scholarly journals Comparative Effects of Valganciclovir and Ganciclovir on the Congenital Cytomegalovirus Infection and Hearing Loss: A Randomized Controlled Trial

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Lili Yang ◽  
Aijuan Qiu ◽  
Jing Wang ◽  
Zhaojun Pan

Background: Cytomegalovirus (CMV) is a highly specific herpes virus spreading only from person to person. Valganciclovir (VGCV) and ganciclovir (GCV) are effective in the treatment of neonatal congenital CMV infection. Objectives: This study aimed to compare the curative effects of VGCV and GCV among neonates with CMV infection and evaluate their effects on hearing. Methods: A total of 48 neonates with congenital CMV infection admitted to Huaian Maternal and Child Health Care Hospital, China, were selected from January 2016 to December 2019 and randomly divided into two equal groups of intervention and group (n = 24 each). While the control group received intravenous injection of GCV, the intervention group received oral VGCV. After a 6-week course of treatment, polymerase chain reaction (PCR) was applied to detect the CMV load in both urine and blood. We used the ELISA method to detect the serum CMV-IgM expression level before and after treatment. Moreover, we compared the positive rates of CMV-DNA and CMV-IgM, hyperbilirubinemia, retinitis, hepatosplenomegaly, thrombocytopenia, neutropenia, as well as the results of hearing screening and brainstem auditory evoked potentials (BAEP). Results: Before treatment, there was no statistical difference in blood/urine CMV-DNA expression level and positive expression rates of blood/urine CMV-DNA and CMV-IgM between the groups (P > 0.05). After treatment, blood/urine CMV-DNA expression and the positive expression rates of blood/urine CMV-DNA and CMV-IgM significantly decreased in both groups compared to before treatment (P < 0.05), but there was no statistical significance between the two groups (P > 0.05). Before treatment, there was no significant difference in hearing abnormality rates between the control (50%) and intervention (62.5%) groups (P > 0.05). After treatment, both the control (20.83%) and intervention (29.17%) groups had significantly decreased hearing abnormality rates, and the difference was statistically significant compared with before treatment (P < 0.05), but the difference between the two groups was not statistically significant (P > 0.05). After treatment, the results of comparing BAEP showed that both groups had no statistically significant differences in the number of neonates with normal hearing, mild hearing loss, moderate to severe hearing loss, severe hearing loss, and extremely severe hearing loss (P > 0.05). Before treatment, both groups had no statistically significant differences in the number of neonates with hyperbilirubinemia, retinitis, hepatosplenomegaly, thrombocytopenia, and neutropenia (P > 0.05). After treatment, while the number of neonates with hyperbilirubinemia, retinitis, hepatosplenomegaly, and thrombocytopenia decreased, neutropenia cases increased, and the difference before and after treatment was statistically significant (P < 0.05); however, the difference between the two groups was not statistically significant (P > 0.05). Conclusions: VGCV is similar to GCV in the treatment of neonatal congenital CMV infection, but the oral route of administration of VGCV is more acceptable among neonates.

2014 ◽  
Vol 1 (suppl_1) ◽  
pp. S291-S291
Author(s):  
Swetha G. Pinninti ◽  
Mackenzie Dreher ◽  
Karen Fowler ◽  
Zdenek Novak ◽  
William J. Britt ◽  
...  

ORL ro ◽  
2018 ◽  
Vol 4 (41) ◽  
pp. 24
Author(s):  
Mădălina Georgescu

PEDIATRICS ◽  
1992 ◽  
Vol 90 (6) ◽  
pp. 862-866 ◽  
Author(s):  
W. Daniel Williamson ◽  
Gail J. Demmler ◽  
Alan K. Percy ◽  
Francis I. Catlin

