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Category Archives: Living with Hepatitis B

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 Diagnosis & Monitoring, Living with Hepatitis B

HBsAg Levels Linked with Fibrosis in HBeAg-Positive Patients

Below is a publication from “Healio Hepatology, February 21, 2013 – HbsAg Levels Linked with Fibrosis in HBeAg-Positive Patients” , showing the correlation between HBsAg and HBV DNV virus levels and the risk of moderate to severe fibrosis in HBeAg positive patients.

Patients with hepatitis B who tested positive for hepatitis B e antigen were at increased risk for moderate-to-severe fibrosis with lower levels of hepatitis B surface antigen in a recent study.

Researchers evaluated serum samples and liver biopsy results from 406 treatment-naive patients with chronic hepatitis B. HBV genotype and hepatitis B e antigen (HBeAg) status were recorded along with levels of HBV DNA and hepatitis B surface antigen (HBsAg).

HBeAg-positive patients (n=101) had a higher mean fibrosis stage than HBeAg-negative patients (1.86 ± 1.18 vs. 1.40 ± 0.99; P<.001) and had greater levels of HBV DNA (7.06 ± 1.71 vs. 4.12 ± 1.67)and HBsAg (4.24 ± 0.9 vs. 3.53 ± 0.92) (P<.0001 for both). Investigators observed strong correlations between HBV DNA and HBsAg levels (r=0.44; P<.0001) and between fibrosis severity and HBsAg levels (r=0.43; P<.0001) among HBeAg-positive patients, but not among HBeAg-negative participants.

HBeAg-positive patients with moderate-to-severe fibrosis had lower HBsAg (3.84 ± 1.01 vs. 4.63 ± 0.58; P<.0001)and HBV DNA levels (6.47 ± 1.81 vs. 7.62 ± 1.40; P<.001) than those with mild or no fibrosis. HBeAg-positive patients with genotypes B, D or E had significantly higher HBsAg levels than HBeAg-negative patients, along with higher HBV DNA levels regardless of genotype.

Modeling analysis established an HBsAg cutoff of 3.85 log IU/mL-1 with a theoretical sensitivity of 100%, specificity of 86% and NPV of 100% for predicting moderate-to-severe fibrosis among HBeAg-positive patients with genotypes B or C. Investigators noted that the small cohort size used to establish this cutoff requires further validation to be clinically useful.

“To our knowledge, the current study is only the second to associate an HBsAg cutoff with the prediction of fibrosis severity in CHB patients,” the researchers wrote. “It will be of considerable interest to see whether the serum HBsAg and HBV DNA levels in the patients infected with different genotypes are significantly different from the mean values of the overall HBeAg-positive group, and if they will require the development of genotype-specific cutoffs, or whether a single cutoff is applicable to all HBV genotypes.”

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

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, Living with Hepatitis B

Checking In On Your Hepatitis B Related 2013 Resolutions

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It’s week two of 2013.  How are your New Years’ Resolutions going?  When you were making your resolutions, did you consider hepatitis B specific New Year’s resolutions?  Here are a few ideas…

