Hep B Blog

Tag Archives: Hep B Awareness

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HBF and HBUP’s Hepatitis B Awareness Raising Event at the Philadelphia Art Museum

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What a great hepatitis B awareness raising event for the Hepatitis B Foundation (HBF) and Hep B United Philadelphia (HBUP). The event took place at on the “Rocky Steps” of the Philadelphia Art Museum.  Participants including student volunteers, community leaders and health care professionals were dressed in their super hero t-shirts and red capes for their run up the steps to raise HBV awareness.

 

 

 

 

 

 

 

 

 

 

 

Hep B Heroes joined Philadelphia Councilman David Oh as he presented a city council resolution to eliminate Hepatitis B in the City of Philadelphia.

 

A special guest appearance was made by HBF’s own mascot, O’Liver B Hepatitis. In the past, O’Liver has appeared at numerous public events, and he was thrilled to step up and raise HBV awareness on the Rocky Steps.

 

 

 

 

 

Multicultural dancers get a thumbs up from O’Liver as he and other participants enjoy their performance on the steps.

 

 

 

 

 

 

 

B A Hero. B sure. Get Tested. Get vaccinated…

 

 

 

 

 

Hepatitis B Prevention

Celebrate Mother’s Day by Breaking the Cycle of Hepatitis B Transmission From Mother to Baby

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Great blog written by Corinna Dan, RN, MPH, Viral Hepatitis Policy Advisor, Office of HIV/AIDS and Infectious Disease Policy, HHS , discussing the strategy to eliminate perinatal transmission of hepatitis B in the U.S. In many parts of the world, transmission from an HBV infected mother to her baby is the most common mode of transmission.  If you are a pregnant woman, please ask your doctor to screen you for hepatitis B. If you learn you have hepatitis B, talk to your doctor to be sure your baby receives appropriate prophylaxis within 12 hours of birth so you can break the cycle of transmission from mother to baby. Happy Mothers Day! 

Eliminating Perinatal Transmission of Hepatitis B: More Than Just a Test 

Hepatitis B in the U.S.

Nationally, new hepatitis B infections have been reduced by 82% since 1991 because of the availability of safe and effective vaccines, as well as improved prevention in healthcare settings. The Centers for Disease Control and Prevention (CDC) estimates that 1.4 million Americans are living with chronic hepatitis B infection. Unfortunately, many of these people became infected before the widespread availability of the hepatitis B vaccine in the early 1980s. Most are unaware of their infection, which places them at greater risk for severe complications of the disease, and for transmitting the virus to others. For women of childbearing age, this lack of awareness also increases the likelihood of transmitting hepatitis B to their infants.

Perinatal hepatitis B – spread from an infected mother to her infant at the time of birth – is estimated to account for 800-1,000 new infections each year in the United States. Unfortunately, this number of annual new, preventable infections has remained unchanged in recent years, which is why the elimination of mother-to-infant transmission of hepatitis B is one of the main goals of the Action Plan for the Prevention, Care & Treatment of Viral Hepatitis. As the Plan observes, the persistent annual number of perinatal hepatitis B cases is particularly concerning because approximately 90% of HBV-infected newborns develop chronic infection; up to 25% of these children will die of cirrhosis, liver failure, or liver cancer later in life.

Tackling Perinatal Hepatitis B

To achieve the goal of eliminating perinatal HBV, the Action Plan calls for the provision of postexposure prophylaxis (i.e., hepatitis B immune globulin and hepatitis B vaccine) to all infants born to HBV-infected women, a strategy consistent with the recommendations of the Advisory Committee on Immunization Practices (ACIP) in its “Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States.” This recommended treatment is to be provided within 12 hours of birth followed by timely completion of the rest of the three-dose hepatitis B vaccine series, to prevent the infant from contracting hepatitis B. The Action Plan and ACIP also observe that care coordination is needed to ensure that infants born to HBV-infected women receive the services needed to protect them against hepatitis B.

