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Hepatitis B Advocacy

Advocate Nadine Shiroma Champions Civil Rights for All Affected by Hepatitis B

Nadine Shiroma and her grandchild.
Nadine Shiroma and her grandchild.

By Nadine Shiroma

I am a retiree and volunteer working to address hepatitis B discrimination, which involves a serious, relatively unknown chronic disease that impacts Asian-American and Pacific Islander American (AAPIA) immigrants and refugees who are often isolated by culture and language, which makes this discrimination especially egregious.

As a fifth-generation AAPIA, I’d heard of hepatitis B but was not aware that it leads to cirrhosis or liver cancer or that AAPIAs make up 50 percent of the country’s estimated 2 million hepatitis B cases, but represent less than 5 percent of the U.S. population.

These facts came into sharp focus in 2010, when a college senior was devastated to learn she would not be permitted to enroll in a healthcare program due to her chronic hepatitis B. Nothing in the school’s admissions policy or information published by the profession’s national admissions coordinating agency had prepared the student for this. When the student informed me that an older friend with hepatitis B was completing a similar healthcare program at a different institution, I advised her to challenge her school’s exclusion policy.

The issue raised many questions that called for research and consultation with hepatitis B specialists and community health and civil rights advocates to find out how and why schools were permitted to have such different hepatitis B policies. I also sought to compare various institutional policies with their respective state licensing laws for providers with hepatitis B. Fortunately, I was referred to an attorney who had an understanding of the disease who challenged the school’s exclusion policy. This led to the school’s implementation of a new, progressive policy for students with chronic hepatitis B.

Though gratified with the outcome for this student, I feared other students with hepatitis B would face similar discrimination, because too many medical school policies barring enrollment of students with hepatitis B were undisclosed. Future victims might not know how or where to access assistance or legal help. Given the World Health Organization’s map of global regions with high rates of hepatitis B and the current patterns of U.S. immigration, I believed hepatitis B discrimination would soon impact other immigrant/refugee communities.

My initial contact with the Hepatitis B Foundation in 2010 developed into a working relationship that won justice for five additional medical and dental students who contacted us between 2011 and 2013.

At the urging of the foundation and hepatitis B specialists,  the Centers for Disease Control and Prevention (CDC) revised and updated its 20-year old policy for infected healthcare workers; and the disability complaint I filed with the Department of Justice (DOJ) resulted in a Settlement Agreement for two students and a Technical Assistance Letter jointly issued by three federal agencies to inform healthcare schools of their responsibilities to accommodate individuals with hepatitis B and point out that failure to comply could also violate Title VI, which prohibits discrimination on the basis of race, ethnicity or national origin.

Hepatitis B civil rights advocacy is now focused on policies of all U.S. military services, including the Coast Guard, Public Health Service and the National Oceanic and Atmospheric Administration, which ban individuals with hepatitis B from joining.

Between 2013 and 2016, we advised nine active duty personnel and students who were not permitted to enlist for military service or scholarship programs or were discharged from active duty or a U.S. military academy due to hepatitis B. We continue to advocate for the Department of Defense to revise the policies that prohibit the people with chronic hepatitis B and establish reasonable, science-based accommodation policies for existing or future personnel who are diagnosed with chronic hepatitis B

Continuing hepatitis B education and civil rights challenges

Most immigrants and refugees do not understand the seriousness of the silent disease or the importance of hepatitis B screening. If diagnosed with hepatitis B, they often fear being treated as ‘pariahs’ in a society where they already feel like outsiders; or they worry that others in their family will be stigmatized or that hepatitis B will be used as an excuse to prevent immigrants from entering the U.S. Still others may be silenced by a code of silence within their professions.

Adding complexity to hepatitis B education and outreach are the diverse languages and cultures of the immigrant/refugee communities, along with the economic and social disparities experienced by so many families who start new lives in the U.S. living in relative isolation with limited English proficiency and few financial resources.

Lest we think hepatitis B discrimination is limited to Asian- and African-American and immigrant/refugee communities, new pockets of hepatitis B infection linked to the opioid epidemic have been reported in rural regions. Outbreaks of hepatitis B infection in majority white, non-immigrant, economically-depressed regions suggest that some of those infected may not have been immunized due to a lack of knowledge or healthcare access. These are social and economic disparities that mirror the disparities experienced by many immigrant/refugee families.

Like their healthier peers, teens and young adults with hepatitis B seek opportunities to fulfill their potential, earn a living wage and improve their lives. To this end, hepatitis B advocates are working to protect the rights of infected persons and ensure that our schools and institutions, and public and private employers administer reasonable, science-based chronic hepatitis B policies and accommodations.

Nadine Shiroma is a community civil and voting rights advocate and policy advisor to the Hepatitis B Foundation. She can be contacted at nadine.shiroma@gmail.com.

