Hep B Blog

Tag Archives: hepatitis D

Hepatitis B Research, Hepatitis B Treatment

Clinical Trials Finder – Find A Clinical Trial Near You!

 

The Hepatitis B Foundation is thrilled to announce the addition of a new clinical trials search tool to our website! People around the world can now easily search for clinical trial opportunities on the Hepatitis B Foundation website. Created by Antidote – a company that designs technologies to link patients with scientific opportunities – the new tool filters through all of the trials listed in the U.S. National Library of Medicine’s database of private and publicly funded studies. Searching for clinical trials can be time-consuming and confusing to navigate, but this resource eases the process by finding the best trials for you based upon a series of questions.

You can now search for hepatitis B, hepatitis D and liver cancer clinical trials with a few simple clicks! Clinical trials are a series of research phases that a new drug must go through in order to be approved for widespread use. They are an essential to proving that a treatment is safe and effective for the larger population. Generally, these trials take 10-15 years to go from the laboratory to the public, but delays in finding or retaining enough volunteers can extend the process. 

Diverse participation in clinical trials is needed to make sure that a treatment is effective for all groups. Research diversity matters greatly for several reasons. Studies have shown that different races and ethnicities may respond differently to a certain medication. In addition, researchers need to examine the impact of the medication on the populations that will eventually use them. According to data from the U.S. Food and Drug Administration (US FDA), individuals from Africa and Asia or of African and Asian descent consistently remain underrepresented in clinical trials; these populations are also disproportionately impacted by hepatitis B.  If these groups are underrepresented in trials for hepatitis B treatments, new drugs may not be as effective in these communities, or there may be side effects that researchers were not aware of. 

How Our Clinical Trials Finder Works 

 Using our Clinical Trial Finder takes just a few minutes. After clicking the ‘search’ button, the user will answer a series of questions of general demographic and health questions to determine what trials are near you and you fit the criteria for. You will be able to view the available trials at any point while answering questions, but answering all of the questions will give you the best results. You will also have the option to leave your email to receive personalized trial alerts for new trials that you are eligible for in your area! The new tool is designed to match those who wish to join a clinical trial to the best option for them; it is not designed to benefit any company.

 Benefits of Participating in Clinical Trials

While participating in clinical trials helps drug developers, it can also provide major benefits to the participant as well! Blood work, treatments, and monitoring – which can be expensive –  are often provided for free to those who are eligible for the duration of their participation in the study. Volunteers can also potentially benefit from the latest medical advancements and developments! 

Help Improve the Future of Clinical Trials 

You can also help improve the future of drug development and clinical trials by taking our patient engagement survey! The survey, which takes approximately 20-25 minutes to complete, will be made available for use by the US FDA and drug development researchers to help clinical trial development for future hepatitis B therapies. All survey responses are anonymous.  

 

Hepatitis Delta (HDV)

Where Can I Order Hepatitis Delta Testing?

By Sierra Pellechio, BS, CHES, Hepatitis Delta Connect Program Manager

Historically, testing for hepatitis delta has been difficult to access and often not commercially available. With the rise in awareness about hepatitis B and delta coinfection, more tests are beginning to be offered by multiple labs for clinicians in the United States looking to test their patients. Because hepatitis delta can only infect people who also have hepatitis B, the Hepatitis B Foundation’s medical director and leading hepatologist Dr. Robert Gish recommends testing all hepatitis B patients for hepatitis delta. “Screening all hepatitis B patients will allow a better understanding of hepatitis delta prevalence and its impact on outcomes and will identify patients who can be offered treatment within or outside clinical trials.”

The first step in diagnosing an infection is the HDV antibody total (anti-HDV) test. Patients who have recovered from or are currently infected will be positive for the anti-HDV and will present high titers in later stages of acute infection and persist in cases of chronic infection. If the HDV antibody total test is positive, it should be followed by the HDV RNA (PCR) test to confirm an active infection. If this test is negative, a current infection is unlikely.

Testing hepatitis B patients for hepatitis delta is important because when people with hepatitis B are exposed to the hepatitis delta virus, 90% will develop a chronic infection1. Coinfection will alter treatment and management plans, because antivirals effective on hepatitis B do not control hepatitis delta2. While the standard treatment of interferon is less than 30% effective in controlling coinfection, there are new drugs in development. With two of these drugs set to enter phase 3 clinical trials in 2019, it is more important than ever to identify coinfected patients and connect patients into clinical trials.

