PT  - JOURNAL ARTICLE
AU  - Nghia H Nguyen
AU  - Brittany E Yee
AU  - Christine Chang
AU  - Minjuan Jin
AU  - Glen Lutchman
AU  - Joseph K Lim
AU  - Mindie H Nguyen
TI  - Tolerability and effectiveness of sofosbuvir and simeprevir in the post-transplant setting: systematic review and meta-analysis
AID  - 10.1136/bmjgast-2015-000066
DP  - 2016 Jan 01
TA  - BMJ Open Gastroenterology
PG  - e000066
VI  - 3
IP  - 1
4099  - http://bmjopengastro.bmj.com//content/3/1/e000066.short
4100  - http://bmjopengastro.bmj.com//content/3/1/e000066.full
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.