  • Organize your hepatitis B lab data and make a table with the date of the blood draw and the associated blood test results. You’ll want to start by requesting copies of all of your labs from your doctor. Then you can generate data tables using Excel, Word or a pencil and paper table for your charted data.  It will help you visualize your HBV over time, and you may find your doctor likes to see both the lab results and your table of results.
  • Generate a list of questions for your next appointment with your liver specialist.  People get nervous anticipating what their doctor might say about their health. It is very easy to forget those important questions, so be sure to write them down. If the option is available, have a family member or friend attend the appointment with you. That will allow you to pay closer attention while your friend or family member takes notes for you.
  • Avoid the use of alcohol. Hepatitis B and alcohol is a dangerous combination. An annual toast to the New Year? Sure. Drinking daily, weekly or even monthly? Not a good idea.  Binge drinking? Dangerous. A recent study shows an increased risk for liver cancer among cirrhotic patients with HBV. Don’t let it get that far. If you have HBV and you are still drinking alcohol, seek the help you need to stop.
  • Exercise. Many people think that having a chronic illness precludes them from exercise. This is rarely the case, but if you have concerns, talk to your doctor. If you consistently exercise, keep up the good work. If you don’t, please start slowly and work your way up to a more strenuous routine, and follow general physical activity guidelines for adults. Join a gym or find an exercise buddy. Don’t compare yourself to others and work at your own pace. Set realistic workout goals. You don’t need to run a marathon. Brisk, daily walking is great, too. You may find that you experience both physical and emotional benefits, and if you exercise with friends, you’ll also benefit socially. Clinical and experimental studies show that physical exercise helps prevent the progression of liver cancer and improves quality of life. Get moving. It’s good for your overall health and specifically your liver!
  • Maintain a healthy weight by eating a well-balanced diet. This is a favorite on the New Year’s Resolution list for just about everyone with or without HBV. You can’t prevent or cure HBV with a healthy diet, but it does help, and it helps prevent additional problems like the onset of fatty liver or diabetes. If you’ve been following trending health problems, then you are well aware that fatty liver disease and type 2 diabetes are huge problems in the U.S. and are growing issues globally. Both fatty liver disease and type 2 diabetes can often be prevented with a healthy diet and regular exercise. If you are overweight, or make unhealthy choices, make a commitment to change this year. Start by avoiding fast foods, and processed foods. Cut down on fatty foods. Reduce the amount of saturated fats, trans fats and hydrogenated fats in your diet. Saturated fats are found in deep fried foods, red meats and dairy products. Trans and hydrogenated fats are found in processed foods. The liver stores excess dietary fat, and which can eventually lead to fatty liver disease. A fatty liver slows down the digestion of fats. If you have hepatitis B, you want to avoid any additional complications that may arise with fatty liver disease. Diabetes and HBV together can also be very complicated.  Your doctor won’t mind if you try to avoid “white foods”, or foods that that are white in color and have been processed and refined. This includes foods like white flour, rice, pasta, bread, crackers, cereal, simple sugars and high fructose corn syrup.  (Feel free to eat plenty of white cauliflower, turnips, white beans, etc) Avoid sugary treats and drinks. So what should you eat? Eat plenty of fresh vegetables, fresh fruits, whole grains and lean meats.  Go back to the basics! If you have specific questions about your diet, be sure to talk to your doctor.
  • Don’t worry, be happy… Easy to say, but not so easy to accomplish. Anxiety and depression associated with a chronic illness are challenging problems that may be short term, or can worm their way into nearly every aspect of your life. They can even create physical symptoms that may be confusing and may result in even more worry. Please talk to your doctor if you believe your anxiety or depression is something you are unable to manage on your own. Consider joining a support group where you can talk to others facing the same challenges. Personally I found the Hepatitis B Information and Support List a wonderful source of information and support. Chronic illness can feel very lonely – especially with a disease like HBV that has a stigma associated with it. Find a trusted confident with whom you can share your story.

Liver Cancer, Living with Hepatitis B

Aspirin Use Associated With Lower Risk of Developing Hepatocellular Carcinoma and Dying of Chronic Liver Disease

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HBF welcomes special guest bloggers, Vikrant V. Sahasrabuddhe, M.B.B.S., M.P.H., Dr.P.H and Katherine A. McGlynn, Ph.D, M.P.H. both researchers at the National Cancer Institute of the NIH, and study authors of the recent Journal of the National Cancer Institute publication.

Hepatocellular carcinoma (HCC) is the most common type of liver cancer.  New cases of HCC and deaths related to HCC have been increasing in the United States since the 1980s.  Most cases of HCC occur in individuals with chronic liver disease (CLD).  CLD is caused by chronic inflammation related to viral infection, excess alcohol consumption or other causes.  While HCC is relatively rare in the U.S., occurring in fewer than 10 per 100,000 persons per year, CLD is more common.  Unfortunately, CLD is among the top 10 causes of death in adults between the ages of 45 and 75 years.

