Author:
Martino Massimo,Pitino Annalisa,Gori Mercedes,Bruno Benedetto,Crescimanno Alessandra,Federico Vincenzo,Picardi Alessandra,Tringali Stefania,Ingrosso Claudia,Carluccio Paola,Pastore Domenico,Musuraca Gerardo,Paviglianiti Annalisa,Vacca Adriana,Serio Bianca,Storti Gabriella,Mordini Nicola,Leotta Salvatore,Cimminiello Michele,Prezioso Lucia,Loteta Barbara,Ferreri Anna,Colasante Fabrizia,Merla Emanuela,Giaccone Luisa,Busca Alessandro,Musso Maurizio,Scalone Renato,Di Renzo Nicola,Marotta Serena,Mazza Patrizio,Musto Pellegrino,Attolico Immacolata,Selleri Carmine,Canale Filippo Antonio,Pugliese Marta,Tripepi Giovanni,Porto Gaetana,Martinelli Giovanni,Carella Angelo Michele,Cerchione Claudio
Abstract
Despite effective treatments, cytomegalovirus (CMV) continues to have a significant impact on morbidity and mortality in allogeneic stem cell transplant (allo-SCT) recipients. This multicenter, retrospective, cohort study aimed to evaluate the reproducibility of the safety and efficacy of commercially available letermovir for CMV prophylaxis in a real-world setting. Endpoints were rates of clinically significant CMV infection (CSCI), defined as CMV disease or CMV viremia reactivation within day +100-+168. 204 adult CMV-seropositive allo-SCT recipients from 17 Italian centres (median age 52 years) were treated with LET 240 mg/day between day 0 and day +28. Overall, 28.9% of patients underwent a haploidentical, 32.4% a matched related, and 27.5% a matched unrelated donor (MUD) transplant. 65.7% were considered at high risk of CSCI and 65.2% had a CMV seropositive donor. Low to mild severe adverse events were observed in 40.7% of patients during treatment [gastrointestinal toxicity (36.3%) and skin rash (10.3%)]. Cumulative incidence of CSCI at day +100 and day +168 was 5.4% and 18.1%, respectively, whereas the Kaplan-Meier event rate was 5.8% (95% CI: 2.4-9.1) and 23.3% (95% CI: 16.3-29.7), respectively. Overall mortality was 6.4% at day +100 and 7.3% at day +168. This real-world experience confirms the efficacy and safety of CMV.