Diagnosed in March, 2009, with stage 4 metastatic non-Hodgkin’s lymphoma, Nadine spent the remainder of the year undergoing chemotherapy and recurrent hospitalizations. “That I lived and recovered is due to doctors at the City of Hope Cancer Research Center, my family and especially my husband and daughter,” she recalled. “Assisting the college senior in 2010 helped me discover a new normalcy. On that day in 2011, when a new, progressive chronic hepatitis B accommodation policy was published by the healthcare school that previously excluded students with hepatitis B, I told myself, ‘This is why I lived.’”

 

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

How to Find a Liver Specialist Who Really Knows Hepatitis B

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Image courtesy of stockimages at FreeDigitalPhotos.net
Image courtesy of stockimages at FreeDigitalPhotos.net

By Christine Kukka

If you have chronic hepatitis B or are newly-diagnosed, it’s important to see a liver specialist who has experience with hepatitis B.

Having a specialist with hepatitis B expertise on your team not only safeguards your health, it also lessens the stress of having a chronic liver disease. “My specialist gave me all the possible scenarios, but most importantly, he gave me my life back,” one hepatitis B patient recalled.

When first diagnosed, it’s often a primary health provider (PCP) or for children a pediatrician who gets the test results and calls to break the news. Doctors may run additional blood tests and/or immediately refer you to a liver specialist. They may recommend a specialist who accepts your insurance or practices in the same healthcare system, but you may have to do some research to find the best specialist to treat your hepatitis B.

There are two types of specialists who treat liver diseases:

  • A gastroenterologist is an internist who has trained in digestive disorders including the liver, but how much liver expertise a gastroenterologist (GI doctor) has varies based on their training. It’s important to find out if they specialize in liver diseases.
  • A hepatologist is a physician who specializes in the liver. This doctor has the most expertise and should be up-to-date about new treatments and clinical trials. But not all hepatologists have treated hepatitis B. Many will have treated hepatitis C, but not hepatitis B, so you need to ask.

Tips for finding a specialist:

  • Are they in the Hepatitis B Foundation directory? The foundation has a Physician Directory of liver specialists who treat hepatitis B around the world. These doctors have voluntarily signed up  for the database. It is not an exhaustive list, there may be hepatitis B specialists in your area who have not yet joined the directory.
  • Call the practice ahead of time and ask questions. How many hepatitis B patients have they treated? Do they participate in any clinical trials?  Are they aware of current monitoring and treatment guidelines for hepatitis B?
  • What’s the doctor’s reputation? Does anyone in your community see a liver specialist for viral hepatitis? Whom do they recommend?
  • Will you actually see the specialist or an assistant? Do you see a specialist only if there is a need for treatment? If you go to a teaching hospital, do you see the doctor or an intern, fellow or resident?

You are entering into a long-term relationship with someone who may care for you for many years. You need their expertise, but you also need to feel comfortable working with them. Do they listen when you speak and make eye contact? Trust and rapport are very critical.

“It’s really important that they don’t judge me,” one hepatitis B patient explained.  Another patient said that finding a doctor who spoke his language, or had an assistant who was fluent in his language, helped immensely.

Once you identify a specialist, here are some questions to ask:

  • Is the specialist accepting new patients? How long do you have to wait to get an appointment?
  • What hospital or lab do they use, and are they convenient for you? It’s important for you to always use the same lab so you have consistent results that allow apples-to-apples comparisons.
  • Will the doctor call you with the results or will a nurse or other assistant communicate with you?
  • What would you like your care plan to be? Will you go for blood tests and then see the specialist? Typically, hepatitis B patients get blood tests once or twice a year to monitor their liver, unless they are undergoing treatment.

How to design a long-distance care plan if the specialist is far away:  Sometimes, the best hepatitis B specialist is a few hours-drive from where you live, but distance doesn’t have to be a deal breaker. Many people see a specialist for a first visit, and afterwards simply have their PCPs or local labs email lab results to the specialist. For this remote healthcare relationship to work, your PCP needs to be willing to partner with the specialist. Also, your specialist needs to be open to telephone consultations with you as needed.

Technology matters. Sharing medical records and lab tests electronically make a remote relationship work smoothly. If there are firewalls between practices, find out how to ensure your PCP and specialist share your medical records. Be prepared, you may have to be the conduit if the two healthcare systems don’t talk to each other.

Insurance and cost: Ideally, the hepatitis B specialist closest to you accepts your insurance or is in your provider network. That doesn’t always happen so finding out the charges in advance is important.

  • Will the specialist bill your insurance or will you need to pay the fee upfront and manage the insurance reimbursement yourself?
  • How much do you have to pay out-of-pocket if the specialist is outside your network, or if you are not insured? Some specialists charge a lower fee to uninsured patients. You may be able to have an annual consultation with a specialist and bring your lab results.

