Ahmed Ossama A, Elsebaey Mohamed A, Fouad Mohamed Hassan A, Elashry Heba, Elshafie Ahmed I, Elhadidy Ahmed A, Esheba Noha E, Elnaggar Mohammed H, Soliman Shaimaa, Abd-Elsalam Sherief
Department of Internal Medicine, Ain Shams University, Faculty of Medicine, Cairo, Egypt.
Department of Internal Medicine, Tanta University, Tanta, Egypt.
Infect Drug Resist. 2018 Mar 28;11:441-445. doi: 10.2147/IDR.S160593. eCollection 2018.
Treatment of hepatitis C virus (HCV) changed dramatically with the introduction of oral direct-acting antiviral drugs due to their high antiviral potency and safety profile. Sofosbuvir plus daclatasvir combination therapy was extensively investigated in HCV genotypes 1, 2, and 3, while published data regarding its real-life application in the treatment of genotype 4 is lacking. Therefore, we conducted this study to assess the outcomes and predictors of treatment response with sofosbuvir plus daclatasvir with or without ribavirin in Egyptian patients with genotype 4 hepatitis C virus infection.
This prospective study included 300 Egyptian patients with chronic genotype 4 HCV, treated with sofosbuvir plus daclatasvir with or without ribavirin for 12-24 weeks. Primary outcome was the number of patients who achieved sustained virologic response (SVR12), and secondary outcome was the occurrence of adverse events.
A total of 92.67% of all patients achieved SVR12. SVR12 rates of 96.55% and 84.54% were reported in non-cirrhotic and cirrhotic patients, respectively. SVR12 in treatment-naïve and treatment-experienced patients were 94.12% and 87.01%, respectively. A total of 19.7% of patients experienced mild adverse events. Older age, cirrhosis, and low platelet count were the predictors of treatment non-response.
Based on this multi-center prospective study, sofosbuvir plus daclatasvir with or without ribavirin for 12-24 weeks appears to have favorable outcomes in the treatment of genotype 4 HCV-infected Egyptian patients. Older age, cirrhosis, especially Child-Pugh class B, and low platelet count are independent risk factors of treatment non-response.
随着口服直接抗病毒药物的问世，丙型肝炎病毒（HCV）的治疗发生了巨大变化，因为这些药物具有很高的抗病毒效力和安全性。索磷布韦加达卡他韦联合疗法已在HCV 1、2和3基因型中得到广泛研究，但关于其在4基因型治疗中的实际应用的已发表数据尚缺。因此，我们开展了这项研究，以评估索磷布韦加达卡他韦联合或不联合利巴韦林治疗埃及4基因型丙型肝炎病毒感染患者的治疗效果及治疗反应的预测因素。
这项前瞻性研究纳入了300例埃及慢性4基因型HCV患者，接受索磷布韦加达卡他韦联合或不联合利巴韦林治疗12 - 24周。主要结局是实现持续病毒学应答（SVR12）的患者数量，并次要结局是不良事件的发生情况。
所有患者中共有92.67%实现了SVR12。非肝硬化和肝硬化患者的SVR12率分别为96.55%和84.54%。初治和经治患者的SVR12分别为94.12%和87.01%。共有19.7%的患者经历了轻度不良事件。年龄较大、肝硬化和血小板计数低是治疗无应答的预测因素。
基于这项多中心前瞻性研究，索磷布韦加达卡他韦联合或不联合利巴韦林治疗12 - 24周在治疗4基因型HCV感染的埃及患者中似乎有良好的疗效。年龄较大、肝硬化，尤其是Child-Pugh B级，以及血小板计数低是治疗无应答的独立危险因素。