A vital partner in these efforts to eliminate mother-to-infant transmission of hepatitis B is CDC’s Perinatal Hepatitis B Prevention Program (PHBPP) which supports activities in all 50 states, six cities, and five territories. The PHBPP was established in collaboration with state/local health departments and healthcare providers to promote use of the available tools – prenatal testing and vaccines – to reduce perinatal HBV transmission. The program works to identify pregnant women who are infected and provides case management services to ensure that infants receive the appropriate vaccines after birth to help prevent perinatal transmission. This program has been successful, ensuring that 95% of the identified infants born to infected mothers and case managed by the program received hepatitis B immune globulin and the first dose of hepatitis B vaccine within one day of birth and 83% of these infants complete the hepatitis B series by 12 months of age. In addition, whenever possible, the mother is counseled about hepatitis B and encouraged to talk with her healthcare provider for a full HBV evaluation. The program also seeks to identify household and sexual contacts of women who test HBV-positive – CDC reports that in 2011 the programs identified 9,681 such contacts – providing prevention information and recommending screening.

Despite these successful outcomes, challenges remain; the PHBPP estimates it identifies and case manages only about half of the expected births to hepatitis B infected women annually. Although hepatitis B screening is recommended for all pregnant women as part of routine prenatal care, not all women are screened. Some women do not seek or remain in prenatal care. In other cases, even when HBV screening occurs, health departments are not informed of screening results that reveal a pregnant woman is infected with hepatitis B – in some cases this is because such reporting is not required in that jurisdiction, in other cases it is an error or oversight. Under these circumstances, the health department cannot connect the expectant mother and her family to the services available through the PHBPP.

Another key support to efforts to eliminate perinatal HBV transmission is the implementation of provisions of the Affordable Care Act that will help improve prenatal hepatitis B screening. Under the Affordable Care Act, the hepatitis B test for pregnant women is among the Preventive Services that new health insurance plans issued after September 23, 2010 are required to cover without the consumer having to pay a copayment or co-insurance or meet her deductible. By making hepatitis screening more widely accessible and eliminating cost barriers, the healthcare law will also help bring us closer to the Action Plan’s goal of eliminating perinatal transmission of HBV.

In order to further reduce the number of infants who are perinatally infected with hepatitis B, healthcare providers, practices, and hospitals that care for pregnant women need to increase awareness and efforts to accurately report hepatitis B-infected pregnant women and refer the families to the PHBPP.

What Can Healthcare Providers Do?

Healthcare providers play a key role in eliminating perinatal hepatitis B. Steps that healthcare providers can take include:

  • Ensure that your practice is collaborating with the public health department to report women who are chronically infected so that their infants can benefit from case management. The CDC viral hepatitis reporting form [PDF 46KB] is available online.
  • Educate your patients about hepatitis B and listen to their concerns; the CDC has great educational materials available for patients.
  • Work with your local hospitals and birthing centers to ensure that they are following recommended policies and procedures.
  • Reach out to your state/local Perinatal Hepatitis B Coordinator if you have any questions or need additional assistance to implement the CDC recommendations.

What Can Pregnant Women Do?

  • Ask your healthcare provider if you were tested for hepatitis B and what the result of the test was.
  • Learn more about hepatitis B to make sure your new infant receives the preventive services needed to prevent hepatitis B infection at birth and throughout your child’s life.
  • If you learn that you are living with hepatitis B, check out the CDC’s frequently asked questions and talk with your healthcare provider to find out what you should do to stay healthy and ensure that you will be there to nurture and watch your child grow.

On this Mother’s Day during Hepatitis Awareness Month, please take the opportunity to learn more about hepatitis B and what steps you can take to realize the goal of eliminating mother-to-infant transmission of this preventable disease.

Please link to the original article if you would like to listen to this blog in it’s entirety.

 

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Hepatitis B Awareness Month at HBF

Daniel Chen - "Hep B Hero", HBF Public Health Program Manager, today's guest blogger

“B a hero!” is not simply a slightly-cheesy-yet-very-awesome campaign theme and slogan. It is a statement that we stand behind and strive for. It is about having the courage to stand up for the disenfranchised among us. It is about taking the time and effort to improve the lives of those we could have easily ignored. It is about not just doing the right thing, but going above and beyond.

Over 900 people. That’s the number of people we provided free hepatitis B screening tests for within just the past 12 months. The screening tests were offered at 17 different events that took place all around the city.

Over 70 organizations. That’s the number of partners we currently work with to serve the community and empower the underserved. Besides hosting screening events, our partners also help us raise awareness through education, provide in-language patient follow up service for linkage to care, connect us with new partners, and many more aspects of our work in the community.

