Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119077, Singapore.
Division of Gastroenterology & Hepatology, University of Utah Health, Salt Lake City, UT 84112, USA.
Viruses. 2023 Jun 30;15(7):1489. doi: 10.3390/v15071489.
About 5% of chronic hepatitis C (CHC) patients experienced treatment failure with direct-acting antiviral (DAA) treatment. The global data on the practice and treatment outcomes of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) in DAA-experienced CHC patients remains sparse. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of SOF/VEL/VOX as a salvage treatment in DAA-experienced CHC patients. We searched five electronic databases from inception to 31 January 2023. The study outcomes were SVR12 and treatment-related adverse effects, with subgroup analysis performed based on genotype, cirrhosis, HCC, prior SOF/VEL exposure, and region. We identified and analyzed data from 24 studies (2877 DAA-experienced CHC patients); 17.2% had prior SOF/VEL exposure, 25% received ribavirin with SOF/VEL/VOX, and 42% had pre-treatment resistance-associated substitution (RAS) testing performed. Eastern Mediterranean had a higher pooled SVR12 than the America and Europe regions ( < 0.05). Predictors of SOF/VEL/VOX failure were genotype 3, active HCC, baseline cirrhosis, and prior SOF/VEL. Baseline RAS mutation and ribavirin supplementation were not associated with higher SVR12. Treatment discontinuation because of drug-related adverse events was uncommon (10 studies, 0.2%). In summary, SOF/VEL/VOX is efficacious and safe for retreatment in DAA-experienced CHC patients, even with RAS mutation. Our findings support SOF/VEL/VOX as a first-line rescue treatment for DAA-experienced CHC patients.
约 5%的慢性丙型肝炎 (CHC) 患者在接受直接作用抗病毒 (DAA) 治疗后出现治疗失败。关于 DAA 经验的 CHC 患者中索磷布韦/维帕他韦/伏西瑞韦 (SOF/VEL/VOX) 的实践和治疗结果的全球数据仍然很少。我们进行了一项系统评价和荟萃分析，以评估 SOF/VEL/VOX 作为 DAA 经验的 CHC 患者挽救治疗的疗效和安全性。我们从成立到 2023 年 1 月 31 日搜索了五个电子数据库。研究结果是 SVR12 和与治疗相关的不良反应，根据基因型、肝硬化、HCC、先前 SOF/VEL 暴露和地区进行亚组分析。我们确定并分析了 24 项研究的数据（2877 例 DAA 经验的 CHC 患者）；17.2%的患者有先前 SOF/VEL 暴露，25%的患者接受 SOF/VEL/VOX 联合利巴韦林治疗，42%的患者在治疗前进行了耐药相关替代 (RAS) 检测。与欧洲和美洲地区相比，东地中海地区的 SVR12 更高（<0.05）。SOF/VEL/VOX 失败的预测因素是基因型 3、活动期 HCC、基线肝硬化和先前 SOF/VEL。基线 RAS 突变和利巴韦林补充与更高的 SVR12 无关。由于药物相关不良反应而停药的情况并不常见（10 项研究，0.2%）。总之，SOF/VEL/VOX 对 DAA 经验的 CHC 患者的再治疗是有效和安全的，即使存在 RAS 突变也是如此。我们的研究结果支持 SOF/VEL/VOX 作为 DAA 经验的 CHC 患者的一线挽救治疗。
