Hep B Blog

Category Archives: Hepatitis B Prevention

Hepatitis B Diagnosis & Monitoring, Hepatitis B Prevention, Hepatitis B Treatment

HBV Journal Review – September 2013

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HBF is pleased to connect our blog readers to Christine Kukka’s monthly HBV Journal Review that she writes for the HBV Advocate. The journal presents the
latest in hepatitis B research, treatment, and prevention from recent academic and medical journals. This month, the following topics are explored:

  • 39.2% of U.S. Newborns Aren’t Getting Hepatitis B Vaccine at Birth
  • Researchers Suggest Banning or Restricting Lamivudine to Avoid Drug Resistance
  • Knowledge Gap About Hepatitis B Persists Among Asian-Americans
  • Even Liver Specialists Fail to Immunize Patients Against Viral Hepatitis
  • Many Seek Viral Hepatitis Tests Only When Symptoms Appear
  • After Six Years of Tenofovir Treatment, Still No Signs of Drug Resistance
  • More Studies Examine Link Between Vitamin D and Liver Damage
  • Study Examines Which Hepatitis B Patients Relapse with Chemotherapy
  • Interferon Treatment May Cause Some Hearing Loss
  • African-Americans Suffer the Highest Rates of New HBV Infections in the U.S.

HBV Journal Review
September 1, 2013
Volume 10, Issue 8
by Christine M. Kukka 

 

 39.2% of U.S. Newborns Aren’t Getting Hepatitis B Vaccine at Birth

Which newborns aren’t getting immunized against hepatitis B in the U.S.? The infants who:

  • • Do not have health insurance
  • • Live in states without a universal hepatitis B vaccine supply policy
  • • And have only one provider who administered vaccines.

According to a U.S. Centers for Disease Control and Prevention study, published in the August issue of the journal Preventive Medicine, an alarming 39.2% of newborns missed the first, critical birth dose of hepatitis B vaccination that can protect newborns from hepatitis B even if their mothers are infected.

These results come from data analysis of the 2009 National Immunization Survey of 17,053 U.S. children, aged 19-35 months.

“Children who reside in states without a universal hepatitis B vaccine supply policy, and are not covered by health insurance are two important modifiable risk factors for not receiving the birth dose hepatitis B vaccination, future intervention studies could be needed to help control those modifiable risk factors,” CDC researchers wrote.

Source: www.ncbi.nlm.nih.gov/pubmed/23988497

Researchers Suggest Banning or Restricting Lamivudine to Avoid Drug Resistance
A global team of researchers suggest lamivudine (Epivir-HBV) never be used to treat hepatitis B patients because it frequently leads to drug resistance and sets the stage for resistance to other antivirals, such as entecavir (Baraclude).

Lamivudine, the first antiviral approved for hepatitis B treatment, has fallen out of favor in North America and Europe because of its high rate of drug resistance. But because of its low cost, it continues to be commonly used to treat hepatitis B virus (HBV) infection in Asia and Africa, where the majority of the world’s hepatitis B patients live.

This report, published in the July 30 issue of PLoS One, examined the molecular make-up of the virus in many patients who had been treated with lamivudine as well as patients who had never been treated. They found the many untreated patients carry a mutation that allows HBV to quickly mutate and develop resistance to lamivudine.

“Our findings strongly suggest that the use of lamivudine will not benefit …patients,” they wrote because of the high risk of lamivudine resistance.

“Finally, since patients can quickly develop drug resistance to entecavir in the presence of lamivudine mutations, the lamivudine mutations can significantly compromise the efficacy of entecavir,” they concluded.

They proposed that doctor screen patients for these mutations before ever prescribing lamivudine,”… to most effectively treat chronic hepatitis B patients by selecting only sensitive drugs.” …

Continue reading about this and additional HBV related studies

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

Kudos to HBF’s Blog Voted as a “Sexual Health Top 10, Must Read Blog”

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The team at Health Express has voted HBF’s blog as one of the “Must Read Blogs of 2013 – Sexual Health Top 10!”  HealthExpress.co.uk is an online clinic that provides support, advice and treatment for common medical conditions that patients do not always feel comfortable talking about. You can take a look at their recommended Top 10 blogs and learn more about them at healthexpress.co.uk.

