni, Juan ;
Rojas Lievano, Jhon ;
Berrocal, Leire ;
Inciarte, Alexy ;
de la Mora, Lorena ;
Gonzalez-Cordon, Ana ;
Martinez-Rebollar, Maria ;
Laguno, Montserrat ;
Torres, Berta ;
Ugarte, Ainoa ;
Chivite, Ivan ;
Leal, Lorna ;
de Lazzari, Elisa ;
Miro, Jose M. ;
Blanco, Jose L. ;
Martinez, Esteban ;
Mallolas, Josep .
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 2022, 77 (04) :1133-1139
[3]  
[Anonymous], 2022, EUROPEAN AIDS CLIN S
[4]   Inhibition of Adipose Tissue Beiging by HIV Integrase Inhibitors, Dolutegravir and Bictegravir, Is Associated with Adipocyte Hypertrophy, Hypoxia, Elevated Fibrosis, and Insulin Resistance in Simian Adipose Tissue and Human Adipocytes [J].
Ayissi, Kenza Ngono ;
Gorwood, Jennifer ;
Le Pelletier, Laura ;
Bourgeois, Christine ;
Beaupere, Carine ;
Auclair, Martine ;
Foresti, Roberta ;
Motterlini, Roberto ;
Atlan, Michael ;
Barrail-Tran, Aurelie ;
Le Grand, Roger ;
Desjardins, Delphine ;
Feve, Bruno ;
Lambotte, Olivier ;
Capeau, Jacqueline ;
Bereziat, Veronique ;
Lagathu, Claire .
CELLS, 2022, 11 (11)
[5]   Contemporary antiretrovirals and body-mass index: a prospective study of the RESPOND cohort consortium [J].
Bansi-Matharu, Loveleen ;
Phillips, Andrew ;
Oprea, Cristiana ;
Grabmeier-Pfistershammer, Katharina ;
Gunthard, Huldrych F. ;
De Wit, Stephane ;
Guaraldi, Giovanni ;
Vehreschild, Jorg J. ;
Wit, Ferdinand ;
Law, Matthew ;
Wasmuth, Jan-Christian ;
Chkhartishvili, Nikoloz ;
Monforte, Antonella d'Arminio ;
Fontas, Eric ;
Vesterbacka, Jan ;
Miro, Jose M. ;
Castagna, Antonella ;
Stephan, Christoph ;
Llibre, Josep M. ;
Neesgaard, Bastian ;
Greenberg, Lauren ;
Smith, Colette ;
Kirk, Ole ;
Duvivier, Claudine ;
Dragovic, Gordana ;
Lundgren, Jens ;
Dedes, Nikos ;
Knudsen, Andreas ;
Gallant, Joel ;
Vannappagari, Vani ;
Peters, Lars ;
Elbirt, Daniel ;
Sarcletti, Mario ;
Braun, Dominique L. ;
Necsoi, Coca ;
Mussini, Cristina ;
Muccini, Camilla ;
Bolokadze, Natalie ;
Hoy, Jennifer ;
Mocroft, Amanda ;
Ryom, Lene .
LANCET HIV, 2021, 8 (11) :E711-E722
[6]   An Italian approach to postmarketing monitoring: Preliminary results from the SCOLTA (Surveillance cohort long-term toxicity antiretrovirals) Project on the safety of lopinavir/ritonavir [J].
Bonfanti, P ;
Martinelli, C ;
Ricci, E ;
Carradori, S ;
Parruti, G ;
Armignacco, O ;
Magnani, C ;
Quirino, T .
JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, 2005, 39 (03) :317-320
[7]   Antiretroviral therapy and weight gain in naive HIV-1 infected patient: a narrative review [J].
Dupont, Emilie ;
Cyr-Yombi, Jean .
AIDS REVIEWS, 2022, 24 (03) :122-132
[8]   The Triglyceride-to-HDL Cholesterol Ratio Association with insulin resistance in obese youths of different ethnic backgrounds [J].
Giannini, Cosimo ;
Santoro, Nicola ;
Caprio, Sonia ;
Kim, Grace ;
Lartaud, Derek ;
Shaw, Melissa ;
Pierpont, Bridget ;
Weiss, Ram .
DIABETES CARE, 2011, 34 (08) :1869-1874
[9]   The Integrase Inhibitors Dolutegravir and Raltegravir Exert Proadipogenic and Profibrotic Effects and Induce Insulin Resistance in Human/Simian Adipose Tissue and Human Adipocytes [J].
Gorwood, Jennifer ;
Bourgeois, Christine ;
Pourcher, Valerie ;
Pourcher, Guillaume ;
Charlotte, Frederic ;
Mantecon, Matthieu ;
Rose, Cindy ;
Morichon, Romain ;
Atlan, Michael ;
Le Grand, Roger ;
Desjardins, Delphine ;
Katlama, Christine ;
Feve, Bruno ;
Lambotte, Olivier ;
Capeau, Jacqueline ;
Bereziat, Veronique ;
Lagathu, Claire .
CLINICAL INFECTIOUS DISEASES, 2020, 71 (10) :E549-E560
[10]   Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial [J].
Kityo, Cissy ;
Hagins, Debbie ;
Koenig, Ellen ;
Avihingsanon, Anchalee ;
Chetchotisakd, Ploenchan ;
Supparatpinyo, Khuanchai ;
Gankina, Natalya ;
Pokrovsky, Vadim ;
Voronin, Evgeny ;
Stephens, Jeffrey L. ;
DeJesus, Edwin ;
Wang, Hui ;
Acosta, Rima K. ;
Cao, Huyen ;
Quirk, Erin ;
Martin, Hal ;
Makadzange, Tariro .
JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, 2019, 82 (03) :321-328