Ichikawa Tatsuki, Miyaaki Hisamitsu, Miuma Satoshi, Taura Naota, Motoyoshi Yasuhide, Akahoshi Hiroshi, Nakamura Satomi, Nakamura Junpei, Takahashi Youichi, Honda Tetsurou, Yajima Hiroyuki, Uehara Ryouhei, Hino Naoyuki, Narita Syouhei, Tanaka Hisaya, Sasaki Seina, Nakao Kazuhiko
Department of Gastroenterology, Nagasaki Harbor Medical Center, Nagasaki, Japan.
Innovation and Translational Research Center, Nagasaki Harbor Medical Center, Nagasaki, Japan.
Hepatol Res. 2018 Feb;48(3):E232-E239. doi: 10.1111/hepr.12974. Epub 2017 Nov 13.
Direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) infection have a significantly high sustained virologic response rate after a short treatment course and do not have any severe adverse effects. Patient-reported outcomes (PROs) have become increasingly important to assess the total impact of a chronic disease. We aimed to evaluate the changes in symptoms of patients with HCV infection treated with DAAs by using PROs.
A total of 107 patients with chronic HCV infection were treated with DAAs. Daclatasvir/asunaprevir or sofosbuvir/ledipasvir was used for HCV 1B infection, and sofosbuvir/ribavirin for HCV 2A/2B infection. The PROs measured at the start of treatment and 1 year after the start of treatment were cirrhosis-related symptom score (CSS), presence of restless legs syndrome (RLS), Epworth sleepiness scale (ESS), Pittsburg sleep quality index (PSQI), Kessler 6 score (K-6), and the SF-36 to measure quality of life (QOL). All patients had a sustained virologic response rate of 24.
The CSS, PSQI, K-6, and RLS scores were improved 1 year after beginning treatment. However, QOL had not recovered. Changes in total CSS were correlated with HCV genotype, sex, hypertensive drug use, serum low-density lipoprotein, and ESS at the start of treatment and RLS 1 year after the start of treatment. The factors that contributed to worsening of CSS were HCV genotype 2B and RLS 1 year after the start of treatment.
Treatment with DAAs eliminated HCV-RNA and improved most symptoms, but QOL did not recover.
用于治疗丙型肝炎病毒（HCV）感染的直接抗病毒药物（DAA）在短疗程治疗后具有显著较高的持续病毒学应答率，且无任何严重不良反应。患者报告结局（PRO）对于评估慢性病的总体影响变得越来越重要。我们旨在通过使用PRO评估接受DAA治疗的HCV感染患者症状的变化。
共有107例慢性HCV感染患者接受了DAA治疗。对于HCV 1B感染，使用达卡他韦/阿舒瑞韦或索磷布韦/来迪帕司韦，对于HCV 2A/2B感染，使用索磷布韦/利巴韦林。在治疗开始时和治疗开始后1年测量的PRO包括肝硬化相关症状评分（CSS）、不安腿综合征（RLS）的存在情况、爱泼华嗜睡量表（ESS）、匹兹堡睡眠质量指数（PSQI）、凯斯勒6项心理困扰量表评分（K-6）以及用于测量生活质量（QOL）的SF-36。所有患者的持续病毒学应答率均为24。
治疗开始后1年，CSS、PSQI、K-6和RLS评分有所改善。然而，生活质量并未恢复。CSS总分的变化与治疗开始时的HCV基因型、性别、高血压药物使用情况、血清低密度脂蛋白以及ESS和治疗开始后1年的RLS相关。导致CSS恶化的因素是治疗开始后1年的HCV基因型2B和RLS。
DAA治疗消除了HCV-RNA并改善了大多数症状，但生活质量并未恢复。
