Hep B Blog

Category Archives: Hepatitis B Treatment

HBV Journal Review – August 2013

HBF is pleased to connect our blog readers to Christine Kukka’s monthly HBV Journal Review that she writes for the HBV Advocate. The journal presents the
latest in hepatitis B research, treatment, and prevention from recent academic and medical journals. This month, the following topics are explored:

*First Clinical Trial Using “RNA Interference” for Hepatitis B Begins
*Why Do Some People Clear HBsAg After Years of Chronic Infection?
*Longer Antiviral Treatment Urged after Seroconversion to Prevent Relapse
*Federal Officials Dramatically Undercount Liver Disease Deaths in the U.S.
*More Women Than Men Retain Protection Against Hepatitis B After
*Immunization Hepatitis B Cirrhosis Declines in China, But Alcohol-related
*Cirrhosis Rises Hepatitis E Vaccine Development Shows Promise
*Tenofovir Most Effective Antiviral Treatment in HIV-HBV Coinfected Patients
*Study Confirms Coffee Protects the Liver in European Populations
*Hepatitis C Is Also a Risk for Southeast Asians, Including Women
*In Small Trial, Chinese Herbal Medicine Reduces ALT Levels

HBV Journal Review
August 1, 2013
Volume 10, Issue 8
by Christine M. Kukka

First Clinical Trial Using “RNA Interference” for Hepatitis B Begins

A ground-breaking approach to hepatitis B treatment, which manipulates RNA messengers to halt viral replication, has begun its first human clinical trial. If successful, this approach would be a paradigm shift in treatment, possibly re- placing interferon and antivirals.

In animal trials, reported in the May 2013 journal Molecular Therapy, RNA interference (RNAi) treatment reduced hepatitis B surface antigen (HBsAg) levels to undetectable within 24 hours in mice and the antigen remained undetectable for nearly a month.

RNAi treatment works by destroying or “silencing” the molecular messengers that carry im- portant genetic information to the hepatitis B virus (HBV) antigen/ protein factories. Without the critical information that messenger RNA molecules carry, these antigen factories shut down and HBV reproduction de- clines dramatically.

Early RNAi research found that RNA silencing worked extremely well in the liver, but the challenge has been to create a formula and delivery system to target hepatitis B antigens in liver cells without affecting other important cells.

Arrowhead Research Corp. found that when the small RNA interrupters are linked to cholesterol, they target liver cells extremely well, and the addition of special polymers helps the gene silencing process. Arrowhead designed an intravenous formula, called ARC-520, that is utilized in its Phase 1 trial.

The hope is that when the viral load is dramatically reduced, the body’s immune system can gain the upper hand and eradicate the infection on its own.

In addition to its mouse trial, a similar trial involving an HBV infected chimp with an extremely high viral load also led to rapid reduction in HBV DNA and a 90% reduction in another hepatitis B antigen—the hepatitis B “e” antigen (HBeAg).

The clinical trial of ARC-520 (which uses a Dynamic Polyconju- gate delivery platform and includes two distinct RNA silencing agents that should shut down hepatitis B anti- gen reproduction) in humans is taking place in Melbourne, Australia. It is a randomized, double-blind, placebo- controlled trial. Each group of six healthy volunteers will receive either a placebo intra- venous injection or a single dose of ARC- 520…
Continue reading about this and additional studies…

 

HBV Journal Review – July 2013

HBF is pleased to connect our blog readers to Christine Kukka’s monthly HBV Journal Review that she writes for the HBV Advocate. The journal presents the
latest in hepatitis B research, treatment, and prevention from recent academic and medical journals. This month, the following topics are explored:

