Hep B Blog

Tag Archives: Research

Hepatitis B and Vitamin D

Vitamin D is essential for everyone, but how might vitamin D help those living with HBV? Vitamin D is especially important for children and older adults, as it aids in the body’s absorption and regulation of calcium and phosphorus, which helps form and maintain healthy bones and teeth.  Vitamin D is also a potent immune modulator, and aids in the prevention of hypertension, and cancer. Vitamin D levels appear to play a critical role in type I and type II diabetes, glucose intolerance, and metabolic disorders.  Studies have also shown a link between low vitamin D levels and NAFLD (Non-alcoholic fatty liver disease), independent of metabolic syndrome, diabetes, or insulin-resistance profile (for those without HBV). The lower the vitamin D level, the higher the risk for NAFLD, or fatty liver disease.  The liver plays such an integral part in digestion, regulation, storage, and removal of toxins – the list goes on.  You can’t live without it!  As a result, it seems logical that healthy levels of vitamin D would benefit those living with HBV, if adequate vitamin D levels help reduce the risk of NAFLD, metabolic syndrome, etc.

Vitamin D is a potent immune modulator.  It has been on the radar for the prevention and treatment of infectious diseases for years. If you are being treated for HBV, you may want to discuss the potential benefits of adding vitamin D to your current therapy.  It has been shown to benefit hepatitis C patients undergoing treatment.  There is currently a clinical trial in Israel looking into the possible benefits of adding vitamin D supplementation to hepatitis B patients undergoing Peginterferon, or treatment with nucleotide analogs.

While researching this blog, I ran across a couple references that mention Fanconi’s Syndrome and vitamin D.  This is interesting since Fanconi’s Syndrome may be acquired as a result of HBV treatment with tenofovir.  Fanconi’s Syndrome and supplementation with vitamin D is also mentioned on the Mayo Clinic site.  The problem is there are no studies that definitively discuss the benefits of vitamin D supplementation for those living with HBV.  I am no doctor, but there seems to be a connection between vitamin D and good liver health.

Start by talking to your doctor or liver specialist about the pros and cons of considering additional vitamin D in your diet. Request that your vitamin D levels be tested so you get a snapshot of your current levels. I had my girls’ levels checked.  They were adequate, but I regretted having them tested during the summer break when they are outside more often. I wonder how this reflects on their levels in the winter when they are rarely outside?  Food for thought.

The 25-hydroxyvitamin D (25(OH) D) blood test is used to measure serum levels of vitamin D. Normal serum levels, indicated by the Institute of Medicine (NIH), are 50 nmol/L (20 ng/mL) or greater.  Low levels are under 30 nmol/L (12 ng/mL).  See detailed charts for age specific requirements. There are all kinds of reasons for inadequate levels of vitamin D, so it is important to follow up with your doctor if your results are out of the normal range.  You may require additional testing.

It is important to maintain a balance and use common sense when considering supplementing your diet with Vitamin D.  Vitamin D is essential, but too much of a good thing can be dangerous to your health. Be sure to keep your doctor in the loop – especially if you are currently undergoing HBV treatment.

Check out Thursday’s blog for those looking for vitamin D details and sources.

The Hepatitis B Foundation’s Hepatitis B Clinical Trials Page

Did you check out Tuesday’s Hep B Blog, “Participating in HBV Clinical Trials” for those living with Hepatitis B?  It’s time to have a more in-depth look at the HBV  trial entries that are updated monthly on The Hepatitis B Foundation’s (HBF’s) Hepatitis B Clinical Trials web page. Roughly 350 trials out of the 112,278 clinical trials maintained by ClinicalTrials.gov pertain to HBV related studies.  The ClinicalTrials.gov site is a registry of trials that located in 175 different countries.  Changes to ClinicalTrials.gov are an ongoing process.

Each month the HBF’s Hepatitis B Clinical Trials web page is updated based on a thorough review of clinicalTrials.gov registry.   Trials that are new and are recruiting are added.  Completed trials are deleted, and modifications are made based on the “last updated date” of the each trial entry. All identified trials are active and currently recruiting patients. Modifications may include anything from additional site locations added to the trial, to new contact information, or even a change in protocol.  A few international trials are in an unknown state, but remain on our page until we hear word if the trial is completed, or no longer recruiting patients.  If you are local and interested, it is worth pursing to get the current status.

The page is divided into U.S. trials, International trials, Co-Infection trials, Pediatric trials, HBV & Liver Transplantation, HBV & Liver Cancer, and HBV Reactivation and Lymphoma. Some of these categories are more recent and were added to address other areas for those living with HBV.

Recently HBF has made an effort to include trials, within the country of origin for the trial, that not only treat HBV, but also monitor patients.  These long term studies may use new, experimental techniques to monitor HBV patients, or those at high risk for HCC.  There are also opportunities to participate in long-term studies that monitor patients and look for common factors, trends etc. among those living with HBV.  It’s another opportunity to meet with  cutting-edge liver specialists, and possibly even contribute by helping researchers determine factors that may cause HBV disease to activate, or worsen, or hopefully improve.

So have a seat at your computer and review HBF’s Hepatitis B Clinical Trials web page, or go to the individual section that interests you.  The trials listed contain the original title, the purpose, or basic description of the trial.  Due to logistics, the trial site is very important, which is why all entries contain the countries included in the site unless they are too great to list. Then they are listed as “international“. Contact information is also maintained and updated, with a link to email and phone contact info.  Most importantly is the NCT number (NCT followed by an 8 digit identifier), or ClinicalTrials identifier, which is how all trials are referenced in the ClinicalTrials.gov registry. By clicking on the NCT#, you will be linked to the trial of interest directly within ClinicalTrials.gov, where you can investigate the details of the trial and see if it is of interest, and whether or not you meet the criterion for participation.

