Key result
Sofosbuvir-based therapy in patients with chronic hepatitis C caused mild, transient ECG changes, such as a QTc increase at 1 week (P=0.013), but no cases of symptomatic bradycardia or syncope.
Why the study?
Several cases of symptomatic, sometimes fatal bradycardia during the first days of direct-acting antiviral administration in chronic hepatitis C patients have been reported, prompting detailed analysis of ECG changes.
Does sofosbuvir-based therapy cause clinically significant electrophysiological adverse effects or bradyarrhythmias in patients with chronic hepatitis C compared to non-sofosbuvir regimens?
Cohort (n=39)
No
Does sofosbuvir-based therapy cause clinically significant electrophysiological adverse effects or bradyarrhythmias in patients with chronic hepatitis C compared to non-sofosbuvir regimens?
Absolute Event Rate: 0% vs 0%
Sofosbuvir-based therapy for chronic hepatitis C is associated with only mild and transient ECG changes, without clinically significant electrophysiological effects in the absence of amiodarone coadministration.
Transient QTc changes appear benign without events; hypothesis-generating for safety monitoring in cardiac-comorbid hepatitis C.
Recently, several cases of symptomatic, sometimes fatal bradycardia during the first days of direct-acting antiviral (DAA) (eg, sofosbuvir [SOF]) administration have been reported. We analyzed in detail electrocardiographic (ECG) changes during SOF- or non-SOF-based chronic hepatitis C (CHC) treatment, specifically focusing on bradyarrhythmias. All 39 consecutive patients treated at our center with any interferon-free regimen between June and December 2015 were included in this study (26 SOF-based therapy vs 13 no-SOF interferon-free regimens). ECG tracings were obtained from all patients the first day of treatment and after 7, 14, and 28 days. ECG parameters (P-wave, QRS, QT interval, JT interval, Tapex-Tend interval duration) were compared between the 2 groups at baseline and at the 3 different time points during antiviral therapy. There were no cases of symptomatic bradycardia/syncope. In the SOF group, QTc duration rose after 1 week (from 424.3 to 431.2 milliseconds; P = .013) and returned to baseline during therapy. QT dispersion dropped since week 1 (from 85.6 to 67.2 milliseconds) and remained significantly reduced until the end of the observation period (72.9 msec) (P = .003). JT dispersion reduced up to week 2 (P = .010) and returned to baseline at week 4; in the no-SOF group, QRS dispersion transiently reduced (from 41 to 34.5 milliseconds, day 7). No other significant changes were observed in the remaining parameters. In CHC patients treated with SOF 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.
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Durante‐Mangoni et al. (2017) conducted a cohort in Chronic hepatitis C (n=39). Sofosbuvir-based therapy vs. Non-sofosbuvir interferon-free regimens was evaluated on Symptomatic bradycardia/syncope. Sofosbuvir-based therapy in patients with chronic hepatitis C caused mild, transient ECG changes, such as a QTc increase at 1 week (P=0.013), but no cases of symptomatic bradycardia or syncope.
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