Nguyen Mindie H, Trinh Huy, Do Son, Nguyen Thuan, Nguyen Pauline, Henry Linda
Stanford University Medical Center, Stanford, Caliornia, USA.
San Jose Gastroenterology, San Jose, California, USA.
Am J Gastroenterol. 2017 Dec;112(12):1824-1831. doi: 10.1038/ajg.2017.399. Epub 2017 Oct 31.
Hepatitis C genotype 6 (HCV-GT6) is one of the most prevalent genotypes in Southeast Asia. Ledipasvir and sofosbuvir fixed-dose combination (LDV/SOF FDC) for 12 weeks has been shown to be effective for multiple HCV genotypes including treatment-naïve HCV-6. Our goal was to examine treatment outcomes in a diverse HCV-6 population.
We prospectively enrolled 60 HCV-GT6 patients at four US centers. Treatment -naïve without cirrhosis patients received open-labeled LDV/SOF FDC orally once a day for 8 weeks; All cirrhotic and/or treatment-experienced patients received LDV/SOF FDC for 12 weeks. The primary outcome was sustained virological response 12 weeks after therapy (SVR12). Secondary outcomes were adverse events (AEs) and/or serious adverse events (SAEs). All patients gave written consent.
Overall mean age was 58±10 and 58% were male. All patients were Asian and foreign born. The 8-week group included 20 patients (33.3%) and the 12-week included 40 patients (66.7%). There were 2 (5%) patients with decompensation, 3 with liver cancer (7.5%), and 14 with prior treatment (35%) in the 12-week group. SVR12 was 95.0% for the 8-week group (19/20) and 95.0% for the 12-week group (38/40). AEs included fatigue (5%), insomnia (3.3%), headache (1.7%), and nausea (1.7%); however, all patients completed the intended treatment duration. There were two treatment-unrelated SAEs.
LDV/SOF FDC for 8 or 12 weeks was safe and effective for patients without cirrhosis or prior treatment failure as well as for patients with cirrhosis and/or prior treatment failure, respectively.
丙型肝炎病毒6型（HCV - GT6）是东南亚地区最常见的基因型之一。已证明，12周的来迪派韦和索磷布韦固定剂量复方制剂（LDV/SOF FDC）对包括初治HCV - 6在内的多种HCV基因型有效。我们的目标是研究不同HCV - 6患者群体的治疗结果。
我们在美国的四个中心前瞻性招募了60例HCV - GT6患者。初治且无肝硬化的患者接受开放标签的LDV/SOF FDC，每日口服一次，共8周；所有肝硬化和/或有治疗史的患者接受LDV/SOF FDC治疗12周。主要结局是治疗12周后的持续病毒学应答（SVR12）。次要结局是不良事件（AE）和/或严重不良事件（SAE）。所有患者均签署了书面知情同意书。
总体平均年龄为58±10岁，58%为男性。所有患者均为亚洲出生的外国人。8周治疗组包括20例患者（33.3%），12周治疗组包括40例患者（66.7%）。12周治疗组中有2例（5%）患者出现失代偿，3例（7.5%）患有肝癌，14例（35%）有过治疗史。8周治疗组的SVR12为95.0%（19/20），12周治疗组为95.0%（38/40）。不良事件包括疲劳（5%）、失眠（3.3%）、头痛（1.7%）和恶心（1.7%）；然而，所有患者均完成了预定的治疗疗程。有两例与治疗无关的严重不良事件。
8周或12周的LDV/SOF FDC分别对无肝硬化或既往治疗未失败的患者以及有肝硬化和/或既往治疗失败的患者安全有效。
