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JAC Advance Access originally published online on January 15, 2009
Journal of Antimicrobial Chemotherapy 2009 63(3):600-608; doi:10.1093/jac/dkn521
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© The Author 2009. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Original research

Valganciclovir as pre-emptive therapy for cytomegalovirus infection post-allogenic stem cell transplantation: implications for the emergence of drug-resistant cytomegalovirus

Tiziano Allice1, Alessandro Busca2, Franco Locatelli2, Michele Falda2, Fabrizia Pittaluga3 and Valeria Ghisetti1,3,*

1 Laboratory of Microbiology and Virology, Department of Infectious Disease, Amedeo di Savoia Hospital, Turin, Italy 2 Bone Marrow Transplant Unit, San Giovanni Battista Hospital, Turin, Italy 3 Laboratory of Microbiology, Molinette Hospital, Turin, Italy

Received 6 August 2008; returned 29 September 2008; revised 21 October 2008; accepted 3 December 2008

* Corresponding author. Laboratory of Microbiology and Virology, Department of Infectious Disease, Amedeo di Savoia Hospital, Corso Svizzera 164, Torino, Italy. Tel: +39-011-4393838; Fax: +39-011-4393820; E-mail: valeria.ghisetti{at}unito.it

Objectives: Valganciclovir is a well established drug for the management of cytomegalovirus (CMV) infection in haematopoietic stem cell transplantation (HSCT). Data concerning its safety regarding the development of drug resistance are required. The aim of the present study was to retrospectively investigate CMV drug resistance in a group of HSCT patients experiencing relapses of CMV infection after a first-line pre-emptive antiviral therapy.

Methods: Thirteen adult HSCT patients out of 26 with asymptomatic CMV infection, experiencing relapsing infections 45–155 days after either intravenous (iv) ganciclovir (2 patients) or valganciclovir (11 patients), were studied. Genotypic assays for mutations in the viral phosphotransferase (UL97) and DNA-polymerase (UL54) genes were directly applied on patient specimens. Baseline CMV sequences were compared with those at the time of relapses to identify drug-resistant strains.

Results: UL97 mutations A594V and M460V known to confer drug resistance developed in one relapsing patient who received iv ganciclovir as first-line therapy, corresponding to a rate of 7.7% of relapses due to drug-resistant strains and an overall 3.8% rate of infections due to CMV drug-resistant strains. UL54 drug resistance mutations were absent. No evidence of drug resistance was found in patients on valganciclovir either as first-line therapy or as treatment for relapses.

Conclusions: The safety profile of valganciclovir as anti-CMV pre-emptive therapy was confirmed, as well as that monitoring CMV drug resistance with genotypic tests on sequential isolates over the time-course of therapy offers guidance to tailor antiviral treatment in a clinically relevant time frame.

Keywords: CMV , UL97 , UL54 , sequences , mutations


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