索磷布韦/维帕他韦联合治疗 F0-F1 纤维化期 HCV 感染患者的 SVR12 率高于 99%：真实世界经验。
SVR12 rates higher than 99% after sofosbuvir/velpatasvir combination in HCV infected patients with F0-F1 fibrosis stage: A real world experience.
机构信息
Liver Unit, IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy.
Infectious Diseases Unit, Presidio Ospedaliero "Vittorio Emanuele II", Bisceglie, Italy.
出版信息
PLoS One. 2019 May 15;14(5):e0215783. doi: 10.1371/journal.pone.0215783. eCollection 2019.
BACKGROUND AND OBJECTIVES
The pangenotypic single tablet regimen of NS5B inhibitor sofobuvir (SOF) and NS5A inhibitor velpatasvir (VEL) is advised for 12 weeks in HCV-infected patients including those with compensated cirrhosis. Addition of ribavirin (RBV) may be considered in genotype 3 (GT3) with compensated and is recommended in decompensated cirrhosis. Real-life results with SOF/VEL are limited. To evaluate efficacy and safety in a large real-world-cohort including patients with different GTs and various fibrosis stages.
DESIGN
In total, 1429 patients were treated with SOF/VEL 400/100 mg for 12 weeks in the Puglia registry between June 2017 and May 2018. 1319 (92.3%) reached week 12 post-treatment (SVR12) at the moment. Only 41 received RBV. Diagnosis of cirrhosis was based on transient elastography and/or APRI or FIB-4 scores. Sensitivity analysis in the population including all patients except non virological failure was conducted. Primary efficacy endpoint was the percentage of patients with SVR12.
RESULTS
Patients' mean age was 63.8 years, 42.3% had GT1. The majority were naïve and 735 (55.5%) F0/F2. Of the remaining 587, 282 had cirrhosis. SVR12 was 98.5%, 98.0% in GT1, 99.4% in GT2, 97.1% in GT3, 100% in GT4. Overall, SVR12 by sensitivity analysis was 99.4%; 99.7% among F0-F1. Among 218 PWID, SVR12 was 94.5%. Discontinuation rates were 3.7% among PWID and 0.7% among non-PWID (p = 0.004).
CONCLUSIONS
SOF/VEL treatment of chronic HCV infection reaches very high cure rates in a variety of patients; including those with F0/F1 and PWID.
背景与目的
含 NS5B 抑制剂索磷布韦（SOF）和 NS5A 抑制剂维帕他韦（VEL）的泛基因型单一片剂方案被建议用于治疗包括代偿性肝硬化在内的 HCV 感染患者，疗程为 12 周。对于基因型 3（GT3）合并代偿性肝硬化的患者，可以考虑加用利巴韦林（RBV），而对于失代偿性肝硬化则建议加用 RBV。目前关于 SOF/VEL 的真实世界研究结果有限。本研究旨在评估 SOF/VEL 治疗方案在包括不同 GT 及不同纤维化分期患者在内的大型真实世界队列中的疗效和安全性。
方法
2017 年 6 月至 2018 年 5 月，在普利亚大区登记处，1429 例患者接受了 SOF/VEL 400/100mg 治疗 12 周。截至目前，1319 例（92.3%）患者在治疗结束后第 12 周达到了持续病毒学应答（SVR12）。仅有 41 例患者接受了 RBV 治疗。肝硬化的诊断基于瞬时弹性成像和/或 APRI 或 FIB-4 评分。对排除非病毒学失败的所有患者进行了人群敏感性分析。主要疗效终点是 SVR12 患者的比例。
结果
患者的平均年龄为 63.8 岁，42.3%为 GT1 型。大多数患者为初治患者，735 例（55.5%）为 F0/F2 期。其余 587 例患者中，282 例为肝硬化患者。SVR12 率为 98.5%，GT1 型为 98.0%，GT2 型为 99.4%，GT3 型为 97.1%，GT4 型为 100%。总体而言，敏感性分析的 SVR12 率为 99.4%；F0/F1 期为 99.7%。在 218 例注射吸毒者（PWID）中，SVR12 率为 94.5%。PWID 组的停药率为 3.7%，而非 PWID 组为 0.7%（p=0.004）。
结论
SOF/VEL 治疗慢性 HCV 感染可在多种患者中达到非常高的治愈率，包括 F0/F1 期患者和 PWID。
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