EASL新闻稿。我今天早些时候报道了本新闻稿中提到的关于SOF

StephenW

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Attachments9:47 AM (6 hours ago)
       
to nataphcv, HCV/HIV, undefined, Natap
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SEE FULL DATA PRESENTATION BELOW following this press release.

EASL Press Release. I reported earlier this morning the TRIO data on SOF/VEL/VOX retreatment mentioned in this release.
‘This important real-world experience from Germany and the USA showed that almost all patients with chronic hepatitis C – Including DAA treatment failures – can finally be cured,” said Professor Markus Cornberg from Hannover Medical School in Germany, a member of EASL’s governing board.

‘Real-world’ studies conducted in Germany and the USA have confirmed the effectiveness and tolerability of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) when used to treat individuals with chronic hepatitis C (HCV) infection who had previously failed direct-acting antivirals (DAAs). The two studies presented today at The International Liver Congress™ 2019 in Vienna, Austria, reported sustained virological response rates (SVR) of 93–100%, confirming the effectiveness of this treatment in clinical practice.

DAAs have transformed HCV therapy and made virological cure possible in most patients.1 Combination regimens of DAAs achieve SVR rates in excess of 90%, regardless of HCV genotype (GT), disease stage, or treatment history.2 While DAAs rarely fail to achieve viral clearance, up to 10% of patients will experience virological relapse/failure,3 with HCV RNA reappearing a few weeks after completing therapy. In the past, treatment options for these patients were limited.4,5 The once-daily, all-oral combination tablet containing SOF/VEL/VOX, was approved in Europe in July 20176 for patients infected with any genotype who have previously failed therapy with DAAs.1

In the first study presented today, a German research group evaluated all consecutive patients enrolled into the German Hepatitis C Registry (DHC-R) who were retreated with SOF/VEL/VOX ± ribavirin (RBV) due to virological failure up to February 2019 (N=110; HCV GT1 [71%], GT3 [34%], and GT4 [5%]; median age 54 years; 86% male; 27% with cirrhosis). Prior DAA regimens included paritaprevir/ritonavir/ombitasvir ± dasabuvir ± RBV (PrO ± D ± RBV [n=30]), ledipasvir/sofosbuvir ± RBV (LDV/SOF ± RBV [n=35]), SOF/velpatasvir ± RBV (SOF/VEL ± RBV [n=18]), daclatasvir + SOF ± RBV (DCV + SOF ± RBV [n=13]), elbasvir/grazoprevir (EBR/GZR [n=8]), SOF + RBV (n=2), and simeprevir + SOF + RBV (n=1). Four patients had received SOF/VEL/VOX + RBV (HCV GT1b [n=2], GT3a [n=2]).

According to investigator Dr Johannes Vermehren from the Goethe University Hospital in Frankfurt, Germany, with SVR data available from 74 patients as of February 2019, sustained virologic response was 100%. SOF/VEL/VOX was well tolerated, with fatigue (14%) and headaches (10%) the most frequently reported adverse events (AEs). No severe AEs were attributed to SOF/VEL/VOX treatment.

In the USA, data from 196 patients treated with SOF/VEL/VOX between July 2017 and April 2018 were collected from a health management program provider (Trio Health) and analysed. Duration of treatment was 12 weeks for all but one patient, who received treatment for >12 weeks. Seven patients (4%) also received RBV off-label. Most patients were treatment experienced (173/196; 88%) while 21 patients (11%) were treatment naïve. Treatment status for two patients was unavailable. The most frequently-used prior therapies were: LDV/SOF ± RBV (n=92), SOF/VEL ± RBV (n=20), EBR/GZR ± RBV (n=19), other SOF-based regimens (n=17), and PrOD (n=11). The SVR rates at 12 weeks after therapy in the per-protocol and intent-to-treat groups were reported to be 98% (183/186) and 93% (183/196), respectively. Of the 3 patients that did not achieve SVR12 in the per-protocol group, 2/3 were white males, cirrhotic (F4), and had prior regimens of SOF/VEL and LDV/SOF ± RBV while 1/3 was a black female with moderate fibrosis (F2); her prior regimen was not specified. One patient had a baseline viral load between 800K-6MM and the other 2 patients had baseline viral loads >6MM. The insurance types were: 1 (commercial), 1 (Medicare), and 1 (not specified); all 3 patients were GT1.

‘We are now seeing real-world evidence that SOF/VEL/VOX is highly effective when used in clinical practice to treat patients who have failed previous DAA therapy,’ concluded Dr Bruce Bacon from Saint Louis University School of Medicine, St Louis, USA.

‘This important real-world experience from Germany and the USA showed that almost all patients with chronic hepatitis C – Including DAA treatment failures – can finally be cured,” said Professor Markus Cornberg from Hannover Medical School in Germany, a member of EASL’s governing board.