*Experts Describe When to Treat Pregnant Women with Antivirals
Does pregnancy worsen hepatitis B?
When should pregnant women be treated?
Which antivirals are safe to use during pregnancy?
What if women have elevated ALTs before becoming pregnant and have never         been treated?
What about women with normal ALTs and high viral loads?
Is it safe to use antivirals during the entire pregnancy?
Monitoring recommendations after delivery
Can a woman taking antivirals breastfeed?
* Half of Patients Treated Long-Term with Tenofovir Lose HBeAg
*Even Patients with High Viral Load Lose HBeAg with Tenofovir
*New Type of Interferon Effective in Phase 2 Hepatitis B Trial
*Majority of Hepatitis B Patients Have Vitamin D Deficiency
*But Patients with Healthy Vitamin D Levels Are More Likely to Clear HBsAg
*Activists Develop a National Plan to Eradicate Hepatitis B in the U.S.
*New Guidelines Urge Britain’s Doctors to Improve Hepatitis B Care
*Measuring HBsAg Levels May Identify Fibrosis and Avoid Liver Biopsies
*HBsAg Levels May Also Predict Cancer Risk in HBeAg-negative Patients

HBV Journal Review


July 1, 2013, Vol 10, no 7
by Christine M. Kukka

Experts Describe When to Treat Pregnant Women with Antivirals
Two U.S. hepatitis B experts have crafted guidelines for doctors to use when deciding when to treat pregnant women infected with the hepatitis B virus (HBV) with antivirals in order to safeguard the women’s health and prevent infection of newborns.

More than half of new hepatitis B infections result from mother-to-child (vertical) transmission and despite immediate immunization and administration of HBIG (hepatitis antibodies), about 30% of infants born to women with high viral loads become infected. Additionally, women who want to become pregnant may already be treated with antivirals because of liver damage.  There is little medical guidance on whether treatment is safe over the entire pregnancy.

Does pregnancy worsen hepatitis B? Generally it does not unless the woman has cirrhosis (severe liver scarring.) Studies show a pregnant woman’s viral load generally does not increase over a pregnancy, but after the baby is born and the woman’s hormone levels change (akin to a sudden decline in steroids), some women experience a “flare” and their alanine transaminase (ALT) levels may increase due to moderate liver cell damage. Because of these flares, doctors must monitor new mothers carefully for several weeks after childbirth.

When should pregnant women be treated? Starting in the second or third trimester of pregnancy, antiviral treatment is recommended when women have high viral loads—exceeding 1 million copies per milliliter or 200,000 international units per milliliter. However, if women are already receiving antiviral treatment when they become pregnant, treatment should probably continue over the pregnancy to prevent worsening liver disease.

Which antivirals are safe to use during pregnancy? The experts recommend tenofovir (Viread) in the event the woman continues to need antiviral treatment because this drug has a very low rate of drug resistance, or telbivudine (Tyzeka). Both have been shown to be safe and cause no birth defects when used in pregnant women infected with HIV or HBV.

Continue reading about this and additional studies…


High HBV Viral Load Tied to Low Serum Vitamin D Levels

An interesting study published in Healio Hepatology:  “High HBV viral load tied to low serum vitamin D levels” discusses the relationship between the HBV viral load and vitamin D levels. In fact is shows seasonal fluctuations of HBV viral load associated with vitamin D levels. Vitamin D has been on the radar for years, but this interesting correlation between HBV virus flucuations and vitamin D levels warrants additional research to investigate how adequate vitamin D levels can positively impact treatment for those living with chronic HBV. Please refer to earlier blogs, Hepatitis B and Vitamin D and Got HBV? Adding Vitamin D to Your Diet for additional information.  As always, please talk to your doctor and have your serum vitamin D levels checked before making any drastic changes to your diet or supplements you may be taking. Don’t forget that vitamin D is the sunshine vitamin, so be sure to keep in mind the impact of the seasons on your levels. 

Patients with chronic hepatitis B who also were vitamin D deficient had significantly higher HBV DNA levels than patients with adequate vitamin D concentrations in a recent study.

