Wei Bin, Ji Fanpu, Yeo Yee Hui, Ogawa Eiichi, Zou Biyao, Stave Christopher D, Dang Shuangsuo, Li Zongfang, Furusyo Norihiro, Cheung Ramsey C, Nguyen Mindie H
Division of Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto, California, USA.
Department of Infectious Diseases, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
BMJ Open Gastroenterol. 2018 Jun 29;5(1):e000207. doi: 10.1136/bmjgast-2018-000207. eCollection 2018.
Sofosbuvir plus ribavirin (SOF+RBV) for 12 weeks is the standard treatment for chronic hepatitis C (CHC) genotype 2 (GT2) in most of Asia despite availability of new CHC medications. SOF-RBV real-world effectiveness has only been reported in small and/or single-centre studies. Our goal was to determine the real-world effectiveness of 12-week SOF+RBV therapy for CHC GT2 in Asia.
A systematic search on PubMed and Embase was conducted through 30 June 2017. We identified full articles and conference proceedings of at least 10 adult patients with CHC GT2 treated with SOF+RBV for 12 weeks under real-world setting in Asia.
A total of 2208 patients from 13 studies were included. The pooled sustained virological response 12 weeks after the end of treatment (SVR12) was 95.8% (95% CI 94.6% to 96.9%) with non-significant heterogeneity (I=34.4%). Anaemia (27.9%) was the most common adverse event (AE), with serious AEs in 2.0% and only 0.7% discontinued therapy prematurely. In subgroup analyses, patients with cirrhosis had 8.7% lower SVR12 than non-cirrhotic patients (<0.0001), and treatment-experienced patients had 7.2% lower SVR12 than treatment-naïve patients (=0.0002). Cirrhotic treatment-experienced patients had the lowest SVR12 at 84.5%. There were no significant differences in pooled SVR12 among patient subgroups: RBV dose reduction versus no dose reduction (=0.30); hepatocellular carcinoma (HCC) versus no HCC (=0.10); GT 2a versus 2b (=0.86); and <65 vs ≥65 years of age (=0.20).
SOF+RBV for 12 weeks was safe and effective for patients with CHC GT2 in Asia, although those with cirrhosis and prior treatment failure had a lower pooled SVR12 rate.
CRD42017067928.
尽管有新型丙型肝炎药物，但在亚洲大部分地区，索磷布韦联合利巴韦林（SOF+RBV）治疗12周仍是慢性丙型肝炎（CHC）基因2型（GT2）的标准治疗方案。SOF-RBV在真实世界中的有效性仅在小型和/或单中心研究中有报道。我们的目标是确定12周SOF+RBV治疗亚洲CHC GT2的真实世界有效性。
截至2017年6月30日，在PubMed和Embase上进行了系统检索。我们纳入了至少10例在亚洲真实世界环境下接受SOF+RBV治疗12周的CHC GT2成年患者的完整文章和会议论文。
共纳入13项研究中的2208例患者。治疗结束12周时的汇总持续病毒学应答（SVR12）为95.8%（95%CI 94.6%至96.9%），异质性无统计学意义（I=34.4%）。贫血（27.9%）是最常见的不良事件（AE），严重AE发生率为2.0%，仅0.7%的患者提前停药。亚组分析显示，肝硬化患者的SVR12比非肝硬化患者低8.7%（<0.0001），经治患者的SVR12比初治患者低7.2%（=0.0002）。肝硬化经治患者的SVR12最低，为84.5%。患者亚组之间的汇总SVR12无显著差异：利巴韦林剂量减少与未减少（=0.30）；合并肝细胞癌（HCC）与未合并HCC（=0.10）；GT 2a与2b（=0.86）；年龄<65岁与≥65岁（=0.20）。
12周的SOF+RBV治疗对亚洲CHC GT2患者安全有效，尽管肝硬化和既往治疗失败的患者汇总SVR12率较低。
CRD42017067928。