Over 30 vaccine clinics. That’s the number of vaccine clinics we will have held in collaboration with the Philadelphia Department of Public Health at community sites by the end of 2013. By hosting the clinics at community sites, we remove the transportation and language barriers and make vaccines much more accessible for community members.

The list of accomplishments goes on. And all of this became possible because Philadelphia, as a city, has decided to “B a hero”. So get involved this May and help us celebrate the Hepatitis Awareness Month by coming out to one of our events. Come and support heroes everywhere in our fight against hepatitis B.

Friday, May 17

Hepatitis B Awareness & Media Event

11:30am-12:15pm @ Rocky Steps (Philadelphia Museum of Art, 2600 Benjamin Franklin Pkwy)

Join us in celebration of Hepatitis Awareness Month and Asian Pacific American Heritage Month by running up the Rocky Steps with us! All participants get a “B a hero” t-shirt and a cape. City Councilman David Oh will present a city council resolution, and a surprise performance will take place when we reach the middle level of the steps.

Saturday, June 1

Independence Dragon Boat Regatta

8am-5pm @ Schuylkill River (Kelly Drive, near St. John’s Boathouse)

Come cheer for team Philadelphia Hep B Heroes as well paddle our way to victory! The regatta is a family event with lots of entertainment such as cultural performances, rock climbing, and of course the exciting dragon boat races. So visit the Hepatitis B Foundation/Team Philadelphia Hep B Heroes tent for some snacks and cheer for our heroes.

Additional event:

Saturday, May 11

Hepatitis B Screening & Mini Health Fair

10am-1pm @ AmeriCare Pharmacy (600 Washington Avenue, Unit 18E, Philadelphia)

May Hepatitis Awareness Month would be incomplete without a screening event. In collaboration with the Jefferson Medical College APAMSA medical students and the AmeriCare Pharmacy, we will be providing free hepatitis B screening tests for those who were born in Asia or whose parents were born in Asia. Additional service such as blood pressure and blood glucose measurements will also be available at this event.

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Hep B Discrimination – Part Deux

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Francis Deng is a medical student at Washington University School of Medicine in St. Louis. He is a graduate of Harvard University, Bachelor of Arts (AB), magna cum laude, Human Development and Regenerative Biology. Mr. Deng was an instrumental leader of Team HBV – President at Harvard, and the co-chair of the National Advisory Board, Team HBV Collegiate.

I wrote previously about discrimination against health care workers and trainees who have chronic hepatitis B on KevinMD.com.  Since that time, major advances have happened. News surfaced that since 2011, the US Department of Justice (DOJ) has investigated 4 cases of Asian/Pacific Islander students who were infected and were not allowed to enroll in specific medical or dental schools, both private and public, that they were initially accepted to. Another case is still pending investigations from the Department of Health and Human Services Civil Rights Division.

In March 2013, the DOJ released a settlement noting that chronic hepatitis B infection is considered a disability, so discrimination, under specific circumstances, is prohibited under the Americans with Disabilities Act (ADA). This was groundbreaking in being the first ADA settlement ever reached on behalf of hepatitis B carriers. If you or someone you know has experienced HBV-related discrimination in the community, school, or the workplace, you are encouraged to file ADA complaints to the DOJ.

You might be thinking, I’ve never heard of such a thing, there must be so few cases where denial of admission or other discrimination has occurred based on hepatitis B status; or I know my school has students with hep B, so this really isn’t an important issue.

Here’s why the issue is important. Discrimination issues are only ever important to minority groups; I don’t mean racial minorities, I mean people who are not the majority in some way. It happens to people who don’t have a political voice or were not involved with policy making and are helpless in the face of institutional policies. When there are not explicit and systematic policies to protect such individuals, they are at the mercy of individuals who make judgments on behalf of the institution. In this situation, school administrators may be reasonable, allow students with hep B to matriculate, ensure proper precautions are made with respect to patient care, and give non-coercive guidance to students regarding career decisions. I know several schools where this is the case. Or they may be unreasonable and ignorant (willfully or unwillfully) of the CDC recommendations regarding HBV-infected health care workers. They may bar such infected students to matriculate, bar them from clinical activities even when it’s reasonably safe (i.e. they are not highly viremic or it’s a minimally invasive activity), or coerce them into going into specialties that do not involve direct patient care. Their lives are derailed and redirected needlessly.

Here’s who should care.

