Liao H-T, Tan P, Huang J-W, Yuan K-F
Department of Liver Surgery, Liver Transplantation Division, West China Hospital, Sichuan University, Chengdu, China.
Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, China.
Transplant Proc. 2017 Oct;49(8):1855-1863. doi: 10.1016/j.transproceed.2017.04.014.
Studies focusing on the efficacy and safety of ledipasvir (LDV) + sofosbuvir (SOF) therapy in liver transplant (LT) recipients with hepatitis C virus (HCV) recurrence are still limited. Therefore, the aim of our work was to perform a systematic review and meta-analysis to evaluate outcome data of LDV + SOF therapy in LT recipients.
Multiple databases were systematically searched for eligible studies. We included studies reporting sustained virological response 12 weeks after treatment (SVR12) and treatment-related adverse events (AEs) in LT recipients treated with LDV + SOF ± ribavirin (RBV) for HCV recurrence. All statistical analyses were conducted by using R version 3.3.1 (The R Foundation for Statistical Computing, Vienna, Austria).
Twelve studies with a total of 994 LT recipients were included, most of which were diagnosed with HCV genotype 1 infection. The overall SVR12 reached 96.3% (95% confidence interval [CI]: 94.9%-97.5%) and no significant heterogeneity was observed (Q statistic = 10.63, P = .47; I = 0%). No difference was found in SVR12 between treatments for 12 weeks and 24 weeks (P = .18). Patients treated with LDV + SOF + RBV (n = 525) exhibited an SVR12 rate of 95.1% (95% CI 92.8%-96.6%), which showed no difference from the findings in the LDV + SOF treatment group (n = 314) with an SVR12 reaching 94.9% (95% CI 91.5%-97.0%; P = .92). There was a tendency for a higher SVR12 in patients without cirrhosis than those with cirrhosis (P < .05). The most common AEs were listed as following: anemia 41.9% (n = 203 of 484), fatigue 39.1% (n = 207 of 530), headache 24.2% (n = 128 of 530), nausea 21.9% (n = 106 of 484), and diarrhea 19.0% (n = 92 of 484).
LDV + SOF-based treatment is highly effective and well tolerated in LT recipients with HCV reinfection.
关于来迪派韦（LDV）+索磷布韦（SOF）疗法对丙型肝炎病毒（HCV）复发的肝移植（LT）受者的疗效和安全性的研究仍然有限。因此，我们研究的目的是进行一项系统评价和荟萃分析，以评估LDV+SOF疗法在LT受者中的疗效数据。
系统检索多个数据库以查找符合条件的研究。我们纳入了报告接受LDV+SOF±利巴韦林（RBV）治疗HCV复发的LT受者治疗后12周持续病毒学应答（SVR12）和治疗相关不良事件（AE）的研究。所有统计分析均使用R 3.3.1版本（奥地利维也纳的R统计计算基金会）进行。
纳入了12项研究，共994例LT受者，其中大多数被诊断为HCV 1型感染。总体SVR12达到96.3%（95%置信区间[CI]：94.9%-97.5%），未观察到显著异质性（Q统计量=10.63，P=.47；I²=0%）。治疗12周和24周的SVR12之间未发现差异（P=.18）。接受LDV+SOF+RBV治疗的患者（n=525）的SVR12率为95.1%（95%CI 92.8%-96.6%），与LDV+SOF治疗组（n=314）的结果无差异，后者的SVR12达到94.9%（95%CI 91.5%-97.0%；P=.92）。无肝硬化患者的SVR12有高于肝硬化患者的趋势（P<.05）。最常见的AE如下：贫血41.9%（484例中的203例）、疲劳39.1%（530例中的207例）、头痛24.2%（530例中的128例）、恶心21.9%（484例中的106例）和腹泻19.0%（484例中的92例）。
基于LDV+SOF的治疗对HCV再感染的LT受者高效且耐受性良好。
