valganciclovir and Hearing-Loss

Viral loads (VLs) frequently are followed during treatment of symptomatic congenital cytomegalovirus disease, but their predictive value is unclear.. Post hoc analysis of 2 antiviral studies was performed. Seventy-three subjects were treated for 6 weeks and 47 subjects were treated for 6 months. Whole blood VL was determined by real-time polymerase chain reaction before and during therapy.. Higher baseline VL was associated with central nervous system involvement (3.82 log, range 1-5.65 vs 3.32 log, range 1-5.36; P = .001), thrombocytopenia (3.68 log, range 1-5.65 vs 3.43 log, range 1-5.36; P = .03), and transaminitis at presentation (3.73 log, range 1-5.60 vs 3.39 log, range 1-5.65; P = .009), but with overlap in the amount of virus detected between groups. In subjects treated for 6 months, lower VL at presentation correlated with better hearing outcomes at 12 months, but VL breakpoints predictive of hearing loss were not identified. Sustained viral suppression during 6 months of therapy correlated with better hearing outcomes at 6, 12, and 24 months (P = .01, P = .0007, P = .04), but a majority without viral suppression still had improved hearing.. In infants with symptomatic congenital cytomegalovirus disease, higher whole blood VL before initiation of antiviral therapy has no clinically meaningful predictive value for long-term outcomes.

Topics: Administration, Intravenous; Administration, Oral; Antiviral Agents; Central Nervous System Diseases; Child Development; Cytomegalovirus; Cytomegalovirus Infections; DNA, Viral; Female; Ganciclovir; Hearing; Hearing Loss; Humans; Infant; Infant, Newborn; Male; Predictive Value of Tests; Sustained Virologic Response; Thrombocytopenia; Valganciclovir; Viral Load

The aim of this study was to capture multifaceted clinical characteristics of congenital cytomegalovirus (CMV) infection from diagnosis to treatment using a multidisciplinary approach including obstetrics, pediatrics, pathology, and otorhinolaryngology-head and neck surgery.. This is a retrospective study including 30 consecutive cases of congenital CMV infection that were diagnosed at a single tertiary hospital located in Seoul, Korea from January 2009 to December 2020. Congenital CMV infection was defined as a positive result by polymerase chain reaction from urine, saliva or cerebrospinal fluid or positive CMV IgM from neonatal blood sampled within 3 weeks after birth. All cases were analyzed with respect to whole clinical characteristics from diagnosis to treatment of congenital CMV by a multidisciplinary approach including prenatal sonographic findings, maternal immune status regarding CMV infection, detailed placental pathology, neonatal clinical manifestation, auditory brainstem response test, and antiviral treatment (ganciclovir or valganciclovir). Long-term outcomes including developmental delay and hearing loss were also investigated.. The total number of births during the study period in our institution was 19,385, with the prevalence of congenital infection estimated to be 0.15%. Among 30 cases of congenital CMV, the median gestational age at delivery was 32.2 weeks [range, 22.6-40.0] and 66.7% of these infants were delivered preterm at less than 37 weeks. Suspected fetal growth restriction was the most common prenatal ultrasound finding (50%) followed by ventriculomegaly (17.9%) and abnormal placenta (17.9%), defined as thick placenta with calcification. No abnormal findings on ultrasound examination were observed in one-third of births. Maternal CMV serology tests were conducted in only 8 cases, and one case each of positive and equivocal IgM were found. The most common placental pathologic findings were chronic villitis (66.7%) and calcification (63.0%), whereas viral inclusions were identified in only 22.2%. The most common neonatal manifestations were jaundice (58.6%) followed by elevation of aspartate aminotransferase (55.2%) and thrombocytopenia (51.7%). After excluding cases for which long-term outcomes were unavailable due to death (n = 4) or subsequent follow up loss (n = 3), developmental delay was confirmed in 43.5% of infants (10/23), and hearing loss was confirmed in 42.9% (9/21) during the follow-up period. In our cohort, 56.7% (17/30) of neonates were treated for congenital CMV with ganciclovir or valganciclovir.. Our data show that prenatal findings including maternal serologic tests and ultrasound have limited ability to detect congenital CMV in Korea. Given that CMV is associated with high rates of developmental delay and hearing loss in infants, there is an urgent need to develop specific strategies for the definite diagnosis of congenital CMV infection during the perinatal period by a multidisciplinary approach to decrease the risks of neurologic impairment and hearing loss through early antiviral treatment.