The accolades from the HealthExpress team are a great opportunity to review transmission of the hepatitis B virus. HBV is transmitted through infected blood and body fluids. This includes direct blood-to-blood contact, unprotected sex, unsterile needles, and from an infected woman to her newborn baby at birth.  Sharing sharp, personal items that may have trace amounts of blood on them such a razors, toothbrushes, nail clippers and body jewelry including earrings, can also spread the virus.  Remember that the HBV virus may live up to a week on a surface resulting in possible transmission through direct blood-to-blood contact. This is why close, household contacts or family members are at greater risk of infection if one or more members are living with HBV. Don’t forget to be sure your tattoo or piercing experience is safe and that the parlor carefully follows infection control practices. Hepatitis B is also 50-100 times more infectious than the HIV virus.

Hepatitis B is also a sexually transmitted disease and is spread through infected semen, vaginal fluids and any blood that may be exchanged as part of a sexual practice – most often through sexual intercourse. In the United States, sexual transmission is the most common mode of HBV transmission and is responsible for 2/3 of acute HBV infections. A common question is “what about oral sex?” In general, oral sex would be considered less risky, but any kind of intimate sharing that may result in the exchange of bodily fluids will present some degree of risk.

So how can you prevent hepatitis B transmission between sexual partners? Fortunately there is a safe and effective hepatitis B vaccine to protect against the spread of HBV.  Get screened for HBV and vaccinate to protect – especially if you or your partner has more than one sexual partner, or if one or more partners is at greater risk.  When in doubt, get screened. Keep in mind that HBV is referred to as a “silent infection” since it may take decades for symptoms to occur. People with chronic HBV may be completely unaware of their infection and inadvertently spread HBV to their partner(s) if precautions are not taken.

Other precautions include practicing safe sex by using a latex or polyurethane condom. A lambskin condom will not prevent the spread of hepatitis B or other viral STDs. Looking for condom details?

A general comment to those with multiple sex partners– We are very fortunate to have a vaccine to protect against the hepatitis B virus. However, practicing safe sex with an effective condom is always advised to prevent the transmission of other infectious diseases that are not vaccine preventable, such as HCV and HIV, along with condom use to prevent the spread of other sexually transmitted diseases. Use common sense. No one wants a sexually transmitted disease, and if you have HBV, you really don’t want a coinfection. It can really complicate your life.

Hepatitis B Diagnosis & Monitoring, Hepatitis B Prevention

World Hepatitis Day in Ghana

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Ghanians lined up for a viral hepatitis screening at last year's World Hepatitis Day event in Tamale, Ghana (Northern Region)

HBF is pleased to share World Hepatitis Day plans of our friend Theobald Owusu-Ansah of the Theobald Hepatitis B Foundation in Ghana. The Foundation is also a voting member of the World Hepatitis Alliance. 

On July 28th, 2013, The Theobald Hepatitis B Foundation and the Hepatitis Coalition of Ghana will join the World with one voice to celebrate World Hepatitis Day in Sunyani at Victoria Park. In attendance will be the Chiefs, members of Parliament, District Chief Executives, Municipal Chief Executives, Assembly Members and all the Opinion Leaders of the Region.

The Theobald Hepatitis B Foundation is a non-profit organization whose main aim is to educate and create awareness of hepatitis B and C to the general public, ranging from the causes, and symptoms of viral hepatitis, to preventive measures.

On World Hepatitis Day, the activities will start with an early morning Float with music and dance throughout the principal streets of Sunyani, along with the members and volunteers of the Foundation and the Coalition distributing educational materials to the crowds. These leaflets, posters, banners and stickers are part of the ongoing media blast that will draw the public’s attention to problem of chronic hepatitis B among the people of Ghana.

