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  • Tolerability and effectiveness of sofosbuvir and simeprevir in the post-transplant setting: systematic review and meta-analysis

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Hepatology
Tolerability and effectiveness of sofosbuvir and simeprevir in the post-transplant setting: systematic review and meta-analysis
  1. Nghia H Nguyen1,
  2. Brittany E Yee1,
  3. Christine Chang2,
  4. Minjuan Jin3,
  5. Glen Lutchman2,
  6. Joseph K Lim4,
  7. Mindie H Nguyen2
  1. 1School of Medicine, University of California, San Diego, La Jolla, California, USA
  2. 2Department of Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto, California, USA
  3. 3Department of Epidemiology and Biostatistics, Zhejiang University School of Public Health, Hang Zhou, China
  4. 4Yale Liver Center, Yale University School of Medicine, New Haven, Connecticut, USA
  1. Correspondence to Dr Mindie H Nguyen; mindiehn{at}stanford.edu

Abstract

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.

  • HEPATITIS C
  • LIVER TRANSPLANTATION
  • IMMUNE RESPONSE

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjgast-2015-000066

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