艾格在2020年肝脏会议Dig​​ital Experience™中展示临床试验结

StephenW

Eiger Presents Clinical Trial Results at The Liver Meeting Digital Experience™ 2020
January 6, 2021 hepbtalk       

By Beatrice Zovich

The 2020 meeting of the American Association for the Study of Liver Diseases (AASLD) in November offered the opportunity for scientists from industry and academia to present their findings from clinical trials, studying new medications for hepatitis B and D. Two such presentations were given by Eiger BioPharmaceuticals, Inc. who presented their findings about how well their medications peginterferon lambda and lonafarnib work, both independently and in combination, to treat hepatitis delta virus (HDV) and halt liver fibrosis. The results are promising and offer hope for those affected by HDV.

The two medicines under investigation in these studies work in different ways. Lonafarnib works by blocking farnesyl transferase, an enzyme involved in prenylation, the modification of proteins that is necessary for the life cycle of HDV. Peginterferon lambda, on the other hand, triggers immune responses that are crucial for host protection during viral infections. Lambda can also target liver cells accurately, thus reducing the effects of inadvertently targeting central nervous system cells and making it more tolerable to those taking it (Eiger, 2020).

Eiger’s first study examined how well peginterferon lambda and lonafarnib (known as LIFT – Lambda InterFeron combo Therapy) work together to lower levels of HDV RNA, 24 weeks post-treatment (Eiger, 2020). This was a Phase 2 study. Lambda was administered at a dosage of 180 mcg once weekly, in combination with 50 mg of Lonafarnib and 100 mg of ritonavir given twice daily, for 24 weeks. The results of this study found that 77% of the 26 participants saw their HDV RNA levels decline and reach a level that was either undetectable or below the level of quantification. 23% of these participants were able to maintain these levels for 24 weeks after treatment had ended. Both tenofovir and entecavir were started prior to treatment for management of HBV. The observed side effects of this regimen were mild to moderate and included mostly gastrointestinal issues or were related to blood chemistry (Eiger, 2020).

The second study found that peginterferon lambda caused the regression of liver fibrosis after 48 weeks of treatment in people living with hepatitis delta. Two case studies emerged from the completed Phase 2 LIMT (Lambda Interferon MonoTherapy) study (Eiger, 2020). In these studies, a total of 33 participants received either 180 µg or 120 µg of lambda subcutaneous injections weekly for 48 weeks. Results indicated that degrees of liver fibrosis and levels of HDV RNA declined below the level of quantification in some participants, even after 72 weeks in a handful of cases. In some instances, ALT levels decreased as well. Side effects were found to be mild to moderate and fewer than those experienced by participants who had taken peginterferon alpha in the past. Side effects were primarily flu-like in nature (Eiger, 2020).

Therapies for hepatitis B and D will only continue to improve and become more precise and targeted as time goes by. Check out the Hepatitis Delta Connect website for detailed information on HDV, as well as current clinical trials and a drug watch page, both of which are updated regularly. (A brand-new clinical trial has just been added!) For more information about Eiger BioPharmaceuticals, click here.

References

Eiger BioPharmaceuticals, Inc. (2020, November 17). Eiger Announces Positive Peginterferon Lambda – Lonafarnib Combination End of Study Results from Phase 2 LIFT HDV Study in Late-Breaker Session at The Liver Meeting Digital Experience™ 2020. Retrieved December 30, 2020, from https://www.biospace.com/article ... al-experience-2020/

Eiger BioPharmaceuticals, I. (2020, November 16). Eiger Announces Case Studies Demonstrating Regression of Liver Fibrosis Following 48 Weeks of Therapy with Peginterferon Lambda in Patients with Chronic Hepatitis Delta Virus (HDV) Infection Presented at The Liver Meeting Digital Experience™ 2020. Retrieved December 30, 2020, from https://www.prnewswire.com/news- ... ver-meeting-digital–301173992.html

clinical trialsHDVhepatitis DResearch

StephenW

艾格在2020年肝脏会议Dig​​ital Experience™中展示临床试验结果
2021年1月6日

比阿特丽斯·佐维奇（Beatrice Zovich）

美国肝病研究协会（AASLD）于2020年11月召开的会议为工业界和学术界的科学家提供了机会，展示他们的临床试验结果，研究了乙型和丁型肝炎的新药。 Eiger BioPharmaceuticals，Inc.提出了他们的发现，即聚乙二醇干扰素lambda和lonafarnib的药物分别或联合治疗肝炎三角洲病毒（HDV）和阻止肝纤维化的效果如何。结果令人鼓舞，并为受HDV影响的人们提供希望。