Until recently, only the anti-HDV test was widely available in the United States. In February 2019, Quest Diagnostics began offering HDV RNA testing, making it easier for patients and their physicians to access this more detailed level of testing. A complete list of labs offering testing is below.

Quest Diagnostics (US)

Tests Offered:

ARUP Laboratories (US) 

Tests Offered:

Cambridge Biomedical (US, Limited States)

Tests Offered:

Mayo Clinic Laboratories (US)

Tests Offered:

Viracor (US)

Tests Offered:

Centers for Disease Control and Prevention (CDC) (US & International)

Tests Offered:

  • HDV Antibody Total
  • HDV RNA
  • Genotyping

Disclaimer: This may not be a comprehensive list of all available labs offering testing.

Please note, if you are a patient in the U.S. and wish to be tested for hepatitis delta, these tests must be ordered through a clinician.

It is very important for coinfected patients to be managed by a liver specialist who is familiar with managing coinfected patients. For assistance in locating a specialist near you, please visit our Physician Directory page. For additional questions, please visit www.hepdconnect.org, email connect@hepdconnect.org, or call our hotline at 215-489-4900.

References:

  1. Hooks, B., Billings, J., & Herrera, J. (2009). Hepatitis D Virus. Practical Gastroenterology.

2. Farci, P., & Anna Niro, G. (2018). Current and Future Management of Chronic Hepatitis D. Gastroenterology & hepatology, 14(6), 342-35

About Hepatitis B, Living with Hepatitis B

What’s the Difference: Hepatitis B vs Hepatitis C?

With five different types of viral hepatitis, it can be difficult to understand the differences between them. Some forms of hepatitis get more attention than others, but it is still important to know how they are transmitted, what they do, and the steps that you can take to protect yourself and your liver!

This is part one in a three-part series.

What is Hepatitis?

Hepatitis means “inflammation of the liver”. A liver can become inflamed for many reasons, such as too much alcohol, physical injury, autoimmune response, or a reaction to bacteria or a virus. The five most common hepatitis viruses are A, B, C, D, and E. Some hepatitis viruses can lead to fibrosis, cirrhosis, liver failure, or even liver cancer. Damage to the liver reduces its ability to function and makes it harder for your body to filter out toxins.

Both hepatitis B and C are blood-borne pathogens, which means that their primary mode of transmission is through direct blood-to-blood contact with an infected person. Also, both hepatitis B and C can cause chronic, lifelong infections that can lead to serious liver disease. Hepatitis B is most commonly spread from mother-to-child during birth while hepatitis C is more commonly spread through the use of unclean needles used to inject drugs.

 

Hepatitis B vs. Hepatitis C

Despite having an effective vaccine, hepatitis B is the world’s most common liver infection; over 292 million people around the world are estimated to be living with chronic hepatitis B. While hepatitis C tends to get more attention and research funding, hepatitis B is considerably more common and causes more liver-related cancer and death worldwide than hepatitis C. Combined, chronic hepatitis B and C account for approximately 80% of the world’s liver cancer cases. However, studies show that those with chronic hepatitis B are more likely to die from liver-related complications than those who are infected with hepatitis C. With hepatitis C, most people develop cirrhosis, or scarring of the liver, before liver cancer. In certain cases of hepatitis B, liver cancer can develop without any signs of cirrhosis, which makes it extremely difficult to predict the virus’ impacts on the body, and makes screening for liver cancer more complicated.

The hepatitis B virus is also approximately 5-10 times more infectious than hepatitis C, and far more stable. It can survive – and remain highly contagious – on surfaces outside of the body for at least seven days if it is not properly cleaned with a disinfectant or a simple bleach solution. A new study suggests that the hepatitis B virus has the ability to survive in extreme temperatures, whereas the hepatitis C virus has been known to survive outside of the body for a short period of time on room-temperature surfaces. However, more research will need to be done on the topic.