In a new study from the National Cancer Institute, researchers investigated whether reduction of inflammation, through the use of non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, could reduce the risk of developing HCC or death due to CLD. The study was published in the Journal of the National Cancer Institute on November 28, 2012.

The researchers studied a cohort of over 300,000 men and women between the ages of 50 and  71 years who were enrolled in the NIH-AARP Diet and Health Study.  Aspirin and non-aspirin NSAID (for example Advil, Motrin) use was compared among persons who developed HCC or died from CLD and those who did not develop these outcomes.  In all, 250 study participants developed HCC and 428 died from CLD.  Almost three-fourths of the participants reported using aspirin and approximately one-half reported using non-aspirin NSAIDs.

The study found that participants who reported taking aspirin were 41% less likely to develop HCC, and 45% less likely to die from CLD than those who did not take aspirin. Use of non-aspirin NSAIDS did not reduce the risk of developing HCC, but did reduce the risk of dying from CLD by 26%. The researchers note that additional studies will be required to confirm these findings.

While this study will not lead to any immediate changes in clinical practice, it raises interesting new questions on the role of inflammation in risk for HCC.  Although the researchers took into consideration the effect of alcohol intake (a major risk factor for HCC) as well as smoking and body mass index, the study had no information on hepatitis B virus (HBV) or hepatitis C virus (HCV) status of the study participants.  In addition, NSAID use was only measured for the past 12 months, and the study had no information on the indication, duration or dose.  To partially overcome such limitations, results were analyzed after excluding participants who reported hypertension or cardiovascular disease at the beginning of the study. Those individuals might be taking a low-dose aspirin for a longer duration for the prevention of cardiovascular disease. The results were similar after excluding these participants, which suggests that the main results are likely valid regardless of the indication, duration or dose of aspirin.

The study is the largest population-based study to date to assess development of HCC and risk of death due to CLD in relation to NSAID use.  HCC and CLD involve chronic, long-term inflammatory changes in liver cells, which are caused by enzymes such as cyclooxygenases (COX).  One of the primary ways that NSAIDs modulate the risk of chronic inflammation is by stopping or inhibiting the action of COX enzymes; thus inflammatory changes that contribute to the development of CLD and HCC are reduced.  It is also speculated that aspirin may have other anti-inflammatory mechanisms.  NCI researchers are investigating these hypotheses through basic and translational research studies, as well as assessing the risk of developing HCC and dying of CLD in association with NSAID intake in other epidemiologic studies.

The full study is by:

Vikrant V. Sahasrabuddhe, Munira Z. Gunja, Barry I. Graubard, Britton Trabert, Lauren M. Schwartz, Yikyung Park, Albert R. Hollenbeck, Neal D. Freedman and Katherine A. McGlynn. Nonsteroidal Anti-inflammatory Drug Use, Chronic Liver Disease, and Hepatocellular Carcinoma. J Natl Cancer Inst (2012). Published online at: doi: 10.1093/jnci/djs452

Editorial Comments by W. Thomas London, HBF Senior Medical Advisor

In previous blogs I reported that several drugs commonly used to treat or prevent diseases or conditions other than liver cancer or chronic liver disease may also prevent these serious liver diseases.  These included propranolol used to reduce pressure in the portal vein; metformin used to treat diabetes; and statins for the lowering of cholesterol and reducing the risk of heart disease.

The above report adds aspirin to this list, but people with chronic hepatitis B or C should not begin taking aspirin immediately.  Aspirin may cause serious bleeding that is sometimes fatal.  In order for blood to clot, platelets (cell fragments in blood) must clump.  One of aspirin’s actions is to prevent platelets from aggregating (clumping). This action may be the main reason that regular aspirin may prevent heart attacks. Patients with CLD are already at risk of developing serious bleeding.  The take home message is that patients with chronic hepatitis B or C should consult their doctor before taking aspirin or any other drug.

About the blog authors:

Vikrant Sahasrabuddhe,M.B.B.S., M.P.H., Dr.P.H.

Associate Investigator in the Hormonal and Reproductive Epidemiology Branch and is currently detailed to the NCI from the faculty at Vanderbilt University School of Medicine.

