Oral Valganciclovir Therapy in Infants Aged ≤2 Months with Congenital Cytomegalovirus Disease: A Multicenter, Single-Arm, Open-Label Clinical Trial in Japan
Our aims were to determine the clinical impact of oral valganciclovir (VGCV) in infants aged ≤2 months with congenital cytomegalovirus (CMV) disease and evaluate the efficacy of VGCV when initiated beyond the neonatal period. The multicenter, single-arm, open-label clinical trial was conducted in Ja...
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MDPI AG
2022-06-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/11/13/3582 |
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| author | Ichiro Morioka Yasumasa Kakei Takashi Omori Kandai Nozu Kazumichi Fujioka Naoto Takahashi Tetsushi Yoshikawa Hiroyuki Moriuchi Yoshinori Ito Akira Oka |
| author_facet | Ichiro Morioka Yasumasa Kakei Takashi Omori Kandai Nozu Kazumichi Fujioka Naoto Takahashi Tetsushi Yoshikawa Hiroyuki Moriuchi Yoshinori Ito Akira Oka |
| author_sort | Ichiro Morioka |
| collection | DOAJ |
| description | Our aims were to determine the clinical impact of oral valganciclovir (VGCV) in infants aged ≤2 months with congenital cytomegalovirus (CMV) disease and evaluate the efficacy of VGCV when initiated beyond the neonatal period. The multicenter, single-arm, open-label clinical trial was conducted in Japan. Twenty-five infants aged ≤2 months with congenital CMV disease involving the central nervous system were enrolled and treated with VGCV for 6 months. The primary endpoint was the change in the whole blood CMV load before and after treatment. The secondary endpoint was the change in the auditory brainstem response (ABR) before and after treatment. Changes in ABR were assessed between the younger and older age groups (≤ and >30 days at treatment initiation). Of the 25 patients, one was excluded owing to epilepsy before VGCV administration. The median change in the CMV DNA level in whole blood was −246.0 IU/mL. The best ear and total ear assessments based on ABR were categorized as (improved + unchanged) after treatment for 100% and 93.8%, respectively. No differences in hearing efficacy were observed between the younger and older age groups. Oral VGCV is a potential therapeutic option for treating infants aged ≤2 months with congenital CMV disease. |
| first_indexed | 2024-03-09T04:05:49Z |
| format | Article |
| id | doaj.art-a5da803704ca4badbe9ee597368958c8 |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-09T04:05:49Z |
| publishDate | 2022-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-a5da803704ca4badbe9ee597368958c82023-12-03T14:06:54ZengMDPI AGJournal of Clinical Medicine2077-03832022-06-011113358210.3390/jcm11133582Oral Valganciclovir Therapy in Infants Aged ≤2 Months with Congenital Cytomegalovirus Disease: A Multicenter, Single-Arm, Open-Label Clinical Trial in JapanIchiro Morioka0Yasumasa Kakei1Takashi Omori2Kandai Nozu3Kazumichi Fujioka4Naoto Takahashi5Tetsushi Yoshikawa6Hiroyuki Moriuchi7Yoshinori Ito8Akira Oka9Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo 173-8610, JapanDepartment of Oral and Maxillofacial Surgery, Kobe University Graduate School of Medicine, Kobe 650-0017, JapanDivision of Biostatistics, Department of Social/Community Medicine and Health Science, Kobe University Graduate School of Medicine, Kobe 650-0017, JapanDepartment of Pediatrics, Kobe University Graduate School of Medicine, Kobe 650-0017, JapanDepartment of Pediatrics, Kobe University Graduate School of Medicine, Kobe 650-0017, JapanDepartment of Pediatrics, The University of Tokyo, Tokyo 113-8655, JapanDepartment of Pediatrics, Fujita Health University School of Medicine, Toyoake 470-1192, JapanDepartment of Pediatrics, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8501, JapanDepartment of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo 173-8610, JapanDepartment of Pediatrics, The University of Tokyo, Tokyo 113-8655, JapanOur aims were to determine the clinical impact of oral valganciclovir (VGCV) in infants aged ≤2 months with congenital cytomegalovirus (CMV) disease and evaluate the efficacy of VGCV when initiated beyond the neonatal period. The multicenter, single-arm, open-label clinical trial was conducted in Japan. Twenty-five infants aged ≤2 months with congenital CMV disease involving the central nervous system were enrolled and treated with VGCV for 6 months. The primary endpoint was the change in the whole blood CMV load before and after treatment. The secondary endpoint was the change in the auditory brainstem response (ABR) before and after treatment. Changes in ABR were assessed between the younger and older age groups (≤ and >30 days at treatment initiation). Of the 25 patients, one was excluded owing to epilepsy before VGCV administration. The median change in the CMV DNA level in whole blood was −246.0 IU/mL. The best ear and total ear assessments based on ABR were categorized as (improved + unchanged) after treatment for 100% and 93.8%, respectively. No differences in hearing efficacy were observed between the younger and older age groups. Oral VGCV is a potential therapeutic option for treating infants aged ≤2 months with congenital CMV disease.https://www.mdpi.com/2077-0383/11/13/3582auditory brainstem responseclinical trialcytomegalovirusneonateneutropeniavalganciclovir |
| spellingShingle | Ichiro Morioka Yasumasa Kakei Takashi Omori Kandai Nozu Kazumichi Fujioka Naoto Takahashi Tetsushi Yoshikawa Hiroyuki Moriuchi Yoshinori Ito Akira Oka 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 auditory brainstem response clinical trial cytomegalovirus neonate neutropenia valganciclovir |
| title | Oral Valganciclovir Therapy in Infants Aged ≤2 Months with Congenital Cytomegalovirus Disease: A Multicenter, Single-Arm, Open-Label Clinical Trial in Japan |
| title_full | Oral Valganciclovir Therapy in Infants Aged ≤2 Months with Congenital Cytomegalovirus Disease: A Multicenter, Single-Arm, Open-Label Clinical Trial in Japan |
| title_fullStr | Oral Valganciclovir Therapy in Infants Aged ≤2 Months with Congenital Cytomegalovirus Disease: A Multicenter, Single-Arm, Open-Label Clinical Trial in Japan |
| title_full_unstemmed | Oral Valganciclovir Therapy in Infants Aged ≤2 Months with Congenital Cytomegalovirus Disease: A Multicenter, Single-Arm, Open-Label Clinical Trial in Japan |
| title_short | Oral Valganciclovir Therapy in Infants Aged ≤2 Months with Congenital Cytomegalovirus Disease: A Multicenter, Single-Arm, Open-Label Clinical Trial in Japan |
| title_sort | oral valganciclovir therapy in infants aged ≤2 months with congenital cytomegalovirus disease a multicenter single arm open label clinical trial in japan |
| topic | auditory brainstem response clinical trial cytomegalovirus neonate neutropenia valganciclovir |
| url | https://www.mdpi.com/2077-0383/11/13/3582 |
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