One hepatitis B patient reported he was not entirely happy with the specialist his PCP referred him to. “At the time, I had great insurance so all the tests he ordered weren’t a lot of money out-of-pocket,” he said. “But then I changed jobs and I couldn’t afford all of his tests, and he wanted me to go on treatment though my lab reports didn’t justify it.

“I went looking for a new one and found one in the Hepatitis B Foundation’s website,” he said. “I had to drive farther to see him, but his knowledge and patience were very comforting and he spoke my primary language. He really helped me regain confidence in life. ”

Prepare for your visit: Before you see the specialist, put together a list of questions (see sample questions) and have your lab reports available — either bring hard copies or call ahead of time to make sure the doctor has access to your latest labs and medical records.

After you meet with your specialist, take some time to reflect. Are you happy with the doctor? Did he or she communicate well? Are you clear about what you need to do in the weeks and months ahead to take charge of your health? If the answer is yes, congratulations, you have assembled a good healthcare team.

Hepatitis B Prevention

A Valuable Tool Against Chronic Hepatitis B Goes Unused in Many Developing Countries

Image courtesy of tuelekza at FreeDigitalPhotos.net.
Image courtesy of tuelekza at FreeDigitalPhotos.net.

By Christine Kukka

A critical tool that stops the spread of nearly half of all new chronic hepatitis B infections is still unavailable in many developing countries – the hepatitis B vaccine birth dose.

When the hepatitis B vaccine is immediately administered to a baby born to a hepatitis B-infected mother, it stops the terrible spread of hepatitis B to a new generation.

But this vaccine remains unavailable and financially out-of-reach for many parents in rural areas of Africa, Asia and other regions.

“In Ghana, even if parents know where to find the vaccine, the cost sometimes deters them from accessing it,” said Theobald Owusu-Ansah of the Hepatitis B Foundation of Ghana.   “And when midwives help mothers deliver their babies in their homes, they do not have the vaccine with them because it must be refrigerated.”

While a global childhood immunization program, sponsored by the global vaccine alliance GAVI, has saved millions of lives, the hepatitis B birth dose remains a critical, missing piece of its otherwise successful global immunization strategy.

Image courtesy of africa at FreeDigitalPhotos.net.
Image courtesy of africa at FreeDigitalPhotos.net.

To effectively prevent mother-to-child (perinatal) transmission of hepatitis B, the single-dose hepatitis B vaccine must be administered within 12 to 24* hours of birth. In about 90 percent of cases, this vaccine effectively prevents infection, unless the mother’s viral load is extremely high.**

Today, GAVI funds and promotes the pentavalent vaccine, which prevents five diseases including hepatitis B, for nearly all children in developing countries. But here’s the catch, the earliest the first dose of the pentavalent vaccine can be administered is six weeks of age because it contains the diphtheria vaccine. This is far too late to prevent perinatal hepatitis B infection.

GAVI’s pentavalent vaccine makes economic and medical sense. One vaccine that prevents several diseases lowers manufacturing and shipping costs and requires fewer injections. Indeed, widespread immunization with GAVI’s pentavalent vaccine in 73 developing countries has prevented 7 million deaths, but it doesn’t prevent chronic hepatitis B acquired at birth.

The World Health Organization (WHO) has made eradication of hepatitis B by 2030 a major goal, but it is unattainable unless perinatal infection is prevented.

Without GAVI’s financing or promotion of the hepatitis B birth dose, many developing countries have done little to promote the birth dose, despite their high rates of hepatitis B. According to the WHO, in 2015, 8.4 million babies were born in African countries that did not provide the birth dose of the hepatitis B vaccine.

In addition to a lack of political will on the part of GAVI and these countries, there are other barriers to distributing the hepatitis B birth vaccine. As Owusu-Ansah explained, about one-third of births in his native Ghana  and about 45 percent of all births in Africa take place without a healthcare worker or midwife present.

Volunteers from the Rann India Foundation teach villagers about hepatitis B testing and prevention in India.
Volunteers from the Rann India Foundation teach villagers about hepatitis B testing and prevention in India.

Suren Surender, founder and president of the Rann Bhoomi Foundation, which educates rural villagers in India about hepatitis B prevention, added that even when healthcare workers are present at childbirths, “there is a lack of knowledge about birth dose administration and there is also a lack of community awareness about the benefits of getting the birth dose.”

Having a global leader like GAVI lend financial and strategic support for the hepatitis B birth vaccine would go far to chip away at these high perinatal infection rates in rural regions. In 2013, GAVI and the global vaccine alliance explored funding the hepatitis B birth dose as part of its Vaccine Investment Strategy (VIS),  but officials decided not to fund it.

According to a GAVI spokeswoman, the key deterrent was implementation — getting the refrigerated vaccine birth dose to rural areas within hours of a child’s birth – rather than cost.

