Yang Young-Mo, Choi Eun Joo
Department of Pharmacy, College of Pharmacy, Chosun University, Gwangju, South Korea.
Ther Clin Risk Manag. 2017 Apr 12;13:477-497. doi: 10.2147/TCRM.S134818. eCollection 2017.
With the appearance of oral direct-acting antivirals (DAAs), the field of hepatitis C virus (HCV) treatment has been dramatically changed. This evolution makes possible for all oral treatments to be available for the treatment of HCV-infected patients. The aims of this review were to report the efficacy and safety of sofosbuvir (SOF)-based regimens for the treatment of patients with chronic HCV infection and to provide our clinical perspectives on these regimens.
A literature search of clinical studies published in PubMed and posted on ClinicalTrials.gov website was performed to identify studies evaluating the efficacy or safety of SOF-containing treatment regimens.
A total of 23 clinical trials were examined in the review. The evaluated SOF-based regimens are as follows: SOF/daclatasvir (DCV) ± ribavirin (RBV), SOF/ledipasvir (LDV) ± RBV, SOF/simeprevir (SMV), SOF/velpatasvir (VEL) ± RBV, and SOF/RBV ± peginterferon (peg-IFN). These SOF-based regimens were at least effective and safe for HCV-infected patients with or without cirrhosis. The SOF/VEL ± RBV regimen, a pan-genotypic DAA regimen, was effective for the treatment of patients with HCV genotype 1, 2, 3, 4, 5, or 6 infection. The 24-week SOF/RBV regimen was as effective as the 12-week SOF/RBV/peg-IFN regimen. Patients with HCV genotype 3 infection could have benefits from the use of the 24-week SOF/RBV regimen. For cirrhotic patients with HCV genotype 3 infection, the 12-week SOF/RBV/peg-IFN regimen could be considered as an alternative treatment option when access to SOF-based regimens with other DAAs is limited. In the included studies, significant adverse events due to SOF-based regimens were not reported.
The clinical trials suggest that SOF-based treatment regimens for HCV-infected patients with or without cirrhosis can be at least effective and safe patient-convenient medications. However, it is necessary to monitor HCV-infected patients, since rare adverse events, drug-drug interactions, and drug-disease interactions can occur in real clinical settings.
随着口服直接抗病毒药物（DAAs）的出现，丙型肝炎病毒（HCV）治疗领域发生了巨大变化。这种演变使得所有口服治疗方法都可用于治疗HCV感染患者。本综述的目的是报告基于索磷布韦（SOF）的治疗方案治疗慢性HCV感染患者的疗效和安全性，并提供我们对这些方案的临床观点。
对发表在PubMed上并发布在ClinicalTrials.gov网站上的临床研究进行文献检索，以确定评估含SOF治疗方案疗效或安全性的研究。
本综述共审查了23项临床试验。评估的基于SOF的治疗方案如下：SOF/达卡他韦（DCV）±利巴韦林（RBV）、SOF/来迪派韦（LDV）±RBV、SOF/西米普明（SMV）、SOF/维帕他韦（VEL）±RBV以及SOF/RBV±聚乙二醇干扰素（peg-IFN）。这些基于SOF的治疗方案对有或无肝硬化的HCV感染患者至少是有效且安全的。SOF/VEL±RBV方案是一种泛基因型DAA方案，对HCV基因1、2、3、4、5或6型感染患者有效。24周的SOF/RBV方案与12周的SOF/RBV/peg-IFN方案疗效相同。HCV基因3型感染患者可从使用24周的SOF/RBV方案中获益。对于HCV基因3型感染的肝硬化患者，当使用其他DAA的基于SOF的方案受限，12周的SOF/RBV/peg-IFN方案可被视为替代治疗选择。在纳入的研究中，未报告基于SOF的方案导致的重大不良事件。
临床试验表明，基于SOF的治疗方案对于有或无肝硬化的HCV感染患者至少是有效且安全、方便患者的药物。然而，有必要对HCV感染患者进行监测，因为在实际临床环境中可能会发生罕见的不良事件、药物相互作用和药物-疾病相互作用。
