ArticleEuropean journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology2009
Oral valganciclovir treatment in newborns with symptomatic congenital cytomegalovirus infection.
Article in European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
22 citing papers in PubMed, 74 citations in OpenAlex.
- Valganciclovir for symptomatic congenital cytomegalovirus disease.The New England journal of medicine · 2015Trial
- Pharmacokinetics and pharmacodynamics of valganciclovir in infants with severe HIV-associated pneumonia in Africa: a sub-study of the EMPIRICAL randomised controlled trial.EClinicalMedicine · 2026Article
- Changes in Neutrophil Count During Valganciclovir Therapy for Symptomatic Congenital Cytomegalovirus Infection.Biomedicines · 2025Article
- Progress and Challenges in the Management of Congenital Cytomegalovirus Infection.Clinics and practice · 2024Review
- Efficacy and Safety of Valganciclovir in Congenital Cytomegalovirus Infection with Isolated Intrahepatic Cholestasis: A Randomized Controlled Trial.Pediatric gastroenterology, hepatology & nutrition · 2024Article
- Treatment of congenital cytomegalovirus infection.Clinical and experimental pediatrics · 2023Article
- Role of Valganciclovir in Children with Congenital CMV Infection: A Review of the Literature.Children (Basel, Switzerland) · 2023Review
- Treatment of Congenital Cytomegalovirus and Ganciclovir Therapeutic Drug Monitoring in Twin Preterm Infants.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023Article
- Oral Valganciclovir Therapy in Infants Aged ≤2 Months with Congenital Cytomegalovirus Disease: A Multicenter, Single-Arm, Open-Label Clinical Trial in Japan.Journal of clinical medicine · 2022Article
- Congenital CMV, Lights and Shadows on Its Management: The Experience of a Reference Center in Northern Italy.Children (Basel, Switzerland) · 2022Article
- A UHPLC-MS/MS Method for Therapeutic Drug Monitoring of Aciclovir and Ganciclovir in Plasma and Dried Plasma Spots.Biomedicines · 2021Article
- Development of a Vaccine against Human Cytomegalovirus: Advances, Barriers, and Implications for the Clinical Practice.Vaccines · 2021Review
- Long-Term Clinical, Audiological, Visual, Neurocognitive and Behavioral Outcome in Children With Symptomatic and Asymptomatic Congenital Cytomegalovirus Infection Treated With Valganciclovir.Frontiers in medicine · 2020Article
- Efficacy of Valganciclovir Treatment Depends on the Severity of Hearing Dysfunction in Symptomatic Infants with Congenital Cytomegalovirus Infection.International journal of molecular sciences · 2019Article
- Potential Benefit of Selective CMV Testing after Failed Newborn Hearing Screening.International journal of neonatal screening · 2018Review
- An Italian Prospective Experience on the Association Between Congenital Cytomegalovirus Infection and Autistic Spectrum Disorder.Journal of autism and developmental disorders · 2017Article
- Pulmonary Hypoplasia Caused by Fetal Ascites in Congenital Cytomegalovirus Infection Despite Fetal Therapy.Frontiers in pediatrics · 2017Article
- Awareness of Cytomegalovirus Infection among Pregnant Women in Geneva, Switzerland: A Cross-sectional Study.International journal of environmental research and public health · 2015Article
- Pharmacokinetics and pharmacodynamics of antibacterials, antifungals, and antivirals used most frequently in neonates and infants.Clinical pharmacokinetics · 2014Review
- Emergence of antiviral resistance during oral valganciclovir treatment of an infant with congenital cytomegalovirus (CMV) infection.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
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Registered trials
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