Liver Unit, Fondazione IRCCS "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy.
Infectious Disease Unit, Ospedale "Galliera", 16128 Genova, Italy.
Cells. 2019 Apr 4;8(4):313. doi: 10.3390/cells8040313.
In clinical trials, a sofosbuvir/velpatasvir (SOF/VEL) pangenotypic single-tablet regimen was associated with high sustained virological response (SVR) rates at 12 weeks (SVR12) after the end of treatment, regardless of genotype and fibrosis stage. No real-life data on genotype 3 (GT3) cirrhotic patients with portal hypertension are available. The aim of this study was to assess the effectiveness of SOF/VEL in GT3 cirrhotics with portal hypertension. Patients with GT3 and advanced cirrhosis were treated for 12 weeks with SOF/VEL without ribavirin at five different centers in Italy from June 2017 to August 2018 and their SVR12 was assessed. Of the 227 GT3 cirrhotics evaluated, 205 met the inclusion criteria and 111 had transient elastography results ≥20 KPa. SVR12 was 97.6% (95% CI 94.4-98.9), rates were 99.1% (95% CI 95.7-99.8) in patients with ≥20 KPa and 95.8% (95% CI 89.5-98.3) in those with <20 KPa (p = 0.18). Analyzed by presence of esophageal varices, the SVR12 rates were 98.4% (95% CI 91.4-99.7) and 97.1% (95% CI 92.9-98.9) in patients without and with varices, respectively (p = 1.0). In real life, SOF/VEL GT3 cirrhotic patients with evidence of portal hypertension can achieve SVR12 levels comparable to those of patients without portal hypertension. These SVR12 rates are similar to what is reported in compensated cirrhosis treated within clinical trials.
在临床试验中，一种索磷布韦/维帕他韦（SOF/VEL）泛基因型单片治疗方案在治疗结束后 12 周（SVR12）时具有很高的持续病毒学应答（SVR）率，无论基因型和纤维化阶段如何。目前尚无关于伴有门静脉高压的基因型 3（GT3）肝硬化患者的真实数据。本研究旨在评估 SOF/VEL 在伴有门静脉高压的 GT3 肝硬化患者中的疗效。2017 年 6 月至 2018 年 8 月，意大利的五个中心对 GT3 且合并晚期肝硬化的患者使用 SOF/VEL 治疗 12 周，且未使用利巴韦林，评估他们的 SVR12。在评估的 227 例 GT3 肝硬化患者中，205 例符合纳入标准，111 例有瞬时弹性成像结果≥20kPa。SVR12 为 97.6%（95%CI94.4-98.9），20kPa 以上患者的 SVR12 率为 99.1%（95%CI95.7-99.8），20kPa 以下患者的 SVR12 率为 95.8%（95%CI89.5-98.3）（p=0.18）。根据是否存在食管静脉曲张进行分析，无静脉曲张患者的 SVR12 率为 98.4%（95%CI91.4-99.7），有静脉曲张患者的 SVR12 率为 97.1%（95%CI92.9-98.9）（p=1.0）。在真实世界中，伴有门静脉高压证据的 SOF/VEL GT3 肝硬化患者可以达到与无门静脉高压患者相似的 SVR12 水平。这些 SVR12 率与临床试验中代偿性肝硬化治疗的报道相似。
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