Pre-health students, especially 1st and 1.5 generation API Americans: If you were born outside of the US or your parents were born outside the US, particularly in a highly endemic region such as Asia, Africa, or Eastern Europe, you should know that you are at greater risk for having chronic hepatitis B infection. You may have been vaccinated as a requirement of entering school, and you may feel in excellent health, but you probably will have never been screened for hepatitis B infection or antibodies until you enter a healthcare environment. In these cases investigated by the DOJ, 3 out of 4 students were previously vaccinated but did not discover their infection until entering medical/dental training. This is because maternal screening and newborn vaccination policies have not been universally applied until recently, and screening children is not standard. There are always holes in the health care system where people fall through, whether in the US or (especially) abroad. Further, HBV immunization at birth, while effective, is not guaranteed to protect against infection. Get tested.

Health students: If you know of someone who has been denied enrollment based on HBV infection or experienced other types of discrimination in any kind of arena (childcare, employment, etc.), get in contact with hep B advocates. They can connect you to private or pro bono attorneys that will help you file a complaint with the DOJ. This can be confidential (name not public) and doesn’t even have to be filed by the individual. Nadine Shiroma, a community civil rights advocate, gave me most of the information I used to write this blog post. Joan Block, co-founder and executive director of the Hepatitis B Foundation, is another key resource.

School administrators: Protect your institution by implementing clear policies regarding HBV that are compliant with the ADA, and consistent with CDC recommendations for that matter. Help prospective students by making these policies public.

Student leaders: If you’re in APAMSA, serve on school policy committees, you can push your schools to make public and make clear their policies regarding hepatitis B infected students and staff involved in health care.

Hepatitis B Advocacy

Justice Department Settles with the UMDNJ Over Discrimination Against People with Hepatitis B

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Direct from the Department of Justice (see below), the first DOJ settlement of an American with Disabilities Act (ADA) case involving people with hepatitis B was announced.  The Hepatitis B Foundation is proud to have played a critical role in successfully advocating for these students who suffered from discrimination as a result of chronic hepatitis B infection.

You may recall an earlier story posted both in the HBF Spring Newsletter, 2012 and the HBF’s Hep B Blog, “Dreams on Hold – A personal story of an aspiring medical student .“ This was one of four cases that spurred the HBF into action on behalf of these students and their rights.

July 2011, a meeting was convened by the CDC, with the HBF and others, resulting in the July 2012 CDC update “Recommendations for the Management of Hepatitis B virus-Infected Health Care Providers and Students. ”These recommendations were cited in the DOJ statement and clearly contributed to the DOJ settlement on behalf of people living with chronic HBV eliminating them from being excluded or discriminated against due to health issues. Since all applicants are from the Asian American Pacific Islander (AAPI) community, which accounts for more than 50% of Americans living with chronic HBV, The DOJ assures that the Civil Rights Division is committed to ensuring discrimination does not occur in this community as a result of this disability.  On behalf of those living with HBV, the HBF applauds this decision by the DOJ. 

The Justice Department announced today that it has reached a settlement with the University of Medicine and Dentistry of New Jersey School (UMDNJ) under the Americans with Disabilities Act (ADA).   The settlement resolves complaints that the UMDNJ School of Medicine and the UMDNJ School of Osteopathic Medicine unlawfully excluded applicants because they have hepatitis B.   This is the first ADA settlement ever reached by the Justice Department on behalf of people with hepatitis B.In 2011, the two applicants in this matter applied and were accepted to the UMDNJ School of Osteopathic Medicine, and one of them was also accepted to the UMDNJ School of Medicine. The schools later revoked the acceptances when the schools learned that the applicants have hepatitis B.   The Justice Department determined that the schools had no lawful basis for excluding the applicants, especially because students at the schools are not even required to perform invasive surgical procedures, and that the exclusion of the applicants contradicts the Centers for Disease Control and Prevention’s (CDC) updated guidance on this issue.

According to the CDC’s July 2012 “Updated Recommendations for Preventing Transmission and Medical Management of Hepatitis B Virus (HBV) – Infected Health Care Workers and Students,” no transmission of Hepatitis B has been reported in the United States from primary care providers, clinicians, medical or dental students, residents, nurses, or other health care providers to patients since 1991.

