Sharafi Heidar, Alavian Seyed Hoda, Behnava Bita, Saeid Rezaee-Zavareh Mohammad, Nikbin Mehri, Alavian Seyed Moayed
Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Baqiyatallah University of Medical Sciences, Tehran, Iran.
Middle East Liver Diseases (MELD) Center, Tehran, Iran.
Caspian J Intern Med. 2020 Winter;11(1):41-46. doi: 10.22088/cjim.11.1.41.
Treatment of hepatitis C virus (HCV) infection with recently introduced direct-acting antiviral agents (DAA) is effective and safe, however there is little known regarding safety and efficacy of generic DAAs in the real-life clinical setting. This study aimed to evaluate the efficacy and safety of generic sofosbuvir/ledipasvir (SOF/LDV) in a real-life clinical experience.
In this prospective cohort study, patients with chronic HCV infection who referred to Middle East Liver Diseases (MELD) Center were included. Based on the patients' condition, they were treated with SOF/LDV fixed-dose combination with or without ribavirin (RBV) for 12 or 24 weeks.
A total of 30 (M/F: 19/11) patients with chronic HCV genotype 1 infection with a mean age of 49.8 years were treated with generic SOF/LDV with (9 patients) or without (11 patients) RBV for 12 (27 patients) or 24 (3 patients) weeks. Ten (33.3%) had cirrhosis and 13 (43.3%) with a previous history of treatment with interferon (IFN)-based regimens. Among the 30 patients, 26 (86.7%, 95% CI=70.3%-94.7%) achieved a rapid virologic response, 30 (100%, 95% CI=88.7%-100%) achieved the end of treatment response and 30 (100%, 95% CI=88.7%-100%) achieved a sustained virologic response. No severe treatment adverse event was observed however, 6 (20%) patients experienced mild to moderate adverse events.
The treatment of HCV genotype 1 infection with generic SOF/LDV found to be safe and effective even in patients with cirrhosis and previous history of treatment with IFN-based treatments.
使用最近推出的直接作用抗病毒药物（DAA）治疗丙型肝炎病毒（HCV）感染是有效且安全的，然而在现实临床环境中，关于仿制药DAA的安全性和有效性知之甚少。本研究旨在评估仿制药索磷布韦/维帕他韦（SOF/LDV）在现实临床经验中的疗效和安全性。
在这项前瞻性队列研究中，纳入了转诊至中东肝脏疾病（MELD）中心的慢性HCV感染患者。根据患者情况，给予他们使用或不使用利巴韦林（RBV）的SOF/LDV固定剂量组合治疗12周或24周。
共有30例（男/女：19/11）慢性HCV 1型感染患者，平均年龄49.8岁，接受了含（9例患者）或不含（11例患者）RBV的仿制药SOF/LDV治疗12周（27例患者）或24周（3例患者）。10例（33.3%）有肝硬化，13例（43.3%）有基于干扰素（IFN）方案的既往治疗史。在这30例患者中，26例（86.7%，95%CI = 70.3% - 94.7%）实现了快速病毒学应答，30例（100%，95%CI = 88.7% - 100%）实现了治疗结束应答，30例（100%，95%CI = 88.7% - 100%）实现了持续病毒学应答。未观察到严重治疗不良事件，然而，6例（20%）患者经历了轻度至中度不良事件。
发现使用仿制药SOF/LDV治疗HCV 1型感染即使在有肝硬化和基于IFN治疗既往史的患者中也是安全有效的。