“Many births in GAVI-supported countries do occur outside health facilities,” she noted. “Indeed, coverage of hepatitis B birth dose in many countries delivering this intervention is low. Ultimately, the Vaccine Investment Strategy analysis and consultations recommended that (GAVI) should focus its limited resources on other high-impact vaccines at the time.”

However, research suggests the hepatitis B vaccine may be effective for several days or weeks in warm climates without refrigeration, which could increase their use in rural regions if there was more financial and political support.

In 2018, GAVI will reconsider potential support for the hepatitis B birth dose when it develops a new Vaccine Investment Strategy, with a decision expected in late 2018.

GAVI’s support for the birth vaccine is needed immediately. Only GAVI has the resources and political clout to help countries realign their immunization policies to allow the next generation of children born to hepatitis B-infected parents to live without liver disease.

*North American medical guidelines recommend the first hepatitis B vaccine dose be administered within 12 hours of birth, while WHO recommends the vaccine be given within 24 hours of birth.

**The addition of a dose of HBIG (hepatitis B antibodies) along with the vaccine raises the prevention rate a few percentage points. However, the vaccine alone is highly effective.

Hepatitis B Advocacy, Hepatitis B Prevention, Hepatitis B Treatment

Kate Moraras: Making Sure Federal Policies Work to Eliminate Hepatitis B Locally

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Kate Moraras, Hepatitis B Foundation senior program director and Hep B United director.
Kate Moraras, Hepatitis B Foundation senior program director and Hep B United director.

By Christine Kukka

It’s Kate Moraras’ job to make sure federal programs crafted in the elite halls and federal agencies of Capitol Hill are what’s really needed to eliminate hepatitis B in Asian-American, African and other at-risk communities across the country.

Simply put, her goal is to eradicate, “the most staggering health disparity facing immigrant communities.”

The people on whose behalf Moraras works are among the most vulnerable and powerless in the country. They include Asian-American and Pacific Islander (AAPI) and African immigrants who were infected at birth or by contaminated syringes or medical tools in their countries of origin.

As senior program director at the Hepatitis B Foundation and director of the Hep B United national coalition for the past three years, Moraras has worked with federal officials and dozens of hepatitis community advocates across the country to align federal policy with the need of diverse, hard-to-reach communities.

“I have always been drawn to systems-level change and I saw public health policy as a key area where there are opportunities to make an impact,” she explained. She was energized by the prospect of finding solutions that would improve healthcare at the individual and community level, and she obtained her master in public health at George Washington University.

After graduation, Moraras learned about hepatitis B when she was working on AAPI health disparities in the federal government. “Then, my uncle found out he had chronic hepatitis B when he tried to donate blood,” she recalled. Suddenly, what had been a matter of political injustice became a personal cause and she began working at the foundation.

Moraras knows federal policies don’t succeed unless they make a difference on the streets of America. “Grassroots and culturally-focused organizations are pivotal to eradicating hepatitis B because they know their communities and how they are at risk of hepatitis B,” she explained.

Preventing and treating hepatitis B in immigrant communities requires cultural nuance. Each community has its own language, cultural practices and healthcare beliefs. Many lack insurance coverage and when they finally reach a clinic or doctor’s office, the cultural disconnect creates an insurmountable barrier to learning about this complex disease.

This is why having local organizations whose staff know the culture, speak the language and can bridge the glaring healthcare gap that now stops people from getting vaccinated and treated for hepatitis B is key. “Their communities trust them, which is so critical when it comes to navigating healthcare and communicating accurate information about hepatitis B, a disease that is stigmatized in many AAPI communities. If we want to eradicate hepatitis B in the U.S., we must partner with local organizations and make sure they have adequate resources to do the job.”

Hep B United and the foundation are working to make sure federal policy helps, rather than hinders, these vital, local initiatives.

“Fortunately, we have had champions within the federal government who have taken the opportunity to lead national efforts to address hepatitis B — for example, former Assistant Secretary for Health Dr. Howard Koh who led the development of the National Viral Hepatitis Action Plan and a White House Initiative tasked with specifically focusing on AAPI communities, with a cross-cutting voice and broad reach,” she said.

“CDC now has a multilingual communications campaign, the Know Hepatitis B campaign, to encourage hepatitis B testing among AAPI communities with educational materials in a variety of Asian languages,” she added. At state and local levels, there have been city councilors and state legislators who have become champions who advocate for funding for effective community programs to increase public awareness.

“What remains challenging is the disconnect between local groups providing direct services to people and federal agencies that are working to make and implement policy at the 30,000-foot level,” she said. “For example, we still do not have a national surveillance system to monitor chronic hepatitis B cases and trends and there remains an overall lack of awareness and attention to hepatitis B at the national level. We must all continue to ask for real investment by the federal government to combat hepatitis B.

