{
    "abstract": "To evaluate the long-term hearing outcomes of infants with symptomatic congenital cytomegalovirus (CMV) disease who received 16\u00a0mg/kg of oral valganciclovir (VGCV) twice daily for six months.\nWe 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.\nAt 3 years, among 48 ears from 24 infants, the number of \"improved hearing,\" which was 19 (40.0\u00a0%) ears at 6 months, increased to 27 (56.3\u00a0%) ears (p\u00a0=\u00a00.032). 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\u00a0%) and 45 (93.7\u00a0%) ears at 3 years, which were 25 (52.5\u00a0%) and 45 (93.7\u00a0%) ears at 6 months, respectively. Infants with milder hearing impairment at baseline showed high likelihood of hearing improvement (p for trend\u00a0=\u00a00.018 by the regression analysis). No adverse events were observed after completion of the administration period.\nOral 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.",
    "authors": [
        {
            "affiliation": "Department of Pediatrics and Child Health, Nihon University School of Medicine, 30-1 Oyaguchi, Kami-cho, Itabashi-ku, Tokyo 173-8610, Japan. Electronic address: morioka.ichiro@nihon-u.ac.jp.",
            "firstname": "Ichiro",
            "initials": "I",
            "lastname": "Morioka"
        },
        {
            "affiliation": "Department of Oral and Maxillofacial Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan; Clinical and Translational Research Center, Kobe University Hospital, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan. Electronic address: ykakei@med.kobe-u.ac.jp.",
            "firstname": "Yasumasa",
            "initials": "Y",
            "lastname": "Kakei"
        },
        {
            "affiliation": "Clinical and Translational Research Center, Kobe University Hospital, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan. Electronic address: imai@med.kobe-u.ac.jp.",
            "firstname": "Takumi",
            "initials": "T",
            "lastname": "Imai"
        },
        {
            "affiliation": "Department of Pediatrics, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan. Electronic address: fujiokak@med.kobe-u.ac.jp.",
            "firstname": "Kazumichi",
            "initials": "K",
            "lastname": "Fujioka"
        },
        {
            "affiliation": "Department of Pediatrics, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan. Electronic address: ntakahashi@m.u-tokyo.ac.jp.",
            "firstname": "Naoto",
            "initials": "N",
            "lastname": "Takahashi"
        },
        {
            "affiliation": "Department of Pediatrics, Fujita Health University School of Medicine, 1-98, Kutsukake-cho, Dengakugakubo, Toyoake, Aichi 470-1192, Japan. Electronic address: tetsushi@fujita-hu.ac.jp.",
            "firstname": "Tetsushi",
            "initials": "T",
            "lastname": "Yoshikawa"
        },
        {
            "affiliation": "Department of Pediatrics, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan. Electronic address: hiromori@nagasaki-u.ac.jp.",
            "firstname": "Hiroyuki",
            "initials": "H",
            "lastname": "Moriuchi"
        },
        {
            "affiliation": "Department of Pediatrics, Aichi Medical University, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan. Electronic address: yoshi-ito@aichi-med-u.ac.jp.",
            "firstname": "Yoshinori",
            "initials": "Y",
            "lastname": "Ito"
        },
        {
            "affiliation": "Saitama Prefectural Children's Medical Center, 1-2 Shin-toshin, Chuo-ku, Saitama, Saitama 330-8777, Japan. Electronic address: oka.akira@saitama-pho.jp.",
            "firstname": "Akira",
            "initials": "A",
            "lastname": "Oka"
        },
        {
            "affiliation": null,
            "firstname": null,
            "initials": null,
            "lastname": null
        }
    ],
    "conclusions": "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.",
    "copyrights": "Copyright \u00a9 2025 Elsevier B.V. All rights reserved.",
    "doi": "10.1016/j.jcv.2025.105778",
    "journal": "Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology",
    "keywords": [
        "Auditory brainstem response",
        "Clinical trial",
        "Cytomegalovirus",
        "Valganciclovir"
    ],
    "methods": null,
    "publication_date": "2025-03-15",
    "pubmed_id": "40086367",
    "results": "At 3 years, among 48 ears from 24 infants, the number of \"improved hearing,\" which was 19 (40.0\u00a0%) ears at 6 months, increased to 27 (56.3\u00a0%) ears (p\u00a0=\u00a00.032). 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\u00a0%) and 45 (93.7\u00a0%) ears at 3 years, which were 25 (52.5\u00a0%) and 45 (93.7\u00a0%) ears at 6 months, respectively. Infants with milder hearing impairment at baseline showed high likelihood of hearing improvement (p for trend\u00a0=\u00a00.018 by the regression analysis). No adverse events were observed after completion of the administration period.",
    "title": "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.",
    "xml": "<Element 'PubmedArticle' at 0x788506aaf4c0>"
}