In a retrospective study, researchers measured the serum levels of 25-hydroxyvitamin D (25OHD) in 203 treatment-naive patients with chronic hepatitis B seen between January 2009 and December 2012. Patients with 25OHD levels less than10 ng/mL were considered severely deficient, levels below 20 ng/mL were considered deficient, and levels of 20 ng/mL or greater were considered adequate. Patients’ samples were collected upon initial presentation, except 29 participants whose samples were taken at antiviral therapy initiation.

The mean 25OHD concentration for the cohort was 14.4 ng/mL. Forty-seven percent of participants were considered 25OHD deficient; 34% were severely deficient. 25OHD levels were similar between Caucasians (14.38 ng/mL) and non-Caucasians (14.59 ng/mL) (P=.7).

An inverse correlation was observed between levels of HBV DNA and 25OHD (P=.0003). Multivariate analysis indicated that HBV DNA was strongly predictive of low 25OHD levels (P=.000048), and vice versa (P=.0013). Patients with HBV DNA levels less than 2,000 IU/mL had 25OHD concentrations of 17 ng/mL; those with 2,000 IU/mL or higher had concentrations of 11 ng/mL (P<.00001 for difference). Participants who tested positive for hepatitis B e antigen (HBeAg; n=26) had significantly lower 25OHD levels than HBeAg-negative participants (P=.0013); this association was significant only under univariate analysis.

Investigators also noted fluctuations in HBV DNA and 25OHD levels according to season. Significantly lower HBV DNA levels were observed among samples taken during spring or summer than in autumn or winter (P=.01).

“The present study demonstrates a profound association between higher levels of HBV replication and low [25OHD] serum levels in chronic hepatitis B patients,” the researchers wrote. “At least in patients without advanced liver disease … HBV DNA viral load appears to be the strongest determinant of low [25OHD] serum levels. … Future studies to evaluate a therapeutic value of vitamin D and its analogs in HBV infection may be justified.”

HBV Journal Review – June 2013

HBF is pleased to connect our blog readers to Christine Kukka’s monthly HBV Journal Review that she writes for the HBV Advocate. The journal presents the
latest in hepatitis B research, treatment, and prevention from recent academic and medical journals. This month, the following topics are explored:

• U.S. Doctors Failing to Treat Patients Who Need Treatment
• Doctors Say Poor Training and Limited Resources Contribute to
Substandard Care • More Proof—Many Patients with Slightly Elevated ALTs
Have Fibrosis • Tenofovir Reduces Viral Load in HBeAg-Positive Patients
Faster than Entecavir • Researchers Find Tenofovir Does Not Damage
Kidneys • Tenofovir and Entecavir Highly Effective—If Taken as
Prescribed • Family History of Liver Cancer Boosts Cancer Risk to 15.8%
Among HBV-Infected • Vitamin D Deficiencies Found in People with High
Viral Loads • More Evidence Shows Breastfeeding Does Not Transmit HBV
Infection • Cesareans Do Not Reduce Mother-to-Child HBV Infection
• 2% of HBV Genotype D Adults Lose HBsAg Annually

HBV Journal Review

June 1, 2013, Vol 10, no 6
by Christine M. Kukka

U.S. Doctors Failing to Treat Patients Who Need Treatment
Fewer than 50% of patients infected with the hepatitis B virus (HBV) who need treatment get antivirals or interferon from their primary care doctors and fewer than 70% of patients who go to university liver clinics get appropriate treatment, according to research presented at the Digestive Disease Week medical conference held in Orlando in May.

Stanford University researchers conducted a real-life study to see what percentage of 1,976 hepatitis B patients treated in various clinical settings over four years received treatment. They used current medical guidelines when evaluating whether patients received appropriate treatment.

Continue reading about this and additional studies…

 

 

 

 

 

 

 

 

 

 

Diagnosed with Chronic Hepatitis B? What do the HBe Blood Tests Mean?

Your liver specialist has informed you that you have a chronic hepatitis B infection, and that he wants to run additional blood work so he can learn more about your HBV. Some of this blood work may need to be repeated over a period of time, but over the next 6 months or so, your doctor will determine whether or not you are a good candidate for treatment.  Regardless, he will definitely want to continue monitoring. Remember, treatment is important, but rarely an emergency, so be patient.