Free screening and hepatitis B vaccinations will be ongoing throughout the day’s activities. Resource persons will be delivering their messages and educating the general public about viral hepatitis. It is important that the people learn and understand whether or not they are positive or negative for viral hepatitis, and if they are positive, what is next.

The Delegation of the Government and other health care professionals will educate the public on Viral Hepatitis Policies and the way forward. Dieticians will also take the general public through the kind of food and diet one needs to eat, and the importance of avoiding alcohol, in order to defuse the public cry of the cost of prevention and treatment of hepatitis B.

Participating organizations will then take the opportunity to appeal for funds from the government officials and the Chiefs of the region present, in order to enable us to successfully organize our last programme of the year.

At the end of the event, the public will be provided with advice, and directed to seek medical information from qualified health professionals, in order to avoid falling into wrong hands of those trying to sell false cures for those with hepatitis B.

Please join us for our World Hepatitis Day activities in Victoria Park if you are in Sunyani, Ghana.

Theobald Owusu Ansah
Theobald Hepatitis B Foundation
P.O. Box GP 21325 Accra-Ghana:

Phone: 00233-20-8269214
theobald2003@yahoo.com
Theobald Hepatitis B Foundation website

 

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.

 

Hepatitis B Advocacy, Hepatitis B Prevention, Liver Cancer, Living with Hepatitis B

The Hepatitis B Foundation Participates in Liver Capitol Hill Day, 2013 – A Personal Reflection

Yesterday the Hepatitis B Foundation participated in the American Association for the Study of Liver Diseases (AASLD) annual “Liver Capitol Hill Day” visits. This is a great opportunity to get in front of state Senators and Congressmen in order to make requests known to them. It is also an opportunity to educate. As a constituent, your state representatives are interested in what you have to say. The “Asks” for the day were to support funding for liver related research, prevention strategies, and support of liver patient access to quality medical care.  Specifically, we were asking for NIH funding growth, rather than the 20% cut over the last decade, along with support of government agencies such as the CDC Division of Viral Hepatitis, and the delivery of health care systems and payment policies for patients living with liver diseases.  Prevention is also critical with specific asks for new, one-time hepatitis C testing and screening for hepatitis B for at-risk patients. As we are all aware, budgets are tight and we will all soon feel the effects of the Sequester. Research programs may no longer be funded, or severely cut, public health agencies and programs will be cut, and patients who are currently receiving medical assistance will suffer. For treated patients with HBV, it is essential nothing interrupts the daily antiviral use, and of course HBV and liver cancer prevention through screening, vaccination and surveillance is both necessary and cost effective in the long run.

Due to the Sequester, the day started in a panic for many Hill visitors. I was fortunate to arrive early – a good thing since I waited in a long security line for 45 minutes that wrapped around the building. As Maryland residents, Dave Li and I met with staff from both Senator Ben Cardin’s (D) and Senator Barbara Mikulski’s (D) offices.  Senator Mikulski was recently appointed the Chairperson of the U.S. Senate Appropriations Committee. This means she will have a great deal of influence on budget and spending decisions. We were told that due to the Sequester, the Continuing Resolution (CR) will remain in place for the remainder of the 2013, but Senator Mikulski is optimistic that the FY14 and future funding for the NIH, specifically, will be maintained. As a Maryland Senator, this is extremely important to Sen. Mikulski on many fronts. Senator Cardin has been making visits to agencies in MD, including the NIH, and researchers are frustrated they are unable to do their work.  Both Senator Cardin and Senator Mikulski support federal agencies (such as the CDC, Division of Viral Hepatitis, Public Health Agency etc.) and initiatives that provide care and services to meet the health care needs of Marylanders.  Fortunately this supports the Health and U.S. Health and Human Services (HHS) Viral Hepatitis Action Plan initiatives, since both Senators are supportive of prevention and surveillance initiatives.  Dave and I walked out of our Senate meeting feeling pretty good.