“We need to build a national hepatitis B grassroots movement, which is something that I would like to see happen through my job and Hep B United in the years ahead,” she added. “We have built a strong coalition that continues to expand every year, we have powerful advocates from local communities who have taken on leadership roles in national hepatitis advocacy and I would like to see our movement continue to grow and translate to the millions of individuals we have the potential to reach.”

Hep B United is a national coalition to address and eliminate hepatitis B, a serious liver infection that is the leading cause of liver cancer.  An estimated 2 million people in the United States are chronically infected with the hepatitis B virus.  Hep B United aims to meet this public health challenge by increasing hepatitis B awareness, testing, vaccination and treatment.

Hepatitis B Treatment

Global Researchers Brainstorm Solutions in the Search for a Cure for Hepatitis B

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Timothy Block, cofounder and president of the Hepatitis B Foundation and the Baruch Blumberg Institute, discussed reducing hepatitis B surface antigen production as a strategy to stop chronic hepatitis B infection at the workshop.
Timothy Block, cofounder and president of the Hepatitis B Foundation and the Baruch Blumberg Institute, discussed reducing hepatitis B surface antigen production as a strategy to stop chronic hepatitis B infection at the workshop.

By Christine Kukka

Liver specialists, virologists and immunologists from around the world met at the 3rd International Workshop on a Hepatitis B Cure in Toronto last week to share their advances and brainstorm solutions to the challenges they face as they hunt for a cure for the liver infection that affects 240 million worldwide.
Eradicating hepatitis B virus (HBV) infection is no easy task. HBV is a far more complicated and resilient virus than hepatitis C, and scientists predict a cure will require a careful orchestration of drugs and immune-enhancing treatments that could:
  • Eliminate HBV antigens—especially the hepatitis B surface antigen (HBsAg). This viral protein appears able to “exhaust” or disable the immune system’s T cells so they’re unable to effectively fight the infection.
  • Find a vulnerability in the HBV replication cycle that can be exploited to keep the virus from entering liver cells and inserting its genetic material (cccDNA) required for viral reproduction.
  • Enhance or “wake up” the exhausted T cells, after HBsAg is reduced or eliminated, so the immune system can successfully eradicate the HBV-infected liver cells.

As researchers learn more about why HBV is so successful at evading the immune system and hijacking liver cells for viral production, they are also realizing how much they don’t know and what tools they lack to identify if and when they find successful treatment strategies. Here are some of the challenges the researchers addressed during the day-long brainstorming session.

Panelists (left to right) Jordan Feld of the Toronto Western Hospital Liver Center, Stephen Urban, head of Translational Virology at Heidelberg University Hospital, Harry Janssen, head of the Toronto Centre for Liver Disease, and Marion Peters, chief of hepatology research at the University of California at San Francisco, were among the speakers at the 3rd International Workshop on Hepatitis B Cure.
Panelists (left to right) Jordan Feld of the Toronto Western Hospital Liver Center, Stephen Urban, head of Translational Virology at Heidelberg University Hospital, Harry Janssen, head of the Toronto Centre for Liver Disease, and Marion Peters, chief of hepatology research at the University of California at San Francisco, were among the speakers at the 3rd International Workshop on Hepatitis B Cure.

What will a cure look like? Can scientists ever expect to totally eradicate HBV from the liver? Even when healthy adults are able to clear HBV following an acute infection, small reservoirs of the virus remain – similar to chicken pox that causes shingles later in life when the immune system can no longer hold it in check. Should researchers instead set their sights on a cure that duplicates what Mother Nature now achieves following an acute infection, which simply eradicates most of the virus and greatly reduces the risk of liver damage.