Topics: Antiviral Agents; Child; Cytomegalovirus Infections; Female; Fetal Growth Retardation; Ganciclovir; Hearing Loss; Humans; Immunoglobulin M; Infant; Infant, Newborn; Parturition; Placenta; Pregnancy; Retrospective Studies; Valganciclovir

A 32-week preterm-born male with symptomatic congenital cytomegalovirus infection was treated with valganciclovir. He was also affected by congenital severe bilateral hearing loss and, unexpectedly, a normalization of the hearing threshold was reached at one year of age. The improvement of hearing level in relationship with both the late development of the auditory system and the administration of antiviral therapy is discussed. This case also highlights the importance of early diagnosis of congenital cytomegalovirus associated with close follow-up.

Topics: Antiviral Agents; Cytomegalovirus Infections; Hearing; Hearing Loss; Hearing Loss, Sensorineural; Hearing Tests; Humans; Infant, Newborn; Male; Valganciclovir

Congenital cytomegalovirus (cCMV) infection is a major cause of hearing loss in children. A few cases of cCMV twin pregnancies are reported in the literature. Twins can react differently to maternal infection, but hearing loss is rarely evaluated. Two couples of twins with cCMV infection and different audiologic outcomes are reported. The first couple of twins was composed by two male twins, both affected by cCMV infection. The first born had normal hearing function, and the second born had sensorineural hearing loss (SNHL). In the second couple, a male and a female twin, only the male twin was affected by cCMV infection, and both had normal hearing function. In this case series, an interesting finding was the association between the presence of viral DNA in liquor and hearing loss in one newborn. Further research is needed to better understand the pathophysiology of SNHL caused by cCMV infection.

Topics: Antiviral Agents; Audiology; Audiometry, Pure-Tone; Cytomegalovirus; Cytomegalovirus Infections; DNA, Viral; Female; Ganciclovir; Hearing Loss; Hearing Loss, Sensorineural; Hearing Tests; Humans; Infant, Newborn; Male; Neonatal Screening; Pregnancy; Twins; Valganciclovir

Topics: Antiviral Agents; Child; Cytomegalovirus; Cytomegalovirus Infections; Hearing Loss; Humans; Infant; Infant, Newborn; Neonatal Screening; Valganciclovir

Australian national surveillance data was used to assess recognition, sequelae, and antiviral therapy for congenital cytomegalovirus (CMV) cases.. Data from congenital CMV cases reported through the Australian Paediatric Surveillance Unit born January 1999 to December 2016 were described and Chi-square tests used to characterise trends and associations in case reporting, maternal CMV serology testing, and antiviral therapy. Descriptive analyses for hearing loss and developmental delay were reported for cases born ≥2004, following introduction of universal neonatal hearing screening.. There were 302 congenital CMV cases (214 symptomatic, 88 asymptomatic). Congenital CMV was suspected in 70.6% by 30 days of age, with no differences across birth cohorts. Maternal CMV serology testing was associated with maternal illness during pregnancy but not birth cohort. There was increasing antiviral use for symptomatic cases, being used in 14% born 1999-2004, 19.6% born 2005-2010, and 44.4% born 2011-2016 (p < 0.001). For those born ≥2004, hearing loss was reported in 42.1% of symptomatic and 26.6% of asymptomatic cases; while developmental delay was reported in 16.9% of symptomatic and 1.3% of asymptomatic cases.. There appears to be under-reporting and under-recognition of congenital CMV despite increasing use of antiviral therapy. Universal newborn CMV screening should be considered to facilitate follow-up of affected children and targeted linkage into hearing and developmental services, and to provide population-level infant CMV epidemiology to support research and evaluation of antiviral and adjunctive therapies.

Topics: Antiviral Agents; Australia; Cytomegalovirus; Cytomegalovirus Infections; Deafness; Disease Progression; Epidemiological Monitoring; Female; Hearing Loss; Hearing Tests; Humans; Infant, Newborn; Male; Mothers; Neonatal Screening; Pregnancy; Serologic Tests; Valganciclovir