Now you need additional lab work to determine your HBe status, which will tell you whether or not you are HBeAg and HBeAb (anti-HBe) negative or positive. This reveals a great deal about your HBV such as whether or not the virus is replicating, and how infectious you are to others.

At this point, it is helpful to have a little background on antigens and antibodies.  An antigen is a foreign substance in your body that evokes an immune response. This may include viruses, bacteria or other environmental agents such as pollen or a chemical. In this case, it is the HBV e antigen. Your previous hepatitis B panel tested for the surface antigen, or HBsAg.

Antibodies are produced as a result of an immune system response to antigens. These antigen/antibody pairings are unique. An antibody response can be generated as a result of an immune response to an actual infection, or as a result of vaccination.  An uninfected person vaccinated against hepatitis B will generate an immune response, or surface antibody (HBsAb, or anti-HBs) to the HBV vaccine.

The hepatitis e antigen, or HBeAg, is a marker of an actively replicating HBV virus infection. Those with a positive HBeAg have active replication in their liver cells, more of the virus circulating in their blood, and as a result, they are more infectious, with a higher likelihood of transmitting HBV to others.  Most often, when a person is HBeAg positive, they tend to be HBeAb negative and vice-versa. This active, replicating phase may go on for weeks, as in the case of an acute infection, or for years, or even decades in those chronically infected.

Eventually most move into a non-replicative stage. During this time, e antigen (HBeAg) is no longer in the blood, and the anti-HBe antibody (HBeAb) is generated and appears in blood work. This HBeAg serconversion, or loss of HBeAg and the gaining of the antibody, HBeAb, can happen due to treatment, or spontaneously without treatment. Entering this stage is typically a good thing, and is often a goal of treatment.  However, monitoring by your liver specialist bi-annually or at least annually is essential, even if you have had an HBeAg serconversion years ago and are considered in the non-replicative phase.

HBV is complicated, and sometimes you may relapse. In other words, you may seroconvert losing HBeAg and gaining the HBeAb antibody, but it may not be durable, and you may have an HBeAg reversion to an actively replicating stage where you are once again HBeAg positive and HBeAb negative.  Years ago they called it “flip-flopping”.  This possibility is one of many reasons why regular monitoring by your liver specialist is so important.

The other possibility is the development of HBe-negative hepatitis B, which is the result of hepatitis B mutations. These precore or core promoter mutations replicate without generating the HBe antigen. However, they are actively generating the virus, though typically not at the levels of those with HBeAg positive HBV.  Once again, it is critical to continue regular monitoring by your liver specialist, so you are sure you have not begun active generation of HBe negative mutations.

Additional blood work ordered by your liver specialist will further clarify your HBeAg and over-all HBV status, and whether or not treatment may benefit you.

More next time…

Diagnosed with Hepatitis B? Do You Need Treatment?

When people learn they are infected with hepatitis B, the first thing they want to know is “what can I take to get rid of this disease?” It can be complicated, and what can be even more difficult to understand is that during different stages of the disease there may be absolutely no benefit from currently available treatments.

Just diagnosed with HBV? Are you acute or chronic? 

First, if you have just been diagnosed with HBV, it is imperative that you determine if you have an acute or chronic infection. If you have an acute, or new infection, then it is important to know that very few people require any sort of treatment. Just be sure you are being monitored by your doctor, and take good care of your health and be sure to prevent transmission to others during this time.

Chronically infected, now what?

If your doctor determines you are chronically infected, then you will need additional information to determine what your next steps should be.

Remember that unless you display urgent symptoms, such as jaundice, or a bloated abdomen, or severe illness, you really can wait a few weeks, or even a few months, to see a liver specialist. Many people panic if they are unable to see a liver specialist immediately.  Relax, find a good doctor, learn what you can about hepatitis B, and take care while you wait.