Another major difference between the two forms of hepatitis is how the virus attacks a cell. The hepatitis C virus operates like other viruses; it enters a healthy cell and produces copies of itself that

Hepatitis C Virus
Courtesy of Google Images

go on to infect other healthy cells. The hepatitis B virus reproduces in a similar fashion, but with one large difference – covalently closed circular DNA. Covalently closed circular DNA (cccDNA) is a structure that is unique to only a few viruses. Unlike a typical virus, hepatitis B’s cccDNA permanently integrates itself into a healthy cell’s DNA – a component of the cell that allows it to function properly and produce more healthy cells. The cccDNA resides within an essential area of the cell called the nucleus and can remain there even if an infected person’s hepatitis B surface antigen (HBsAg) levels are undetectable. Its presence means that a person with chronic hepatitis B may have a risk of reactivation even if the HBsAg levels have been undetectable for a long period of time. The complex nature and integration process of cccDNA contributes to the difficulties of finding a cure for hepatitis B. The cccDNA’s location inside of the nucleus is especially troublesome because it makes it difficult to isolate and destroy the cccDNA without harming the rest of the cell.

Hepatitis C, on the other hand, has a cure! Approved by the FDA in 2013, the cure is in the form of an antiviral pill that is taken once a day over the course of 8-12 weeks. For hepatitis C, a cure is defined as a sustained virologic response (SVR), which means that the virus is not detected in a person’s blood 3 months after treatment has been completed. In the United States, an affordable, generic version of the hepatitis C cure is set to be released by Gilead Sciences, Inc. in January 2019.

People living with chronic hepatitis B are susceptible to hepatitis Delta. Only people with hepatitis B can contract hepatitis D as well. Hepatitis Delta is considered to be the most severe form of hepatitis because of its potential to quickly lead to more serious liver disease than hepatitis B alone. Of the 292 million people living with chronic hepatitis B, approximately 15-20 million are also living with hepatitis D. Unlike HIV and hepatitis C coinfections, there are currently no FDA approved treatments for hepatitis Delta. However, there are ongoing clinical trials that are researching potential treatments!

Hepatitis B/C Coinfection

It is possible to have both hepatitis B and C at the same time. The hepatitis C virus may appear more dominant and reduce hepatitis B to low or undetectable levels in the bloodstream. Prior to curative treatment for hepatitis C, it is important for people to get tested for hepatitis B using the three-part blood test (HBsAg, anti-HBc total and anti-HBs). People currently infected with hepatitis B (HBsAg positive) or those who have recovered from past infection (HBsAg negative and anti-HBc positive) should be carefully managed according to the American Association for the Study of Liver Diseases (AASLD) treatment guidelines in order to avoid dangerous elevation of liver enzymes resulting in liver damage.

How to Protect Yourself   

The hepatitis B vaccine is the best way to protect yourself and your family against hepatitis B. Although there is no vaccine for hepatitis C, you can protect yourself from both liver infections by following simple precautions! Simple steps such as not sharing personal items such as razors or toothbrushes, thoroughly washing your hands, and disinfecting surfaces that have been in contact with blood, can keep your liver healthy!

 

Hepatitis Delta (HDV), Liver Cancer, Uncategorized

Where is Hepatitis D? High Prevalence of Hepatitis B/D Coinfection in Central Africa

By Sierra Pellechio, Hepatitis Delta Connect Coordinator

While hepatitis B is known to be highly endemic to sub-Saharan Africa and is estimated to affect 5-20% of the general population, the burden of hepatitis D, a dangerous coinfection of hepatitis B, has largely been left undescribed. Since the virus’s discovery 40 years ago, Africa has faced structural barriers that have contributed to the ongoing prevalence of the virus in this region. Widespread instability, under-resourced health systems, and poor surveillance have contributed to inadequate research and a lack of understanding about the health burden of hepatitis D on hepatitis B patients, particularly in Central Africa.

New data, however, reveals pockets of hepatitis B/D coinfection in this region, particularly in countries such as Cameroon, Central African Republic and Gabon. In a recently published study of nearly 2,000 hepatitis B infected blood samples from 2010-2016 in Cameroon, 46.7% tested positive for hepatitis D antibodies, a marker of past or current hepatitis D coinfection. Another study of 233 chronic hepatitis B carriers from 2008-2009 found a 17.6% positivity for hepatitis D antibodies. Other small studies from the Central African Republic have revealed 68.2% prevalence in hepatitis B patients, 50% coinfection in liver cancer patients and an 18.8% coinfection in hepatitis B infected pregnant women. Not only are new studies revealing evidence that there are groups at higher risk for hepatitis D, but a 2008 study on 124 community members in Gabon found 66% of them had markers for hepatitis D, proving this virus can also be circulating in the general population. Globally, hepatitis D is thought to affect about 5-10% of hepatitis B patients, making Central Africa an area of extremely high prevalence.

