Hep B Blog

What New Treatments Are on the Horizon for Hepatitis B/D Coinfected Patients?

Although there are highly effective treatments available to manage hepatitis B, there are few available treatments for hepatitis D, and none are U.S. Food and Drug Administration (FDA) approved. Hepatitis D is the most severe form of viral hepatitis, and coinfection can accelerate liver damage and cause cirrhosis or liver cancer in as little as 5 years for some patients. Currently there is no approved drug for acute or chronic hepatitis B/D coinfection, but in trials pegylated interferon alpha has shown to be somewhat effective. By stimulating the body’s immune system, around 25-30% of patients are able to suppress their hepatitis D viral load with weekly injections over 48 weeks. Emerging research is showing higher rates of effectiveness with prolonged interferon treatment beyond one year, but it can be difficult for patients to continue due to the physical and mental toll of interferon on the body. Antiviral medications that are proven effective against hepatitis B are sometimes prescribed along with interferon therapy for patients with a high hepatitis B viral load, but these have no effect on hepatitis D. It is urgent that more treatment options be developed for the millions of hepatitis B/D patients that are eagerly awaiting them.

The good news is that with renewed scientific interest, research and funding, eight new drugs are currently in development that offer hope for more treatment options in the coming years. Two drugs have even been granted special designations by the FDA and one by European Medicines Agency (EMA), paving the way for increased resources and funding for development. Due to recent advancements, the future looks hopeful, and within a few years it is likely there will be more treatment options available. Below is a chart that provides more information on these new drugs and their current clinical trial status.

Pegylated Interferon Lambda

Pegylated-interferon-lambda (PEG-IFN-λ) is a well-characterized, late-stage, first in class, type III interferon that stimulates cell-mediated immune responses that are critical for the development of host protection during viral infections. This drug has now been granted “Orphan Drug Designation” by the FDA, fast-tracking the development process.

Myrcludex B

This drug is an “entry inhibitor” that prevents the virus from entering into hepatocytes (liver cells) and has shown activity against the hepatitis B virus. It may also stop the development of a hepatitis D infection. A recent study showed promise for Myrcludex B when combined with PEG-INF in reducing hepatitis D viral levels. It has been granted PRIME Eligibility by the European Medicines Agency, a status that promotes support in development of drugs that serve an unmet medical need.

Ezetimibe

Currently used to lower cholesterol in the blood, Ezetimibe is being studied for effectiveness against hepatitis D. Ezetimibe possesses pharmacophore features to stop NTCP, the receptor required for hepatitis B and hepatitis D hepatocyte entry.

Lonafarnib

This drug works by targeting the protein assembly process, preventing the production of new virus particles. In a current clinical trial, Lonafarnib combined with Ritonavir has shown promise in reducing hepatitis D viral levels, and the FDA has granted it fast-track status since this class of drugs have been developed for the treatment of cancers and have been shown to be safe.

Rep 2139

This compound is known as a “Nucleic acid-based Amphipathic Polymer” (NAP) which prevents the release of hepatitis B surface antigen (HBsAg) from infected liver cells and is being evaluated for hepatitis D virus in combination with pegylated interferon (PEG IFN).

GI-18000

GI-18000 Tarmogen is being studied for its effectiveness in causing a T cell immune response against cells infected with Hepatitis D and thereby improving outcomes. The strategy is to identify molecular targets that distinguish diseased cells from normal cells and activate the immune system to selectively target and eliminate only the diseased cells.

ALN-HDV

This approach is being used for both the hepatitis B and hepatitis D virus to “silence” the viral RNA with compounds that interfere with and cause the destruction of the viral genome (e.g. stop replication of the virus).

As clinical trials progress, sites may open across the world that are enrolling hepatitis D patients. Keep checking here for an up-to-date list of all current clinical trials.

Click here for more information about the phases of the clinical trial process.

For more information about hepatitis B/D coinfection, please visit www.hepdconnect.org or email us at connect@hepdconnect.org.

Join a Twitter Chat: Organizations Share Highlights From Hepatitis Awareness Month

Join Hepatitis B Foundation, NASTAD and CDC’s Division of Viral Hepatitis for a Twitter #HepChat at 2 p.m. (EST) Thursday, June 14. The chat will highlight Hepatitis Awareness Month outreach events and allow hepatitis B and C partner organizations to share their successes, challenges and lessons learned from their efforts.

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May 19 is National Hepatitis Testing Day

May is Hepatitis Awareness Month and Saturday, May 19this National Hepatitis Testing Day in the United States. This day is an opportunity to increase awareness and testing for both hepatitis B and C. It is also a reminder for health care providers and the public of the importance of testing for viral hepatitis.

Why is hepatitis B testing necessary? Hepatitis B is largely asymptomatic, which means that symptoms don’t always occur or are not obvious. Some people will not know that they have hepatitis B until it is too late, or they may learn of their infection from a blood donation screening or lab work.  There are groups of people who have a greater risk of hepatitis B compared to others, so it doesn’t hurt to be sure. here are some places around the world that have an extremely high hepatitis B prevalence (where many people are infected). It is important that people who are at high risk for a hepatitis B infection see a doctor to get tested, to find out if they have a hepatitis B infection. People living with chronic hepatitis B should be monitored regularly and appropriately screened for liver cancer. So, if you find you do have hepatitis B, talk to your doctor about what to do next.