Congenital cytomegalovirus (CMV) infection is a major public health problem because 30 000 to 40 000 neonates with the infection are born each year in the United States. Although 90% of the congenitally infected infants are asymptomatic at birth, evidence is accumulating that these infants are at risk for audiologic, neurologic, and developmental sequelae. The current study describes the audiologic outcome of 59 infants with asymptomatic congenital CMV infection compared with 26 control infants. Eight of 59 infected infants had congenital sensorineural hearing loss (SNHL) but none of the control subjects did. Longitudinal audiologic assessments revealed that 5 of the 8 infants had further deterioration of their SNHL; a ninth infant with initially normal hearing experienced a unilateral SNHL during the first year of life, with further deterioration subseguently. The frequency of SNHL was similar for infected infants born to mothers with recurrent CMV infections during pregnancy (2 of 9) and for those born to mothers who experienced primary CMV infections (5 of 26). There was a significant difference between the occurrence of hearing loss in infected infants with normal computed tomographic scans (2 of 40) compared with those with either periventricular radiolucencies (4 of 13) or calcifications (1 of 3). Children with SNHL often have no identified cause of the loss; thus, it is likely that many of these children had asymptomatic congenital CMV infection. Given the progressive nature of SNHL associated with asymptomatic congenital CMV infection, longitudinal audiologic assessments are mandatory.


2020 ◽  
Vol 163 (4) ◽  
pp. 662-670
Author(s):  
Ashley Satterfield-Nash ◽  
Ayesha Umrigar ◽  
Tatiana M. Lanzieri

Objective To conduct a scoping review on etiologic investigation of prelingual hearing loss among children <2 years of age in the era of universal newborn hearing screening (UNHS). Data Sources PubMed, Embase, PsycInfo, CINAHL, and Cochrane Library databases. Review Methods We searched for articles published from January 1, 1998, to February 19, 2020. We reviewed studies that (1) included children identified with either congenital or delayed-onset hearing loss before 2 years of age among cohorts who had undergone UNHS and (2) investigated ≥1 etiologies of hearing loss. We defined hearing loss as congenital when confirmed after UNHS failure and as delayed onset when diagnosed after ≥1 assessments with normal hearing. Results Among 2069 unique citations, 115 studies met criteria for full-text assessment, and 20 met our inclusion criteria. Six studies tested children diagnosed with hearing loss for genetic etiology, 9 for congenital cytomegalovirus (CMV) infection, and 5 for both. Among 1787 children with congenital hearing loss and etiologic investigation, 933 (52.2%) were tested for genetic mutations and 1021 (57.1%) for congenital CMV infection. The proportion of congenital hearing loss cases attributable to genetic etiology ranged between 7.7% and 83.3% and to congenital CMV infection between 0.0% and 32.0%. Conclusion Data are lacking on the identification and etiology of delayed-onset hearing loss in children <2 years of age in the UNHS era. The proportion of congenital hearing loss cases attributable to genetic etiologies and congenital CMV infection appears to vary widely.


2008 ◽  
Vol 88 (7) ◽  
pp. 722-730 ◽  
Author(s):  
Li Li ◽  
Isao Kosugi ◽  
Gui-Ping Han ◽  
Hideya Kawasaki ◽  
Yoshifumi Arai ◽  
...  

PEDIATRICS ◽  
2014 ◽  
Vol 134 (5) ◽  
pp. 972-982 ◽  
Author(s):  
J. Goderis ◽  
E. De Leenheer ◽  
K. Smets ◽  
H. Van Hoecke ◽  
A. Keymeulen ◽  
...  