A diagnosis with hepatitis B and D can increase the risk for cirrhosis and liver cancer by nearly three times, and with only one available treatment, the future for coinfected patients if often uncertain. Although hepatitis B and D can be safely prevented by completing the hepatitis B vaccine series, which is available in many countries throughout Africa, the birth dose of the hepatitis B vaccine is often not given within the recommended 24 hours of birth. Lack of awareness, availability, and high cost mean many infants will not begin the vaccine series until 6 weeks of age, creating a window for exposure to hepatitis B. Greater than 95% of babies infected with hepatitis B will go on to develop chronic hepatitis B infections, leaving them susceptible to a future hepatitis D infection. Spread the same way as hepatitis B, through direct contact with infected blood and sexual fluids, hepatitis D can be contracted through unsterile medical and dental equipment and procedures, blood transfusions, shared razors and unprotected sex. Although the severity of disease varies greatly by hepatitis D genotype, coinfection always requires expert management by a knowledgeable liver specialist, which are often difficult to find.

As an increasing number of studies continue to describe the widespread endemicity of hepatitis B/D coinfection and its public health burden, researchers and the Hepatitis Delta International Network are calling on the World Health Organization (WHO) to declare hepatitis D a “threat” in this region in order to promote increased priority and awareness. Addressing hepatitis B/D coinfection prevention and management will be complex and require a multi-pronged approach through methods such as government prioritization, increased funding for health systems, hepatitis B vaccination awareness programs, birth dose prioritization, better sterilization techniques in hospitals, clinics, and barbers, and public awareness of the disease.

For more information about hepatitis B/D coinfection and the Hepatitis Delta Connect program, please visit www.hepdconnect.org or email us at connect@hepdconnect.org. Hepatitis Delta Connect seeks to provide information, resources and support for hepatitis B/D patients and their families through its website, social media, fact sheets, webinars and hepatitis D liver specialist directory.

Hepatitis Delta (HDV), Living with Hepatitis B

Karen and Dave’s Story

One Couple’s Journey through Hepatitis B, Hepatitis D and Liver Cancer

“Dave knew he had hepatitis B for decades, but honestly, no one ever seemed concerned. His liver
enzymes were slightly elevated, so the doctor told him to just watch what he ate and drank. He didn’t
even insist on bi-yearly blood tests!

In 2016, Dave was scheduled for a routine colonoscopy. Because he’d been looking pale and sickly
around that time, I suggested they do a blood test first at his family doctor. His numbers were off the
chart. They sent us back for the colonoscopy and added an endoscopy too. They found four varices
(enlarged veins in the esophagus that can indicate serious liver disease). How did this happen?

This was when I started to get angry. The gastroenterologist called us in to discuss the results. He asked
if Dave knew he had hepatitis B. Dave said yes, knowing his drug use in his teens and early twenties was
likely the source. Dave never felt shame about it at all, and just accepted it as a path he took, and
thankfully came out of. After that conversation, the doctor slammed his chart shut and pushed it across
the desk. He said that Dave’s liver was so badly damaged that there was nothing he could do and to
‘come back in a year’. When we asked about his options for treatment for the varices and his hepatitis B,
he actually told me that no one would treat the varices unless they were bleeding! He also told us that
hepatitis B antivirals would “make things worse”. That didn’t make sense. We asked about a transplant.
He said there was ‘no way’ anyone would give him a new liver. He didn’t even let us know that there
were actual liver clinics for this very purpose. He sent Dave away to die, really.

Many months later, with much perseverance, we made it to Stanford, where he was immediately put on
entecavir to treat his hepatitis B and to hopefully relieve some of his liver damage. That doctor alerted
us that he should also be tested for hepatitis D, a coinfection of hepatitis B. “It won’t be good if you have
it.” He did.

Due to changes in our health insurance, we were sent to continue at the University of California San
Francisco Liver Center…they were our saving grace. They treated the varices right away and put him on
other medications to help his failing systems. His hepatitis B viral load was now undetectable, with
hepatitis D being the biggest concern. Dave tried interferon to treat the hepatitis D, but with no luck. His
only chance was a transplant, but even though he was doing poorly, his test results didn’t qualify him to
get on the transplant list right away. He had lots of ER visits – 210 office visits in 2017 alone. It was a
whirlwind. Dave hadn’t even driven in 2 ½ years. It was an enormous stress on me, too.

