Chang Christine Y, Nguyen Pauline, Le An, Zhao Changqing, Ahmed Aijaz, Daugherty Tami, Garcia Gabriel, Lutchman Glen, Kumari Radhika, Nguyen Mindie H
Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto University of California, Los Angeles School of Medicine, Los Angeles, CA Department of Cirrhosis, Institute of Liver Disease, Shuguang Hospital, Shanghai University of T.C.M., Shanghai, P.R. China.
Medicine (Baltimore). 2017 Feb;96(6):e6128. doi: 10.1097/MD.0000000000006128.
Real-life data on interferon (IFN)-free direct acting antiviral (DAA) therapies for chronic hepatitis C (CHC) is limited for Asian Americans.To evaluate sustained virologic response (SVR) and adverse events (AE) in Asian Americans treated with sofosbuvir (SOF)-based, IFN-free DAA therapies.This is a retrospective study of 110 consecutive Asian Americans with HCV genotypes 1 to 3 or 6 treated with IFN-free SOF-based regimens for 8 to 24 weeks between February 2014 and March 2016 at a university center in Northern California.Mean age was 63 ± 12 years, mean BMI was 25 ± 6 (kg/m), and about half (52%) were male. Most patients were infected with HCV genotype 1 (HCV-1, 64%), followed by HCV-2 (14%), HCV-6 (13%), and HCV-3 (8%). Half had cirrhosis, and the majority of these (67%) had decompensation. Overall SVR12 was 93% (102/110), and highest among patients without cirrhosis, liver transplant, or HCC (100%, 37/37). SVR12 was lower among patients with HCC (82%, 14/17), decompensated cirrhosis (84%, 31/37), or liver transplant (89%, 17/19), regardless of treatment and genotype. Most common AEs were anemia (25%), fatigue (20%), and headache (12%). Anemia was highest in patients receiving SOF/RBV (67%). There was 1 treatment-unrelated serious adverse effect (SAE). There were 7 dose reductions due to anemia or fatigue from RBV and 2 treatment discontinuations due to fatigue or loss of insurance authorization.This real-life cohort of Asian American CHC patients treated with IFN-free SOF-based therapies showed high overall treatment response and good tolerability, despite very high rates of advanced disease and prior treatment failure.
关于亚洲裔美国人慢性丙型肝炎(CHC)使用无干扰素直接抗病毒(DAA)疗法的真实世界数据有限。为评估接受基于索磷布韦(SOF)的无干扰素DAA疗法治疗的亚洲裔美国人的持续病毒学应答(SVR)和不良事件(AE)。这是一项对2014年2月至2016年3月期间在北加利福尼亚州一所大学中心接受基于SOF的无干扰素方案治疗8至24周的110例连续亚洲裔美国人进行的回顾性研究,这些患者的丙型肝炎病毒(HCV)基因型为1至3型或6型。平均年龄为63±12岁,平均体重指数为25±6(kg/m²),约一半(52%)为男性。大多数患者感染HCV基因型1(HCV-1,64%),其次是HCV-2(14%)、HCV-6(13%)和HCV-3(8%)。一半患者有肝硬化,其中大多数(67%)有失代偿。总体SVR12为93%(102/110),在无肝硬化、肝移植或肝癌的患者中最高(100%,37/37)。无论治疗和基因型如何,肝癌患者(82%,14/17)、失代偿性肝硬化患者(84%,31/37)或肝移植患者(89%,17/19)的SVR12较低。最常见的AE是贫血(25%)、疲劳(20%)和头痛(12%)。接受SOF/RBV的患者贫血发生率最高(67%)。有1例与治疗无关的严重不良事件(SAE)。因RBV引起的贫血或疲劳有7次剂量减少,因疲劳或保险授权丧失有2次治疗中断。尽管晚期疾病发生率和既往治疗失败率很高,但这一接受基于SOF的无干扰素疗法治疗的亚洲裔美国CHC患者的真实世界队列显示出较高的总体治疗应答率和良好的耐受性。