This multicenter real-world study from the PRESTIGIO Registry evaluated the effectiveness and durability of lenacapavir-based regimens in heavily treatment-experienced people with HIV and ongoing viremia due to multidrug resistance. Participants had documented resistance to multiple antiretroviral classes and limited remaining therapeutic options. After initiation of lenacapavir with an optimized background regimen, a high proportion of patients achieved virological suppression (HIV-1 RNA <50 copies/mL) during follow-up. CD4+ T-cell counts improved, indicating immunological recovery. Treatment discontinuation was uncommon, and the regimen was generally well tolerated. Overall, the study shows that lenacapavir is an effective and durable salvage therapy option in real-world clinical practice for patients with advanced, multidrug-resistant HIV infection.
Durability of lenacapavir in viremic heavily treatment-experienced people with HIV: real-world data from the PRESTIGIO Registry / Clemente, Tommaso; Torkjazi, Golnaz; Capra, Nicolò; Gagliardini, Roberta; Cattelan, Anna Maria; Lolatto, Riccardo; Fronti, Elisa; Fiscon, Marta; De Socio, Giuseppe Vittorio; Orofino, Giancarlo; Santoro, Maria Mercedes; Spagnuolo, Vincenzo; null, null; Castagna, Antonella; Spagnuolo, Vincenzo; Armenia, Daniele; Bonora, Stefano; Calza, Leonardo; Cattelan, Anna Maria; Cenderello, Giovanni; Cervo, Adriana; Comi, Laura; Di Biagio, Antonio; Focà, Emanuele; Gagliardini, Roberta; Giacomelli, Andrea; Lagi, Filippo; Marchetti, Giulia; Rusconi, Stefano; Saladini, Francesco; Santoro, Maria; Zazzi, Maurizio; Galli, Andrea; Armenia, Daniele; Saladini, Francesco; Santoro, Maria; Zazzi, Maurizio; Carini, Elisabetta; Bagaglio, Sabrina; Piromalli, Girolamo; Lolatto, Riccardo; Capra, Nicolò; Tavio, Marcello; Paggi, Alessandra Mataloni; Magnani, Silvia; Colafigli, Manuela; Schioppa, Ornella; Zanussi, Stefania; Da Ros, Valentina; Rossetto, Silvia; Saracino, Annalisa; Balena, Flavia; Comi, Laura; Valenti, Daniela; Viale, Pierluigi; Calza, Leonardo; Malerba, Federica; Cretella, Silvia; Riccardi, Riccardo; Castelli, Francesco; Focà, Emanuele; Minisci, Davide; Menzaghi, Barbara; Farinazzo, Maddalena; Abeli, Chiara; Cacopardo, Bruno; Celesia, Maurizio; Paternò Raddusa, Michele Salvatore; Giarratana, Carmen; Fusco, Paolo; Olivadese, Vincenzo; Mongiardi, Simona; Pan, Angelo; Fornabaio, Chiara; Brambilla, Paola; Bartoloni, Alessandro; Lagi, Filippo; Corsi, Paola; Sasha, Trevisan; Giuseppe, Gasparro; Costa, Cecilia; Bellucci, Alessio; Mariabelli, Elisa; Santantonio, Teresa; Caputo, Sergio Lo; Ferrara, Sergio; Narducci, Arianna; Pontali, Emanuele; Feasi, Marcello; Sarà, Antonio; Bassetti, Matteo; Di Biagio, Antonio; Blanchi, Sabrina; Piconi, Stefania; Bottanelli, Martina; Pontiggia, Silvia; Giada, Valsecchi; Rusconi, Stefano; Bassoli, Cinzia Roberta; Bassani, Francesco; Bevilacqua, Liana; Castagna, Antonella; Spagnuolo, Vincenzo; Muccini, Camilla; Clemente, Tommaso; Papaioannu Borjesson, Rebecka; Lolatto, Riccardo; Capra, Nicolò; Carini, Elisabetta; Bagaglio, Sabrina; Piromalli, Girolamo; Galli, Andrea; Torkjazi, Golnaz; Antinori, Spinello; Giacomelli, Andrea; Formenti, Tiziana; Marchetti, Giulia; Gazzola, Lidia; Trionfo Fineo, Fabiana; Puoti, Massimo; Moioli, Cristina; D'Amico, Federico; Elena, Simoncini; Serena, Sassi; Mussini, Cristina; Cervo, Adriana; Nardini, Giulia; Manzillo, Elio; Gallicchio, Antonella; Cattelan, Anna Maria; Mazzitelli, Maria; Cascio, Antonio; Trizzino, Marcello; Fronti, Elisa; Laccabue, Diletta; Carli, Federica; Gulminetti, Roberto; Pagnucco, Layla; Demitri, Mattia; Ferrari, Alessandra; De Socio, Giuseppe Vittorio; Francisci, Daniela; Schiaroli, Elisabetta; Garlassi, Elisa; Corsini, Romina; Gagliardini, Roberta; Fusto, Marisa; Sarmati, Loredana; Malagnino, Vincenzo; Mulas, Tiziana; Compagno, Mirko; Torti, Carlo; Di Giambenedetto, Simona; Lamonica, Silvia; Salvo, Pierluigi; Cenderello, Giovanni; Pincino, Rachele; Laurenda, Davide; Madeddu, Giordano; De Vito, Andrea; Tumbarello, Mario; Fabbiani, Massimiliano; Panza, Francesca; Rancan, Ilaria; Di Perri, Giovanni; Bonora, Stefano; Ferrara, Micol; Calcagno, Andrea; Fantino, Silvia; Orofino, Giancarlo; Calleri, Guido; Marta, Guastavigna; Nardi, Stefano; Fiscon, Marta. - In: JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY. - ISSN 0305-7453. - ELETTRONICO. - 81:(2026), pp. dkaf415.0-dkaf415.0. [10.1093/jac/dkaf415]
Durability of lenacapavir in viremic heavily treatment-experienced people with HIV: real-world data from the PRESTIGIO Registry
Lagi, Filippo;Bartoloni, Alessandro;Lagi, Filippo;Sasha, Trevisan;Giuseppe, Gasparro;
2026
Abstract
This multicenter real-world study from the PRESTIGIO Registry evaluated the effectiveness and durability of lenacapavir-based regimens in heavily treatment-experienced people with HIV and ongoing viremia due to multidrug resistance. Participants had documented resistance to multiple antiretroviral classes and limited remaining therapeutic options. After initiation of lenacapavir with an optimized background regimen, a high proportion of patients achieved virological suppression (HIV-1 RNA <50 copies/mL) during follow-up. CD4+ T-cell counts improved, indicating immunological recovery. Treatment discontinuation was uncommon, and the regimen was generally well tolerated. Overall, the study shows that lenacapavir is an effective and durable salvage therapy option in real-world clinical practice for patients with advanced, multidrug-resistant HIV infection.
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