Remember, hepatitis B does not discriminate. Don’t wait for symptoms. B sure. B tested. If you do not have hepatitis B, then give yourself lifelong protection with the hepatitis B vaccine. The hepatitis B vaccine is safe and effective. Children or adults can get the 3-shot vaccine series, and there isa newly approved two-dose adult vaccine to protect us against hepatitis B! However, the vaccine doesn’t work if you are already infected.

Don’t forget to check out these free, confidential hepatitis screenings this weekend! Check out Hep B United’s resource to find local events in your area. You can also visit the CDC’s website for more ideas on how to increase awareness on National Hepatitis Testing Day, and every day!

Hepatitis Victoria’s “Little Hep B” Hero Book

Hepatitis Victoria in Melbourne, Australia recently released their “bright, colorful, positive and silly” children’s book, Little Hep B Hero! In addition to creating a book, Hepatitis Victoria also created an animation.

Little Hep B Hero, which is available in English, Simplified Chinese and Vietnamese, gives children and their families a delightful glimpse into a young girl’s visit to her neighbor and friend, Rosa. As Rosa and the young girl prepare food and lemonade together, Rosa tells her about living with chronic hepatitis B. Rosa explains what the liver does, what hepatitis B is, how the virus is transmitted, how she maintains a healthy lifestyle with chronic hepatitis B, and shares tips on preventing hepatitis B transmission. Little Hep B Hero also provides cute and easy to understand visuals of the little girl as a superhero while Rosa explains this information.

The book does an excellent job of explaining liver functions and what the hepatitis B virus does to the liver! The analogy of using a sieve to demonstrate how the liver filters toxins in the body was creative. The book also does a great job of indirectly tackling some myths associated with hepatitis B. For example, people are often hesitant to share meals with those living with chronic hepatitis B. Little Hep B Hero lets its audience know that you cannot get hepatitis B through food preparation or sharing a meal, so Rosa cooks a meal for her neighbors.

Little Hep B Hero is an important read for future generations and their families! Getting the conversation started early about hepatitis B will address the stigma and discrimination associated with it. When children are talking about hepatitis B and are knowledgeable about it, hepatitis B isn’t a scary topic anymore. The message of hepatitis B as a family matter highlights the importance of educating and testing family members.

For more information, check out their press release, and to purchase Little Hep B Hero, visit Hepatitis Victoria’s website here.

May is Hepatitis Awareness Month

Hepatitis Awareness Month is dedicated to increasing awareness of hepatitis in the United States and to encourage high risk populations to get tested. If you’re not sure how you can get involved in the hepatitis B community this month, here are some ways you can!

  • Share and spread hepatitis B knowledge. CDC’s Know Hepatitis B Campaign is a great resource to learn more about hepatitis B and to promote testing in your area! They also have great posters, handouts, and videos available in different languages including Spanish, Mandarin, Vietnamese, Korean, French, and more! You can also look for some of the Hepatitis B Foundation’s fact sheets and #justB storytelling campaign videos.
  • Join or organize a screening event. May 19th is National Hepatitis Testing Day! Organizations around the country will provide viral hepatitis screenings – both hep B and C! Be sure to look for some Hep B United partners’ websites for screenings in your local area, especially if you’re interested in volunteering.
  • Organize or join a flash mob to increase awareness! With our local hepatitis B campaign in Philadelphia, Hep B United Philadelphia, we held a “B A Hero Flash Mob” in the past. It is a great way to open the discussion about hepatitis B in an engaging and fun way!
  • Become an HBV advocate! You can join our Hep B United Action Center to get all the updates on our advocacy efforts. You can also share your hepatitis B knowledge on social media too!
  • Check out and share Hepatitis Victoria’s Little Hep B Hero book and animation. Hepatitis Victoria created an engaging book to explain hepatitis B to six to twelve-year-old children. Their book is available to order and in English, Simplified Chinese, and Vietnamese.
  • Join the #HepAware Thunderclap. You can easily share and show your support for CDC Hepatitis’s efforts by joining their Thunderclap by May 19th, Hepatitis Testing Day. You can use Facebook, a Facebook page you manage, Twitter, and Tumblr.
  • Join our international #HepBeLIeVER Social Media Contest. Not only will you be spreading hepatitis B awareness, but you can also get a chance to WIN a $50 AMAZON GIFTCARD and other Hepatitis B Foundation swag. All you have to do is take a picture loving your liver and upload it to Twitter, Instagram, or Facebook with #HepBeLIeVER. More information here.

There are endless possibilities to celebrate this month! If you need even more ideas, CDC has a plethora of resources available dedicated to Viral Hepatitis Awareness month. You can also check out our Hepatitis Awareness Month webinar from Hep B United, NASTAD, and CDC or Hep B United and NOHep’s webinar: The NOHep Fight for Elimination!