Efficacy and Safety of Sofosbuvir/Velpatasvir Plus Ribavirin in Patients with Hepatitis C Virus-Related Decompensated Cirrhosis.
Efficacy and Safety of Sofosbuvir/Velpatasvir Plus Ribavirin in Patients with Hepatitis C Virus-Related Decompensated Cirrhosis.
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DOI：
10.3390/v15102026
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发表时间：
2023-09-29
期刊：
影响因子：
--
通讯作者：
Samuel D
中科院分区：
文献类型：
--
作者：
Flamm S;Lawitz E;Borg B;Charlton M;Landis C;Reddy KR;Shiffman M;Alsina A;Chang C;Ravendhran N;Hernandez C;Hézode C;Scherbakovsky S;Mercier RC;Samuel D
索非布韦/维帕他韦（SOF/VEL）加基于体重的利巴韦林（RBV）的固定剂量组合12周被推荐用于治疗丙型肝炎病毒（HCV）相关失代偿性肝硬化患者。然而，大型全球研究虽然证实了SOF/VEL在广泛患者中的有效性，但通常排除了这些患者。这项在法国和美国HCV相关失代偿性肝硬化成人患者中进行的II期、单臂、开放标签研究旨在提供关于SOF/VEL联合RBV治疗12周在该人群中的安全性和疗效的进一步数据。患者接受SOF 400 mg/VEL 100 mg+基于体重的RBV的固定剂量组合治疗，每日一次，持续12周。入选标准为慢性HCV感染（≥6个月）、筛选时可定量的HCV RNA、Child-Turcotte-Pugh分级B或C级肝硬化，以及第1天前6个月内的肝脏成像以排除肝细胞癌。在32例开始治疗的患者中，78.1%在治疗结束后12周达到持续病毒学应答（SVR 12）。未达到SVR 12是由于非病毒学原因（研究者判断，n = 1;死亡，n = 6）。符合方案人群中的所有25名患者均达到了SVR 12，除1名患者外，所有患者均在治疗结束后24周达到了持续病毒学应答。不良事件（AE）与晚期肝病患者人群的预期一致。认为所有3-4级和严重AE和死亡均与治疗无关。在HCV相关失代偿性肝硬化患者中，SOF/VEL加RBV获得了较高的SVR 12率，并且通常耐受良好。
A fixed-dose combination of sofosbuvir/velpatasvir (SOF/VEL) plus weight-based ribavirin (RBV) for 12 weeks is recommended for the treatment of patients with hepatitis C virus (HCV)-associated decompensated cirrhosis. However, large global studies, while confirming the effectiveness of SOF/VEL in a broad range of patients, often exclude these patients. This Phase 2, single-arm, open-label study in adult patients with HCV-associated decompensated cirrhosis in France and the USA aimed to provide further data on the safety and efficacy of SOF/VEL plus RBV for 12 weeks in this population. Patients were treated with a fixed-dose combination of SOF 400 mg/VEL 100 mg plus weight-based RBV once daily for 12 weeks. The inclusion criteria were chronic HCV infection (≥6 months), quantifiable HCV RNA at screening, Child–Turcotte–Pugh class B or C cirrhosis, and liver imaging within 6 months of Day 1 to exclude hepatocellular carcinoma. Among 32 patients who initiated treatment, 78.1% achieved sustained virologic response 12 weeks after the end of treatment (SVR12). Failure to achieve SVR12 was due to non-virologic reasons (investigator discretion, n = 1; death, n = 6). All 25 patients in the per-protocol population achieved SVR12 and all but one achieved sustained virologic response 24 weeks after the end of treatment. Adverse events (AEs) were as expected for a patient population with advanced liver disease. All Grade 3–4 and serious AEs and deaths were deemed unrelated to treatment. In patients with HCV-associated decompensated cirrhosis, SOF/VEL plus RBV achieved high SVR12 rates and was generally well tolerated.
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