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Abstract：
Background and Objectives: Chronic hepatitis C (CHC) can be cured with direct-acting antiviral (DAA) therapy. In Korea, sofosbuvir (SOF) and ledipasvir (LDV)/SOF were launched in 2016. Patients who achieve a sustained virologic response (SVR) following DAA treatment are predicted to have a favorable prognosis. Nevertheless, little is known regarding the prognosis of Korean CHC patients who receive SOF-based treatment and achieve SVR. Therefore, the purpose of this study was to look into the long-term outcomes for these patients. Materials and Methods: This was a prospective, multicenter observational study. CHC patients were enrolled who, following SOF or LDV/SOF treatment, had achieved SVR. The last day for follow-up was December 2023. The primary endpoint was HCC occurrence, which was checked at least once per year. Results: A total of 516 patients were included in this analysis, with a median follow-up duration of 39.0 months. Among them, 231 were male patients (44.8%), with a median age of 62.0 years. Genotypes were 1 (90, 17.4%), 2 (423, 82.0%), and 3 (3, 0.6%). The combination of SOF plus ribavirin was the most common treatment (394, 76.4%). In total, 160 patients were cirrhotic (31.0%), and the mean Child-Pugh score was 5.1. Within a maximum of 7 years, 21 patients (4.1%) developed HCC. Patients with HCC were older (69 vs. 61 years, p = 0.013) and had a higher cirrhosis incidence (81.0 vs. 28.9%, p < 0.001), higher AFP (6.0 vs. 3.3, p = 0.003) and higher APRI (0.8 vs. 0.5, p = 0.005). Age over 65 (p = 0.016) and cirrhosis (p = 0.005) were found to be significant risk factors for HCC by Cox regression analysis. Conclusions: Patients who achieved SVR with SOF-based treatment had a relatively favorable prognosis. However, the risk of HCC was not eliminated, especially in older and cirrhotic patients. Therefore, routine follow-up, surveillance, and early treatment are required.
摘要：
背景与目的：慢性丙型肝炎（CHC）可以通过直接抗病毒（DAA）治疗来治愈。在韩国,sofosbuvir（SOF）和ledipasvir（LDV）/SOF于2016年推出。预测在DAA治疗后实现持续病毒学应答(SVR)的患者具有良好的预后。然而，对接受SOF治疗并达到SVR的韩国CHC患者的预后知之甚少.因此,本研究的目的是研究这些患者的长期结局.材料与方法：这是一个前瞻性的，多中心观察研究。CHC患者被纳入，SOF或LDV/SOF治疗后，实现了SVR。随访的最后一天是2023年12月。主要终点是HCC发生，每年至少检查一次。结果：共纳入516例患者，中位随访时间为39.0个月。其中,男性患者231例（44.8%），平均年龄为62.0岁。基因型为1（90，17.4%），2（423，82.0%），和3（3，0.6%）。SOF加利巴韦林的组合是最常见的治疗方法（394，76.4％）。总的来说,160例肝硬化（31.0%），平均Child-Pugh评分为5.1.最长7年内,21例患者（4.1％）发展为HCC。HCC患者年龄较大（69vs.61年,p=0.013），肝硬化发病率较高（81.0vs.28.9%,p<0.001)，较高的AFP（6.0与3.3，p=0.003）和更高的APRI（0.8与0.5，p=0.005）。年龄超过65（p=0.016）和肝硬化（p=0.005）通过Cox回归分析发现是HCC的重要危险因素。结论：使用基于SOF的治疗获得SVR的患者预后相对良好。然而,肝癌的风险没有消除，尤其是老年和肝硬化患者。因此,常规随访,监视,需要早期治疗。
