Three-year hearing outcomes in infants with congenital cytomegalovirus disease treated with oral valganciclovir: Interim results of a six-year follow-up study in Japan
Ichiro Morioka , Yasumasa Kakei , Takumi Imai , Kazumichi Fujioka , Naoto Takahashi , Tetsushi Yoshikawa , Hiroyuki Moriuchi , Yoshinori Ito , Akira Oka , for the Japanese Congenital Cytomegalovirus Study Group
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Abstract
Objective
To evaluate the long-term hearing outcomes of infants with symptomatic congenital cytomegalovirus (CMV) disease who received 16 mg/kg of oral valganciclovir (VGCV) twice daily for six months.
Study design
We have currently performed a long-term extension study of an investigator-initiated, single-arm, prospective, multicenter clinical trial, in which 24 infants were treated with VGCV. Hearing outcomes up to three years after treatment initiation were described and the longitudinal changes in the proportion of "Improved hearing" were analyzed using logistic regression. The factors associated with these outcomes were explored. Adverse events that occurred after the completion of the administration period were assessed.
Results
At 3 years, among 48 ears from 24 infants, the number of "improved hearing," which was 19 (40.0 %) ears at 6 months, increased to 27 (56.3 %) ears (p = 0.032). When including “maintaining normal hearing” or “maintaining normal hearing or the same degree of hearing impairment”, the corresponding numbers were observed in 35 (72.9 %) and 45 (93.7 %) ears at 3 years, which were 25 (52.5 %) and 45 (93.7 %) ears at 6 months, respectively. Infants with milder hearing impairment at baseline showed high likelihood of hearing improvement (p for trend = 0.018 by the regression analysis). No adverse events were observed after completion of the administration period.
Conclusion
Oral administration of VGCV demonstrated efficacy in improving hearing in infants with symptomatic congenital CMV disease at 3 years of age. These results suggest that the treatment response may be particularly favorable in patients with a lower initial degree of hearing impairment.
期刊介绍:
The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice.
The journal publishes on topics that include:
• new diagnostic technologies
• nucleic acid amplification and serologic testing
• targeted and metagenomic next-generation sequencing
• emerging pandemic viral threats
• respiratory viruses
• transplant viruses
• chronic viral infections
• cancer-associated viruses
• gastrointestinal viruses
• central nervous system viruses
• one health (excludes animal health)