Pediatric Gastroenterology, Hepatology & Nutrition

The Korean Society of Pediatric Gastroenterology, Hepatology and Nutrition (대한소아소화기영양학회)
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Efficacy and Safety of Valganciclovir in Congenital Cytomegalovirus Infection with Isolated Intrahepatic Cholestasis: A Randomized Controlled Trial

  • Salahuddin Mahmud (Department of Pediatric Gastroenterology, Hepatology & Nutrition, Bangladesh Shishu Hospital & Institute) ;
  • Tanzila Farhana (Department of Pediatric Gastroenterology, Hepatology & Nutrition, Bangladesh Shishu Hospital & Institute) ;
  • Ataul Mustufa Anik (Department of Statistics, Shahjalal University of Science and Technology) ;
  • Fayaza Ahmed (Child Development Centre, HSM, DGHS) ;
  • Mashud Parvez (Department of Pathology, Bangladesh Shishu Hospital & Institute) ;
  • Madhabi Baidya (Department of Pediatric Gastroenterology, Hepatology & Nutrition, Bangladesh Shishu Hospital & Institute) ;
  • Rafia Rashid (Department of Pediatric Gastroenterology, Dr. M R Khan Shishu Hospital & Institute of Child Health) ;
  • Farhana Tasneem (Department of Pediatrics, BIHS General Hospital, Diabetic Association of Bangladesh) ;
  • Ahmed Rashidul Hasan (Department of Pediatric Gastroenterology, Hepatology & Nutrition, Bangladesh Shishu Hospital & Institute) ;
  • Mohammad Jahangir Alam (Department of Pediatrics, Bangladesh Shishu Hospital & Institute) ;
  • Shafi Ahmed Muaz (Department of Pediatric Gastroenterology, Hepatology & Nutrition, Bangladesh Shishu Hospital & Institute)
  • Received : 2023.01.26
  • Accepted : 2024.06.06
  • Published : 2024.09.15
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Abstract

Purpose: Cytomegalovirus (CMV) infection affects the hepatic, neurologic, hematopoietic, respiratory, gastrointestinal, and other organs, resulting in a high mortality rate and longterm sequelae. It may cause acute or chronic hepatitis, or even lead to hepatic cirrhosis. Valganciclovir (VGCV) is an effective, safe, and well-tolerated treatment for congenital CMV infection, without any serious adverse effects. This study was conducted to evaluate the clinical, biochemical, and virological profiles of infants with CMV with intrahepatic cholestasis and to determine the outcomes with or without treatment with VGCV. Methods: Twenty infants aged <6 months diagnosed with congenital CMV infection with evidence of intrahepatic cholestasis were included in this study. Randomization was used to divide the study participants into 2 groups. The control group (n=10) was treated with only supportive management, and the intervention group (n=10) was treated with oral VGCV at 16 mg/kg/dose 12 hours a day for 6 weeks plus supportive treatments. Physical examinations and biochemical, serological, and virological tests were performed at the time of diagnosis and at the end of 6 weeks and 6 months. Results: The control and intervention groups were compared in terms of clinical and laboratory parameters such as jaundice, dark urine, pale stool, hepatomegaly, total bilirubin, aminotransferases, gamma-glutamyl transferase, alkaline phosphatase, and CMV polymerase chain reaction load, which showed a significant reduction after treatment in the intervention group (p<0.05) with oral VGCV, with very few side effects, whereas the control group showed no significant changes. Conclusion: Oral VGCV can be used to effectively treat CMV infection with intrahepatic cholestasis without notable side effects.

Keywords

Acknowledgement

Planning, Monitoring, and Research (PMR) Operational Plan, Directorate General of Health Services (DGHS).

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