Is sofosbuvir/ledipasvir safe for the hearts of children with hepatitis C virus?

Carolyne Ghobrial1, Rodina Sobhy2, Engy Mogahed1

  • 1The Pediatric Hepatology Unit, Cairo University, Egypt.

Insights

Sofosbuvir/ledipasvir treatment for chronic hepatitis C in children showed no cardiovascular adverse events. This study found no symptomatic bradycardia or bradyarrhythmias in pediatric patients.

Area of Science:

  • Pediatric Cardiology
  • Hepatology
  • Pharmacology

Background:

  • Symptomatic bradycardia is a known risk in adults treated for chronic hepatitis C with sofosbuvir-based regimens.
  • Assessing cardiac safety in pediatric populations is crucial due to potential differences in drug response.

Purpose of the Study:

  • To evaluate the cardiac safety of sofosbuvir/ledipasvir in Egyptian children and adolescents with chronic hepatitis C.
  • To monitor electrocardiographic parameters during antiviral therapy.

Main Methods:

  • A cohort of 40 children and adolescents (12-17 years) with chronic hepatitis C received sofosbuvir/ledipasvir (Harvoni) daily for 12 weeks.
  • Standard 12-lead surface electrocardiography (ECG) was performed at baseline, 4 weeks, and 12 weeks.
  • Key ECG parameters including heart rate, RR interval, and QT interval were analyzed and compared across time points.

Main Results:

  • No cardiovascular symptoms or adverse events, including symptomatic bradycardia or syncope, were reported during treatment.
  • A significant decrease in heart rate and significant prolongation of RR and QT intervals were observed at baseline compared to therapy.
  • Lower heart rate and longer RR intervals were noted in patients with higher viral loads.

Conclusions:

  • Sofosbuvir/ledipasvir demonstrated a favorable cardiovascular safety profile in pediatric patients with chronic hepatitis C.
  • No bradyarrhythmias were observed, indicating safety in this specific pediatric cohort.
Abstract

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