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Tag Archives: HBV vaccine

Who’s at Risk for Hepatitis B? Learning the Hep B Basics

 

Are you or someone you know at risk for hepatitis B? You might be more at risk than you think, and since hepatitis B is vaccine preventable, it makes sense to get tested and vaccinated for HBV.  Hepatitis B is the number one cause of liver cancer worldwide. The survival statistics for liver cancer are particularly grim, with a relative 16,6% 5-year survival rate.  The hepatitis B vaccine also protects against hepatitis delta, the most severe form of viral hepatitis.

It is important to note that everyone is susceptible to hepatitis B. It does not discriminate.  It infects, babies, children, teens, adults and seniors. It has no racial or religious bias, though it is certainly more prevalent among certain ethnic groups –mainly because it is endemic to the homelands of these communities. For example, if you look at the prevalence map for hepatitis B, you will see that in most of the world, hepatitis B is at an intermediate, (2-7%) or high HBsAg prevalence (>8%) level.  Looking at the numbers, 2 billion people in the world, that’s 1 out of 3 people, have been infected with HBV and 257 million are chronically infected. That represents three-quarters of our world. Even if you aren’t living in these parts of the world, you may be traveling to some of these areas for work or pleasure, or perhaps your parents and other family members were born in HBV endemic areas.  Since there are often no symptoms for HBV, and screening and vaccination may be lacking in some populations, HBV is transmitted from one generation to the next, with many completely unaware of their HBV status – until it’s too late.

People at risk for hepatitis B include the following: (not noted in a particular order)

  • Health care providers and emergency responders due to the nature of their work and potential for exposure.
  • Sexually active heterosexuals (more than 1 partner in the past six months)
  • Men who have sex with men (MSM)
  • Individuals diagnosed with a sexually transmitted disease (STD)
  • Illicit drug users (injecting, inhaling, snorting, pill popping)
  • Sex contacts or close household members of an infected person (remember, you may not know who is or is not infected)
  • Children adopted from countries where hepatitis B is common (Asia, Africa, South America, Pacific Islands, Eastern Europe, and the Middle East) and their adopted families
  • Individuals emigrating from countries where hepatitis B is common (see above)
  • Individuals born to parents who have emigrated from countries where hepatitis B is common (see above)
  • ALL pregnant women – because infants are so vulnerable to HBV (90% of infected infants will remain chronically infected, and HBV is very effectively transmitted from infected mother to baby.)
  • Recipients of a blood transfusion before 1992
  • Recipients of unscreened blood and blood products – sadly an issue in many parts of the world.
  • Recipients of medical or dental services where strict infection control practices are not followed – sadly another issue in parts of the world.
  • Kidney dialysis patients and those in early renal failure
  • Inmates of a correctional facility
  • Staff and clients of institutions for the developmentally disabled
  • Individuals with tattoos and body piercings performed in a parlor that does not strictly adhere to infection control practices – it may be up to you to ensure proper infection control practices are followed.
  • People living with diabetes are at risk if diabetes-care equipment such as syringes or insulin pens are inadvertently shared.

The good news is that hepatitis B is a vaccine preventable disease. There is a safe and effective, 3-shot HBV vaccine series that can protect you and your loved ones from possible infection with HBV.  The earlier you are vaccinated, the better. In the US, a birth dose of the vaccine is recommended for all infants, since these little ones are most vulnerable to hepatitis. (90% of infected infants will live with HBV for life). HBV vaccination doesn’t give you a free-pass from other infectious diseases such as HCV or HIV, both without vaccines, so strict infection control practices should still be followed. However, HBV is a tenacious virus that survives outside the body for a week and is 50-100 times more infectious than HIV  3-5 times more infectious than HCV.  Plus the HBV vaccine is actually an anti-cancer vaccine, so why not get vaccinated?

Hepatitis B isn’t casually transmitted, but in the right scenario, it is effectively transmitted. You may think that situation may never come about for you, or for your loved ones –especially your little ones who are so vulnerable to HBV. Some people travel to exotic lands with unsafe blood supplies and poor infection control practices, and sometimes they get sick, or require emergency dental or medical services, so they may be put at risk. Most people have had a lapse in judgment – sometimes it’s a one-time thing, sometimes it lasts for years, but the net-net is that it’s unusual to find someone who has not engaged in some sort of high-risk activity, whether intentionally or unintentionally. If you are properly vaccinated to protect against hepatitis B, you can cross that concern off your list.