2021 ◽  
Vol 104 (10) ◽  
pp. 1604-1609

Background: Congenital cytomegalovirus (CMV) infection is the most common non-genetic cause of permanent sensorineural hearing loss in infants and children. A 6-month course of intravenous ganciclovir or valganciclovir is recommended for treatment of patients with moderate to severe symptomatic congenital CMV disease. Hearing status improvement has been reported in those that received treatment within the first month of life. In Thailand, there has been no data of antiviral treatment in symptomatic congenital CMV patients. Objective: To determine the incidence of symptomatic congenital CMV infection in the past 11 years and to evaluate the hearing, neurological, and developmental outcomes of the antiviral treatment and factors associated with hearing outcomes. Materials and Methods: A retrospective observational study was performed at Siriraj Hospital, between January 2008 and December 2019. The medical records of the patients diagnosed of symptomatic congenital CMV infection (ICD10-P351) were reviewed. Results: The incidence of symptomatic congenital CMV infection was 0 to 1.01 case per 1,000 livebirths. Of the 52 patients, 18 received 6-week course of ganciclovir and five continued with oral valganciclovir for three to six months. Developmental delayed was found in 69.2% (36). No difference in hearing outcomes at 6 and 12 months of age between the patients who did or did not receive treatment. Among 24 (46.1%) children who underwent hearing test at two to three years of age, the birth characteristics, as well as antiviral treatment (attributable risk 0.007, 95% CI –0.4 to 0.4, p=0.973), had no difference in hearing outcome. Long-term disability was diagnosed in the lower proportion among the patients receiving antiviral treatment (attributable risk –0.3, 95% CI –0.5 to –0.1, p=0.030). Conclusion: Symptomatic congenital CMV infection resulted in poor hearing and developmental outcomes. Antiviral treatment reduced risk of disability but did not improve hearing outcomes. The results underscore the need for early diagnosis and initiation of antiviral treatment in infants with symptomatic congenital CMV. Keywords: Congenital infection; CMV; Hearing loss; Ganciclovir; Valganciclovir; Disability


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S599-S599
Author(s):  
Alexandra K Medoro ◽  
Cory T Hanlon ◽  
Traci Pifer ◽  
Maria Reyes Escamilla ◽  
Masako Shimamura ◽  
...  

Abstract Background Congenital cytomegalovirus (CMV) is the leading non-genetic cause of sensorineural hearing loss (SNHL) in children. While SNHL is often present at birth, as many as 25% of congenital CMV-infected infants may develop late-onset hearing loss. Antiviral therapy improves hearing outcomes, but its effect on the occurrence of late-onset SNHL is not fully known. Thus, our objective was to describe the prevalence of late-onset SNHL among congenital CMV-infected children treated with antiviral therapy in the first month of age. Methods From 2013 to present, infants with congenital CMV infection referred to Nationwide Children’s Hospital’s (NCH) NEO-ID Clinic, Columbus, OH underwent complete evaluation including hearing testing. Pertinent demographic, clinical, laboratory, and radiographic data were obtained and managed using REDCap electronic data capture tools. Infants who passed the newborn hearing screen and subsequently developed late-onset SNHL were identified and compared with respect to receipt of antiviral therapy in the neonatal period. Statistical analyses were performed using GraphPad Prism for macOS version 8.3.0. Results During the 6-year study period, 99 infants had congenital CMV infection and 69 (70%) of them passed the newborn hearing screen. 46 (46%) neonates received antiviral therapy (1, ganciclovir; 38, valganciclovir; 7, both) for clinically apparent congenital CMV infection. One (2%) child developed late-onset SNHL.This infant was born at 37 weeks’ gestation (birth weight, 2525 g) with microcephaly (head circumference, 31 cm) and cerebral calcifications and was diagnosed with congenital CMV infection at 8 days of age. Treatment with valganciclovir was initiated at 9 days of age, and he developed mild unilateral SNHL at 1 month of age while on treatment and subsequently right severe-profound SNHL and left mild-moderate SNHL. In comparison, among 23 infants with clinically inapparent disease who passed the newborn hearing screen and did not receive antiviral therapy, 5 (22%) subsequently developed SNHL (p=0.014). Conclusion Infants who received antiviral therapy for clinically apparent congenital CMV infection had significantly less late-onset SNHL than untreated infants, thus supporting a hearing protective effect of antiviral treatment. Disclosures All Authors: No reported disclosures


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