Key result
A 12-week combination of sofosbuvir and daclatasvir for HCV infection had no significant effect on heart rate, rhythm, conductivity, or heart rate variability in patients without cardiac disease.
Why the study?
Concerns had arisen regarding the occurrence of significant bradyarrhythmias during treatment with direct-acting antiviral agents for HCV infection.
Does the combination of sofosbuvir and daclatasvir affect heart rate, rhythm, or heart rate variability in patients with HCV infection?
Cohort (n=50)
Single-blind
No
Does the combination of sofosbuvir and daclatasvir affect heart rate, rhythm, or heart rate variability in patients with HCV infection?
Absolute Event Rate: 151.4% vs 154%
p-value: p=0.124
In non-cardiac patients not taking cardioactive medications, the 12-week combination of sofosbuvir and daclatasvir for HCV does not adversely affect heart rate, rhythm, or heart rate variability.
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.
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Missiri et al. (2020) conducted a cohort in Hepatitis C virus (HCV) infection (n=50). Sofosbuvir and daclatasvir vs. Baseline (pre-treatment) was evaluated on PR interval duration (ms) (p=0.124). A 12-week combination of sofosbuvir and daclatasvir for HCV infection had no significant effect on heart rate, rhythm, conductivity, or heart rate variability in patients without cardiac disease.
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