Do researchers currently have the right tools to identify when a treatment works? Nearly all hepatitis B lab tests used today evolved from blood bank tests designed to identify HBV-infected donated blood. As a result, lab tests produce a “positive” or “negative” measurements for the presence of antigens and antibodies, but nothing more nuanced. Labs measure the amount of HBV DNA (viral load) in a patient, but rarely measure HBsAg even though patients can have an undetectable viral load and still have lots of HBsAg circulating in their bodies.
But figuring out when a treatment is able to reduce HBsAg or other antigens may be critical to a cure. Several research initiatives are working to reduce HBsAg, which is produced in great quantities and is believed to prevent the immune system from actively attacking the infection. But right now, most lab tests in the U.S. don’t measure how much HBsAg a patient has in their bloodstream.
“We don’t have great assays (lab tests) for measuring treatment responses (to current or new drugs),” said workshop panelist Jordan Feld, a clinical scientists and researcher from the Toronto Western Hospital Liver Center.
“Maybe we don’t have the right endpoints to measure how effective treatment is,” said Marion Peters, chief of hepatology research at the University of California at San Francisco. “A treatment might be having an effect, but we don’t know what to measure so we don’t know it.”
A lost research opportunity with TAF clinical trials? On Nov. 10, the U.S. Food and Drug Administration (FDA) approved TAF, a new, lower-dose formulation of tenofovir that channels the antiviral more effectively to infected liver cells while reducing the drug’s impact on kidney function and bone loss. Because TAF’s clinical trials focused primarily on comparing the reformulated drug’s impact on viral load, ALT (liver health) and side effects, researchers did not conduct liver biopsies on TAF clinical trial participants.
While lower-dose TAF was found to work as well as tenofovir in slowing viral replication, it did something that researchers didn’t expect. During one clinical trial, 50 percent of patients treated with TAF achieved normal ALT levels–indicating no liver damage– compared to only 32 percent of patients treated with tenofovir.
Why was TAF so effective on liver cells? Was it able to remove some of the cccDNA or prevent HBV from replicating in liver cells in a way that tenofovir could not? “There seems to be a correlation, but because they didn’t have that possible endpoint in mind, they didn’t think to perform liver biopsies, which would have answered some of those questions,” Dr. Peters commented.
“We need to go beyond commercially-available tests so we can see with better sensitivity whether TAF or another drug would actually be more efficient and see what the effect is within the liver,” observed Fabien Zoulim, MD, PhD, associate director of the Liver Department at the Hôtel Dieu hospital in Lyon (France) and scientific director of the INSERM Unit 871.
How to eliminate HBV-infected liver cells without damaging the liver: In chronic hepatitis B, a large percentage of liver cells are infected. Some treatments in development, such as those using small interfering RNAs technology, target HBV antigens including HBsAg and quickly reduce their numbers. Using a combination treatment of antivirals to reduce viral load and RNAii technology to eradicate HBsAg, the immune system can swing into action and attack the infected liver cells. But how do you pace this “attack” so the liver is not severely damaged and the patient’s health threatened?
If only a small percentage of infected liver cells are killed during treatment, others will survive and continue to churn out virus. Kill too few infected liver cells and continual re-treatment is required. Kill too many liver cells and a patient could die from liver failure.
Flares are inevitable when the immune system is attacking infected liver cells – such as during an acute hepatitis B infection — but can this clearance be controlled without harming the patient?
The day before the workshop, the FDA ordered Arrowhead Pharmaceuticals to stop its Phase II human trials of its ARC 520 drug that uses RNAii to eradicate HBsAg after reports of deaths in animals that had been given high doses of the drug. The doses were much higher than were administered to humans in the Phase II clinical trial, which was evaluating the reduction of HBsAg after intravenous administration of ARC-520 in combination with entecavir or tenofovir. Panelists noted that this potential cure may still have promise, but the treatment dose must be examined and monitored carefully.
Takeaway:
The workshop presentations highlighted the inevitable setbacks and advances that scientists make in the search for a cure. But optimism remained. Never have so many researchers been working from so many directions to find the synergistic solution that will one day reduce HBsAg, stop HBV from reproducing and spur T cells to attack infected liver cells.
One panelist suggested in the next five years, researchers should be able to develop ways to reduce viral load while enhancing the immune system’s T cell response to eradicate a hepatitis B infection. Around the world, 240 million people living with hepatitis B are waiting anxiously.
 
The Hepatitis B Foundation was a partner of the workshop. For more information about the workshop and researchers’ presentations, please click here.

Hepatitis B Advocacy, Hepatitis B Treatment

Hepatitis B Foundation Expert Timothy Block Predicts Transformational New Therapies for Hepatitis B

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Hepatitis B Foundation President Timothy Block
Hepatitis B Foundation President Timothy Block

By Christine Kukka

For more than 25 years, Timothy Block, Ph.D,, has worked tirelessly to find a cure for hepatitis B, promoting research, writing papers, mentoring students and collaborating with experts around the world to find a cure for the 240 million people living with this deadly liver disease.

Today, the cofounder and president of the Hepatitis B Foundation, the Baruch S. Blumberg Institute and the Pennsylvania Biotechnology Center, is optimistic and believes there are new therapies in sight for those living with chronic hepatitis B.

An unprecedented number of researchers are scrutinizing every stage of the hepatitis B virus (HBV) replication cycle to find its vulnerabilities and develop drugs to permanently disable it. The cure Block wants would completely eradicate the infection so no one would ever wake up worrying about the risk of liver damage or cancer to themselves or a loved one.

This global, active march towards a cure is in stark contrast to 1991 when Block began his solitary quest, after a friend’s devastating hepatitis B infection made him rethink his career and start focusing on the liver disease that infects more than one in three people worldwide.

Twenty-five years ago, the only available treatment was conventional interferon, which was largely ineffective. The first antiviral, lamivudine, appeared shortly thereafter. It would be one of several to emerge from HIV’s drug arsenal. Since then, more antivirals designed to disrupt HBV’s replication process have been developed that target the polymerase—the essential enzyme needed for HBV replication.

