Efficacy, safety, and pharmacokinetics of oral valganciclovir in patients with congenital cytomegalovirus infection

Suganuma, Eisuke; Sakata, Hideaki; Adachi, Nobuaki; Asanuma, Satoshi; Furuichi, Mihoko; Uejima, Yoji; Sato, Satoshi; Abe, Tomoya; Matsumoto, Daigo; Takahashi, Ryohei; Yamamoto, Sachi; Kawano, Yutaka; Arai, Takashi; Oh‐ishi, Tsutomu

doi:10.1016/j.jiac.2020.08.019

Cited by 12 publications

(16 citation statements)

References 28 publications

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“…Hearing improvement after therapy was related to the severity of baseline hearing loss in 7/18 included studies in this systematic review 17,20–22,30,31,33 . These findings are reported in Figure 4.…”

Section: Resultsmentioning

confidence: 82%

“…The 18 criteria‐meeting studies included a total of 682 treated patients 17–34 . All investigations were conducted in a tertiary center; the majority of the studies were monocentric (14/18).…”

Section: Resultsmentioning

confidence: 99%

“…The proportion of treated children in this review is as follows: 497 symptomatic cCMV, 36 asymptomatic cCMV, 77 isolated hearing loss at birth, and 46 late‐onset hearing loss. A total of 26 children could not be grouped as these categories were not clearly defined by one author 33 …”

Section: Resultsmentioning

confidence: 99%

“…The 18 criteria-meeting studies included a total of 682 treated patients. [17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34] All investigations were conducted in a tertiary center; the majority of the studies were monocentric (14/18). The studies were performed in Israel (n = 6), Japan (n = 3), United States (n = 3), Belgium (n = 2), Italy (n = 2), Spain (n = 1), and Austria (n = 1).…”

Section: Subjectsmentioning

confidence: 99%

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The Effect of (Val)ganciclovir on Hearing in Congenital Cytomegalovirus: A Systematic Review

et al. 2022

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Objective To search for existing evidence of a beneficial effect of (val)ganciclovir on hearing in children with congenital cytomegalovirus (cCMV) infection and to identify future research questions. Study Design Systematic review following the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses guidelines, searches were performed in PUBMED, EMBASE, and WEB OF SCIENCE on December 15, 2021. Methods Studies providing ear‐specific hearing results after treating children with cCMV‐related hearing loss with (val)ganciclovir were retained. A meta‐analysis [Peto odds ratio (OR), Review Manager 5.3] was performed to compare hearing outcome between treated and untreated children. The National Institutes of Health tool was used for quality assessment and heterogeneity was assessed with I2 statistics. Results Eighteen studies with a total of 682 treated patients were included for the systematic review. Our meta‐analysis showed that treating symptomatic children with hearing loss resulted in more hearing improvement [Peto OR 7.72, 95% confidence interval (CI) 3.08–19.34] and less hearing deterioration (Peto OR 0.23, 95% CI 0.10–0.57). Relative to an improvement and deterioration rate of 9.4% and 28.2% in an untreated group, the rate of the treated group was 44.5% and 6.3%, respectively. Conclusions There is sufficient evidence in literature to support treatment with (val)ganciclovir of children with symptomatic cCMV and hearing loss. However, still today, there is insufficient evidence of the potential beneficial role of (val)ganciclovir on hearing outcome of children with isolated hearing loss, late‐onset hearing loss, and asymptomatic cCMV. The urgent need for future prospective, randomized clinical trials still exists. A standardization of definitions and treatment protocols would create uniformity in future studies. Laryngoscope, 132:2241–2250, 2022

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Section: Resultsmentioning

confidence: 82%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Subjectsmentioning

confidence: 99%

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The Effect of (Val)ganciclovir on Hearing in Congenital Cytomegalovirus: A Systematic Review

et al. 2022

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“…The oral VGCV treatment is recommended to begin within the first month of life [8,9]. The efficacy of oral VGCV for hearing or psychomotor development and its safety in treatment for 6 weeks or 6 months has been reported in Japan [10][11][12][13][14][15] and globally [16][17][18][19][20][21]. However, VGCV remains unapproved by the government health insurance for symptomatic congenital CMV disease, both in Japan and worldwide.…”

Section: Introductionmentioning

confidence: 99%

Oral Valganciclovir Therapy in Infants Aged ≤2 Months with Congenital Cytomegalovirus Disease: A Multicenter, Single-Arm, Open-Label Clinical Trial in Japan

Morioka

Kakei²,

Omori³

et al. 2022

JCM

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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.

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2021

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Efficacy, safety, and pharmacokinetics of oral valganciclovir in patients with congenital cytomegalovirus infection

Cited by 12 publications

References 28 publications

The Effect of (Val)ganciclovir on Hearing in Congenital Cytomegalovirus: A Systematic Review

The Effect of (Val)ganciclovir on Hearing in Congenital Cytomegalovirus: A Systematic Review

Oral Valganciclovir Therapy in Infants Aged ≤2 Months with Congenital Cytomegalovirus Disease: A Multicenter, Single-Arm, Open-Label Clinical Trial in Japan

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