Assessing the impact of a combination of sofosbuvir and daclatasvir treatment for hepatitis C virus infection on heart rate, rhythm and heart rate variability using 24-hour ECG monitoring

Abstract

Background: Direct-acting antiviral agents (DAAs) cure patients with hepatitis C virus (HCV) infection. Concerns have arisen the occurrence of significant bradyarrhythmias during treatment with DAAs. The aim of this study was to assess the impact of a DAA combination for the treatment of HCV infection on heart rate, rhythm, and heart rate variability (HRV) using 24-h ECG monitoring. Results: A prospective randomized study of 50 treatment-naïve patients with HCV infection treated with a combination of sofosbuvir 400 mg daily and daclatasvir 60 mg daily for 12 weeks. Surface ECG and 24-h ECG monitoring were performed at baseline and after completion of therapy to assess PR interval, corrected QT interval (QTc), minimum heart rate (HR), maximum HR, average HR, HRV time-domain and frequency-domain measures, significant pauses, tachycardias, bradycardias, premature atrial contractions (PACs), and premature ventricular contraction (PVCs). No differences were detected in all examined parameters between baseline and after completion of treatment. PR interval was 154 ± 25.95 vs 151.4 ± 23.82 ms, respectively (p = 0.124). QTc interval was 397.34 ± 29.38 vs 395.04 ± 30.23 ms, respectively (p = 0.403). No differences were detected for minimum HR, maximum HR, average HR, HRV time-domain and frequency-domain measures, the occurrence of significant pauses, sinus tachycardia episodes, sinus bradycardia episodes, PACs, and PVCs. No episodes of bradyarrhythmias, syncope, and atrial fibrillation, supraventricular, or ventricular tachycardias were reported or detected. Conclusion: In non-cardiac patients receiving no cardioactive medications, the combination of sofosbuvir and daclatasvir for the treatment of HCV infection has no effect on HR, rhythm, conductivity, or HRV. No symptomatic bradycardias, tachycardias, or syncope were reported or detected using 24-h ECG monitoring.

Cardiovascular Risk Assessment after Sofosbuvir and Daclatasvir Regimen for Chronic Hepatitis C Virus Infection

“…The patients who were free of ectopics at baseline did not develop any significant arrhythmia, and there was no change in mean HR and no dynamic ST-T wave change. These results match well earlier studies (20)(21)(22)(23), which concluded that different DAA protocols had no major cardiac events.…”

“…Statistical methods: Data entry and analysis was done by statistical package of social sciences "spss" version 23…”

The Safety of The Directly Acting Antiviral Treatment For Hepatitis C Virus According To The Egyptian National Program Protocol In Patients With Midrange Ejection Fraction

“…We excluded the patients treated with amiodarone because DAAs may increase its concentration by inhibiting intestinal cytochrome P450 3A4 [ 20 ]. Similarly, a randomized study of 50 patients with structurally normal hearts treated with (SOF+ DCV) showed no significant effect on rhythm, heart rate, heart rate variability, or conductivity [ 21 ]. A meta-analysis including nearly 2300 HCV patients treated with SOF found that SOF was not associated with arrhythmias or significant bradycardias [ 22 ].…”

Cardiac effects of direct anti-viral treatment in type II diabetic patients with hepatitis C infection

“…In a recent study conducted in Egypt using 24-h ECG monitoring during treatment, they reported that in non-cardiac patients receiving no cardioactive medications, the combination of sofosbuvir and daclatasvir for the treatment of HCV infection has no effect on heart rate, rhythm, conductivity, or heart rate variability. No symptomatic bradycardias, tachycardias, or syncope were reported or detected [ 18 ]. In a small sized study conducted in Italy, they concluded that in HCV patients treated with sofosbuvir and other DAAs, ECG parameter changes were mild and/or transient and did not translate into clinically significant electrophysiological effects in the absence of amiodarone coadministration [ 19 ].…”