“Excluding people with disabilities from higher education based on unfounded fears or incorrect scientific information is unacceptable,” said Thomas E. Perez, Assistant Attorney General for the Civil Rights Division.   “We applaud the UMDNJ for working cooperatively with the Justice Department to resolve these matters in a fair manner.”

“It is especially important that a public institution of higher learning – especially one with a mission to prepare future generations of medical professionals – strictly follow the laws Congress has enacted to protect from discrimination those people who have health issues,” said U.S. Attorney for the District of New Jersey Paul Fishman. “The remedies to which the school has agreed should ensure this does not happen again.”

Under the settlement agreement, the UMDNJ must adopt a disability rights policy that is based on the CDC’s Hepatitis B recommendations, permit the applicants to enroll in the schools, provide ADA training to their employees and provide the applicants a total of $75,000 in compensation and tuition credits.

Both of the applicants in this matter come from the Asian American Pacific Islander community. The CDC reports that Asian American Pacific Islanders (AAPIs) make up less than 5 percent of the total population in the United States, but account for more than 50 percent of Americans living with chronic Hepatitis B.   Nearly 70 percent of AAPIs living in the United States were born, or have parents who were born, in countries where hepatitis B is common. Most AAPIs with Hepatitis B contracted Hepatitis B during childbirth .   The Civil Rights Division is committed to ensuring that this community is not subjected to discrimination because of disability.

Title II of the ADA prohibits state and local government entities, like the UMDNJ, from discriminating against individuals with disabilities in programs, services, and activities. State and local governments must also make reasonable modifications in policies, practices, and procedures when the modifications are necessary to avoid discrimination on the basis of disability, unless those modifications would result in a fundamental alteration.

More information about the Civil Rights Division and the laws it enforces is available at the website www.justice.gov/crt.  More information about the ADA and today’s agreement with UMDNJ can be accessed at the ADA website at www.ada.gov or by calling the toll-free ADA information line at 800-514-0301 or 800-514-0383 (TTY).

 

 

 

 

 

Hepatitis B Diagnosis & Monitoring, Liver Cancer, Living with Hepatitis B

Launch of New Patient-Focused Website at LiverCancerConnect.org

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A dedicated program of the Hepatitis B Foundation for patients and families 

The statistics are sobering. Liver cancer is the seventh most common cancer in the world, but the third leading cause of cancer-related deaths. Worldwide, more than 700,000 people are diagnosed with primary liver cancer each year, accounting for more than 600,000 deaths annually. Equally disturbing is the fact that while the incidence rates of most cancers have declined in recent years, the incidence rate for liver cancer is increasing.

But there is encouraging progress in the fight against liver cancer. Scientific research into new treatments is yielding promising results. And perhaps more significantly, the major causes of liver cancer— such as chronic hepatitis B or hepatitis C infections, and cirrhosis — are largely preventable. A safe and effective vaccine against hepatitis B has been available since 1986. In fact, this vaccine was named the world’s first “anti-cancer” vaccine, because it prevents chronic hepatitis B infection, the world’s leading cause of liver cancer. While no vaccine for hepatitis C currently exists, new drugs can eliminate the virus, thereby halting the progression to liver cancer. And cirrhosis can be avoided by preventing chronic hepatitis B and C infections, limiting alcohol intake, and preventing fatty liver disease associated with obesity.

Knowing that these risk factors are preventable makes it all the more important to identify people at risk for liver cancer, educate them about prevention and treatment options, and direct them to appropriate medical care.

To provide accurate, easy-to-understand information to people diagnosed with liver cancer, the Hepatitis B Foundation has created the first patient-focused website, www.LiverCancerConnect.org. The website aims to help people better understand how liver cancer is diagnosed and how it can be treated or prevented. In addition, wwwLiverCancerConnect.org includes a Drug Watch of potential new liver cancer therapies, an expanding directory of liver cancer specialists, and a clinical trials listing.

The Hepatitis B Foundation is also organizing a series of webinars in 2013 to educate the public about the link between liver cancer and its main risk factors, namely hepatitis B and C infections and cirrhosis caused by fatty liver disease. The webinars, presented by leading international experts in liver diseases, will explain what primary liver cancer is, the importance of liver cancer screening and surveillance, and the treatment options and clinical trials that are currently available. Additional information will be announced on both the Liver Cancer Connect website and HBF’s blog when it is available.

