RT Journal Article
SR Electronic
T1 Tolerability and effectiveness of sofosbuvir and simeprevir in the post-transplant setting: systematic review and meta-analysis
JF BMJ Open Gastroenterology
FD BMJ Publishing Group Ltd
SP e000066
DO 10.1136/bmjgast-2015-000066
VO 3
IS 1
A1 Nghia H Nguyen
A1 Brittany E Yee
A1 Christine Chang
A1 Minjuan Jin
A1 Glen Lutchman
A1 Joseph K Lim
A1 Mindie H Nguyen
YR 2016
UL http://bmjopengastro.bmj.com//content/3/1/e000066.abstract
AB Background Outcome data on simeprevir and sofosbuvir (SMV+SOF) in patients with liver transplantation (LT) with hepatitis C virus genotype 1 (HCV-1) are limited with individual studies having a small sample size and limited SVR12 (sustained virological response) data. Our goal was to perform a meta-analysis to study the outcome of SMV+SOF±ribavirin (RBV) in recipients with LT.Methods In April 2015, we conducted a literature search for ‘simeprevir’ in MEDLINE/EMBASE and five major liver meetings. We included studies with SVR12 data in ≥5 post-LT mono-infected HCV-1 patients treated with SMV+SOF±RBV. We used random-effects models to estimate effect sizes, and the Cochrane Q-test (p value <0.10) with I2 (>50%) to assess study heterogeneity.Results We included nine studies with a total of 325 patients with post-LT. Studies included mostly men (59–81%). Pooled SVR12 was 88.0% (95% CI 83.4% to 91.5%). In two studies, HCV-1a patients with mild fibrosis (n=108) had an SVR12 rate of 95.0% (95% CI 82.4% to 98.7%), which was significantly higher than that of HCV-1a patients with advanced fibrosis (n=49) with an SVR12 rate of 81.7% (95% CI 69.8% to 89.5%), OR 4.2 (95% CI 1.1 to 16.1, p=0.03). The most common pooled side effects were: fatigue 21% (n=48/237), headache 9% (n=23/254), dermatological symptoms 15% (n=38/254), and gastrointestinal symptoms 6% (12/193).Conclusions SMV+SOF±RBV is safe and effective in recipients with LT with HCV-1 infection.