Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura-Damietta Road, Mansoura, Dakahlia, Egypt.
Hepatology and Gastroenterology Unit, Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
Hepatol Int. 2018 Jul;12(4):339-347. doi: 10.1007/s12072-018-9861-2. Epub 2018 Apr 16.
New regimens involving direct-acting antiviral agents have recently been approved for the treatment of HCV. Our aim was to assess the efficacy and safety of 12 or 24 weeks of Sofosbuvir 400 mg plus Daclatasvir 60 mg, with or without ribavirin (800-1000 mg) in treating chronic hepatitis C genotype 4 patients.
This is an open-label observational study that describes the effect of 12 week or 24 weeks of daily oral Sofosbuvir (SOF) 400 mg plus Daclatasvir (DCV) 60 mg with or without ribavirin (RBV) with dose adjustment if indicated. It included the first 1168 patients that fulfilled the inclusion and exclusion criteria and treated in the Egyptian Liver Research Institute and Hospital, Mansoura, Egypt.
Sustained viral response after 12 weeks of end of treatment (SVR12) was achieved in 96.6% (95% CI 95.1-98.2%) of the patients receiving 12 weeks of DCV + SOF treatment, in 95.7% (95% CI 93.6-97.8%) of the patients receiving 12 weeks of DCV + SOF + RBV, in 93.3% (95% CI 90.0-96.6%) of those receiving 24 weeks of DCV + SOF, and in 92.2% (95% CI 85.4-98.9%) of patients receiving 24 weeks of DCV + SOF + RBV treatment. SVR12 rate was significantly higher in patients with no cirrhosis receiving DCV + SOF only for 12 weeks or 24 weeks (97.4 and 97.4%, respectively) than in patients with cirrhosis (91.7 and 88.9%, respectively). The most common adverse events were fatigue, headache, insomnia, and anemia. No treatment-related serious adverse events or death were reported in the studied groups.
Treatment with SOF (400 mg) plus DCV (60 mg), with or without RBV (800-1000 mg) for 12 or 24 weeks, was effective and well tolerated in chronic hepatitis C genotype 4 patients. SVR rates were higher for patients with no cirrhosis. Addition of RBV has benefit only in treatment-experienced group receiving 24 weeks.
最近批准了新的包含直接作用抗病毒药物的方案用于 HCV 的治疗。我们旨在评估 Sofosbuvir 400mg 加 Daclatasvir 60mg 联合或不联合利巴韦林（800-1000mg）治疗慢性丙型肝炎基因型 4 患者的 12 或 24 周治疗的疗效和安全性。
这是一项开放性观察性研究，描述了 12 周或 24 周每日口服 Sofosbuvir（SOF）400mg 加 Daclatasvir（DCV）60mg 联合或不联合利巴韦林（RBV）的效果，如果需要则进行剂量调整。它包括了在埃及肝研究和医院（Egyptian Liver Research Institute and Hospital），曼苏拉（Mansoura），埃及接受治疗的前 1168 例符合纳入和排除标准的患者。
接受 12 周 DCV+SOF 治疗的患者中，有 96.6%（95%可信区间 95.1-98.2%）在治疗结束后 12 周时达到持续病毒学应答（SVR12），接受 12 周 DCV+SOF+RBV 治疗的患者中，有 95.7%（95%可信区间 93.6-97.8%），接受 24 周 DCV+SOF 治疗的患者中，有 93.3%（95%可信区间 90.0-96.6%），接受 24 周 DCV+SOF+RBV 治疗的患者中，有 92.2%（95%可信区间 85.4-98.9%）。无肝硬化的患者接受 12 周或 24 周 DCV+SOF 治疗的 SVR12 率明显高于肝硬化患者（分别为 97.4%和 97.4%，分别为 91.7%和 88.9%）。最常见的不良反应是疲劳、头痛、失眠和贫血。在研究组中没有报告与治疗相关的严重不良事件或死亡。
SOF（400mg）加 DCV（60mg），联合或不联合利巴韦林（800-1000mg）治疗 12 或 24 周，对慢性丙型肝炎基因型 4 患者有效且耐受性良好。无肝硬化的患者 SVR 率更高。RBV 的添加仅对接受 24 周治疗的治疗经验丰富的患者有益。
