TY  - JOUR
UR  - http://dx.doi.org/10.1007/s40264-017-0586-2
Y1  - 2018/01//
ID  - discovery1569673
TI  - Cardiac Harms of Sofosbuvir: Systematic Review and Meta-Analysis
VL  - 41
JF  - Drug Safety
N2  - INTRODUCTION: Sofosbuvir is a new direct-acting pyrimidine nucleotide analogue antiviral drug that has shown remarkable efficacy in the treatment of hepatitis C in clinical trials. However, observational anecdotal data have recently suggested an increased risk of serious bradycardia among patients treated with sofosbuvir and amiodarone. OBJECTIVE: We aimed to estimate and characterize the cardiac safety of sofosbuvir by performing a systematic review of randomized controlled trials (RCTs). METHODS: We conducted a systematic review of RCTs (PROSPERO 2016: CRD42016033109) comparing sofosbuvir and non-sofosbuvir regimens in patients with chronic hepatitis C by searching the MEDLINE, Embase, and Cochrane Library databases up to January 2017. Non-published data were obtained from the sofosbuvir marketing authorization holder. Random-effects meta-analysis was performed to derive pooled estimates of relative risks (RRs) and corresponding 95% confidence intervals (CIs). RESULTS: Six trials, enrolling 2346 patients (1625 treated with sofosbuvir), were included. The overall risk of bias across studies was moderate. The risk of reported cardiac events (RR 0.87; 95% CI 0.41-1.85), arrhythmias (RR 0.93; 95% CI 0.34-2.51), bradycardia (RR 0.47; 95% CI 0.04-5.20), and tachycardia (RR 0.91; 95% CI 0.20-4.20) were not significantly different between sofosbuvir and non-sofosbuvir regimens. The risks of reported syncope, presyncope, loss of consciousness, or palpitations were similar among those receiving sofosbuvir regimens and controls. CONCLUSIONS: The pooled data from RCTs did not show an increased risk of cardiac outcomes, including arrhythmias (and bradycardia), among sofosbuvir-treated patients, although the overall quality of the evidence supporting this conclusion was very low.
A1  - Caldeira, D
A1  - Rodrigues, FB
A1  - Duarte, MM
A1  - Sterrantino, C
A1  - Barra, M
A1  - Gonçalves, N
A1  - Pinto, FJ
A1  - Ferreira, JJ
A1  - Costa, J
SN  - 1179-1942
EP  - 86
SP  - 77
IS  - 1
AV  - public
ER  -