Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul 02447, Republic of Korea.
Department of Internal Medicine, Inje University Sanggye Paik Hospital, Seoul 01757, Republic of Korea.
Medicina (Kaunas). 2024 Jul 14;60(7):1132. doi: 10.3390/medicina60071132.
: 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. : 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. : 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, = 0.013) and had a higher cirrhosis incidence (81.0 vs. 28.9%, < 0.001), higher AFP (6.0 vs. 3.3, = 0.003) and higher APRI (0.8 vs. 0.5, = 0.005). Age over 65 ( = 0.016) and cirrhosis ( = 0.005) were found to be significant risk factors for HCC by Cox regression analysis. : 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.
慢性丙型肝炎（CHC）可以通过直接作用抗病毒（DAA）治疗治愈。在韩国，索磷布韦（SOF）和雷迪帕韦/索磷布韦于 2016 年推出。接受 DAA 治疗后达到持续病毒学应答（SVR）的患者预计预后良好。然而，对于接受 SOF 治疗并达到 SVR 的韩国 CHC 患者的长期预后知之甚少。因此，本研究的目的是研究这些患者的长期结局。
这是一项前瞻性、多中心观察性研究。纳入了接受 SOF 或 LDV/SOF 治疗后达到 SVR 的 CHC 患者。最后一次随访日期为 2023 年 12 月。主要终点是 HCC 的发生，每年至少检查一次。
本分析共纳入 516 例患者，中位随访时间为 39.0 个月。其中，231 例为男性患者（44.8%），中位年龄为 62.0 岁。基因型为 1 型（90 例，17.4%）、2 型（423 例，82.0%）和 3 型（3 例，0.6%）。SOF 联合利巴韦林是最常见的治疗方案（394 例，76.4%）。共有 160 例患者为肝硬化（31.0%），平均 Child-Pugh 评分为 5.1。在最长 7 年内，21 例（4.1%）患者发生 HCC。发生 HCC 的患者年龄更大（69 岁比 61 岁， = 0.013），肝硬化发生率更高（81.0%比 28.9%， < 0.001），甲胎蛋白（AFP）更高（6.0 比 3.3， = 0.003），APRI 更高（0.8 比 0.5， = 0.005）。Cox 回归分析显示，年龄超过 65 岁（ = 0.016）和肝硬化（ = 0.005）是 HCC 的显著危险因素。
SOF 治疗后达到 SVR 的患者预后相对较好。然而，HCC 的风险并未消除，尤其是在年龄较大和肝硬化患者中。因此，需要进行常规随访、监测和早期治疗。
