SummaryBackgroundSofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) is the recommended rescue therapy for patients with chronic hepatitis C infection who fail direct‐acting antivirals (DAAs). Data are limited on the effectiveness of this treatment after the current first‐line therapies. Our aim was to analyse the effectiveness and safety of SOF/VEL/VOX among patients failing sofosbuvir/velpatasvir (SOF/VEL) or glecaprevir/pibrentasvir (GLE/PIB).MethodsRetrospective multicentre study (26 Spanish hospitals), including chronic hepatitis C patients unsuccessfully treated with SOF/VEL or GLE/PIB, and retreated with SOF/VEL/VOX ± ribavirin for 12 weeks between December 2017 and December 2022.ResultsIn total, 142 patients included: 100 (70.4%) had failed SOF/VEL and 42 (29.6%) GLE/PIB. Patients were mainly men (84.5%), White (93.9%), with hepatitis C virus genotype (GT) 3 (49.6%) and 47.2% had liver cirrhosis. Sustained virological response (SVR) was evaluated in 132 patients who completed SOF/VEL/VOX and were followed 12 weeks after end of treatment; 117 (88.6%) achieved SVR. There were no significant differences in SVR rates according to initial DAA treatment (SOF/VEL 87.9% vs. GLE/PIB 90.2%, p = 0.8), cirrhosis (no cirrhosis 90% vs. cirrhosis 87.1%, p = 0.6) or GT3 infection (non‐GT3 91.9% vs. GT3 85.5%, p = 0.3). However, when considering the concurrent presence of SOF/VEL treatment, cirrhosis and GT3 infection, SVR rates dropped to 82.8%. Ribavirin was added in 8 (6%) patients, all achieved SVR.ConclusionSOF/VEL/VOX is an effective rescue therapy for failures to SOF/VEL or GLE/PIB, with an SVR of 88.6%. Factors previously linked to lower SVR rates, such as GT3 infection, cirrhosis and first‐line therapy with SOF/VEL were not associated with lower SVRs.

中文翻译：

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索磷布韦/维帕他韦/伏西拉瑞韦对既往接受索磷布韦/维帕他韦或 glecaprevir/pibrentasvir 治疗的丙型肝炎患者的真实疗效

摘要背景索磷布韦、维帕他韦和伏西拉瑞韦 (SOF/VEL/VOX) 是对直接作用抗病毒药物 (DAA) 无效的慢性丙型肝炎感染患者的推荐挽救疗法。在目前的一线治疗之后，关于这种治疗效果的数据有限。我们的目的是分析 SOF/VEL/VOX 在索磷布韦/维帕他韦 (SOF/VEL) 或格卡瑞韦/匹布伦他韦 (GLE/PIB) 失败的患者中的有效性和安全性。方法回顾性多中心研究（26 家西班牙医院），包括慢性丙型肝炎患者2017 年 12 月至 2022 年 12 月期间，用 SOF/VEL 或 GLE/PIB 治疗失败，并用 SOF/VEL/VOX ± 利巴韦林复治 12 周。结果总共包括 142 名患者：100 名 (70.4%) 患者 SOF/VEL 失败，42 名患者失败。 (29.6%) GLE/PIB。患者主要为男性（84.5%）、白人（93.9%）、丙型肝炎病毒基因型（GT）3（49.6%）和47.2%患有肝硬化。对 132 名完成 SOF/VEL/VOX 的患者进行了持续病毒学应答 (SVR) 评估，并在治疗结束后 12 周进行了随访； 117 名 (88.6%) 获得了 SVR。根据初始 DAA 治疗，SVR 率没有显着差异（SOF/VEL 87.9% vs. GLE/PIB 90.2%，p= 0.8），肝硬化（无肝硬化 90% vs. 肝硬化 87.1%，p= 0.6）或 GT3 感染（非 GT3 91.9% vs GT3 85.5%，p= 0.3）。然而，当考虑到SOF/VEL治疗、肝硬化和GT3感染同时存在时，SVR率下降至82.8%。 8例（6%）患者加用利巴韦林，全部实现SVR。结论SOF/VEL/VOX是SOF/VEL或GLE/PIB失败的有效挽救疗法，SVR为88.6%。先前与较低 SVR 率相关的因素，如 GT3 感染、肝硬化和 SOF/VEL 一线治疗与较低 SVR 无关。