Katherine A. McGlynn, Ph.D., M.P.H.

Deputy Chief, Hormonal and Reproductive Epidemiology Branch 

 

Hepatitis B Diagnosis & Monitoring, Living with Hepatitis B

Diagnosed With Chronic Hepatitis B? What Stage – HBeAg-Positive Chronic Infection / Immune Tolerant?

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Do you know the stage or phase of your chronic hepatitis B infection? Quite often people may refer to themselves as “hepatitis B carriers”. This statement by itself does not say anything about your chronic hepatitis B infection except that you are someone who tests positive for hepatitis B, and that you are HBsAg positive.

The names of the stages or phases of HBV may vary with the liver society or over the years, but they reflect the natural history of the virus. It can be helpful for your doctor to determine if you are in the immune tolerant, immune active or clearance phase, the inactive carrier phase, have developed HBe negative chronic hepatitis B, or if you are in an HBsAg negative phase. It may take a few months or even half a year to accurately determine the phase, and then your doctor can talk to you about possible treatment options and whether or not treatment would benefit you at this time.  Remember, hepatitis B is typically not an emergency, so try to relax with the process knowing you may not have immediate answers.

If you are acutely infected, you also follow the natural course of the virus in a matter of months (clearance of an acute HBV infection within 6 months is considered an acute hepatitis B  infection). However, at the end of 6 months, those acutely infected will have a resolved infection, and will no longer be HBsAg+. If you are chronically infected, you will pass through many of these phases too, but unfortunately you will likely never get to an HBsAg negative or resolved phase.  The journey from phase to phase is different for each person and the time it takes to move through these phases varies along with the amount of liver damage that occurs.

The importance of a good liver specialist or knowledgeable doctor  cannot be over emphasized. These stages and phases may seem simple to understand, but not everything is black and white. There are often “gray areas” between phases  or time between phases where bloodwork and other diagnostic data must be carefully monitored. Results vary with the patient. New evidence indicates there may be more damage occurring during this gray area than originally thought. There may be a missed opportunity for treatment during this time.

The importance of being actively involved in your hepatitis B care can not be overstated. Tracking your lab data over time and putting it into an excel spreadsheet or graphing the data may help you understand what is happening with the virus and may even be helpful for your doctor, so don’t forget to request copies of all lab results. You are more in control than you think. Get involved with your care!

Once you have confirmed that you have chronic hep B, you need further testing to determine your HBeAg status. Those with chronic hepatitis B  are either HBeAg positive or negative. If you are HBeAg positive, you have a higher hepatitis B viral load/HBV DNA and are more infectious to others. People who are HBeAg positive are either in the immune tolerant stage or the immune clearance stage or in a gray zone. Repeated labs over time will help clarify this for your doctor.

If you are in the immune tolerant stage, you are HBeAg positive and have a high viral load. You will have normal or very mildly elevated ALT (SGPT) levels and mild or no inflammation or damage to the liver. This is very common with chronically infected young children who may have viral loads in the millions or even billions. During this time the virus is actively replicating in the liver, but the immune system has not recognized the virus so it is not trying to kill the infected liver cells. It is not the replication of the virus that kills liver cells, causing liver damage, but it is the response of your immune system to these infected liver cells.

During the immune tolerant phase the virus is happily replicating, completely unchecked by the immune system, which accounts for the high viral load and lack of liver damage during this time. People in the immune tolerant phase may remain in this phase for a couple of years, or it may be decades.  Treatment is not typically recommended during this phase.  However, for those that have been in this phase for decades, treatment is something likely  recommended by a  liver specialist. There is also the concern that a person may be in a gray zone where ALT elevations and subsequent liver damage may be occurring but may be missed. This emphasizes the need for very careful monitoring by a knowledgeable doctor and the possible discussion for treatment.

What happens when you move into the HBeAg-positive chronic hepatitis /Immune Reactive / Immune clearance  phase? Read more. 

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.