How will you be evaluated?

Your liver specialist will do a complete work-up on you. He will perform a physical examination, get a complete medical history, and he will run additional blood tests to learn more about your hepatitis B status and your liver health. He may also get a baseline ultrasound or perform other diagnostic imaging procedures to gain more data so he can make a decision whether or not you would benefit from treatment at this time.  Some of the blood work may need to be repeated over a period of time before your doctor decides whether or not to move forward with treatment. Do not beg your doctor for treatment. Waiting and watching is sometimes the smartest thing to do.  Treatment is rarely an emergency. Time is on your side, so please be patient.

What can you do while you wait?

This is a good time to look at some of your personal lifestyle choices and consider some basic changes that might benefit you at this time. Avoid alcohol, and stop smoking. Focus on eating a well-balanced diet filled with fresh vegetables, fruit, whole grains and lean meats. Avoid fast and processed foods when possible. They may contain trans fats, partially hydrogenated fats, high fructose corn syrup and other less desirable “ingredients”. Don’t’ forget to get everyone in the household screened and vaccinated against HBV if you have not already done so.

What’s next? Tune in next time to learn about some of your blood work…

Does Your Sex Life Interfere With Organ Donation? A Hepatitis B Perspective

Giving or receiving the gift of life through organ donation is truly a gift. This week’s story – “CDC’s proposed guidelines for transplants say two sex partners is too many for top-notch organ donors ” may well jeopardize the availability of this precious gift to those in need.

For those living with HBV, this dilemma is especially disheartening.  With organ donation highly unlikely due to their HBV status, those living with HBV also face the possibility of requiring a liver transplant due to end-stage liver disease or HCC.

Organs for donation don’t come easily.  These proposed guidelines are limiting.  The question is, are these guidelines even realistic?  Dr. Harry Dorn-Arias, a transplant surgeon at the Univeristy of Virginia told MSNBC, said it best: “With the new guidelines, every college student in America will be high-risk”. Perfectly healthy, young candidates may choose to waive their decision to donate their organs because the guidelines seem so… judgmental. They might not even consider the act of donation.

And who will be out there to ensure that the now smaller subset of potential donors isn’t lying, and who will update the information annually? Will the Department of Motor Vehicles (DMV) be quizzing you on your sexual activities when you choose one way or the other to check the organ donor box for your license? If you’re sixteen and standing there with your mom at the DMV, are you going to take a stand and not be an organ donor because you have multiple sex partners, and mom doesn’t even know you’re having sex?  (Just went through the whole DMV process, so it’s fresh in my mind).  What if you are completely monogamous, but your partner is not? Do you have high-risk organs due to association?  And what if you are considering a life-saving, living related donation for your wife, but you’re afraid to tell her you’ve had multiple sexual partners for the last 10 years of the marriage? If you’ve been lying the last 10 years, why stop now? What if you had a very active sex life, but settled into a happy monogamous relationship, but forgot to update your organ donor card?  Although there’s a little levity thrown in here, these scenarios are not that far-fetched.

When you are in need of an organ, and you are fortunate to find a match, you have to assume there will be risks involved in the process.  Naturally you want the safest organ available, but there is not the time or the medical testing available to screen for every medical conceivable complication that might result in a failed transplant. At some point there has to be a leap of faith. Personally I would choose the “high-risk” organ from a healthy 20 year-old with 5 sex partners last-year, over no organ at all.

It’s all about risks vs. benefits.  Slashing the pool of potential donors based on the number of sexual partners is riskier than having no choice from a much smaller, reduced pool filled with many of the same unknown variables.  The donor pool isn’t necessarily safer, it’s just smaller.

Organ donation truly is a gift. If you are living a life style that you know to be high-risk, or if you knowingly have a disease that will put a recipient at risk, then do not donate.  Otherwise, carry your organ donor card with pride and check the box “yes” next time you’re at the DMV.

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.