Dave developed liver cancer but wasn’t in good enough shape to go through treatment. As he got sicker,
he eventually qualified for two different                  
liver transplant waiting lists. Finally, on
Thanksgiving night 2017, we got the call
that a healthy liver was available, and we
took it.
Caregiving is a very tough road. Especially
when your person also has encephalopathy,
caused by years of liver damage – and Dave
had it really bad. The encephalopathy
caused mood swings, short-term memory
loss, hand tremors, low appetite. He could
be down-right nasty. At that time, we were
doing the 4 ½ hour drive to San Francisco
once or twice a week. It was stressful for
both of us – and he was really unaware of
the stress that was put on me. Between
driving, taking out the garbage, bills, our
construction business…you name it, I did it
all.

The first 3-4 months out of the transplant, people were telling him all that had gone on. Much to my
frustration, he didn’t believe any of it! Now, over 6 months post-transplant, little things are coming back
to him. I showed him about 2 dozen pictures of him during his journey, and he was shocked! He said he
thought he was fooling everyone into thinking he was well.

The hardest part of this journey was seeing Dave so sick at times. I spent a lot of time in my closet
crying. It was hard on our adult girls too, to see their dad so weak and disoriented. I had a lot of support
through our girls though, and my family, which made a world of a difference. My sister is also a retired
nurse, and she accompanied us to most of our visits. She was a helpful adviser, since his medications
always needed tweaking, and we were often on long calls with our care team, health insurance
company, and pharmacies.

The good we took away is his health! He still doesn’t feel it’s real. We went through so much, and are so
grateful to be on the other side.

Things I’ve learned:
• Get on a Facebook forum for liver transplant patients…they are a great resource and a wealth of
information from other patients.
• Take a third person with you to doctor visits and procedures. At times, I was so consumed with
my concern for Dave, it was easy for me to forget some of the things we discussed. My sister
would take notes, and we would review them after.
• Always get a second opinion if you don’t have a good feeling about your doctor. You will all
become a team, and it’s important to have a team you can trust.
• Get on the transplant list at multiple hospitals, their criteria for transplant varies!
• Have willing family members and friends get tested to see if they are donor matches. Usually the
recipient’s insurance will pay for the testing and survey if they are a match. My sister-in-law and
I were both tested but were not a match.
• Ask about organ swap programs. Apparently, my kidneys were in perfect health. My
hepatologist had me apply to the kidney donor program, in hopes that I may be able to donate
my kidney in exchange for a piece of someone’s liver for Dave.
• Dave was put on depression and anxiety medication early in the process. He was initially very
resistant, mostly because of the stigma. His doctors finally convinced him it would be very
helpful for his general mood…it was!
• I had to make several phone calls to his team without his knowing. Encephalopathy really makes
you confused, and in Dave’s case, grumpy. I asked the doctor to push for the depression and
anxiety medications, which she did. Also, he wouldn’t exercise or take short walks before
surgery, which she had asked him to, to better prepare for surgery. I made the phone call, and
at the next visit, she set him up with a Fitbit! It helped that the ‘suggestions’ came from his
doctor and not me!
• After the transplant, I was so surprised he wasn’t more ‘thankful’ …that he wasn’t in awe of
what we had all gone through for HIM! I got angry with him. I made a private call to our new
post-transplant team. She said depression right after is very common. The patient feels
overwhelmed, and sometimes not very thankful. It’s kind of a way to deny they were in trouble,
to deny that they needed help. That fits my man to a tee!
• I would strongly suggest lots of patience after the transplant. I wish our team would have told
me the possible mental-state Dave might be in. Don’t force them to be thankful. Don’t play the
‘remember when’ game, “remember when I drove you to the ER in the middle of the night?
Remember when they told us you had cancer? Remember when I tried to be your donor?”
Because a lot of it he doesn’t remember.
• Take pictures along the way, but don’t show them until at least 6 months out. I showed Dave
pictures right away, and they didn’t resonate. I just showed him them the other night…and he
was floored! He really ‘got it’. He’s been looking at things differently lately: he’s calmer and
more loving.
• I wish I had kept a journal. The ups and downs of this journey were sometimes excruciating, and
Dave wasn’t ‘present’ to understand it. Hire cleaning help if needed. Get family and friends to
take the patient to lesser important appointments. Don’t let household things pile up on you. Fix
the gutter. Repair the screen. Hire a gardener for a few hours. Ask family to set things up for
you. It’s amazing how in two years without Dave to physically help around the house, things
started to go south pretty quickly! Luckily, I dug in and kept up.