The Foundation invites you to use www.LiverCancerConnect.org to learn about liver cancer and its treatment options, and to locate liver cancer specialists and clinical trials. We welcome your feedback and suggestions at connect@livercancerconnect.org so that we may continue to build on this valuable resource for the global liver cancer community.

Liver Cancer Connect is available on Facebook and Twitter. Join LCC on Facebook at http://www.facebook.com/LiverCancerConnect and follow LCC on twitter with the handle @LiverCancerConn.

 

 

 

Hepatitis B Diagnosis & Monitoring, Liver Cancer

HBV Genotype C Carries Greater Risk for HCC Than Other Genotypes

Below is a publication from “Healio Hepatology, January 23, 2013 –HBV Genotype C Carries Greater Risk for HCC Than Other Genotypes“, showing the risk of hepatocellular carcinoma among the different hepatitis B genotypes based on a meta-analysis of 43 studies. There are 8 identified HBV genotypes ranging from genotypes A through H. These different genotypes are concentrated in distinct geographic areas of the globe, and may influence the course of disease, as noted below with the greater risk of liver cancer for those with genotype C. 

Patients with hepatitis B genotype C are more likely to develop hepatocellular carcinoma than patients with other HBV genotypes, according to recent results.

Researchers performed a meta-analysis of 43 studies (34 cross-sectional, four case-control, four prospective or retrospective cohort studies and one randomized controlled trial) published between 1999 and 2010 assessing the risk for hepatocellular carcinoma (HCC) across the major genotypes of hepatitis B.

Analysis included data on 14,545 patients with HBV, with 517 cases of genotype A, 4,417 of B, 7,750 of C, 1,506 of D, 57 with A and D in combination and 298 with other and/or mixed genotypes. There were 2,841 patients with HCC across all studies.

In 33 studies comparing genotypes B (n=4,417) and C (n=6,060), HCC was significantly more common among participants with genotype C (25% of patients vs. 12%), with an OR of 2.05 (1.52-2.76). Patients with genotypes A (n=517) and D (n=1,506) were at similar risk for HCC across 12 studies (14% for A vs. 11% for D, OR=0.94, 0.67-1.32). Patients with genotype C (n=1,659) were at significantly higher risk than those with genotypes A or D (n=1,403) in 10 studies (30% vs. 7%, OR=2.34, 1.63-3.34). Analysis of HBV subgenotypes Ce (n=1,440) and Cs (n=715) in eight studies indicated a similar risk for HCC between subgenotypes (OR=1.13, 0.76-1.67) (95% CI for all).

“Genotype C HBV is associated with a higher risk of HCC than genotypes A, B and D HBV based on studies largely observational,” the researchers wrote. “This partly explains a higher risk of HCC among patients in Southeast Asia where genotype C HBV is prevalent. Patients infected with genotype C HBV, which is often associated with more active liver disease and higher risk of liver cirrhosis, should be closely monitored for HCC development and considered for antiviral therapy.”

Disclosure: See the study for a full list of relevant disclosures.

Hepatitis B Prevention

Cast Your Vote for HBF in the Philly DoGooder Video Contest!

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HBF is entering the Philly DoGooder contest with the fantastic video by HBF’s own, Daniel Chen. Click and watch below. There will be 5 winners total, so if we win we’ll be splitting the $250,000 prize money with 4 other organizations. Help us win and get more resources to empower the community by voting once a day!

Voting is easy! Click on the big “VOTE FOR THIS ENTRY” button directly below the video and you will directed to log into your Facebook account. If you don’t have a Facebook account, you can register with your email so you can vote. Every vote counts, so be sure to share this information with family and friends and on all of your social media outlets. Don’t forget to vote once every 24 hours!

Hepatitis B Prevention, Living with Hepatitis B

Personal Reflection on Yesterday’s FDA Vaccine Advisory Panel Review of Dynavax’s New HBV Vaccine

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I was fortunate to have the opportunity to represent the Hepatitis B Foundation at yesterday’s FDA vaccine advisory panel review of Dynavax’s new HEPLISAV vaccine for hepatitis B.  I was there for the public comment period on the second day of the meeting with my prepared statement. I was surprised to find I was the only one there for public comment. Since I’ve never been to anything like this, I don’t know if that is typical or not.  I think my personal story with HBV, and the message from the HBF was important for the FDA panel to hear, so they were sure to be reminded that there are real people affected by chronic hepatitis B.