StephenW

[email protected]

附件9:47 AM（6小时前）

到nataphcv，HCV / HIV，undefined，Natap
www.natap.org

在本新闻稿之后，请参见下面的完整数据演示。

EASL新闻稿。我今天早些时候报道了本新闻稿中提到的关于SOF / VEL / VOX再处理的TRIO数据。
“来自德国和美国的这一重要实际经验表明，几乎所有患有慢性丙型肝炎的患者 - 包括DAA治疗失败 - 终于可以治愈了，”来自德国汉诺威医学院的Markus Cornberg教授说，他是EASL治理委员会的成员。

在德国和美国进行的“真实世界”研究证实了sofosbuvir / velpatasvir / voxilaprevir（SOF / VEL / VOX）用于治疗先前未能直接治疗的慢性丙型肝炎（HCV）感染者的有效性和耐受性。代谢抗病毒药物（DAAs）。今天在奥地利维也纳举行的2019年国际肝病大会上发表的两项研究报告，持续病毒学应答率（SVR）为93-100％，证实了这种治疗在临床实践中的有效性。

DAAs已经改变了HCV治疗，并且在大多数患者中可以进行病毒学治疗.1无论HCV基因型（GT），疾病分期或治疗史如何，DAA的联合治疗方案均可达到超过90％的SVR率.2 DAA很少达不到病毒清除率高达10％的患者会出现病毒学复发/衰竭，3例HCV RNA在完成治疗后几周内再次出现。过去，这些患者的治疗选择是有限的.4,5包含SOF / VEL / VOX的每日一次全口服组合片剂于2017年7月在欧洲批准用于感染先前治疗失败的任何基因型的患者与DAAs.1

在今天发表的第一项研究中，德国一个研究小组评估了所有入选德国丙型肝炎登记处（DHC-R）的连续患者，这些患者由于2019年2月的病毒学失败而被SOF / VEL / VOX±利巴韦林（RBV）复发（ N = 110; HCV GT1 [71％]，GT3 [34％]和GT4 [5％];中位年龄54岁; 86％男性; 27％患有肝硬化）。既往DAA方案包括paritaprevir / ritonavir / ombitasvir±dasabuvir±RBV（PrO±D±RBV [n = 30]），ledipasvir / sofosbuvir±RBV（LDV / SOF±RBV [n = 35]），SOF / velpatasvir±RBV（ SOF / VEL±RBV [n = 18]），达卡他韦+ SOF±RBV（DCV + SOF±RBV [n = 13]），elbasvir / grazoprevir（EBR / GZR [n = 8]），SOF + RBV（n = 2）和simeprevir + SOF + RBV（n = 1）。 4名患者接受了SOF / VEL / VOX + RBV（HCV GT1b [n = 2]，GT3a [n = 2]）。

根据德国法兰克福歌德大学医院的研究员Johannes Vermehren博士的研究，截至2019年2月，74名患者的SVR数据可用，持续的病毒学应答率为100％。 SOF / VEL / VOX耐受性良好，疲劳（14％）和头痛（10％）是最常报告的不良事件（AEs）。没有严重的AE归因于SOF / VEL / VOX治疗。

在美国，从健康管理计划提供者（Trio Health）收集了来自2017年7月至2018年4月期间接受SOF / VEL / VOX治疗的196名患者的数据并进行了分析。除了一名接受治疗> 12周的患者外，所有患者的治疗持续时间均为12周。 7名患者（4％）也接受了RBV标签外。大多数患者接受了治疗（173/196; 88％），而21名患者（11％）接受了初治。两名患者的治疗状况无法获得。最常用的先前疗法是：LDV / SOF±RBV（n = 92），SOF / VEL±RBV（n = 20），EBR / GZR±RBV（n = 19），其他基于SOF的方案（n = 17）和PrOD（n = 11）。据报道，按方案和意向治疗组治疗后12周的SVR率分别为98％（183/186）和93％（183/196）。在每个方案组中未达到SVR12的3名患者中，2/3是白人男性，肝硬化（F4），并且之前的方案为SOF / VEL和LDV / SOF±RBV，而1/3是黑人女性中度纤维化（F2）;她之前的治疗方案没有具体说明。一名患者的基线病毒载量在800K-6MM之间，另外两名患者的基线病毒载量> 6MM。保险类型为：1（商业），1（Medicare）和1（未指定）;所有3名患者均为GT1。

美国圣路易斯圣路易斯大学医学院的Bruce Bacon博士总结说：“我们现在看到现实世界的证据表明SOF / VEL / VOX在临床实践中用于治疗先前DAA治疗失败的患者非常有效。” 。

“来自德国和美国的这一重要实际经验表明，几乎所有患有慢性丙型肝炎的患者 - 包括DAA治疗失败 - 终于可以治愈了，”来自德国汉诺威医学院的Markus Cornberg教授说，他是EASL治理委员会的成员。