Unfortunately, the outlook was not so optimistic on the House side. We visited staffers from Congressman Chris Van Hollen and Congressman Elijah Cummings offices. Although they are working on budgets, they are meeting with opposition and resigned to deep cuts in their supported programs.  Congressman Cumming’s staffer was pleased to hear an optimistic viewpoint from Mikulski’s office.  Although clearly mixed signals from our House and Senate meetings, we can only hope that Congress will eventually work together and move forward with continued funding of agencies and programs that support those living with liver disease.

Please remember that your state Senators and Representatives have been voted to serve YOU. It is imperative that your voice be heard. If you don’t let them know what is important to you, important programs and agencies will be drastically cut.  You do not need to be a political machine to participate. Don’t know your Representative?   Find your Rep. on-line by putting in your zip code or state to learn who you need to contact. Find your Senator, Governor and Congressmen here. Call the Capitol switchboard’s toll free number at 1-888-876-6242 , or send an email  or letter with your asks, and your personal stories. Be sure your message is clear and concise, and personalize it if you can. You can visit your Representative or Senator when you are visiting Washington, D. C., or in the local, state office. Let your voice be heard – especially during this very difficult time.

Hepatitis B Prevention, Living with Hepatitis B

High Viral Load, HBeAg Positivity Increased Risk for Mother-to-Infant HBV Transmission

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The study published by Healio Hepatology, March 8, 2013 discusses the increased risk of mother-to-infant transmission in HBV positive moms who are HBeAg positive and have a high viral load. Current prophylaxis, where infants of HBsAg+ moms receive the first shot of the HBV vaccine and a shot of HBIG within 12 hours of birth, is successful greater than 90% of the time. However, according to the study, HBeAg+ pregnant moms with a viral load above 107  cp/mL(10,000,000 cp/mL) will transmit the virus to their infant despite prophylaxis. Since a particularly elevated viral load appears to determine the failure of current prophylaxis, the need for additional screening for these women and revised intervention strategies is necessary to prevent transmission to their babies at birth.

If you are a pregnant mom that is HBsAg+, please see a liver specialist for further evaluation to determine your HBeAg status and your HBV DNA viral load. If you are HBeAg + and have a high viral load, (a viral load near the 10,000,000 cp/ml threshold) you will want to talk to your liver specialist to determine if you and your baby would benefit from antiviral therapy in order to prevent transmission of HBV to your newborn. Although there are no official guidelines or recommendations, Registry data shows medications for hepatitis B appear safe during pregnancy. Talk to your doctor to see if this is a good option for you and your baby.

If you are a pregnant woman, please read and print HBF’s Chronic Hepatitis B in Pregnancy, and give it to the doctor who will be caring for you during your pregnancy. Sadly, IOM data shows HBV+ women in the U.S. are not always identified and educated about their HBV, and an opportunity for prophylaxis may be missed despite CDC recommendations that ALL infants receive the first dose of the HBV vaccine prior to hospital discharge.

If you live in a developing country, there may be no guidelines in place that automatically screen pregnant women for hepatitis B. Once again, read and print a copy of “Chronic Hepatitis B in Pregnancy” for your doctor. Insist you are screened for HBV, and if you are HBsAg+, please be sure prophylaxis will be available at the hospital where you will give birth to your baby. If you find you are HBeAg+, with a high viral load, please speak to a liver specialist to see if an antiviral is an option for you to prevent HBV transmission to your baby. Don’t’ forget to have your baby tested at 18 months to ensure your baby is HBV free.

*Please note you can convert copies per milliliter (cp/ml) to IU/mL for the article below using WHO’s international standard where 1 IU/mL = 5.2 copies/mL. Please ask your doctor or your lab if you have specific questions regarding the conversion.


Infants born to mothers with a high hepatitis B viral load, particularly those positive for hepatitis B e antigen, are at high risk for contracting hepatitis despite immunoprophylaxis, according to recent results.