There has been a great deal of good press about the new Dynavax vaccine. In studies it has superior immunogenicity when compared to the currently available vaccines. Immunity is generated in 2 doses given one month apart, versus the currently available vaccines where it is a three shot series over 6 months. This is particularly important to subpopulations such as those undergoing dialysis, and diabetic adults who are encouraged to be vaccinated against hepatitis B – a new recommendation by the CDC this year. It is also important to the general adult population, where it is found that 30-50% of adults may not complete the 3 shot HBV vaccine series making them vulnerable to infection. This  need for HBV prevention via a more effective vaccine, particularly in needy subpopulations was what was stressed in HBF’s public statement.

I do believe the panel was well aware of the importance of HBV prevention and one doctor made mention of the importance based on “the public comment”, so they were listening. Another doctor mentioned the burden of the disease not only globally, but also in the US. That is often understated.

The FDA panel met both Wednesday and Thursday. The public comment period was Thursday, and I remained there for the vote on two vital questions.  The first question was about whether the immunogenicity data was adequate to support the effectiveness of HEPLISAV for the prevention of hepatitis B infection in adults 18 through 70 years of age? The vote cast showed unanimous agreement in the efficacy of the vaccine.

The other question was about whether the data was adequate to support the safety of HEPLISAV when administered to adults 18 through 70 years. Five members said “yes”, 1 abstained and 8 voted “no”.

Prior to both votes there was a great deal of discussion amongst the panelists, and the representative from Dynavax who responded directly to questions.

Ultimately it came down to a few key points.  It was clear that the panel was impressed with efficacy or level of immunity generated by this new, 2 shot series. This vaccine uses a unique adjuvant. An adjuvant is a substance that is added to the vaccine in order to increase the body’s immune response to the vaccine.  In this case it was a nucleic acid versus a lipid – details of which I do not even pretend to understand. Although this new adjuvant was exciting based on the great immunogenicity data presented by Dynavax, it was also a source of concern because the panel was not sure if there was enough study data that represented all demographics. In other words, this vaccine performed really well, but they weren’t sure if it had been proven safe in different ethnic groups such as African Americans, Asian-Americans, and Hispanics. Since the US is a melting pot, this is important.

The other concern was that the vaccine had not been administered along with other vaccines. Because this vaccine is to be given to adults, they felt it was important that it could be given when an adult came in for their annual flu shot, or another immunization. Adults just don’t get to the doctor’s office that often! Although this was clearly of interest, it was not a deal breaker like the lack of safety data among all demographics. There was the suggestion to introduce the vaccine into the current sub-populations that were in particular need, but not much discussion beyond.

The votes were cast and the panel and the audience dispersed. Looks like Dynavax will need to complete further studies before the vaccine is once again reviewed by the FDA panel for approval. Personally, I believe there’s a real  need and a place for this vaccine, but of course safety always comes first.

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

Why Give the Hepatitis B Vaccine to Infants?

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The CDC recommends a birth dose of the hepatitis B vaccine for all babies. Pediatrician, Dr. Allison Shuman explains why in this informative video.

If you live in a part of the world where chronic HBV is at a medium (2-7% of population) or high prevalence rate (greater than 8% of population), your child is especially susceptible and at-risk for hepatitis B, with HBV transmission often occurring vertically from mother to child at birth, and horizontally from an HBV infected adult or another child’s infected body fluids to an unvaccinated baby or child. Please be sure that pregnant women are screened for hepatitis B. If mom tests positive for HBV, be sure baby receives a birth dose of the HBV vaccine and a shot of HBIG within 12 hours of birth. If mom tests negative for HBV, be sure that baby receives a birth dose of the HBV vaccine before leaving the hospital. Both babies of HBV infected and uninfected mom’s should receives shots 2 and 3 of the series according to schedule. Babies of infected mom’s should be tested at 18 months to be sure baby is hepatitis B free.

Please make arrangements with your doctor and the hospital to receive the HBV vaccine for your baby, prior to delivery, so you are sure the vaccine and/or HBIG are available at the hospital so prophylaxis can be given within 12 hours of birth. Please feel free to print and distribute  Chronic Hepatitis B in Pregnancy: Screening, Evaluation and Management (Part I and Part II) to your doctor.

 

Baruch S. Blumberg Institute