Quite the journey for sure. I feel blessed to be on this side of health!”

– Karen

Hepatitis Delta (HDV)

Hepatitis Delta: Coinfection vs. Superinfection

By Sierra Pellechio, Hepatitis Delta Connect Coordinator

Hepatitis delta is an aggressive form of hepatitis that can only exist alongside hepatitis B. This means that all hepatitis B patients are at risk for hepatitis delta, but so are people who have not received the hepatitis B vaccination series.

If contracted, 70-90% of people with chronic hepatitis B will go on to also develop a chronic hepatitis delta infection – called a “superinfection”. Approximately 70% of these cases will progress to cirrhosis (liver scarring), compared to 15-30% of those infected only with the hepatitis B virus.

Due to the likelihood of liver complications, hepatitis B patients should be aware of potential exposures to hepatitis delta. The virus is spread the same way as hepatitis B, through direct blood-to-blood contact and unprotected sex with an infected person. It is important to be aware that blood contact could also occur by exposure to unsafe blood transfusions, unsterile medical or dental equipment, and the sharing of razors or toothbrushes with an infected person due to the possibility of infected blood entering the body.

People who are not infected with hepatitis B may be at risk for “coinfection”, when someone contracts hepatitis B and delta simultaneously during one exposure. In these cases, greater than 90% of adults will clear both infections and develop protective antibodies. While a co-infection generally resolves spontaneously after about 6 months, it can sometimes result in a life-threatening or fatal liver failure.

The good news is that the hepatitis B vaccine series can prevent both viruses in people who are not already infected. Once completed, the vaccine can provide a lifetime of protection!

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

Hepatitis B Diagnosis & Monitoring, Hepatitis B Treatment, Hepatitis Delta (HDV)

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.

Hepatitis B Diagnosis & Monitoring, Hepatitis Delta (HDV)

I Have Hepatitis B. Could I Also Be Infected with Hepatitis D?

By Sierra Pellechio, Hepatitis Delta Connect Coordinator

Hepatitis delta, or hepatitis D, is an aggressive form of hepatitis that can only infect someone who is also infected with hepatitis B.

People can become infected with hepatitis B and hepatitis D from the same exposure, or people who are already infected with hepatitis B can later be infected with hepatitis D. Coinfection can promote more rapid progression to cirrhosis and liver cancer than being infected with hepatitis B alone and will require an altered treatment and management plan. Being aware could save your life!

Hepatitis D can be spread similarly to hepatitis B, through exposure to blood or bodily fluids of an infected person. People with hepatitis B are likely to develop a chronic hepatitis delta coinfection if they are exposed to the virus, making it important for you and your doctor to be aware of the signs of a coinfection.

Cues to suspect a coinfection:

  • You have chronic hepatitis B but are not responding to antiviral treatment, or you have signs of liver damage even though your viral load is low (HBV DNA below 2,000 IU/mL)

Note: Fatty liver disease (caused by obesity) and liver damage from alcohol or environmental toxins should be ruled out as causes of liver damage before testing for hepatitis D.

It is also important for hepatitis B patients who originate from Sub-Saharan Africa, China, Russia, the Middle East, Mongolia, Romania, Georgia, Turkey, Pakistan and the Amazonian River Basin to be tested for hepatitis D, where it is more common. Most of the time, patients do not have any signs or symptoms to let them know they are coinfected, so a simple blood test is the only way to know for sure! Talk to your liver specialist about testing at your next appointment.

Hepatitis Delta Connect is a dedicated program of the Hepatitis B Foundation aimed to provide information and support for those affected by hepatitis D. Please visit our website, www.hepdconnect.org for more information and follow us on Facebook, Twitter and Instagram to stay up to date on the latest hepatitis D news! If you are a patient or provider and have questions or concerns, please email us at connect@hepdconnect.org.

Check out our previous posts about hepatitis D here, here, and here.

Hepatitis B Diagnosis & Monitoring, Hepatitis B Prevention, Living with Hepatitis B

Diagnosing Hepatitis D in the U.S.

Robert Gish, MD

David Hillyard, MD

By Sierra Pellechio, Hepatitis Delta Connect Coordinator

Hepatitis D, or hepatitis delta, is the most severe form of viral hepatitis known to humans. The hepatitis D virus infects the liver and is dependent on the hepatitis B virus to reproduce. This means that people who are already infected with hepatitis B are at risk of contracting hepatitis D as well.

