Pharmaceutical Sciences Post-Graduate Program, Department of Pharmacy, Universidade Federal do Paraná, Av. Pref. Lothario Meissner, 632, Jardim Botânico, Curitiba, PR, 80210170, Brazil.
Clin Drug Investig. 2018 May;38(5):389-400. doi: 10.1007/s40261-018-0624-6.
Hepatitis C treatment has changed considerably in recent years, and many interferon (IFN)-free therapies are now available. Considering the high rates of sustained virological response (SVR) presented by clinical trials for these treatments, high rates of effectiveness are also expected in real-world clinical practice. Hence, this study aimed to conduct a systematic review and meta-analysis of observational cohort studies to evaluate the clinical effectiveness and safety of IFN-free therapies for hepatitis C.
The search was performed in four electronic databases and included cohort studies that evaluated IFN-free schemes and provided data on SVR at 12 weeks after the end of treatment (SVR12) as the primary outcome. Overall and subgroup meta-analyses of patients' clinical conditions (e.g. co-infection with human immunodeficiency virus (HIV), cirrhosis, liver transplant, specific genotypes, and other conditions) were performed.
Sixty-eight studies encompassing a total of 24,151 patients were included for quantitative and qualitative analyses, evaluating six treatments: sofosbuvir with ledipasvir, daclatasvir, or simeprevir; daclatasvir with asunaprevir; paritaprevir/ritonavir in combination with ombitasvir and dasabuvir; and sofosbuvir with ribavirin. The overall analysis showed SVR rates of 88-96% for all treatments except sofosbuvir combined with ribavirin, which had SVR rates of approximately 80%. The results of subgroup analyses showed that the genotype 3 virus appears to be the most difficult to treat.
In order to choose the best treatment option, it is necessary to consider the patients' conditions and characteristics. In conclusion, the use of IFN-free therapies meets the high expectations created by clinical trials, including patients in special clinical conditions.
近年来，丙型肝炎的治疗方法发生了很大的变化，现在有许多无干扰素（IFN）的治疗方法。考虑到这些治疗方法的临床试验中持续病毒学应答（SVR）的高率，在真实世界的临床实践中也应该有很高的疗效。因此，本研究旨在对观察性队列研究进行系统回顾和荟萃分析，以评估无干扰素治疗丙型肝炎的临床疗效和安全性。
在四个电子数据库中进行了检索，包括评估无干扰素方案并提供治疗结束后 12 周时 SVR12（主要结局）数据的队列研究。对患者临床情况（如合并人类免疫缺陷病毒（HIV）感染、肝硬化、肝移植、特定基因型和其他情况）进行了总体和亚组荟萃分析。
共纳入了 68 项研究，总计 24151 例患者，评估了六种治疗方法：索非布韦联合雷迪帕韦、达拉他韦或西美瑞韦；达拉他韦联合asunaprevir；泊沙康唑/利托那韦联合奥比他韦和达沙布韦；以及索非布韦联合利巴韦林。总体分析显示，所有治疗方法的 SVR 率为 88-96%，除了索非布韦联合利巴韦林的 SVR 率约为 80%。亚组分析的结果表明，基因型 3 病毒似乎是最难治疗的。
为了选择最佳的治疗方案，需要考虑患者的情况和特点。总之，无干扰素治疗方法符合临床试验所创造的高期望，包括特殊临床条件的患者。
