Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-Sen University, No. 600 Tianhe Road , 510630, Guangzhou City, Guangdong Province, China.
Department of Infectious disease, The First people's hospital of Foshan, Foshan City, Guangdong Province, China.
BMC Gastroenterol. 2024 Feb 14;24(1):73. doi: 10.1186/s12876-024-03147-5.
Sofosbuvir/Velpatasvir (Epclusa, ECS) is the first pan-genotype direct-acting antiviral agent (DAA) for hepatitis C virus (HCV) infection, and Danoprevir (DNV) is the first DAA developed by a Chinese local enterprise, which is suitable for combined use with other drugs to treat genotype 1b chronic hepatitis C. However, previous reports have never compared the real-world data of ECS and DNV.
178 chronic hepatitis C patients were retrospectively recruited, and 94cases were accepted with Sofosbuvir/Velpatasvir ± Ribavirin (ECS group), and others (n = 84 treated with DNV combination therapy (DNV group). The HCV genotype, virological response, adverse effects and some laboratory biochemical indexes were contrasted between above two groups in the real world study.
DNV group had significantly lower level of alpha-fetoprotein (AFP), lower rates of decompensated cirrhosis ( P < 0.05). ECS group possessed more 6a (31.91% vs.13.10%) while DNV group was provided with more 1b (48.81% vs. 22.34%) patients. Significantly poor liver function was detected in ECS group at 4-week treatment (ALT and AST) and 12-week follow-up (AST) (all P < 0.05). The SVR12 undetectable rates of both groups were 100%, and no serious event was observed during the treatment and follow-up in both groups.
In this retrospective real-world study, the efficacy of DNV combined therapy is similar to Sofosbuvir/Velpatasvir ± Ribavirin for chronic HCV infection, and the safety is comparable. DNV based therapy is a promising regimen for chronic hepatitis C.
索磷布韦/维帕他韦（Epclusa，ECS）是首个治疗丙型肝炎病毒（HCV）感染的泛基因型直接作用抗病毒药物（DAA），达诺瑞韦（DNV）是中国本土企业开发的首个 DAA，适用于与其他药物联合使用治疗基因 1b 慢性丙型肝炎。然而，之前的报告从未比较过 ECS 和 DNV 的真实世界数据。
回顾性招募了 178 例慢性丙型肝炎患者，其中 94 例接受了索磷布韦/维帕他韦±利巴韦林（ECS 组）治疗，其余 84 例接受了达诺瑞韦联合治疗（DNV 组）。在真实世界研究中，比较了两组之间的 HCV 基因型、病毒学应答、不良反应和一些实验室生化指标。
DNV 组的甲胎蛋白（AFP）水平显著较低，失代偿性肝硬化的发生率较低（P<0.05）。ECS 组 6a 基因型（31.91%比 13.10%）更多，而 DNV 组 1b 基因型（48.81%比 22.34%）更多。在 4 周治疗（ALT 和 AST）和 12 周随访（AST）时，ECS 组的肝功能明显更差（均 P<0.05）。两组的 SVR12 不可检测率均为 100%，两组在治疗和随访过程中均未观察到严重事件。
在这项回顾性真实世界研究中，DNV 联合治疗方案对慢性 HCV 感染的疗效与索磷布韦/维帕他韦±利巴韦林相似，安全性相当。DNV 为基础的治疗方案是治疗慢性丙型肝炎的一种很有前途的方案。