Worldwide, more than 257 million people live with hepatitis B and of this number, an estimated 15-20 million are also infected with the hepatitis delta virus (HDV). While uncommon in the United States, HDV co-infection is more common in parts of the world such as China, Russia, Middle East, Mongolia, Romania, Georgia, Turkey, Pakistan, Africa, and the Amazonian river basin. For this reason, it is important to test hepatitis B patients who originate from these higher endemic areas for hepatitis D. Anyone with chronic hepatitis B who is not responding to antiviral treatment, or who has signs of liver damage even though they have a low viral load (HBV DNA below 2,000 IU/mL) should also be tested. Fatty liver disease (caused by obesity) and liver damage from alcohol or environmental toxins should be ruled out as causes of liver damage before testing for HDV.  Hepatitis D infections lead to more serious liver disease than hepatitis B infection alone. It is associated with faster progression to liver fibrosis, increased risk of liver cancer, and early decompensated cirrhosis and liver failure. This is why it is so important that people with hepatitis B and D coinfection are diagnosed before it can lead to severe complications.

Robert Gish, MD, Hepatitis B Foundation Medical Director, and David Hillyard, MD, Medical Director, Molecular Infectious Diseases, ARUP Laboratories, tackled the topic of diagnosing hepatitis D in a webinar in October. Dr. Gish also answered additional questions, which are featured below:

  • What is the first step in diagnosing an HDV patient?

The HDV antibody test (anti-HDV) is the first test that is run to see if a patient has been infected with hepatitis delta. Because this test will be positive even if a patient has cleared a hepatitis delta infection, it is followed up with an HDV RNA test, which determines an active infection. There is also an antibody test (anti-HDV igM) that can test for an acute active infection.

  • Are there tests available in the US that can detect the HDV genotypes or just genotype I?

Although there have been 8 genotypes of HDV identified, each with their own distinct progression outcomes, genotype testing in the US remains rare and often difficult to acquire.

  • What is the role of measuring HDV RNA in monitoring chronic HDV progression or response to treatment?

The most effective way to understand the progression of a hepatitis D infection is to use liver ultrasounds, elastrography and fibroscans. These tests can evaluate the health of the liver. Declining HDV RNA level usually indicates a positive response to treatment.

  • Is there value to testing patients for a disease for which there are not many treatments?

Because patients who are coinfected with B and D have twice the risk of cirrhosis and liver cancer compared to monoinfected patients, it is an important diagnosis to make. Although there is currently only 1 treatment, lives are still being saved.

  • Should primary care providers be testing high-risk patients for HBV and HDV at the same time?

No, providers should only test patients who already have hepatitis B. One in twenty people with hepatitis B are thought to also be infected with hepatitis D. Bottom line: testing for hepatitis D is a simple blood test that could change the course of treatment and save your patient’s life!

If you do find out that you have hepatitis D, it can be overwhelming and scary. However, knowing the basics can help you manage your diagnosis. Through the Hepatitis B Foundation’s Hep Delta Connect program, you can get information on how to protect your loved ones, find a physician, and seek out support.

For more information, please click here or visit our Hepatitis Delta Connect program website. Please also contact Sierra Pellechio, the Program Manager for Hepatitis Delta Connect program at sierra.pellechio@hepb.org for any questions.

Hepatitis B Diagnosis & Monitoring, Living with Hepatitis B

The Medical Community Wakes Up to a Dangerous Threat to People with Hepatitis B – Coinfection with Hepatitis D

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hep DBy Christine Kukka

In the U.S. and around the world, the medical community is finally acknowledging a hidden threat to people with hepatitis B – a virulent liver coinfection that requires the presence of the hepatitis B surface antigen (HBsAg) to survive.
Hepatitis D (Delta), which causes the most severe liver infection known to humans, infects between 15 to 20 million people worldwide and an estimated 20,000 people living with chronic hepatitis B in the U.S.
For years, health officials assumed hepatitis D did not threaten Americans and occurred primarily in Central Asia and Sub-Saharan Africa. However, recent U.S. Centers for Disease Control and Prevention (CDC) studies found 4 to 5 percent of Americans with chronic hepatitis B are also infected with hepatitis D.
As a result of these findings, researchers including Hepatitis B Foundation‘s Medical Director Dr. Robert Gish, are now pushing medical organizations to establish hepatitis D testing and monitoring guidelines so doctors will start testing patients for this dangerous liver disease.
Recently, the foundation sponsored a webinar, attended by dozens of healthcare providers, patients and officials from around the world, in which Dr. Gish outlined whom should be tested for hepatitis D, and how it should be treated. A new webinar that examines hepatitis D prevalence in the U.S. is scheduled for 3 p.m. (EST), Wednesday, June 28. To register for the webinar click here.
How do people get infected with hepatitis D? Infection occurs when people are exposed to blood and body fluids from someone with an active hepatitis D infection. Basically, they get both hepatitis B and D in one exposure. This is called an acute coinfection. Some healthy adults are able to clear both infections, but they often experience serious liver damage during the clearance or recovery phase.

