title: Oral valganciclovir treatment in newborns with symptomatic congenital cytomegalovirus infection.
abstract: 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: C(trough), and C(2h) (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 C(trough) = 0.51 +/- 0.3 and C(2h) : 3.81 +/- 1.37 microg/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/microl. 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.
authors.affiliation: Neonatology and Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Lombardi
authors.forename: F
authors.initials: F
authors.lastname: Garofoli
authors.forename: P
authors.initials: P
authors.lastname: Villani
authors.forename: M
authors.initials: M
authors.lastname: Tizzoni
authors.forename: M
authors.initials: M
authors.lastname: Angelini
authors.forename: M
authors.initials: M
authors.lastname: Cusato
authors.forename: L
authors.initials: L
authors.lastname: Bollani
authors.forename: A
authors.initials: A
authors.lastname: De Silvestri
authors.forename: M
authors.initials: M
authors.lastname: Regazzi
authors.forename: M
authors.initials: M
authors.lastname: Stronati
mesh_terms: D000284:Administration, Oral; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D003587:Cytomegalovirus / Q000302:isolation & purification; D003586:Cytomegalovirus Infections / Q000188:drug therapy*; D016903:Drug Monitoring; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000188:drug therapy*; D008297:Male; D010949:Plasma / Q000737:chemistry / Q000821:virology; D016896:Treatment Outcome; D014556:Urine / Q000737:chemistry / Q000821:virology; D000077562:Valganciclovir
chemical_list: D000998:Antiviral Agents; D000077562:Valganciclovir; D015774:Ganciclovir