BOSTON, MA—No clinically significant changes in heart rate or cardiac adverse events were observed in patients with hepatitis C virus (HCV) infection on beta-blockers receiving sofosbuvir (SOF)-based regimens, results of a study presented at The Liver Meeting® have found.
“No trend towards an increase in bradycardic events” were observed, noted Curtis Cooper, MD, Director, Ottawa Hospital and Regional Hepatitis Program, University of Ottawa, Ontario, Canada, and colleagues.
Post-marketing cases of serious, symptomatic bradycardia have been reported in patients on amiodarone treated with SOF in combination with another direct-acting antiviral. To date, however, the effects of SOF-based regimens in combination with beta blockers—which also have bradycardic properties—have not been described.
The investigators performed a retrospective analysis in patients with compensated liver disease included in 10 Phase 3 registration trials conducted by Gilead Sciences, Inc.
The investigators measured change from baseline in heart rate in patients treated with SOF + ribavirin (RBV) for 12 or 24 weeks; SOF + RBV + pegylated-interferon (Peg-IFN) for 12 weeks; LDV/SOF ± RBV for 8, 12, or 24 weeks; and SOF/velpatasvir (VEL) for 12 weeks who were on a continuous beta-blocker and compared them to patients with no beta-blocker use and with those in the placebo arm.
Patients were stratified by treatment regimen and concomitant stable use of a beta-blocker.
“Proportions of patients with ≥10 beats per minute drop in heart rate within 2 weeks of starting SOF-based regimens or placebo were calculated for both groups,” Dr. Cooper noted.
Investigator-reported adverse events of interest were analyzed. These included cardiac disorders, dizziness, and syncope occurring in the first 2 weeks after initiation of a SOF, LDV/SOF, or SOF/VEL regimen, stratified by any beta-blocker use in the first 2 weeks.
Of the more than 4000 patients enrolled in the trials, 406 were on a stable beta blocker, 128 (9%) from the SOF program, 191 (10%) from the LDV/SOF program, 87 (8%) from the SOF/VEL program, and 13 (7%) in the placebo arm. The beta-blockers included atenolol, bisoprolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, and sotalol.
“Patients on stable beta-blockers regimens were older, more likely to have cirrhosis, and more likely to have cardiac risk factors or cardiac disease at baseline,” the investigators reported.
When the population of patients on beta-blockers were compared with those not on beta-blockers, no differences in the proportion with heart rate decreases from baseline ≥10 beats per minute within the first 2 weeks of starting SOF-based treatment were seen.
Among the groups, patients experienced similar rates of AEs of interest: any cardiac AE, dizziness, and syncope.