这些研究中正在研究的两种药物以不同的方式起作用。 Lonafarnib通过阻断法呢基转移酶（法呢基转移酶）来起作用，法呢基转移酶涉及异戊二烯化，这是HDV生命周期所必需的蛋白质修饰。另一方面，聚乙二醇干扰素λ触发免疫反应，这对于病毒感染期间对宿主的保护至关重要。 Lambda还可以精确地靶向肝细胞，从而减少了无意中靶向中枢神经系统细胞的影响，并使之对那些服用它的人更具耐受性（Eiger，2020年）。

艾格（Eiger）的第一项研究研究了聚乙二醇化干扰素lambda和lonafarnib（称为LIFT – Lambda InterFeron联合疗法）在治疗后24周内如何协同工作，以降低HDV RNA水平（Eiger，2020年）。这是第二阶段的研究。 Lambda每周一次的剂量为180 mcg，与50 mg的Lonafarnib和100 mg的ritonavir组合，每天两次，持续24周。这项研究的结果发现，在26名参与者中，有77％的HDV RNA水平下降并达到了不可检测的水平或低于定量水平。这些患者中有23％的患者在治疗结束后能够维持这些水平24周。替诺福韦和恩替卡韦均在治疗HBV之前开始治疗。该方案观察到的副作用为轻度至中度，主要包括胃肠道问题或与血液化学有关（Eiger，2020年）。

第二项研究发现，聚乙二醇化干扰素λ治疗肝炎三角洲患者48周后可导致肝纤维化消退。完成的2期LIMT（Lambda干扰素单一疗法）研究（Eiger，2020年）得出了两个案例研究。在这些研究中，共有33名参与者在48周内每周接受180 µg或120 µgλ皮下注射。结果表明，即使在少数情况下，在72周后，一些参与者的肝纤维化程度和HDV RNA的水平仍低于定量水平。在某些情况下，ALT水平也会下降。发现副作用为轻度至中度，并且比过去服用聚乙二醇干扰素α的参与者所经历的副作用少。自然界中的副作用主要类似于流感（Eiger，2020年）。

随着时间的流逝，对乙型和丁型肝炎的治疗只会继续改善，变得更加精确和有针对性。请访问Hepatitis Delta Connect网站，以获取有关HDV的详细信息，以及当前的临床试验和药物观察页面，这两个信息都会定期更新。 （刚刚添加了全新的临床试验！）有关艾格峰生物制药的更多信息，请单击此处。

参考文献

Eiger BioPharmaceuticals，Inc.（2020年11月17日）。 Eiger在Liver Meeting Digital Experience™2020后期会议上宣布了Peginterferon Lambda – Lonafarnib联合研究结果的后期研究成果，该研究在2020年肝脏会议Dig​​ital Experience™中检索。检索于2020年12月30日，网址为https://www.biospace.com/article / releases / eiger-announces-peginterferon-lambda-lonafarnib-combination-end-of-study-results-of-phase-2-lift-hdv-search-in-breaker-session-the-liver的研究结果会议数字体验2020 /

Eiger BioPharmaceuticals，I。（2020年11月16日）。艾格（Eiger）宣布了一项案例研究，该研究证明了用Peginterferon Lambda治疗慢性肝炎三角洲病毒（HDV）感染的患者48周后肝纤维化的消退。该研究发表在2020年肝脏会议Dig​​ital Experience™（肝脏会议）上，于2020年12月30日检索。 .prnewswire.com / news-releases / eiger-announces-case-studies-在接受peginterferon-lambda治疗的患者中，随着时间的推移，证明其在肝纤维化治疗后48周的回归-肝炎三角洲病毒-hdv感染在肝脏会议数字呈现– 301173992.html

HD肝炎D临床研究