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肝胆相照论坛 论坛 学术讨论& HBV English 大好消息 核衣壳abi—h0731
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大好消息 核衣壳abi—h0731  

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本帖最后由 newchinabok 于 2019-10-16 19:58 编辑

https://investor.assemblybio.com ... osciences-first-and
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发表于 2019-10-16 19:37 |显示全部帖子
ABI-H0731
LP-1
Title: Continued Therapy with ABI-H0731+Nrtl Results in Sequential Reduction/Loss of HBV DNA, HBV RNA, HBeAg, HBcrAg and HBsAg in HBeAg-Positive Patients
Session: Late-breaking Poster Session
Location: Hall B
Date: Monday, November 11, 2019
Time: 8:00am ET-5:30pm ET; Poster presentation: 12:30pm ET-1:30pm ET
Presenter: Mark Sulkowski, MD, Medical Director, Viral Hepatitis Center, Johns Hopkins University School of Medicine
Abstract Summary:  Final results from Phase 2a are reported for HBeAg+ patients with chronic HBV infection treated with 731+Nrtl for 24 weeks. In Study 202 (Rx naïve patients), greater mean log10 declines in HBV DNA (5.27 vs 3.99; p=0.017) and RNA (2.34 vs 0.61; p<0.001) were achieved with 731+Nrtl (entecavir) versus entecavir alone. In Study 201 (Nrtl-suppressed patients), the proportion of patients on 731+Nrtl versus Nrtl alone achieving DNA target not detected (TND) was 69% vs 0% (p<0.001), and the proportion of patients achieving RNA <35 U/mL whose RNA was ≥35 U/mL at baseline was 52% vs 0% (p=0.0013) respectively. In Study 211, there are 64 HBeAg+ patients currently on extended treatment beyond 24 weeks. Among the 27 HBeAg+ patients receiving 731+Nrtl in Study 201, 41% (11/27) have now achieved DNA TND along with RNA <35 U/mL and HBeAg <1 IU/mL. At their last timepoint, Study 202 patients now in Study 211 (n=22) have demonstrated mean DNA and RNA declines of 6.1 and 3.0 logs, respectively, with observed mean log changes of ≥0.6 for HBeAg (11 patients ≥0.5, 4 patients ≥1.0), >0.8 log for HBcrAg (7 patients ≥1.0, 3 patients ≥2.0) and ≥0.4 log for HBsAg (7 patients ≥0.5, 3 patients ≥1.0). 731 continues to exhibit a favorable safety and tolerability profile in patients treated for up to 1 year, with only mild/moderate adverse events and lab abnormalities, and only a single discontinuation due to a Grade 1 rash. The combination of 731+NrtI results in faster and deeper declines in HBV DNA and RNA than NrtI alone, as well as subsequent declines in the surrogate markers of cccDNA (pgRNA, HBeAg and HBcrAg) predictive of cccDNA pool depletion, and HBsAg. The emergent data supports the continued development of 731.  Abstract data are as of the time of submission; the poster is expected to include updated safety and efficacy results.

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本帖最后由 newchinabok 于 2019-10-16 21:02 编辑

间接的降低了cccdna,核衣壳是间接的cccdna抑制剂,耗尽cccdna池。hbsag也下降。有免疫药联合,治愈可期。最起码可以降低hcc发病率。先发简报,美肝会有更多数据。

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发表于 2019-10-16 21:11 |显示全部帖子
wolegequ 发表于 2019-10-16 21:03
是的  这个配合免疫药刺激免疫,治愈真的可期,这次是真的。。不是狼来了 ...

表面抗体出现,需要免疫药

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发表于 2019-10-16 21:45 |显示全部帖子
本帖最后由 newchinabok 于 2019-10-16 21:50 编辑
wolegequ 发表于 2019-10-16 21:41
是的 所以需要一个这款作为前提基础  给力啊  到时看看美肝会数据

表面抗体产生是病人自身产生的,病人大多免疫耐受,需要免疫药外力。激活病人免疫系统
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发表于 2019-10-16 22:10 |显示全部帖子
好消息

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发表于 2019-10-17 12:04 |显示全部帖子
上次在论坛看见某一个申请到FDA的快速绿色审批通道的是这个0731这个药吗?

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发表于 2019-10-17 12:10 |显示全部帖子
回复 wolegequ 的帖子

我记得上次看见这个公司的一个PDF,他们公司还有一个另外数字编号的核衣壳,好像药效更强大,但是好像还没实验到2a。

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发表于 2019-10-17 12:12 |显示全部帖子
好像是H2158,他们公司发布了一个PDF,里面有数据,2158比0731药效更强。

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发表于 2019-10-17 12:59 |显示全部帖子
太好了!
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