The effect of (val)ganciclovir on hearing in children with congenital cytomegalovirus infection.

OBJECTIVES

To assess the effect of (val)ganciclovir on long-term hearing outcome.

METHODS

This matched cohort study presents multicentric data of the Flemish CMV registry (Belgium) collected over 16 years. Treated and untreated cCMV-infected children with a minimal four-year audiological follow-up were included. Primary outcome was hearing evolution. Exact matching for risk factors of spontaneous hearing evolution was performed between the treated and untreated group. The average marginal treatment effect was calculated using a pooled regression model.

RESULTS

Of the 525 children, 98 (18.7 %) were treated. Antiviral therapy did not significantly result in more hearing improvement (RR,1.56; 95 % CI,0.48 to 4.93) or less hearing deterioration (RR,0.89; 95 % CI,0.61 to 1.25). Treatment of children with unilateral congenital hearing loss with valganciclovir for six weeks prevented contralateral late-onset hearing loss compared to untreated children (RR,2.49∗10-8; 95 % CI,9.19∗10-9 to 7.71∗10-8). Similarly, late-onset hearing loss could be prevented in symptomatic children with bilateral normal hearing treated with ganciclovir for six weeks (RR,3.65∗10-7; 95 % CI,2.16∗10-7 to 6.21∗10-7). Prolongation from six weeks to six months showed no beneficial effect on hearing improvement (RR,4.61∗10-8; 95 % CI,1.07∗10-8 to 2.32∗10-7), hearing deterioration (RR,1.21; 95 % CI,0.43 to 2.25), or late-onset hearing loss (RR,1.95; 95 % CI,0.63 to 5.93).

CONCLUSIONS

(Val)ganciclovir for six weeks prevented late-onset hearing loss. No additional benefit of a six-month therapy was found. These novel findings can aid in treatment decision making. Future studies with a larger sample size and investigation on the effect of valganciclovir on long-term neurological outcome are needed.