B sure. Get screened. if you do not have HBV, get vaccinated and be hepatitis B free. If you discover you have HBV, talk to your doctor and have him refer you to a liver specialist who can better evaluate your hepatitis B status and your liver health.

Expert Calls for Viral Load Testing in All Pregnant Women with Hepatitis B

Dr. Ravi Jhaveri, an infectious disease specialist at the University of North Carolina at Chapel Hill School of Medicine, talks to parents.
Dr. Ravi Jhaveri, an infectious disease specialist at the University of North Carolina at Chapel Hill School of Medicine, talks to parents.

Today, all pregnant women are routinely screened for hepatitis B, but a growing number of doctors say this single test doesn’t go far enough to protect the health of women and children.

In a commentary published in the medical journal Pediatrics,  infectious disease specialist Dr. Ravi Jhaveri calls for a mandatory second test in pregnant women infected with hepatitis B. This test would measure the amount of hepatitis B virus (HBV) in her body (called viral load).

When women have high viral loads, their newborns can become infected even if they are immunized at birth and treated with HBIG (hepatitis B antibodies) to prevent infection. Continue reading "Expert Calls for Viral Load Testing in All Pregnant Women with Hepatitis B"

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

 

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.

Why Give the Hepatitis B Vaccine to Infants?

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.

 

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

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.

Options for HBV Vaccine Non-Responders

 

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.

Why Vaccinate Infants Against Hepatitis B?

Sadly, out of all age groups, it is infants and very young children that are at the greatest risk for acquiring a chronic, life-long infection with hepatitis B.  In fact 90% of babies exposed to HBV will become chronically infected, and will live with the virus for the rest of their lives.  This includes mother-to-child transmission, and horizontal transmission from close contacts.  This is why the first dose of the hepatitis B vaccine is recommended before leaving the hospital.  The vaccine is safe and effective.  Choosing to vaccinate is an option those of us with HBV infected children would have LOVED to have.

Hepatitis B is a silent disease.  Forty percent of people living with HBV have no idea how they became infected.  Others have not yet been diagnosed.   Many likely acquired it at birth, or early exposure, and have had the virus smoldering for decades.  They may find out about it in routine blood tests, or from the Red Cross following a blood donation.  Hepatitis B is non-discriminating, although it is more prevalent in certain high risk groups.   Sometimes being part of a high risk group is as simple as having a parent born in a country where HBV is endemic.  Hepatitis B is 100 times more infectious than HIV, and yet many people say they would get vaccinated against HIV if a vaccine existed.  Why not hepatitis B?

So why have your infant vaccinated at birth?  It just makes sense.  How can you be assured all house-hold contacts are not infected?  War heroes get infected, as do health care workers, and other loving family members – mommies, daddies, grandparents, aunts, uncles, and cousins.  Parents go to work, and little ones go to day care.  They play at the neighbor’s house or with friends at pre-school.  Blood spills occur and sometimes they’re not properly managed, or even noticed.   Boo-boo’s come uncovered and little friends touch.  Sometimes “love-bites” are exchanged much to the dismay of parents.  Even the most vigilant parent is going to miss something.   HBV is not transmitted casually, but the possibility of exposure cannot be denied – especially at such a young age.

Hepatitis B is a poster-child for infant vaccination.  It is a tenacious virus, and there is no true cure.  If you are a pregnant woman, be sure you are tested for hepatitis B during your pregnancy.  If you are HBV positive, break the cycle One in five at-risk babies in the U.S. may NOT be receiving the necessary treatment, so SPEAK UP and ensure your baby receives prophylaxis treatment at birth.  Complete the vaccine series and have your baby tested for HBV at his one-year checkup to ensure he is protected.

If you are not HBV positive give yourself piece-of-mind.  When your baby is born, be sure to have her vaccinated before you leave the hospital, and give her a lifetime of protection against hepatitis B.