背景:索非布韦,velpatasvir和voxilaprevir(SOF/VEL/VOX)是对直接作用抗病毒药物(DAA)失败的慢性丙型肝炎感染患者的推荐抢救疗法。在目前的一线治疗之后,关于该治疗的有效性的数据是有限的。我们的目的是分析SOF/VEL/VOX在sofosbuvir/velpatasvir(SOF/VEL)或glecaprevir/pibrentasvir(GLE/PIB)失败患者中的有效性和安全性。
方法:回顾性多中心研究(西班牙26家医院),包括SOF/VEL或GLE/PIB治疗失败的慢性丙型肝炎患者,并在2017年12月至2022年12月期间用SOF/VEL/VOX±利巴韦林治疗12周。
结果:总计,142例患者包括:100例(70.4%)SOF/VEL失败,42例(29.6%)GLE/PIB失败。患者主要为男性(84.5%),白色(93.9%),与丙型肝炎病毒基因型(GT)3(49.6%)和47.2%有肝硬化。在132名完成SOF/VEL/VOX的患者中评估了持续病毒学应答(SVR),并在治疗结束后随访12周;117(88.6%)达到SVR。根据最初的DAA治疗,SVR率没有显着差异(SOF/VEL87.9%vs.GLE/PIB90.2%,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GT391.9%vs.GT385.5%,p=0.3)。然而,当考虑同时存在SOF/VEL治疗时,肝硬化和GT3感染,SVR率降至82.8%。在8例(6%)患者中添加了利巴韦林,都实现了SVR。
结论:SOF/VEL/VOX是SOF/VEL或GLE/PIB失败的有效抢救疗法,SVR为88.6%。以前与较低的SVR率相关的因素,如GT3感染,肝硬化和SOF/VEL一线治疗与低SVRs无关.
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.