Hep B Blog

Tag Archives: Eiger Biopharmaceuticals

Spotlight on Hepatitis Delta: Renewed Scientific Interest Paves the Way for New Data and Treatments

 

For decades, hepatitis delta, the dangerous coinfection of hepatitis B, was thought to only affect about 5-10% of the estimated 292 million people worldwide with chronic hepatitis B infections. With limited data and funding for research related to this complicated virus, true prevalence data, diagnostic tools and skilled physicians to manage hepatitis B and delta coinfection have remained limited until recent years. Publications in 2019 by Miao, et al., Chen, et al., Shen, et al., are helping to reveal a possibly more accurate picture of the burden of coinfection, conducting meta-analyses comprising data from hundreds of thousands of hepatitis B patients and the general population. While it was previously thought that 15-20 million coinfections existed globally, this new research has suggested there may be between 48-74 million1,2,3. Although these studies analyzed data that classified the presence of hepatitis delta antibodies, which can be present in cases of both past or current infection, there is a strong correlation between their presence and likelihood of an ongoing infection. These new studies may place coinfection at upwards of 10-15% of those with hepatitis B, with some of the hardest hit areas facing coinfection rates greater than 30%, in regions like Central Asia, Eastern Europe, Central Latin America and West and Central Africa1,2,3.

 

Understanding hepatitis delta is vital to helping to identify coinfected patients, who require altered treatment and management plans, and who may progress to cirrhosis and/or liver cancer in periods as little as 5-10 years. Diagnosis and management for hepatitis delta is still a challenge in much of the world, but in the US, it is becoming easier than ever before, with Quest Diagnostics, a commercial U.S. lab, rolling out a new HDV RNA test, a game-changer for physicians to easily order the test and manage patients. HDV RNA testing was previously available only through the Utah-based lab, ARUP, and Boston’s Cambridge Biomedical, but had to be specialty ordered. As testing continues to become more widely available and affordable, hepatitis B patients can more easily access testing. The more patients who are diagnosed, the more evidence for the urgent need for improved treatments to combat the virus, which is currently poorly controlled by the only available treatment; pegylated interferon.

Luckily, the virus has attracted the attention of nine pharmaceutical companies from around the world, with each working on a different approach to better controlling, or even curing hepatitis delta. Two of these companies, Eiger Biopharmaceuticals (US) and Myr Pharma (Germany) are now in Phase 3 clinical trials, where patients are flocking to enroll in these trials, which present new opportunities to receive treatments that may be more effective in controlling their coinfection. Eiger’s clinical trials will test their new drug, Lonafarnib, in clinical trial arms with and without pegylated interferon and/or ritonavir, with sites open in many countries throughout the world. Myr’s clinical trial will test their new drug, Myrcludex B, in similar triple-treatment combinations. Their clinical trial sites are now open in Russia, and the drug is already being prescribed for “compassionate use” in France. The United States Food and Drug Administration (FDA) has even taken notice; issuing guidance for industry on the development of hepatitis delta drugs for treatment in October 2019. This provides a valuable set of standards and expectations for clinical trials in regard to ethics, trial design, and patient needs.

Hepatitis delta coinfection has also received more attention this year at international hepatology conferences such as at the European Association for the Study of the Liver (EASL)’s International Liver Congress in Vienna, Austria, the International Liver Congress in American Association for the Study of the Liver (AASLD) meeting in Boston, and HEP DART in Hawaii. This year has brought many milestones for hepatitis delta data, diagnostics, and clinical trials. With continued scientific research and interest, Hepatitis Delta Connect hopes to continue to support these milestones and drive awareness efforts.

References:

1. Zhijiang Miao, Shaoshi Zhang, Xumin Ou, Shan Li, Zhongren Ma, Wenshi Wang, Maikel P Peppelenbosch, Jiaye Liu, Qiuwei Pan, Estimating the global prevalence, disease progression and clinical outcome of hepatitis delta virus infection, The Journal of Infectious Diseases, jiz633.

2. Chen H, Shen D, Ji D, et al. Prevalence and burden of hepatitis D virus infection in the global population: a systematic review and meta-analysis. Gut 2019;68:512-521.

3. Shen D, Ji D, Chen H, et al. Hepatitis D: not a rare disease anymore: global update for 2017–2018. Gut Published Online First: 09 April 2019.

Hepatitis B Foundation Launches Education Initiative for People Coinfected with Hepatitis B and D

hepc-graphicBy Sierra Pellechio

The Hepatitis B Foundation is excited to launch the Hepatitis Delta Connect program to provide education and resources for patients and families affected by hepatitis D, the most aggressive form of viral hepatitis. Hepatitis D infection requires the presence of the hepatitis B surface antigen (HBsAg), so only people already infected with hepatitis B can become infected with hepatitis D.

There is a large gap in knowledge and awareness about this virus, and the foundation is working to provide easily-accessible information and support to those in need.

Because the hepatitis D virus (HDV) is acquired only if a hepatitis B infection is present, it can be effectively prevented through hepatitis B vaccination. While hepatitis D is not common in the United States, worldwide it affects 15-20 million people.

Areas with the highest rates of hepatitis D infection rate include China, Russia, the Middle East, Mongolia, Romania, Georgia, Turkey, Pakistan, Africa and the Amazonian river basin. It is transmitted through direct contact with infected blood and bodily fluids, and most commonly affects high-risk groups such as intravenous drug users, men who have sex with men or have multiple sexual partners, and people emigrating from countries where hepatitis D is common.

Hepatitis D can be acquired either through coinfection (becoming infected with hepatitis D and B at the same time) or a super-infection (becoming infected with hepatitis D after a person has hepatitis B). A coinfection generally resolves spontaneously after about six months, but it can sometimes result in life-threatening or fatal liver failure. Like hepatitis B, hepatitis D may not present with any symptoms, so getting a simple blood test is the only way to know if you are infected.

Treatment options are limited, but pegylated interferon has shown some effectiveness in a small percentage of patients (less than 30 percent). The good news is that there are five promising drugs currently in clinical trials. Visit our HDV Drug Watch and Clinical Trials page for more information about these drugs. We at the Hepatitis B Foundation appreciate the support of Eiger Biopharmaceuticals to help launch this valuable patient-focused program.

Hepatitis D is a complicated virus, and for this reason, it is very important for patients to find a knowledgeable liver specialist (or hepatologist) who can provide the best care and management.

The most important message for those living with hepatitis B is to get a simple blood test to find out if they have hepatitis D if they believe they are at risk. There are promising new treatments that could help prevent the serious complications related to a hepatitis B and D coinfection.

As the coordinator of Hepatitis Delta Connect, I am thrilled about this opportunity to help create a resource for patients who are living with hepatitis D. My experience in health literacy and community outreach blend with my commitment to support those in need, allowing me to promote the project in ways that will help raise the visibility of hepatitis D and let the 15-20 million infected people know that they are not alone.

In addition to our website, please email questions to connect@hepdconnect.org follow us on Facebook, Twitter and Instagram (@hepdconnect) to join the global conversation. We look forward to hearing from you.