| Title: |
Effectiveness of first-line lamivudine/dolutegravir antiretroviral therapy in persons with HIV: real-life data from the ICONA Foundation cohort |
| Authors: |
Vergori, A; Cozzi-Lepri, A; Lo Caputo, S; Tavelli, A; Mazzotta, V; Schiaroli, E; Orofino, G; Mussini, C; Nozza, S; Cingolani, A; Antinori, A; Antinori, S; Castagna, A; Cauda, R; Di Perri, G; Girardi, E; Iardino, R; Lazzarin, A; Marchetti, G C; Quiros-Roldan, E; Sarmati, L; Suligoi, B; von Schloesser, F; Viale, P; Ceccherini-Silberstein, F; Di Biagio, A; Gori, A; Marchetti, G; Maggiolo, F; Puoti, M; Perno, C F; Torti, C; Bandera, A; Bonora, S; Calcagno, A; Canetti, D; Cervo, A; Cinque, P; d'Arminio Monforte, A; Gagliardini, R; Giacomelli, A; Gianotti, N; Guaraldi, G; Lanini, S; Lapadula, G; Lichtner, M; Lai, A; Madeddu, G; Malagnino, V; Mondi, A; Piconi, S; Pinnetti, C; Rossotti, R; Rusconi, S; Santoro, M M; Saracino, A; Spagnuolo, V; Squillace, N; Svicher, V; Taramasso, L; De Benedittis, S; Fanti, I; Lentini, N; Giotta, M; Pastorino, R; Rodanò, A; Roen, A; Bazzichetto, S; Cernuschi, M; Cosmaro, L; Perziano, A; Calvino, V; Russo, D; Farinella, M; Policek, N; Del Negro, V L; Augello, M; Carrara, S; Graziano, S; Prota, G; Truffa, S; Vincenti, D; Rovito, R; Giacometti, A; Costantini, A; Barocci, V; Santoro, C; Milano, E; Comi, L; Suardi, C; Badia, L; Cretella, S; Erne, E M; Pieri, A; Focà, E; Menzaghi, B; Abeli, C; Chessa, L; Pes, F; Maggi, P; Alessio, L; Nunnari, G; Celesia, B M; Vecchiet, J; Falasca, K; Pan, A; Dal Zoppo, S; Segala, D; Bartalesi, F; Bartoloni, A; Borchi, B; Costa, C; Narducci, A; Bassetti, M; Pontali, E; Blanchi, S; Bobbio, N; Del Borgo, C; Marocco, R; Mancarella, G; Molteni, C; Canavesi, G; Pellicanò, G; Russotto, Y; Bono, V; Cossu, M V; Lolatto, R; Moioli, M C; Pezzati, L; Diotallevi, S; Tincati, C; Menozzi, M; Bonfanti, P; Sangiovanni, V; Gentile, I; Esposito, V; Coppola, N; Fusco, F M; Di Filippo, G; Rizzo, V; Sangiovanni, N; Martini, S; Cattelan, A M; Leoni, D; Cascio, A; Trizzino, M; Francisci, D; Parruti, G; Sozio, F; Messeri, D; Bonelli, S I; Lazzaretti, C; Corsini, R; Mastroianni, C; Latini, A; Mastrorosa, I; Lamonica, S; Capozzi, M; Camici, M; Mezzaroma, I; Rivano Capparuccia, M; Iaiani, G; Stingone, C; Gianserra, L; Paulicelli, J; Plazzi, M M; d'Ettore, G; Fusto, M; Coledan, I; De Vito, A; Fabbiani, M; Montagnani, F; Franco, A; Fontana Del Vecchio, R; Di Giuli, C; Calleri, G; Accardo, G; Tascini, C; Londero, A; Battagin, G; Nicolè, S; Starnini, G; Dell'Isola, S |
| Contributors: |
A. Vergori; A. Cozzi-Lepri; S. Lo Caputo; A. Tavelli; V. Mazzotta; E. Schiaroli; G. Orofino; C. Mussini; S. Nozza; A. Cingolani; A. Antinori; S. Antinori; A. Castagna; R. Cauda; G. Di Perri; E. Girardi; R. Iardino; A. Lazzarin; G.C. Marchetti; E. Quiros-Roldan; L. Sarmati; B. Suligoi; F. Von Schloesser; P. Viale; F. Ceccherini-Silberstein; A. Di Biagio; A. Gori; G. Marchetti; F. Maggiolo; M. Puoti; C.F. Perno; C. Torti; A. Bandera; S. Bonora; A. Calcagno; D. Canetti; A. Cervo; P. Cinque; A. D'Arminio Monforte; R. Gagliardini; A. Giacomelli; N. Gianotti; G. Guaraldi; S. Lanini; G. Lapadula; M. Lichtner; A. Lai; G. Madeddu; V. Malagnino; A. Mondi; S. Piconi; C. Pinnetti; R. Rossotti; S. Rusconi; M.M. Santoro; A. Saracino; V. Spagnuolo; N. Squillace; V. Svicher; L. Taramasso; S. De