Prevalence of cytomegalovirus in infants with cholestasis and response to oral antiviral therapy: A prospective cohort study.

Abstract

Objectives: Cholestasis of infancy is characterized by abnormal production or obstruction to bile flow. The link between cytomegalovirus infection and the effectiveness of oral antiviral therapy in cytomegalovirus-related cholestasis remains unclear. This study assessed cytomegalovirus prevalence and antiviral response in infants with cholestasis.

Methods: This single-center prospective study enrolled 147 consecutive cases of infantile cholestasis between May 2023 and December 2024. Participants were subcategorized into those with surgical or medical causes of cholestasis. Cytomegalovirus infection was identified using one of three methods: qualitative urine cytomegalovirus DNA polymerase chain reaction, cytomegalovirus immunoglobulin M, or liver biopsy for inclusion bodies. All cytomegalovirus-positive cases received oral antiviral therapy for 3 months. The outcomes evaluated included viral and biochemical clearance and survival at 18-month follow-up.

Results: Cytomegalovirus infection was detected in 50% (74/147) of the cholestatic cohort, with 65% (40/62) prevalence in the surgical subgroup. Viral clearance and improvement in biochemical profile were observed in 51% (38/74) of cytomegalovirus-positive antiviral-treated cases without serious adverse effects. Eighteen months' native liver survival was 66% (56/85) in the medical subgroup and 30% (19/62) in the surgical subgroup, irrespective of cytomegalovirus infection status. Survival rates in the cytomegalovirus-positive treated surgical subgroup matched those of the cytomegalovirus-negative counterparts (hazard ratio [HR] 0.91, 95% confidence interval [CI] 0.51-1.61; p = 0.73). In contrast, the cytomegalovirus-positive medical subgroup demonstrated lower survival than their cytomegalovirus-negative counterparts despite antiviral therapy (HR 2.86, 95% CI 1.34-6.12; p < 0.01).

Conclusions: The prevalence of cytomegalovirus infection in infantile cholestasis varies regionally. Native liver survival was not worse in cytomegalovirus-positive antiviral-treated surgical cases than in cytomegalovirus-negative infants, however a multicentre randomized control trial is needed to confirm these findings.