Give it some thought and think about whether an HBV clinical trial is an option for you.  Discuss your ideas with your liver specialist, and confer with others in HBV support groups that may have experience with a drug, or past clinical trial experience.  Feel free to contact HBF with any questions you might have regarding clinical trials.

If you think of a way to make our clinical trials page more user-friendly, or trial categories that might be missing, be sure to leave a comment and let me know.  And if you happen to find an HBV trial that is recruiting, but is not listed, please be sure to let us know. HBF is here to help!

Participating in HBV Clinical Trials

Have you considered participating in hepatitis B clinical trial?   A clinical trial can be a great opportunity to take advantage of the latest advancements in HBV treatment and monitoring, typically without expense to the patient.  It can open doors and provide an opportunity to interact with liver specialists on the leading edge of treating HBV.  There are numerous clinical trials for hepatitis B offered all around the world, from adult to pediatric patient populations.

There are three testing phases that drugs go through before they are approved for use for by the FDA.  A fourth phase examines long-term use.  This is a rigorous process, costs hundreds of millions of dollars and takes 12-15 years before a drug is finally approved. Check out the animated Drug Discovery Time Line to get a better appreciation for the process.

A major advantage of participating in a clinical trial is that expensive treating medications, clinical monitoring, and lab work are typically provided without expense to the patient, and the patient is monitored throughout the process by experienced, participating liver specialists.

The next thing to consider is whether or not you are eligible for a particular trial.  There are various inclusion/exclusion criterion.  Some trials or studies are looking for patients that are treatment naïve, (patients who have not taken medications for HBV) while others are looking for patients that are treatment experienced, (patients who have taken particular medications for HBV) but may have failed on one treatment protocol, and might need “rescue therapy,” such as an antiviral to replace a previous antiviral where a resistance to the drug has occurred based on a viral mutation.  It varies with trial.

Other studies may be looking for candidates based on HBe status (positive or negative), degree of liver damage, or ALT or HBV DNA levels over a particular time period. You must first qualify before you consider participation in a trial or study, so be sure to check the qualifying criterion, and discuss with your doctor.

Naturally, each candidate will need to weigh the risks versus the benefits of receiving an experimental drug. Discuss the pros and cons with your doctor. Do you really need treatment for your HBV at this time? What are the possible short and long term side effects? Do you think you can manage them? You know your body best. What about the logistics?  Is there a need for frequent lab work?  Does it need to be done on site, or can blood be drawn at a local lab?  What happens when the trial is complete?  This is especially important when considering antivirals. Will you need to remain on the medication when the trial is complete?  Will you be financially responsible, and if so can you afford it?  Will participating in a trial exclude you from future trials?  What about resistance and cross resistance to future drugs? These are a few of the questions for which you need to think long and hard, and of course discuss them with your liver doctor and the participating specialist.

It also doesn’t hurt to ask other patients on HBV internet support groups.  You might well find someone with personal experience with the drug, keeping in mind that everyone responds somewhat uniquely to the same drug therapy. I have found these forums extremely helpful when considering a new drug.

The Hepatitis B Foundation is committed to maintaining monthly, updated clinical trial data available to friends living with HBV on our website.  We do much of the up-front work for you by sorting through the hundreds of trials available via clinicalTrials.gov, a registry of clinical trials.  We divide the data into unique treating situations that might benefit various patients, such as clinical trials for patients that live in the U.S. or internationally pediatrics, coinfected, candidates for liver transplantation, patients struggling with HBV related hepatocellular carcinoma, and HBV reactivation and lymphoma.  Most trials relate to the treatment of HBV, while some are observational studies, long term studies where patients are monitored over time.  Some relate back to treatment studies – durability of treatment or long term effects, while others study patients with HBV, and identifying factors that may cause the disease to activate or worsen, and are monitored via annual or bi-annual blood work and annual visits.  It varies with the trial.

So if you have HBV, consider your status. If you are a candidate for treatment, consider existing, approved treatments vs. participation in an HBV clinical trial. It’s up to you and your doctor to determine if a clinical trial is a good fit.

 

The Hepatitis B Community Loses Cherished Friend and Advocate

It is with great sadness and heavy hearts that we notify the hepatitis B community of the passing of Dr. Baruch S. Blumberg.  Dr. Blumberg died suddenly on Tuesday, April 5, 2011.  His discovery of the hepatitis B virus and invention of the first vaccine against hepatitis B, which resulted in the Nobel Prize for medicine in 1976, have been among the most important in the history of science and medicine.  In addition to serving as Senior Advisor to the President of Fox Chase Cancer Center, Dr. Blumberg co-founded the Hepatitis B Foundation and served the Foundation as a Trustee Distinguished Scholar.  His ongoing acts of support to the Foundation will always be remembered and admired.

“It has been one of the greatest professional privileges of my life to have known and to have worked with Dr. Blumberg.  He was a wonderful mentor to me, and to all of us at the Hepatitis B Foundation, who had the honor of knowing him.  His curiosity and enormous intellect was always so motivational.  He made it clear to all of us at the Foundation, how one life can do so much to benefit the world.  Nothing will be the same without him, but so much has changed because of him.  He will always be an example and inspiration for us all.” –  Dr. Timothy Block, President of the Hepatitis B Foundation

Please join us in remembering our dear friend, colleague, advocate and champion of the hepatitis B cause, Dr. Blumberg.  Our thoughts and prayers are with the Blumberg family.

Baruch S. Blumberg

1925-2011