Refractory CMV infection in post-transplant phase: epidemiological framing in the Italian context, current patient management and unmet needs


  • Marianna Morani PharmaLex Italy S.p.A.
  • Fausto Baldanti Dipartimento di Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche, Università di Pavia, Pavia - Italy and Dipartimento di Microbiologia e Virologia, Fondazione IRCCS Policlinico San Matteo, Pavia - Italy
  • Fabio Ciceri Dipartimento di Ematologia e Trapianto di Midollo, IRCCS Ospedale San Raffaele, Milano - Italy
  • Franco Citterio Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Roma - Italy
  • Mariano Ferraresso Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico-Università degli Studi di Milano, Milano - Italy
  • Corrado Girmenia Dipartimento di Ematologia, Oncologia e Dermatologia, Unità Operativa Semplice Dipartimentale Pronto Soccorso e Accettazione Ematologica, Azienda Ospedaliero-Universitaria Policlinico Umberto I, Roma - Italy
  • Umberto Maggiore Dipartimento di Medicina e Chirurgia, Università di Parma, Parma - Italy
  • Massimo Martino Centro Unico Regionale Trapianti Cellule Staminali e Terapie Cellulari, Grande Ospedale Metropolitano BMM, Reggio Calabria - Italy
  • Francesco Onida Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico-Università degli Studi di Milano, Milano - Italy
  • Luciano Potena Struttura Semplice Dipartimentale Insufficienza Cardiaca e Trapianti, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna - Italy
  • Fabio Vistoli Divisione di Chirurgia Generale e dei Trapianti, Dipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Università di Pisa, Pisa - Italy
  • Paolo Antonio Grossi Dipartimento di Medicina e Chirurgia, Università degli Studi dell’Insubria, Varese - Italy



Cytomegalovirus infection, Epidemiology, Hematopoietic stem cell transplantation, Patient management, Solid organ transplantation, Unmet needs


Background: Cytomegalovirus (CMV) infection usually occurs asymptomatically but can represent an important cause of morbidity and mortality in patients with compromised immune system such as transplant patients. Infection may not respond to standard therapies leading to refractoriness (with or without resistance) which jeopardizes transplant successful outcome.

Objective: Since refractoriness represents a critical point, a project has been conducted to verify the epidemiology in the Italian context and to convey the current patients’ unmet medical needs.

Methods: The project included: literature analysis, expert interviews and results’ validation through expert opinion. Based on literature data, a questionnaire was built and submitted to 8 experts with proven experience in the management of post-transplant CMV infection. Topics included epidemiology, patient management, unmet needs and future perspective. Outcomes were validated by 3 additional national experts in solid organ transplantation, hematopoietic stem cell transplantation and infectious diseases.

Results: Epidemiological rates from literature applied to current transplantation numbers in Italy estimate approximately 109 adults and 8 children with refractory post-transplant CMV infection in 2021.

If valganciclovir/ganciclovir are ineffective, foscarnet is predominantly used. When foscarnet fails, patients have no therapeutic alternatives. Despite being a minority, this represents a high medical need. Therefore, the introduction of new therapeutic options with a better efficacy/safety profile would lead to a significant improvement in refractory CMV infection management.

Conclusion: Although refractory infections represent a minority, they are the most critical issue that can occur in post-transplant patients resulting in a high unmet need due to the lack of specific treatment options and the toxicity of current treatments used.


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How to Cite

Morani, M., Baldanti, F., Ciceri, F., Citterio, F., Ferraresso, M., Girmenia, C., Maggiore, U., Martino, M., Onida, F., Potena, L., Vistoli, F., & Grossi, P. A. (2023). Refractory CMV infection in post-transplant phase: epidemiological framing in the Italian context, current patient management and unmet needs. AboutOpen, 10(1), 97–102.
Received 2023-01-24
Accepted 2023-06-07
Published 2023-06-28