“But they are not cures,” Block explained during a recent webinar. “They’re good at reducing viral load (HBV DNA), but they don’t get rid of the virus, and considerable viral DNA and  hepatitis B surface antigen (HBsAg) remain in liver cells.” Nor do current antivirals get rid of the HBV chromosome called cccDNA that embed in liver cells and stubbornly remain, ready to churn out more virus if a person stops taking antiviral drugs, or if their immune system weakens due to advancing age or another illness.

There are other roadblocks that make hepatitis B far harder to cure than hepatitis C. HBV generates massive amounts of HBsAg that appear to overwhelm the immune system’s B cells, whose job is to produce antibodies to eradicate HBV’s antigens. When newborns or young children are infected, these B-cells become paralyzed or “exhausted” by the flood of HBsAg engulfing them and they don’t generate the antibodies needed to fight infection. In contrast, when healthy adults are infected, these B-cells act quickly and aggressively to eradicate HBsAg within six months.

“Now for the first time, we’re looking beyond the polymerase to find more targets that are essential for HBV replication,” Block explained. HIV researchers have already done this and have identified more than 30 different “targets” in the HIV replication process. Hepatitis B researchers are also expanding their target range.

There are now new drugs in development, some have even reached Phase II clinical trials, that target new HBV reproductive terrain. They employ a variety of strategies ranging from immune system enhancers to molecular weapons designed to halt cccDNA integration into liver cells.

“If you can suppress cccDNA, the game would be over,” Block said, “but cccDNA is small, tough target. It’s so small compared to other material, that it’s almost impossible to distinguish from other molecules.” However, biologicals that are able to “inhibit” or block cccDNA from entering a liver cell could stop the virus from hijacking and reproducing in liver cells. Here are some types of drug strategies currently in development that could lead to a cure:

Restructured versions of tenofovir: There are two new tenofovir “prodrug” compounds, called TAF and CMX 157, that are more effective at reaching liver cells and impeding HBV replication. TAF is now in Phase III clinical trials and is expected to reach the U.S. Food and Drug Administration (FDA) this month (November 2016).

Molecular agents that target and disable HBV replication:

  • A new agent, called the CRISPR/Cas9 system, may be able to operate on a molecular level to search out and destroy HBV cccDNA molecules.
  • One of the more advanced molecular strategies, already in Phase II trials, is a “silencing” RNA process. This approach uses RNAi gene silencers to target and destroy HBV RNA to prevent viral reproduction. “CccDNA remains,” Block explained, “but all of its gene products it needs are choked.”

Entry inhibitors: Some of these drugs resemble HBsAg, but they work as decoys to prevent the virus from entering or binding to the liver cell. One is in Phase II clinical trial.

Capsid inhibitors: This approach interferes with the viral DNA’s ability to connect or glue together during the replication process. Several of these drugs are in Phase II clinical trials.

HBsAg inhibition and eradication: “There are 1 million more HBsAg as the actual virus,” Block observed. “Why are there so many? What is it doing in the blood? Why is it able to exhaust our B-cells?” Because HBsAg appears to hold a key in stopping infection, researchers are working to develop a way to eradicate HBsAg. Two of these HBsAg eradicator products are in Phase II trials.

Adaptive and innate host defense: This approach involves a two-step strategy, first reducing viral load to undetectable levels by helping liver cells become “in-hospitable” hosts to HBV’s reproductive efforts, and then introducing a vaccine or some other immune enhancer that can break the B-cell exhaustion cycle while firing up immune cells to aggressively fight and eradicate the infection. There are several of these drugs in Phase I and II clinical trials.

Block told his webinar audience that ideally one of these drugs would emerge as a single, simple cure. “But every infectious disease today, such as hepatitis C and HIV, is almost always treated with a combination of drugs. We might see two direct-acting antivirals and maybe a third drug that work as an immune system activator.”

When asked which patients would get first access to a new cure, Block predicted that people with high viral loads and liver damage would be treated first based on medical need. “As drugs get safer, I hope we will  treat people in the immune tolerant phase (with high viral load but no signs of liver damage yet), before they begin to have signs of liver damage.”

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Hepatitis B Advocacy, Hepatitis B Diagnosis & Monitoring

Why Raised Voices, Phone Calls and Letter Writing Are Critical to Eradicate Hepatitis B

2013-05-17_HepbUnitedEventBy Christine Kukka

Getting the medical care we need requires advocacy, because in the U.S. the quality of our healthcare–and even how long we live–depends on our income, ethnicity, gender and where we live. That is especially true when we live with hepatitis B.

Many affected by hepatitis B are not endowed with money, privilege or political power. Most of us are immigrants and people of African and Asian descent. This infection illuminates our country’s racial divides in healthcare. Asian-Americans, for example, have liver cancer rates 13-times higher than white Americans because they were never tested for hepatitis B, diagnosed or treated until it was too late.

