Ganciclovir therapy for symptomatic congenital cytomegalovirus infection in infants: a two-regimen experience
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G Nigro1, H Scholz, U Bartmann
1Pediatric Institute of La Sapienza, University of Rome, Italy.
Insights
A higher dose and longer duration of ganciclovir therapy may improve outcomes for infants with symptomatic congenital cytomegalovirus (CMV) infection. This study compared two ganciclovir regimens, finding the extended, higher-dose therapy more effective in clearing the virus.
Area of Science:
- Virology
- Pediatric Infectious Diseases
- Pharmacology
Background:
- Congenital cytomegalovirus (CMV) infection is a leading cause of non-genetic sensorineural hearing loss and neurodevelopmental disability in infants.
- Symptomatic congenital CMV infection requires effective antiviral treatment to mitigate long-term sequelae.
Purpose of the Study:
- To compare the efficacy of two different ganciclovir treatment regimens in infants with symptomatic congenital CMV infection.
- To evaluate the impact of ganciclovir dosage and duration on virologic clearance and clinical outcomes.
Main Methods:
- A study involving 12 infants with symptomatic congenital CMV infection.
- Infants were divided into two groups: Group 1 received ganciclovir 5 mg/kg twice daily for 2 weeks; Group 2 received ganciclovir 7.5 mg/kg twice daily for 2 weeks, followed by 10 mg/kg three times weekly for 3 months.
- Virologic assessments included CMV cultures, CMV DNA detection via PCR, and CMV-specific antibody testing.
Main Results:
- In Group 1, only 3 of 6 infants achieved sterile CMV cultures, with 2 also having negative CMV DNA. Normal outcomes were observed in only 2 infants.
- In Group 2, all 6 infants achieved negative CMV cultures and CMV DNA results.
- Clinical improvement was seen in 5 of 6 infants in Group 2, though one developed mild psychomotor retardation and another experienced severe psychomotor retardation and hearing loss after initial improvement.
Conclusions:
- A ganciclovir regimen involving a higher dose and more prolonged therapy appears more effective for treating symptomatic congenital CMV infection.
- Further research is warranted to optimize ganciclovir treatment protocols for congenital CMV to maximize efficacy and minimize adverse neurodevelopmental outcomes.
Abstract:
The efficacy of two regimens of ganciclovir therapy was evaluated in 12 infants with symptomatic congenital cytomegalovirus (CMV) infection. Virologic investigations included culture from urine, saliva, and cerebrospinal fluid, detection of CMV DNA by polymerase chain reaction, and detection of CMV class-specific antibodies (IgG, IgA, IgM) by enzyme immunoassays. Six infants were given ganciclovir, 5 mg/kg twice daily for 2 weeks (group 1); the other six infants were given 7.5 mg/kg twice daily for 2 weeks and 10 mg/kg three times weekly for 3 months (group 2). In group 1 the CMV cultures of specimens from three infants became sterile; two of these infants also had negative results on CMV DNA studies; results of culture and CMV DNA study were still positive after ganciclovir therapy in the remaining three infants. Subsequently, normal outcome was observed in only two patients. In group 2, all infants had negative CMV-culture and CMV DNA results; clinical improvement was evident in five infants, one of whom had later development of mild psychomotor retardation. In another infant, severe psychomotor retardation and hearing loss developed after transient improvement developed. These preliminary data indicate that a ganciclovir regimen including a higher dose and more prolonged therapy might be more effective in infants with symptomatic congenital CMV infection.