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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 Prevention

Many Parents Request Delays in Vaccine Schedule -Why the HBV Vaccine is Important for Infants and Young Children

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Last week’s report of a recent study shows that more parents are opting out or delaying some vaccines for their children, and the hepatitis B vaccine is one of those parents sometimes choose to skip or delay.  What is even more disappointing is that the majority of pediatricians polled were comfortable with an alternative HBV vaccine schedule for their young patients.

The unfortunate thing about HBV is that it is very effectively passed from an HBV infected mother to her child during the birth process. Children that are infected with hepatitis B at birth, or as a baby, have a 90% chance of being chronically infected for life.   Young children that are infected horizontally have up to a 50% chance of being chronically infected for life. Children living with HBV are typically highly infectious and very effective at unknowingly spreading the virus to little friends or family members. HBV is present in blood and body fluids and we all know how kids are fascinated by one anothers’ boo-boos, and half of them have some sort of rash or scrapes that are tough to keep covered at all times. The beauty of vaccination is that infants and little ones are protected when they are at day care and pre-school, and when they are playing with the neighborhood kids.  Protocols are in place, but accidents do happen and rules are not always followed. You may think your child’s world is HBV free, but but you may be wrong.  Is it worth the risk when there is a safe and effective vaccine available?

Later in life, HBV is effectively transmitted horizontally in the mode that is often associated with infectious disease – sexually.  We are all sexual beings and at some point sex will become part of our lives.  Will you be thinking about having your teen or college student vaccinated, or will you be like most of us and too busy to even think about it?  What about when your teen or college student comes home with a tattoo or body piercing they got at a bargain tattoo/piercing parlor?  No one likes to think about their children making impulsive decisions, but the reality is that most do.  They have lapses in judgment and they make mistakes. A parent can only control so much, but why not eliminate the chance of HBV infection later in life?

You might think you will deal with HBV if you are faced with it. Even if your child is infected, or playing with a child that is infected, there will be no notable symptoms.  That’s why they call it a “silent infection“. Your liver is a non-complaining organ so symptoms rarely appear unless your liver is in distress. HBV will likely go unnoticed for decades unless it is picked up with routine blood work, during a blood donation, or a blood screening. That doesn’t mean liver damage is not occurring over decades of infection.

Our world keeps getting smaller, and travel to exotic lands is common. The U.S. is a melting pot of countries around the globe – many where HBV is prevalent.  Do you know that 2 billion people in the world have been infected with hepatitis B and that 400 million are living with a chronic, life-long infection? That is 1 out of 3 people in our world that have had an HBV infection!  There are good treatments out there, but there is no complete cure.  Many live long, lives, but lifelong HBV puts you at high risk for advanced liver disease, liver cancer and death.  The stigma associated with HBV leaves many throughout the world unemployable, and even those in the U.S. may suffer from discrimination and judgment by others due to their disease.

People write to HBF and tell us their HBV story.  Many have no idea how they were infected.  It is not casually transmitted, but it is an infectious disease – 50 to 100 times more infectious than HIV and 5 to 10 times more infectious than HCV.  The U.S. is fortunate to have a vaccine available to all children born in this country. Parents worldwide would give anything to have their infant vaccinated to prevent a lifetime with HBV.  Some countries have HBV vaccine shortages.  Many cannot afford the vaccine, and many are unaware of the vaccine until they learn they are infected. In the U.S. we have an opportunity to prevent a life-long infection with HBV with a simple vaccine.  Please don’t choose to delay or omit the hepatitis B vaccine from your child’s vaccine schedule.

Hepatitis B Prevention

Options for HBV Vaccine Non-Responders

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Are you a hepatitis B vaccine non-responder? Approximately 5-15% of people who receive the vaccine are considered non-responders. This is especially important for health care workers, families living in households with people that have HBV, and others who may be at increased risk of exposure to HBV.  A vaccine non-responder is someone that does not build up an adequate immune response after receiving two, 3-shot series of the HBV vaccine.  In other words, they complete one series of the HBV vaccine, and follow it with a surface antibody test (HBsAb or Anti-HBs) 4-6 weeks following the last injection of the series.  If the anti-HBs titre is not greater than 10IU/l, than the series is repeated, preferably with an HBV vaccine from a different manufacturer, and the person is once again tested for immunity by testing for adequate anti-HBs. (See previous blog, “Got Hepatitis B? Keeping loved ones safe though HBV vaccination” for details)

Fortunately there are other options for those concerned with being an HBV vaccine non-responder. There is a higher concentration of the HBV vaccine recommended by the CDC that is used for patients undergoing dialysis, and for those that are immune suppressed.  It is a 40µg/ml concentration. If it has been one year or less since you completed the three-shot series of the regular concentration of the vaccine, you can try one intramuscular dose of 1.0 ml of the 40µg HBV vaccine.  If it has been more than one year since your last three shot series of the vaccine, you can repeat the entire three-shot series with the 40µg concentration of the vaccine.  Follow up with an anti-HBs titre test 4 to 6 weeks following the last injection to ensure it is greater than 10 IU/l, and that you have adequate immunity.

If you continue to remain a non-responder, you can try a series of as many as five intra-dermal injections, given every two weeks, using the 40µg concentration of the HBV vaccine.  Dose one consists of 0.10 ml of the 40µg/ml vaccine, followed by the same dose two 2-weeks later.  At that time an anti-HBs titre test would be drawn to check for immunity.  If there was not adequate immunity, a third-intra-dermal dose of the vaccine would be given two weeks later.  Anti-HBs titres would be checked every two weeks and the patient would be given another intra-dermal injection up to a total of 5 intradermal injections of the 40µg concentration of the HBV vaccine. Don’t forget to ensure that your anti-HBs titre is greater than 10IU/l.

Please note that the schedule for the series might vary depending on the study your doctor chooses to follow.  However, it is recommended that the higher concentration (40µg) of the hepatitis B vaccine be used for best results.

Baruch S. Blumberg Institute