Division of Hepatology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
The Catholic University Liver Research Center, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Korean J Intern Med. 2022 Nov;37(6):1167-1175. doi: 10.3904/kjim.2022.013. Epub 2022 May 27.
BACKGROUND/AIMS: To evaluate the efficacy and safety of ledipasvir/sofosbuvir (LDV/SOF) therapy in hepatitis C virus (HCV)-infected Korean patients in a real clinical setting.
A total of 273 patients who received LDV/SOF therapy between May 2016 and February 2021 were consecutively enrolled and analyzed. A per-protocol analysis was performed to evaluate the virologic response.
Seventy-five percent were infected with genotype 1, and 25% were infected with genotype 2. A hundred eightyone (66.3%) patients had chronic hepatitis, 74 (27.1%) had compensated cirrhosis, eight (2.9%) had decompensated cirrhosis, and 10 (3.7%) had undergone liver transplantation. Undetectable HCV RNA at week 4 was achieved in 90.2% (231/256) of patients, 99.2% (250/252) achieved the end of treatment response, and 98.1% (202/206) achieved sustained virologic response at 12 weeks post-treatment (SVR12). According to liver function, the SVR12 rates were 99.3% (135/136) in chronic hepatitis, 96.4% (53/55) in compensated cirrhosis, and 100% (6/6) in decompensated cirrhosis. The SVR12 rates according to the genotype were 98.2% (167/170) for genotype 1 and 97.2% (35/36) for genotype 2. An 8-week LDV/SOF treatment in treatment-naïve chronic hepatitis patients with HCV RNA < 6,000,000 IU/mL at baseline resulted in 100% (23/23) SVR12 rates. Overall, LDV/SOF was tolerated well, with a 0.7% (2/273) discontinuation rate due to adverse events that were unrelated to LDV/SOF.
LDV/SOF is effective and safe for treating HCV-infected Korean patients with high SVR12 rates.
背景/目的：评估在真实临床环境下，丙型肝炎病毒（HCV）感染的韩国患者接受 ledipasvir/sofosbuvir（LDV/SOF）治疗的疗效和安全性。
共连续纳入并分析了 273 例于 2016 年 5 月至 2021 年 2 月接受 LDV/SOF 治疗的患者。采用方案治疗分析评估病毒学应答。
75%的患者感染基因型 1，25%的患者感染基因型 2。181 例（66.3%）患者为慢性肝炎，74 例（27.1%）为代偿性肝硬化，8 例（2.9%）为失代偿性肝硬化，10 例（3.7%）为肝移植患者。90.2%（231/256）的患者在治疗第 4 周时实现了 HCV RNA 不可检测，99.2%（250/252）达到了治疗结束时的应答，98.1%（202/206）在治疗后 12 周时达到了持续病毒学应答（SVR12）。根据肝功能，慢性肝炎患者的 SVR12 率为 99.3%（135/136），代偿性肝硬化患者为 96.4%（53/55），失代偿性肝硬化患者为 100%（6/6）。基因型 1 的 SVR12 率为 98.2%（167/170），基因型 2 的 SVR12 率为 97.2%（35/36）。基线时 HCV RNA <6,000,000 IU/mL 的初治慢性肝炎患者接受 8 周 LDV/SOF 治疗后，SVR12 率为 100%（23/23）。总体而言，LDV/SOF 耐受性良好，由于与 LDV/SOF 无关的不良事件，仅有 0.7%（2/273）的患者停药。
LDV/SOF 对治疗韩国 HCV 感染患者具有疗效和安全性，可实现高 SVR12 率。
