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

The Hepatitis B Foundation’s Hepatitis B Clinical Trials Page

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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!

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

Participating in HBV Clinical Trials

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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.

 

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

Got Hepatitis B? Share Your Favorite Liver Specialist with the HBV Community

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Do you have a favorite liver specialist that you’d like to share with the Hepatitis B Foundation and friends living with HBV?  Friends with HBV live all over the globe, and we are interested in liver specialists with Hepatitis B treating experience from all over.  Pediatric patients are a special sub-population with special treating needs, too.  We’d love to hear from all of you!  Here’s what we’re looking for…

The Hepatitis B Foundation maintains a database of liver specialists that have experience treating patients with HBV.  Based on your recommendations, we would love to extend an invitation to your liver specialist to participate in our directory of liver specialists.  If your liver specialist replies, we will add his/her name to the list.

We’ve had some wonderful, new HBV friends on facebook from Africa and other continents, and we would encourage all of you to send us your liver specialist’s contact information.  Our international database is a little sparse, so we really need your input!  This would also include parents of children with HBV that are living abroad.  So, if you’ve got experience with a treating specialist that you’d like to share, you can be sure others will benefit from your advice.

Here is what the Hepatitis B Foundation needs to know:

  • Residing country
  • Adult or pediatric specialist
  • Liver specialist’s name and contact information  – including name, address, telephone number and email address (if available)
  • Anything else you’d like to share!

Email this important information to directory@hepb.org .  Please keep in mind that the information you provide is offered as a courtesy to others in the HBV community.  Your name will not be associated, and the addition of your physician does not make you responsible in any way.  This is not a physician referral service, but rather an opportunity for those living with HBV to share resources.  (Please note the disclaimer.)

Thanks to all who participate.  The entire HBV community benefits from your input!

 

Hepatitis B Diagnosis & Monitoring, Living with Hepatitis B

Choosing a Liver Specialist to Treat Your HBV

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Got HepB?  Which doctor is right for you?  Do you need a hepatologist, gastroenterologist (GI doctor), or an infectious disease doctor?  Is the patient an adult or child?  If you’re new to HBV, these specialty doctors are likely foreign to your doctor line-up, and weeding through the specialty titles and training can be confusing.   However, if you have HBV, it’s essential that you find a knowledgeable liver specialist to monitor and potentially treat your hepatitis B.

A hepatologist is a doctor that specializes in diseases associated with the liver.  Hepatology is a sub-specialty of gastroenterology.  This is an obvious choice for patients with HBV, but it may be difficult to find a hepatologist in your vicinity.

A gastroenterologist, or GI doctor, specializes in the function and disorders of the GI tract, which includes the esophagus, stomach, pancreas, intestines and the liver.  This covers a very broad spectrum of functions and diseases.  The key is to find a GI doctor that has experience treating patients with liver disease – specifically, viral hepatitis, and hepatitis B.  If your GI candidate spends much of his week performing endoscopies, he is likely not a good choice for a liver specialist.

Because hepatitis B is an infectious disease, it would seem logical that an infectious disease specialist would be the best choice.  However, this is not usually the case with hepatitis B, or viral hepatitis, but rather HIV and other infectious diseases.  Your best bet will most likely be a hepatologist or a GI doctor.

If the patient is a child, it is imperative that the child see a pediatric liver specialist.  Some of the best and brightest, cutting edge doctors are both pediatric hepatologists and GI docs.  Children with HBV are monitored and treated much differently than adults.  The labs look different, and the treatment protocols also differ.  You need a pediatric specialist.

Ultimately, the key is finding a liver specialist that has experience monitoring and treating patients with hepatitis B.  You need to ask the important questions.   How many patients are they currently monitoring and treating with hep B?  How is your doctor keeping abreast of the latest and greatest advances in the management of hepatitis B?  Does she attend conferences on viral hepatitis?

HBV is a chronic disease, so you are potentially entering into a long term relationship.  Be sure to ask questions that are important to YOU.  How are test results disseminated?  Are frequent visits required?  Is your doctor open minded – perhaps willing to consult with other experts treating patients with HBV?  It would be great if this specialist is affiliated with a large hospital or university center.  This may provide additional options such as clinical trials, should they become available.  Plus they tend to have a larger patient population, hence more case specific experience.

Typically, the need to visit your liver specialist is not that frequent, unless you are undergoing treatment.  Even then, much of the monitoring and follow-up are in the blood work, and much of that can be drawn locally, with the results sent to your liver specialist.  Some treatment protocols require more monitoring and blood work than others, but even so, it is typically for a short period of time.  This fact is significant, as it expands the size of your geographic circle of potential experts.

The Hepatitis B Foundation maintains a wonderful database of liver specialists for both adults and children.  From there you can check out your potential expert with members of HBV support groups that may have personal experience with your candidate.

Good luck choosing your liver specialist!

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

Got Hepatitis B? B Sure to Take Care of U!

As a mother of a child with hepatitis B, I was always concerned my child would transmit the virus to others.  One day a toddler came up and bit her in the finger and drew blood.  She was strapped into her stroller, and yet I felt guilty and fearful she might transmit the virus to “the biter”.  I rushed my child to the pediatrician, and immediately inquired about the safety of the other toddler.  He reminded me that that “blood is a two-way street for the transmission of infectious diseases”.   I should worry about MY child.   The other child was likely vaccinated since HBV vaccination is required in my state. I heeded his advice, and from that day forth I started thinking about the safety of MY child and others infected with HBV.

Fortunately, hepatitis B is a vaccine preventable disease, so that does ease concerns regarding the transmission of HBV to others.  A simple three shot HBV vaccine series does the trick.  There is no reason someone should NOT be protected against a vaccine preventable virus that is 100 times more infectious than HIV!   Stop feeling guilty, and start thinking about protecting YOU!

If you have HBV, Hepatitis A (HAV) can be very dangerous.   HAV is vaccine preventable.  A simple two shot series will keep all those with or without HBV safe from highly-contagious HAV.

Unfortunately, there is no vaccine for HCV or HIV.  If you are HBV+, a  co-infection is complicated and dangerous, and can result in significant liver damage.  The best way to combat infection from HCV, HIV and other infectious diseases is to use standard precautions.

Make standard precautions part of your everyday life.  Simple hand washing and proper avoidance of contact with someone else’s blood and body fluids is an easy way to avoid transmission of potentially life threatening illnesses, or any illness.  Cover open cuts with a Band-Aid.  Provide a barrier between someone else’s blood or body fluids, and any open wounds, sores, mucus membranes and orifices.  You don’t want to get infected with another blood borne pathogen!  Does this mean you need to look like someone out of a bio-hazard lab with goggles and gloves?  No!  Use common sense, and you can be safe without going overboard.   A simple barrier between you and someone else’s body fluids is the best way to avoid exposure.  Keep something like a clean diaper, towel or wrapped sanitary pad, in a plastic baggie, in your car, and on each level of your home.

Personal toiletries should be just that…personal.  Keep your toothbrush away from your sibling, friend or SO. Neatly dispose of used feminine hygiene products because it’s the right thing to do.  Don’t leave your razor or nail clippers lying around.  Sharp, personal objects really are a perfect transmission route for infectious disease.

Got HBV?  Remember, keep YOURSELF safe!  And the kid in the stroller… well she’s a teen, today.  Now there’s a whole new set of worries.

Baruch S. Blumberg Institute