Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.
Liver Unit, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Aliment Pharmacol Ther. 2024 Jul;60(2):201-211. doi: 10.1111/apt.18020. Epub 2024 May 2.
Sofosbuvir, 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).
Retrospective 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.
In 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.
SOF/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.
索磷布韦、维帕他韦和 voxilaprevir(SOF/VEL/VOX)是用于治疗慢性丙型肝炎感染患者的推荐补救疗法,这些患者对直接作用抗病毒药物(DAAs)治疗失败。目前,关于一线治疗后这种治疗的有效性的数据有限。我们的目的是分析索磷布韦/维帕他韦(SOF/VEL)或 glecaprevir/pibrentasvir(GLE/PIB)治疗失败后,SOF/VEL/VOX 的有效性和安全性。
这是一项回顾性多中心研究(涉及 26 家西班牙医院),纳入了索磷布韦/维帕他韦或 glecaprevir/pibrentasvir 治疗失败的慢性丙型肝炎患者,他们在 2017 年 12 月至 2022 年 12 月期间接受了 12 周的 SOF/VEL/VOX±利巴韦林补救治疗。
共有 142 名患者纳入研究,其中 100 名(70.4%)对 SOF/VEL 治疗失败,42 名(29.6%)对 GLE/PIB 治疗失败。患者主要为男性(84.5%)、白人(93.9%),丙型肝炎病毒基因型(GT)为 3 型(49.6%),47.2%有肝硬化。对完成 SOF/VEL/VOX 治疗并在治疗结束后 12 周随访的 132 名患者进行了持续病毒学应答(SVR)评估,其中 117 名(88.6%)达到 SVR。根据初始 DAA 治疗(SOF/VEL 87.9%与 GLE/PIB 90.2%,p=0.8)、肝硬化(无肝硬化 90%与肝硬化 87.1%,p=0.6)或 GT3 感染(非 GT3 91.9%与 GT3 85.5%,p=0.3),SVR 率无显著差异。然而,当同时考虑到 SOF/VEL 治疗、肝硬化和 GT3 感染时,SVR 率下降至 82.8%。8 名(6%)患者加用了利巴韦林,均达到 SVR。
SOF/VEL/VOX 是治疗 SOF/VEL 或 GLE/PIB 治疗失败的有效补救疗法,SVR 率为 88.6%。先前与较低 SVR 率相关的因素,如 GT3 感染、肝硬化和一线治疗用 SOF/VEL,与较低的 SVR 率无关。