Another way to become infected is if someone infected with chronic hepatitis B is exposed to someone with hepatitis D. This is called a superinfection, and in 90 percent of cases, people with chronic hepatitis B will also develop chronic hepatitis D.

Who is at risk of hepatitis D? Anyone with chronic hepatitis B who themselves or their family comes from Sub-Saharan Africa, China, Russia, Middle East, Mongolia, Romania, Georgia, Turkey, Pakistan and the Amazonian River Basin should be tested. Hepatitis D rates in some of these countries can reach up to 30 percent in people infected with chronic hepatitis B.

Banner CurveWhat medical conditions suggest hepatitis D? Anyone with chronic hepatitis B who is not responding to antiviral treatment, or who has signs of liver damage even though they have a low viral load (HBV DNA below 2,000 IU/mL) should be tested. Fatty liver disease (caused by obesity) and liver damage from alcohol or environmental toxins should be ruled out before testing for hepatitis D.
Often, people with hepatitis D have low viral loads (even if they are hepatitis B “e” antigen HBeAg-positive), but they have signs of liver damage, including elevated liver enzyme (ALT/SGPT) levels.

Do hepatitis B antivirals work against hepatitis D? No. The hepatitis D virus (HDV) is structurally different from the hepatitis B virus (HBV) and does not respond to tenofovir and entecavir used to treat hepatitis B. Hepatitis B antivirals will lower HBV DNA, but they don’t reduce HBsAg, which HDV need to thrive and reproduce.

How is hepatitis D treated? The only proven hepatitis D treatment is pegylated interferon. Interferon cures hepatitis D 15 to 25 percent of the time after one year of treatment. Once interferon clears hepatitis D, doctors treat patients who continue to be infected with HBV with antivirals. There are dozens of research companies now looking into hepatitis D treatment, and if researchers can find a cure for hepatitis B that eradicates HBsAg, it will also be effective against hepatitis D.

How should people with hepatitis D be monitored? According to Dr. Gish, doctors should:

  • Monitor patients’ ALT/SGPT and liver function at least every six months
  • Perform an ultrasound of the liver and conduct a liver cancer biomarker panel (including AFP, AFPL3% and DCP) every six months;
  • And, perform viral load (HBV DNA) and HDV RNA testing every six months.

How is hepatitis D prevented? The hepatitis B vaccine prevents hepatitis D infection, as does use of safe sex and safe injection practices. According to Dr. Gish, all hepatitis B-positive pregnant women should be tested for hepatitis D if they or their families are from a country with high rates of hepatitis D, or if they have signs of liver damage — even if they do not come from a region with high hepatitis D rates.

If a pregnant woman is infected with either hepatitis B and/or hepatitis D, immunizing her newborn with the first dose of the hepatitis B vaccine within 12 hours of birth and giving the baby a dose of HBIG (hepatitis B antibodies) will prevent both infections.

Bottom line, if you are infected with chronic hepatitis B, you should be tested for hepatitis D if:

  • You or your family comes from a region with high rates of hepatitis D; and/or
  • You have a low viral load, but you continue to have signs of liver damage, indicated by elevated ALT/SGPT or an ultrasound exam of your liver, if your doctor has ruled out fatty liver, NASH or alcohol-related liver damage.

Talk to your doctor about getting tested. Click here for a hepatitis D fact sheet to give to your doctor and click here for a patient-oriented fact sheet. An affordable hepatitis D test has recently become available in the U.S. For more information, click here.

  • Find answers to frequently-asked-questions about hepatitis D here.
  • To watch the webinar featuring Dr. Gish discussing the hidden, hepatitis D epidemic, click here.

Baruch S. Blumberg Institute