TY - JOUR
T1 - Assessment of patients’ characteristics associated with the efficacy and safety of oral valganciclovir treatment for infants with symptomatic congenital cytomegalovirus disease
AU - Kakei, Yasumasa
AU - Morioka, Ichiro
AU - Imai, Takumi
AU - Itohara, Kotaro
AU - Yano, Ikuko
AU - Takahashi, Naoto
AU - Yoshikawa, Tetsushi
AU - Moriuchi, Hiroyuki
AU - Ito, Yoshinori
AU - Fujioka, Kazumichi
AU - Oka, Akira
AU - Okahashi, Aya
AU - Nagano, Nobuhiko
AU - Hijikata, Midori
AU - Fuwa, Kazumasa
AU - Aoki, Ryoji
AU - Seimiya, Ayako
AU - Imaizumi, Takayuki
AU - Akimoto, Takuya
AU - Hara, Koichiro
AU - Katayama, Daichi
AU - Abe, Shinya
AU - Ashina, Mariko
AU - Nakasone, Ruka
AU - Kyouno, Yuki
AU - Takumi, Kido
AU - Takenaka, Satoshi
AU - Kakiuchi, Satsuki
AU - Kakimoto, Yu
AU - Kozawa, Kei
AU - Funato, Yusuke
AU - Miura, Hiroki
AU - Kawamura, Yoshiki
AU - Ogata, Tsutomu
AU - Nakashima, Yumiko
AU - Kawada, Jun ichi
AU - Torii, Yuka
AU - Suzuki, Takako
AU - Fukuda, Yuto
AU - Haruta, Kazunori
AU - Yamaguchi, Makoto
AU - Masaaki, Teranishi
N1 - Publisher Copyright:
© 2024 Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Infection Prevention and Control
PY - 2024/10
Y1 - 2024/10
N2 - Introduction: Insurance coverage for oral valganciclovir (VGCV) began in Japan in April 2023 on the basis of results, including our clinical trials for symptomatic congenital cytomegalovirus (CMV) disease. The VGCV treatment is available throughout Japan, so clinicians must consider the likelihood of hearing improvement and the possibility of neutropenia before dosing. Materials and methods: We performed a substudy of an investigator-initiated, single-arm, prospective, multicenter, clinical trial in which 24 infants with symptomatic congenital CMV disease were orally administered 16 mg/kg VGCV twice daily for 6 months as an intervention. We examined the infants’ baseline characteristics associated with improved hearing impairment or a severely reduced neutrophil count. Results: Of the 24 patients, 4 had normal hearing on assessment of their ear with the best hearing. Hearing impairment improved in 14 patients and did not respond to VGCV treatment in 6 patients at the 6-month hearing assessment. CMV DNA levels in plasma at baseline were higher in patients in whom hearing did not respond to treatment. A neutrophil count <500/mm3 occurred in 5 (21%) patients for the first 6 weeks and in 8 (33%) patients for the first 6 months. A neutrophil count at screening and the lowest neutrophil count over the 6 months showed the highest correlation (r = 0.477, p = 0.019). Conclusions: Infants with a low plasma viral load at screening tend to have an improvement in hearing impairment. Clinicians should be aware of neutropenia during VGCV treatment particularly in patients with a low neutrophil count during screening.
AB - Introduction: Insurance coverage for oral valganciclovir (VGCV) began in Japan in April 2023 on the basis of results, including our clinical trials for symptomatic congenital cytomegalovirus (CMV) disease. The VGCV treatment is available throughout Japan, so clinicians must consider the likelihood of hearing improvement and the possibility of neutropenia before dosing. Materials and methods: We performed a substudy of an investigator-initiated, single-arm, prospective, multicenter, clinical trial in which 24 infants with symptomatic congenital CMV disease were orally administered 16 mg/kg VGCV twice daily for 6 months as an intervention. We examined the infants’ baseline characteristics associated with improved hearing impairment or a severely reduced neutrophil count. Results: Of the 24 patients, 4 had normal hearing on assessment of their ear with the best hearing. Hearing impairment improved in 14 patients and did not respond to VGCV treatment in 6 patients at the 6-month hearing assessment. CMV DNA levels in plasma at baseline were higher in patients in whom hearing did not respond to treatment. A neutrophil count <500/mm3 occurred in 5 (21%) patients for the first 6 weeks and in 8 (33%) patients for the first 6 months. A neutrophil count at screening and the lowest neutrophil count over the 6 months showed the highest correlation (r = 0.477, p = 0.019). Conclusions: Infants with a low plasma viral load at screening tend to have an improvement in hearing impairment. Clinicians should be aware of neutropenia during VGCV treatment particularly in patients with a low neutrophil count during screening.
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U2 - 10.1016/j.jiac.2024.03.006
DO - 10.1016/j.jiac.2024.03.006
M3 - Article
C2 - 38484931
AN - SCOPUS:85188166224
SN - 1341-321X
VL - 30
SP - 971
EP - 977
JO - Journal of Infection and Chemotherapy
JF - Journal of Infection and Chemotherapy
IS - 10
ER -