Beneditti; I. Fanti; N. Lentini; M. Giotta; R. Pastorino; A. Rodanò; A. Roen; S. Bazzichetto; M. Cernuschi; L. Cosmaro; A. Perziano; V. Calvino; D. Russo; M. Farinella; N. Policek; V.L. Del Negro; M. Augello; S. Carrara; S. Graziano; G. Prota; S. Truffa; D. Vincenti; R. Rovito; A. Giacometti; A. Costantini; V. Barocci; C. Santoro; E. Milano; L. Comi; C. Suardi; L. Badia; S. Cretella |
| Publisher Information: |
Oxford Academic |
| Publication Year: |
2025 |
| Collection: |
The University of Milan: Archivio Istituzionale della Ricerca (AIR) |
| Subject Terms: |
Settore MEDS-10/B - Malattie infettive |
| Description: |
Objectives: This analysis aimed to evaluate the rate of failure of first-line lamivudine/dolutegravir in a real-world setting and assess the effectiveness among people with HIV (PWH) at higher risk of suboptimal response. Methods: The study included PWH from the ICONA cohort who started first-line lamivudine/dolutegravir between 2016 and 2024. The primary endpoint was time to treatment failure (TF), defined as virological failure (VF, two consecutive HIV-RNA of >50 copies/mL >6 months after treatment initiation) or discontinuation due to toxicity/lack virological control/non-adherence or death for any cause. Secondary endpoints were time to treatment discontinuation for any reason (TD) and pure VF. Main exposures of interest were baseline CD4 and HIV-RNA, age, sex at birth and nation of birth. Standard survival analysis and Cox regression models were used. Results: Among 446 participants, after a median follow-up of 22 months, 4.3% (n = 19) experienced TF, the 3 year cumulative probability was 5.8% (95% CI: 2.9%-8.7%). Baseline CD4 count was associated with a 3-fold higher risk of TF, which decreased after adjustments. Higher viral loads (>100 000 copies/mL), age >50 years and foreign-born status were also associated with an increased risk of TF. No differences in TF according to sex at birth were found. By 3 years the probabilities of TD and VF were 13.4% (95% CI: 9.1%-17.6%) and 2.3% (95% CI: 0.19%-4.4%), respectively. Conclusions: In our real-world setting, the TF probability for first-line lamivudine/dolutegravir was below 6% at 3 years, lower than in randomized trials. Our data suggest that, as shown with other regimens, PWH starting lamivudine/dolutegravir with CD4 count of ≤200 cells/mm3, HIV-RNA of >100 000 copies/mL, older age or foreign-born status may be at higher risk of TF, though larger studies are needed to qualify the magnitude of the effect. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/40985146; info:eu-repo/semantics/altIdentifier/wos/WOS:001577971300001; firstpage:1; lastpage:10; numberofpages:10; journal:JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY; https://hdl.handle.net/2434/1185293 |
| DOI: |
10.1093/jac/dkaf345 |
| Availability: |
https://hdl.handle.net/2434/1185293; https://doi.org/10.1093/jac/dkaf345 |
| Rights: |
info:eu-repo/semantics/openAccess ; license:Creative commons ; license uri:http://creativecommons.org/licenses/by-nc/4.0/ |
| Accession Number: |
edsbas.8CB70DEC |
| Database: |
BASE |