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Published on: June 26, 2014
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.
Background:
Symptomatic bradycardia has been reported in adults treated for chronic hepatitis C using sofosbuvir based regimens.
Aim:
We studied the cardiac safety of sofosbuvir/ledipasvir in Egyptian children, treated for chronic hepatitis C.
Methods:
The study included 40 hepatitis C virus infected children and adolescents 12-17 years old, using the combination of sofosbuvir (400 mg)/ledipasvir (90 mg) in a single oral tablet (Harvoni) taken daily for 12 weeks. All subjects underwent a baseline standard 12-lead surface Electrocardiography that was repeated at 4 and 12 weeks of therapy. Electrocardiography parameters (Heart Rate, RR interval, PR interval, QRS, QT interval, corrected QT interval, QT dispersion, JT interval, corrected JT interval, JT dispersion, Tpeak-Tend interval) were compared at the 3 different time points during antiviral therapy.
Results:
No symptoms related to the cardiovascular system were reported during treatment. There were no cases of symptomatic bradycardia/syncope. Heart rate was noted to be significantly lower and RR and QT intervals were significantly longer in the baseline electrocardiography. Heart rate was significantly lower and RR interval was significantly longer in patients with higher viral load.
Conclusion:
No adverse cardiovascular events were observed in this group of HCV infected children and adolescents treated with sofosbuvir/ledipasvir. None of the patients developed bradyarrhythmias during treatment.
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