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/mm(3), 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.
Effectiveness of first-line lamivudine/dolutegravir antiretroviral therapy in persons with HIV: real-life data from the ICONA Foundation cohort / Vergori, Alessandra; Cozzi-Lepri, Alessandro; Lo Caputo, Sergio; Tavelli, Alessandro; Mazzotta, Valentina; Schiaroli, Elisabetta; Orofino, Giancarlo; Mussini, Cristina; Nozza, Silvia; Cingolani, Antonella; Antinori, Andrea; D'Arminio Monforte, Antonella; Null, Null; D'Arminio Monforte, A; Antinori, A; Antinori, S; Castagna, A; Cauda, R; Di Perri, G; Girardi, E; Iardino, R; Lazzarin, A; Marchetti, G C; Mussini, C; Quiros-Roldan, E; Sarmati, L; Suligoi, B; Von Schloesser, F; Viale, P; D'Arminio Monforte, A; Antinori, A; Castagna, A; Ceccherini-Silberstein, F; Cingolani, A; Cozzi-Lepri, A; Di Biagio, A; Girardi, E; Gori, A; Lo Caputo, S; Marchetti, G; Maggiolo, F; Mussini, C; Puoti, M; Perno, C F; Torti, C; Antinori, A; Bandera, A; Bonora, S; Calcagno, A; Canetti, D; Castagna, A; Ceccherini-Silberstein, F; Cervo, A; Cingolani, A; Cinque, P; Cozzi-Lepri, A; D'Arminio Monforte, A; Di Biagio, A; Gagliardini, R; Giacomelli, A; Girardi, E; Gianotti, N; Gori, A; Guaraldi, G; Lanini, S; Lapadula, G; Lichtner, M; Lai, A; Lo Caputo, S; Madeddu, G; Maggiolo, F; Malagnino, V; Marchetti, G; Mondi, A; Mazzotta, V; Mussini, C; Nozza, S; Perno, C F; Piconi, S; Pinnetti, C; Puoti, M; Quiros Roldan, E; Rossotti, R; Rusconi, S; Santoro, M M; Saracino, A; Sarmati, L; Spagnuolo, V; Squillace, N; Svicher, V; Taramasso, L; Torti, C; Vergori, A; Cozzi-Lepri, A; De Benedittis, S; Fanti, I; Lentini, N; Giotta, M; Pastorino, R; Rodanò, A; Roen, A; Tavelli, 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; Saracino, A; Santoro, C; Milano, E; Comi, L; Suardi, C; Viale, P; Badia, L; Cretella, S; Erne, E M; Pieri, A; Quiros Roldan, E; 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; Lo Caputo, S; Narducci, A; Bassetti, M; Pontali, E; Blanchi, S; Bobbio, N; Del Borgo, C; Marocco, R; Mancarella, G; Piconi, S; Molteni, C; Rusconi, S; Canavesi, G; Pellicanò, G; Russotto, Y; Marchetti, G; Antinori, S; Gori, A; Puoti, M; Castagna, A; Bandera, A; Bono, V; Cossu, M V; Giacomelli, A; Lolatto, R; Moioli, M C; Pezzati, L; Diotallevi, S; Tincati, C; Mussini, C; Menozzi, M; Bonfanti, P; Lapadula, G; 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; Schiaroli, E; Parruti, G; Sozio, F; Messeri, D; Bonelli, S I; Lazzaretti, C; Corsini, R; Antinori, A; Cauda, R; Mastroianni, C; Sarmati, L; Latini, A; Cingolani, 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; Madeddu, G; De Vito, A; Fabbiani, M; Montagnani, F; Franco, A; Fontana Del Vecchio, R; Francisci, D; Di Giuli, C; Orofino, G C; Calleri, G; Di Perri, G; Bonora, S; Accardo, G; Tascini, C; Londero, A; Battagin, G; Nicolè, S; Starnini, G; Dell'Isola, S. - In: JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY. - ISSN 0305-7453. - (2025), pp. 1-10. [10.1093/jac/dkaf345]
Effectiveness of first-line lamivudine/dolutegravir antiretroviral therapy in persons with HIV: real-life data from the ICONA Foundation cohort
Mussini, Cristina;
2025
Abstract
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/mm(3), 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.
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