Nat Med:反义寡核苷酸bepirovirsen治疗慢性乙型肝炎疗效

2021-10-15 haibei MedSci原创

研究人员进行了一项2期双盲、随机、安慰剂对照试验,首次评估针对HBV RNA的反义寡核苷酸在治疗无效和病毒抑制的慢性HBV感染者中的安全性。

已有的研究显示,乙型肝炎病毒(HBV)的慢性感染会导致肝硬化和肝细胞癌的死亡风险增加。目前的治疗方案(核苷酸类似物(NAs)和聚乙二醇干扰素)的功能治愈率很低。

Bepirovirsen是一种针对所有HBV信使RNA的反义寡核苷酸;在细胞培养物和动物模型中,Bepirovirsen会导致HBV衍生的RNA、HBV DNA和病毒蛋白的减少。

最近,研究人员进行了一项2期双盲、随机、安慰剂对照试验,首次评估针对HBV RNA的反义寡核苷酸在治疗无效和病毒抑制的慢性HBV感染者中的安全性和活性(NCT02981602)。该试验的主要目标是评估慢性乙型肝炎(CHB)患者使用Bepirovirsen的安全性和耐受性。次要目标是评估抗病毒活性,包括从基线到第29天的血清乙肝表面抗原(HBsAg)的浓度变化。

感染CHB≥6个月且血清HBsAg≥50 IU ml-1的参与者来自香港和韩国的7个中心,并随机(每个剂量组内3:1)在第1和2周(第1、4、8和11天)通过皮下注射接受bepirovirsen或安慰剂治疗,每周两次,在第3和4周(第15和22天)变为每周一次。然后研究人员对参与者进行了为期26周的随访。

血清HBsAg和HBV DNA随时间的变化。

在该试验中,24名参与者是之前未经治疗的,7名参与者正在接受稳定的NA治疗。治疗中出现的不良事件大多为轻度/中度反应(最常见的是注射部位反应)。11名(61.1%)和3名(50.0%)未经治疗的参与者在bepirovirsen组和安慰剂组分别出现了一个或多个治疗突发的不良事件。在接受NA治疗的参与者中,相应的数字为3人(60.0%)和1人(50.0%)。

在bepirovirsen治疗组中,有8名未经治疗的参与者和3名接受稳定NA治疗的参与者观察到短暂的、可自行缓解的丙氨酸氨基转移酶爆发(≥2倍的正常上限)。

此外,研究人员观察到,与安慰剂相比,接受bepirovirsen 300毫克的之前未经治疗的参与者中HBsAg水平有明显的降低P = 0.001),但bepirovirsen150毫克组(P = 0.245)或接受稳定NA治疗的参与者(P = 0.762)没有降低。

在300毫克剂量组中,每组有两名参与者在第29天(n = 3)或第36天(n = 1)时HBsAg水平降到低于定量下限。

因此,该研究表明,Bepirovirsen具有良好的安全性。这些初步观察表明,需要在更大的CHB患者群体中进一步调查bepirovirsen的安全性和活性。

原始出处:

Man-Fung Yuen et al. Safety, tolerability and antiviral activity of the antisense oligonucleotide bepirovirsen in patients with chronic hepatitis B: a phase 2 randomized controlled trial. Nature Medicine (2021). 

 

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    2022-09-17 小小医者

    #GSK#宣布,#bepirovirsen##GSK3228836#、GSK836)治疗#慢性乙肝#的IIb期临床中期结果积极。数据显示,慢性乙肝(CHB)患者在接受24周bepirovirsen治疗后,乙肝表面抗原(HBsAg)和乙肝病毒(HBV) DNA的水平降低,有望实现#功能性治愈#