Many of us are gay or injecting drug users. We are often uninsured or under-insured, which leaves us unable to pay for testing or treatment.

Our doctors, who often work in healthcare systems focused more on the bottom line than patient care, see too many patients in too little time. They may not know to screen us for hepatitis B, or monitor us properly and refer us for treatment when the infection damages our livers.

Despite good intentions, we live with a broken healthcare system and like any political system it requires the actions of patients, voters and advocacy organizations to improve.

Participants Perform a B A Hero Chant
Participants Perform a B A Hero Chant

The Hepatitis B Foundation and national coalitions including Hep B United are working within the political system to make healthcare more equitable and accountable.  They’re fighting to get more funding so the U.S. Centers for Disease Control and Prevention and the National Institute of Health have more resources to eradicate hepatitis B. Recently, these advocates scored a victory. Continue reading "Why Raised Voices, Phone Calls and Letter Writing Are Critical to Eradicate Hepatitis B" →

Hepatitis B Advocacy, Hepatitis B Prevention, Living with Hepatitis B

Hepatitis B Foundation: Answering Questions and Dispelling Fears One Call or Email at a Time

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Maureen Kamischke, Hepatitis B Foundation's social media and outreach manager.
Maureen Kamischke, Hepatitis B Foundation’s social media and outreach manager.

Hepatitis B is a complex infection, it can impact our health, lifestyle choices and threaten relationships. Sometimes, we need to ask for help.

One of the most personal and valuable services the Hepatitis B Foundation provides is answering individuals’ emails and phone calls about hepatitis B. These queries, which can come from all over the world, often involve discrimination, disclosure and how to interpret lab tests that baffle inexperienced doctors and nurses.

One of the people at the foundation who answers these emails and calls is Maureen Kamischke, the foundation’s social media and outreach manager. Kamischke, whose daughter had hepatitis B, knows first-hand the difficulty of finding healthcare providers with expertise in hepatitis B treatment. She has grappled with decisions about disclosing her child’s infection at school and to friends. Today, she continues to advise her daughter (now an adult) about her liver health, and she also answers the dozens of emails and calls that reach the foundation each week.

Maureen Kamischke's daughter Maren.
Maureen Kamischke’s daughter Maren.

Today, guided by decades of personal and professional hepatitis B experience, Kamischke helps others navigate the challenging world of hepatitis B. “My goals are to disseminate accurate information, provide hope and information that will empower people living with hepatitis B to make simple lifestyle changes that will help them feel like they have some control over their lives,” she explained. “I understand that the disease will shape them, but I want them to understand it should not define or limit them. “ Continue reading "Hepatitis B Foundation: Answering Questions and Dispelling Fears One Call or Email at a Time" →

Hepatitis B Treatment, Liver Cancer, Living with Hepatitis B

Do You Forget Your Daily Hepatitis B Antiviral? Why We “Forget” Our Meds, and How to Improve Compliance

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Image courtesy of foto76 at FreeDigitalPhotos.net
Image courtesy of foto76 at FreeDigitalPhotos.net

By Christine Kukka

Your daily antiviral pill can save your life when you have liver damage from chronic hepatitis B. Entecavir or tenofovir (Viread) quickly reduce the amount of virus in your liver and the damage it causes.

All you have to do is take it. Every day. But 20 to 30 percent of prescriptions are never filled, and about 50 to 70 percent of us don’t take our medications as prescribed. When we stop taking our daily antiviral, hepatitis B can reactivate and threaten our health.

In one study, researchers provided 100 hepatitis B patients with an entecavir pill dispenser that monitored whether or not they took their daily pill over a 16-week period. They found about 70 percent of patients took their antiviral pill as prescribed more than 80 percent of the time — which means these patients were “medication compliant.”

Those who missed taking their antivirals more than 20 percent of the time–and were “noncompliant”–tended to be younger and had indifferent attitudes about whether or not the antiviral was really needed or would work.

Image courtesy of Carlos Porto at FreeDigitalPhotos.net
Image courtesy of Carlos Porto at FreeDigitalPhotos.net

According to experts, whether we are “medication compliant” or not depends on how much trust we have in our doctors. If we like our healthcare provider and feel comfortable asking questions, we’re much more likely to take our medication on time. And, if our friends and family support and encourage us, we’re even more inclined to take our medication as prescribed.

“The trust I have in my doctor is a big factor,” said a member of the Hepatitis B Support List. “It is important to find a doctor who understands hepatitis B and is willing to work with me in terms of explaining what the options are and what the best approach is in managing my condition.”

“I know antivirals won’t cure me,” another email list member wrote, “but I’m committed to staying healthy and productive as long as God permits.” Continue reading "Do You Forget Your Daily Hepatitis B Antiviral? Why We “Forget” Our Meds, and How to Improve Compliance" →

Baruch S. Blumberg Institute