This study investigated the relationship between lenticulostriated vasculopathy (LSV) and hearing loss in 141 infants with congenital cytomegalovirus (cCMV) infection.. We included all infants with cCMV infection who were followed in our clinic for more than a year with only LSV signs of brain involvement on initial brain ultrasound. Group one comprised 13 infants with no hearing impairment at birth who were not treated with gan/valganciclovir during 2006-2009. Group two was 51 infants with LSV and no hearing impairment who had been treated since mid-2009. Group three was 25 infants born with LSV and hearing loss, who had been treated from birth. Group four was 52 control infants born during the same period with asymptomatic cCMV. Hearing tests were performed during the neonatal period and every four to six months until four years of age.. Hearing deterioration was more extensive in group one (85%) than in group two (0%, p < 0.001) and the asymptomatic group (10%, p < 0.001) and occurred more often in group four (10%) than in group two (0%, p = 0.008).. Lenticulostriated vasculopathy was common in infants with cCMV infection and may serve as a sign of central nervous system involvement and further hearing deterioration. Antiviral treatment may be prudent in such infants.

Topics: Antiviral Agents; Basal Ganglia Cerebrovascular Disease; Cytomegalovirus Infections; Female; Ganciclovir; Hearing Loss; Humans; Infant, Newborn; Male; Retrospective Studies; Risk Factors; Valganciclovir

To analyze the results of a neonatal universal screen for congenital cytomegalovirus (CMV) using saliva real-time polymerase chain reaction (rt-PCR).. During one year (15/5/2011-15/5/2012), saliva was collected from 9845 infants (97% of 10,137 newborns). Viral DNA was extracted by Magna-Pure LC (Roche) and was tested for the presence of CMV IE and gB genes. Urine culture was collected from positive infants for confirmation. For all infants with congenital CMV maternal data were collected and head ultrasound, blood count, liver enzymes, retinal examination and auditory brainstem response testing were performed. Parents were notified in advance and had the option to avoid screening. The ethical committee approved retrospective analysis of the data.. Fifty six infants (0.57%) had a positive saliva assay. Of these, 47 were confirmed by urine rt-PCR and culture, in another one maternal sero-conversion was documented during pregnancy (48 infants). Twenty-eight mothers (28/47, 60%) had primary infection during pregnancy, 14 (30%) had non-primary infection, and no serological data were obtained from five (10%). Four infants (8.5%), two with prenatal diagnosis of CMV and normal fetal brain imaging and two born to mothers sero-positive before pregnancy, exhibited symptoms related to CMV and were offered antivirals. Hearing impairment was diagnosed in two infants (late onset HI in one case).. Saliva rt-PCR assay is a feasible and effective means of universal neonatal CMV screening that can detect affected infants who might benefit from treatment and follow-up. The long-term clinical significance of screening and its cost effectiveness are yet to be determined.

Topics: Adult; Antiviral Agents; Cytomegalovirus; Cytomegalovirus Infections; DNA, Viral; Evoked Potentials, Auditory, Brain Stem; Female; Ganciclovir; Hearing Loss; Humans; Immediate-Early Proteins; Infant, Newborn; Israel; Liver; Male; Mass Screening; Mothers; Neonatal Screening; Pregnancy; Pregnancy Complications, Infectious; Real-Time Polymerase Chain Reaction; Retina; Retrospective Studies; Saliva; Serologic Tests; Valganciclovir; Young Adult

We report prolonged valganciclovir (VGCV) treatment of a symptomatic cytomegalovirus infection case. Automated auditory brainstem evoked response performed at 5 days of age revealed severe hearing impairment. Cranial magnetic resonance (MR) imaging at 11 days of age showed abnormal findings. At 5 weeks of age, VGCV was started. The viral load in blood cells, plasma, and urine decreased during the 6-week treatment. Because of improvement of hearing level and no adverse effects, VGCV was restarted for an additional 6 weeks. Neither the patient's hearing impairment nor results of cranial MR imaging have become worse in 6 months. It is crucial to gather information from as many cases as possible treated with VGCV to establish a standard protocol for VGCV treatment.

Topics: Antiviral Agents; Brain; Cytomegalovirus; Cytomegalovirus Infections; DNA, Viral; Evoked Potentials, Auditory, Brain Stem; Ganciclovir; Hearing Loss; Humans; Infant, Newborn; Infant, Newborn, Diseases; Magnetic Resonance Imaging; Male; Radiography; Valganciclovir; Viral Load

Topics: Administration, Oral; Adult; Antiviral Agents; Audiometry; Cytomegalovirus Infections; Disease Progression; Female; Ganciclovir; Hearing Loss; Humans; Infant; Infant, Newborn; Neonatal Screening; Pregnancy; Pregnancy Complications, Infectious; Valganciclovir