Researchers evaluated 303 mother-infant pairs in which mothers tested positive for hepatitis B surface antigen (HBsAg). Maternal viral load and hepatitis B e antigen (HBeAg) status were determined, and children were tested for HBsAg at ages 4 to 8 months (n=250) and/or 1 to 3 years (n=53 for an initial test; n=183 for a follow-up test). All children received HBV vaccine within the first week of birth and at 1 and 6 months, with a 100% completion rate; children born to mothers who tested positive for HBeAg received hepatitis B immunoglobulin within 24 hours of birth.

HBeAg-positive mothers (81 cases) had higher viral loads than those who did not (7.4 ± 1.9 log10 copies/mL vs. 2.7 ± 1.4 log10 copies/mL; P<.0001 for difference). Chronic HBV infection was identified in 10 children, all born to HBeAg-positive mothers with high viral loads (range 6.5-9.5 log10 copies/mL), and all with the same HBV genotypes and subtypes as their mothers.

Investigators identified a significant association between maternal viral load and a child’s risk for infection via multivariate analysis, after adjusting for factors including age; birth type; infant gender, weight and gestational age, and feeding practices (adjusted OR=3.49; 95% CI, 1.63-.7.48 per log10 copy/mL increase). Predictive rates for maternally transmitted HBV infection were found to be statistically significant at 7 (6.6%; P=.033), 8 (14.6%; P=.001), and 9 (27.7%; P<.001) log10 copies/mL.

“High maternal viral load is the most important factor causing maternally transmitted HBV infection, and is significantly correlated with maternal HBeAg status,” the researchers wrote. “Our predictive model including multiple risk factors showed that children with a maternal viral load above 10,000,000 to 100,000,000 copies/mL (or would have a significant risk of infection despite immunoprophylaxis. Our data provide important information for the rational design of future screening and intervention strategies to further reduce maternally transmitted HBV infection.”

Wen W-H. J Hepatol. 2013;doi:10.1016/j.jhep.2013.02.015.

March 8, 2013

Hepatitis B Prevention, Liver Cancer

Liver Cancer Webinar Series: What You Need to Know

Missed the webinar? Download the March 6th Webinar and listen to Hepatitis B and Liver Cancer: What You Need to Know, by Dr. Robert Gish. 

Due to an overwhelming response, continued registration for  this Wednesday’s webinar with Dr. Gish is closed. Stay tuned as the webinar will be recorded in it’s entirety, and will be made available. Stay tuned for details! 

Did you know?

Liver cancer is the third leading cause of cancer-related deaths and the seventh most common cancer worldwide. But the major causes of liver cancer— such as chronic hepatitis B or hepatitis C, and cirrhosis— are largely preventable. And treatments for liver cancer are available.

Learn more about liver cancer

Join The Hepatitis B Foundation’s webinar series to learn about the risk factors for liver cancer and the importance of liver cancer screening and surveillance. The expert presenters will describe currently available treatment options and clinical trials.

The first webinar of the series will be Liver Cancer and Hepatitis B: What You Need to Know, presented by Robert G. Gish, MD, an internationally renowned liver diseases expert.

Dr. Gish is a Clinical Professor of Medicine, Section Chief of Hepatology, and Co-Director of the Center for Hepatobiliary Disease and Abdominal Transplantation at the University of California, San Diego Health Systems.

Dr. Gish has an active research program in viral hepatitis and has published more than 600 original articles, abstracts, and book chapters, and more than 120 peer-reviewed publications.

Liver Cancer and Hepatitis B: What You Need to Know webinar details:

Presented by:Dr. Robert G. Gish
Date: Wednesday, March 6, 2013
Time: 12 noon EST; 9 am PST
Click here to register

For additional accurate, easy-to-understand information on liver cancer, visit the Hepatitis B Foundation’s new, dedicated website, www.LiverCancerConnect.org.

 

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