Oral valganciclovir treatment in newborns with symptomatic congenital cytomegalovirus infection

G. Lombardi, F. Garofoli, P. Villani, M. Tizzoni, M. Angelini, M. Cusato, L. Bollani, A. De Silvestri, M. Regazzi, M. Stronati

Research output: Contribution to journalArticlepeer-review


This study was performed to assess oral valganciclovir V-GCV (GCV pro-drug), 15 mg/kg bid for 6 weeks to 13 neonates with symptomatic congenital cytomegalovirus (CMV). We monitored plasma levels of GCV within 30 days of therapy: Ctrough, and C2h (before and the 2 hours after administration), we performed viral assessment in plasma and urine and tolerability at baseline, and every fortnight. Pharmacokinetics showed GCV stable and effective plasma concentrations: mean Ctrough = 0.51∈±∈0.3 and C2h : 3.81∈±∈1.37 μg/ml. No significant variability was seen neither intra-patient nor inter-patients. One newborn discontinued therapy because of thrombocytopenia, another finished with a neutrophils count of 1,000/μl. At the end of therapy 6 out of 12 and 8 out of 12 newborns were negative for CMV in urine and plasma. The 4 newborns positive for CMV DNA showed a 90% reduction of pre-therapy values. Clinically, the 4 patients reporting hepatic disease and the 3 with thrombocytopenia recovered after 6 weeks of therapy. Eight newborns suffered from SNHL; at the 6-month follow-up no patients had worsened, 2 had improved, and no deterioration was reported in 3 newborns with chorioretinitis scarring. The paucity of adverse events, and the effectiveness and stability of drug plasma concentrations are the important findings of our study.

Original languageEnglish
Pages (from-to)1465-1470
Number of pages6
JournalEuropean Journal of Clinical Microbiology and Infectious Diseases
Issue number12
Publication statusPublished - Dec 2009

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases


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