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Category Archives: Research

Eiger Presents Clinical Trial Results at The Liver Meeting Digital Experience™ 2020

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/releases/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/

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-releases/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–301173992.html 

Eighth Annual Hep B United Summit a Success!

Hep B United is very pleased to report that the eighth annual (and first virtual) Hep B United Summit was a great success! With over 200 attendees from around the US, the summit brought together partners – both new and familiar – to discuss and collaborate on the successes and challenges of the past year, and strategies to move forward toward the elimination of hepatitis B.  

The theme of this year’s summit was “Standing Up for Hepatitis B: Creative Collaborations to Amplify Awareness, Access, and Equity.” The event included many exciting sessions on topics such as progress toward a hepatitis B cure; strategies for providing hepatitis B services in the time of COVID-19; federal updates on hepatitis B; methods for incorporating hepatitis B into viral hepatitis elimination planning efforts at state and local levels; the path to universal adult hepatitis B vaccination; expansion of hepatitis B outreach in non-traditional settings, such as pharmacies, harm reduction centers, and correctional facilities; the pandemic of structural racism and how to bridge gaps in healthcare; and elevating the patient voice to move elimination efforts forward. The event included a poster session with over 20 submissions from presenters around the country, ranging from medical students to organizational partners, and covering a diverse and comprehensive array of topics related to hepatitis B. 

The virtual platform offered a dynamic and engaging experience, with opportunities for networking, game participation, social media involvement, and learning. The Summit concluded with an award ceremony in which nine Hepatitis B Champions and a Federal Champion were honored for their efforts and dedication to hepatitis B advocacy, awareness, prevention, and elimination efforts over the past year. 

 As in previous years, the Summit provided an opportunity for colleagues to gather and to exchange innovative and creative ideas that will help to advance hepatitis B elimination and elevate hepatitis B as an issue deserving of widespread national attention. Recordings of the Summit are available on Hep B United’s YouTube channel – check them out today!

All of Us Research Program

Medicine is not one size fits all. Changing that idea takes All of Us. 

Why is it that an African American woman in her thirties living in a large city tends to receive the same medical care as a man in his sixties of European descent who lives on a farm in rural America, who in turn receives the same treatment as a Korean American mother of two in her forties living in a midwestern suburb? Each of these people has different ancestry, lifestyle, environment, socioeconomic status, and genetics, all of which have a major impact on health. Why should these factors not impact healthcare as well?

The All of Us Research Program, an initiative of the National Institutes of Health, is working to change that. The goal of the program is to diversify the pool of available biomedical data, so that researchers can study many different people and groups, and doctors in turn can then make much more informed decisions about prevention, diagnosis, and treatment of various conditions, that are much more tailored to individual people and to specific groups of people, a practice known as precision medicine. For far too long, doctors have been using data from and information about “the average person” (typically a white man) to make decisions and provide care to everyone in the extraordinarily diverse population of the United States. Now there is a great opportunity for all of us to come together to help them change that! 

The overall objective of the project is to recruit one million or more participants and to follow them over ten years.The Hepatitis B Foundation, in partnership with Hep Free Haw aii and the Asian Engagement and Recruitment Core (ARC), is working to spread the word about the All of Us Research Program to everyone, but particularly among Asian American, Native Hawaiian, and Pacific Islander communities, who are under-represented in this area, historically and currently. 

Why should I participate?

This is an important chance to learn about your own health, including risk factors and exposures.  This is also a great opportunity to help fight diseases, start to close the gaps in a healthcare system that currently does not provide all Americans with the same high quality of healthcare, and more quickly find solutions to serious healthcare problems. Examples of some questions you could help answer are: “How can we prevent the chronic pain that affects more than 100 million people across the US each year? How can we develop cancer treatments that will work the first time, so that we can skip painful trial-and-error chemotherapy? Why does the heart medication Plavix have a much lower success rate among Asian Americans than those of European descent? What would be a more appropriate treatment?” The answers to these questions can be found by gathering more data and more insights from more people. People like you! You have the power to change the course of healthcare for yourself, your community, and future generations.

How Can I Get Involved?

Getting involved is quick and easy! The steps to follow are:

  • Visit www.joinallofus.org to learn more, enroll, and provide consent for the sharing of your electronic health record, where all of your medical information is digitally stored. 
  • Complete a series of surveys that will ask for information about your lifestyle, environment, family history, and background.
  • Provide health measurements like height, weight, waist circumference, and heart rate, among others. 
  • Provide biosamples of blood, urine, and saliva. 
  • Start using apps and technology to track your behaviors and routine activities, starting with a FitBit and including others down the road that are still under development. 

You will receive help and guidance at each stage in the process. 

What about my privacy?

Glad you asked! Any data that you provide will be highly secure and protected. Data security for this project has been built by experts with input from the public. All data is encrypted with identifying information removed, and guaranteed by a Certificate of Confidentiality. Researchers must also agree to a Code of Conduct before accessing the data. You will have access to any and all of your data at any time throughout the program and the highest standard of transparency is practiced. 

What if I don’t want to continue?

You are in control. You can stop your participation at any time. If you have already provided data and no longer want it to be used, you can simply let All of Us know and your data will be destroyed. 

Partners in the Process

All of Us is not a project where researchers know all of the answers and are just mining participants for data. Choosing to participate in All of Us means that you are a partner in the research process. Your thoughts and insights are valuable and you will play a direct role in shaping healthcare for yourself and your community both now and in the future – not just with your data, but as an active participant in the research process, including in the proposal and guidance of future research. 

The All of Us Research Program aims to serve people better, to be more inclusive in biomedical research, to find healthcare solutions that are realistic for and meaningful to more people, and to work toward research and medical breakthroughs that are more reflective of the diversity of the United States. Take the next step to make sure we are Invisible No Longer. Visit www.joinallofus.org to get started today!