    0

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topicName=null, topicId=null, topicList=[TopicDto(id=37664, encryptionId=03753e66414, topicName=反义寡核苷酸)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bfc816121587, createdName=fyxzlh, createdTime=Sun Oct 17 07:28:10 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1611297, encodeId=dcfa161129eba, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Sun Oct 17 07:28:10 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1700430, encodeId=60b61e0043038, content=<a href='/topic/show?id=2f93465966d' target=_blank style='color:#2F92EE;'>#寡核苷酸#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46596, encryptionId=2f93465966d, topicName=寡核苷酸)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=491a30091205, createdName=DEXTER3149, createdTime=Fri Apr 08 18:28:10 CST 2022, time=2022-04-08, status=1, ipAttribution=)]
    2022-06-16 xsm918
  4. [GetPortalCommentsPageByObjectIdResponse(id=1885453, encodeId=a3571885453c3, content=<a href='/topic/show?id=3b2112532d8' target=_blank style='color:#2F92EE;'>#Nat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12532, encryptionId=3b2112532d8, topicName=Nat)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e6f107, createdName=liye789132251, createdTime=Mon Aug 29 06:28:10 CST 2022, time=2022-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1249479, encodeId=a4a912494e9dd, content=<a href='/topic/show?id=68ca828e57' target=_blank style='color:#2F92EE;'>#GSK#</a>宣布,<a href='/topic/show?id=7826104e2900' target=_blank style='color:#2F92EE;'>#bepirovirsen#</a>(<a href='/topic/show?id=a368103860f9' target=_blank style='color:#2F92EE;'>#GSK3228836#</a>、GSK836)治疗<a href='/topic/show?id=678f5346e1e' target=_blank style='color:#2F92EE;'>#慢性乙肝#</a>的IIb期临床中期结果积极。数据显示,慢性乙肝(CHB)患者在接受24周bepirovirsen治疗后,乙肝表面抗原(HBsAg)和乙肝病毒(HBV) DNA的水平降低,有望实现<a href='/topic/show?id=b5a4328934f' target=_blank style='color:#2F92EE;'>#功能性治愈#</a>。, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8287, encryptionId=68ca828e57, topicName=GSK), TopicDto(id=104729, encryptionId=7826104e2900, topicName=bepirovirsen), TopicDto(id=103860, encryptionId=a368103860f9, topicName=GSK3228836), TopicDto(id=53467, encryptionId=678f5346e1e, topicName=慢性乙肝), TopicDto(id=32893, encryptionId=b5a4328934f, topicName=功能性治愈)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=小小医者, createdTime=Sat Sep 17 06:15:43 CST 2022, time=2022-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1945663, 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time=2022-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1271318, encodeId=0b6112e131857, content=<a href='/topic/show?id=3d745346316' target=_blank style='color:#2F92EE;'>#慢性乙型肝炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53463, encryptionId=3d745346316, topicName=慢性乙型肝炎)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/iaP1mV9qBwx5tE2F4xcG1r4x1PibWvluIFLB8VsViakqNMBia2Z0wFibVrYwDEILvHB1OomzzTAAGy5MVl5BrdEv9Bw/132, createdBy=e11f100, createdName=guguangxiang, createdTime=Sun Oct 17 07:28:10 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1575381, encodeId=ed3c15e538167, content=<a href='/topic/show?id=03753e66414' target=_blank style='color:#2F92EE;'>#反义寡核苷酸#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, 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  5. [GetPortalCommentsPageByObjectIdResponse(id=1885453, encodeId=a3571885453c3, content=<a href='/topic/show?id=3b2112532d8' target=_blank style='color:#2F92EE;'>#Nat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12532, encryptionId=3b2112532d8, topicName=Nat)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e6f107, createdName=liye789132251, createdTime=Mon Aug 29 06:28:10 CST 2022, time=2022-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1249479, encodeId=a4a912494e9dd, content=<a href='/topic/show?id=68ca828e57' target=_blank style='color:#2F92EE;'>#GSK#</a>宣布,<a href='/topic/show?id=7826104e2900' target=_blank style='color:#2F92EE;'>#bepirovirsen#</a>(<a href='/topic/show?id=a368103860f9' target=_blank style='color:#2F92EE;'>#GSK3228836#</a>、GSK836)治疗<a href='/topic/show?id=678f5346e1e' target=_blank 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time=2022-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1271318, encodeId=0b6112e131857, content=<a href='/topic/show?id=3d745346316' target=_blank style='color:#2F92EE;'>#慢性乙型肝炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53463, encryptionId=3d745346316, topicName=慢性乙型肝炎)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/iaP1mV9qBwx5tE2F4xcG1r4x1PibWvluIFLB8VsViakqNMBia2Z0wFibVrYwDEILvHB1OomzzTAAGy5MVl5BrdEv9Bw/132, createdBy=e11f100, createdName=guguangxiang, createdTime=Sun Oct 17 07:28:10 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1575381, encodeId=ed3c15e538167, content=<a href='/topic/show?id=03753e66414' target=_blank style='color:#2F92EE;'>#反义寡核苷酸#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, 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  6. [GetPortalCommentsPageByObjectIdResponse(id=1885453, encodeId=a3571885453c3, content=<a href='/topic/show?id=3b2112532d8' target=_blank style='color:#2F92EE;'>#Nat#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12532, encryptionId=3b2112532d8, topicName=Nat)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e6f107, createdName=liye789132251, createdTime=Mon Aug 29 06:28:10 CST 2022, time=2022-08-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1249479, encodeId=a4a912494e9dd, content=<a href='/topic/show?id=68ca828e57' target=_blank style='color:#2F92EE;'>#GSK#</a>宣布,<a href='/topic/show?id=7826104e2900' target=_blank style='color:#2F92EE;'>#bepirovirsen#</a>(<a href='/topic/show?id=a368103860f9' target=_blank style='color:#2F92EE;'>#GSK3228836#</a>、GSK836)治疗<a href='/topic/show?id=678f5346e1e' target=_blank style='color:#2F92EE;'>#慢性乙肝#</a>的IIb期临床中期结果积极。数据显示,慢性乙肝(CHB)患者在接受24周bepirovirsen治疗后,乙肝表面抗原(HBsAg)和乙肝病毒(HBV) DNA的水平降低,有望实现<a href='/topic/show?id=b5a4328934f' target=_blank style='color:#2F92EE;'>#功能性治愈#</a>。, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8287, encryptionId=68ca828e57, topicName=GSK), TopicDto(id=104729, encryptionId=7826104e2900, topicName=bepirovirsen), TopicDto(id=103860, encryptionId=a368103860f9, topicName=GSK3228836), TopicDto(id=53467, encryptionId=678f5346e1e, topicName=慢性乙肝), TopicDto(id=32893, encryptionId=b5a4328934f, topicName=功能性治愈)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=小小医者, createdTime=Sat Sep 17 06:15:43 CST 2022, time=2022-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1945663, 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time=2022-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1271318, encodeId=0b6112e131857, content=<a href='/topic/show?id=3d745346316' target=_blank style='color:#2F92EE;'>#慢性乙型肝炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=53463, encryptionId=3d745346316, topicName=慢性乙型肝炎)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/iaP1mV9qBwx5tE2F4xcG1r4x1PibWvluIFLB8VsViakqNMBia2Z0wFibVrYwDEILvHB1OomzzTAAGy5MVl5BrdEv9Bw/132, createdBy=e11f100, createdName=guguangxiang, createdTime=Sun Oct 17 07:28:10 CST 2021, time=2021-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1575381, encodeId=ed3c15e538167, content=<a href='/topic/show?id=03753e66414' target=_blank style='color:#2F92EE;'>#反义寡核苷酸#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, 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  7. 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