Liver Cancer, Living with Hepatitis B

More on Metformin and Statins: Drugs Approved by the FDA for Other Purposes That May Prevent Liver Cancer

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From HBF’s expert Guest Blogger, Dr. Thomas London…

In an earlier blog, I pointed out that the available drugs to treat or prevent primary liver cancer (hepatocellular carcinoma, HCC) have been disappointing.  I noted that there may be drugs used for other purposes that may work against HCC.  The most promising of these was an old drug called metformin that has been used to treat type II diabetes for 17 years.  Now a new study on metformin provides the most intriguing results yet.

At the 2012 Digestive Disease Week meeting in San Diego, an enormous study from Taiwan was reported that encompassed almost all of Taiwan’s 23 million people. (I am indebted to Christine Frangou for her excellent report in Gastroenterology and Endoscopy News and have quoted from it extensively.) The investigators used the Taiwan National Insurance Database to identify all cases of HCC diagnosed from 1997 to 2008. There were 97,430 patients with HCC (most of whom would have had chronic hepatitis B). They were compared with 200,000 controls matched to the HCC cases by age, gender, and date of first physician visit.  Using the same database they linked all patients with diabetes and their treatment methods to patients with and without HCC.

From this they were able to show that patients with diabetes had a 2.3-fold increased risk of developing HCC.  In those patients who were taking metformin, however, HCC occurred about 20% less often than in those who were not treated with metformin. Furthermore, the longer patients took metformin, the lower their risk of HCC; about 7% lower for each year that they took the drug.

This study is not the final answer.  We don’t know why some diabetic patients were treated with metformin and some were not.  It is possible that the patients who did not take metformin had some unknown liver abnormality and were deliberately not treated with metformin.  Nevertheless, anti-tumor effects of metformin in experimental animals and in cell culture systems continue to be reported.  I will keep my eye out for more research on metformin and HCC and report it as it hits the medical press.

Statins are another group of drugs that are in common use. They were first approved by the FDA in 1987 to lower serum cholesterol levels and thereby prevent heart disease.  Statins inhibit an enzyme in the liver used to make cholesterol.  Several isolated reports suggested that statins might also help prevent HCC.  This month investigators at the Mayo Clinic in Rochester, Minnesota reported a meta-analysis (a statistical method to combine results from different studies) of all the reports in the medical literature of new cases (incidence) of HCC and exposure to statin therapy.  Ten studies reporting a total of 4,928 HCC cases in 1,459,417 patients were analyzed.  Overall, patients who were treated with statins had a 40% lower risk of developing HCC than those who were untreated.  The results varied from population to population. Asian populations which were more likely to also have chronic hepatitis B, had a 50% lower risk of developing HCC, while western populations had about a 30% lower risk.

At this time we do not know what the mechanism of a preventative effect of statins on HCC might be.  Nor do we know whether statins might have been withheld from patients with high cholesterol levels because they had a liver abnormality. It is likely, however, that more information on these issues will become available in the near future.  When that happens I will report it to you.

 

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.

 

Hepatitis B Advocacy, Living with Hepatitis B

Consider Viral Hepatitis Issues When you Vote

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Election Day is fast approaching, and while there are many important issues to ponder, don’t forget to consider the candidates’ positions on vial hepatitis and health care issues.  There are 435 seats in the House of Representatives on the ballot, along with 33 senate seats.  The National Viral Hepatitis Roundtable (NVHR) sent surveys to the House and Senate asking them their position on viral hepatitis funding, the Affordable Care Act, the syringe exchange ban, HHS strategic plan, and the Viral Hepatitis Testing Act. Surveys continue to be returned, but were updated October 24th to reflect new additions. To read the returned candidate responses, go to NVHR’s Candidate Survey .  If you don’t see your state’s candidate included in the collection of surveys, contact the candidate, educate them on viral hepatitis issues, and personalize the cause if you are able.  If you need help, contact Ryan Clary, Director or Programs, and ask him about your Congressional candidate’s position on viral hepatitis prevention and treatment efforts, and what you might do to help the cause. Be sure to get out there and vote – Tuesday, November 6th.

 

Baruch S. Blumberg Institute