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Category Archives: Hepatitis B Diagnosis & Monitoring

The Medical Community Wakes Up to a Dangerous Threat to People with Hepatitis B – Coinfection with Hepatitis D

hep DBy Christine Kukka

In the U.S. and around the world, the medical community is finally acknowledging a hidden threat to people with hepatitis B – a virulent liver coinfection that requires the presence of the hepatitis B surface antigen (HBsAg) to survive.
Hepatitis D (Delta), which causes the most severe liver infection known to humans, infects between 15 to 20 million people worldwide and an estimated 20,000 people living with chronic hepatitis B in the U.S.
For years, health officials assumed hepatitis D did not threaten Americans and occurred primarily in Central Asia and Sub-Saharan Africa. However, recent U.S. Centers for Disease Control and Prevention (CDC) studies found 4 to 5 percent of Americans with chronic hepatitis B are also infected with hepatitis D.
As a result of these findings, researchers including Hepatitis B Foundation‘s Medical Director Dr. Robert Gish, are now pushing medical organizations to establish hepatitis D testing and monitoring guidelines so doctors will start testing patients for this dangerous liver disease.
Recently, the foundation sponsored a webinar, attended by dozens of healthcare providers, patients and officials from around the world, in which Dr. Gish outlined whom should be tested for hepatitis D, and how it should be treated. A new webinar that examines hepatitis D prevalence in the U.S. is scheduled for 3 p.m. (EST), Wednesday, June 28. To register for the webinar click here.
How do people get infected with hepatitis D? Infection occurs when people are exposed to blood and body fluids from someone with an active hepatitis D infection. Basically, they get both hepatitis B and D in one exposure. This is called an acute coinfection. Some healthy adults are able to clear both infections, but they often experience serious liver damage during the clearance or recovery phase.

Another way to become infected is if someone infected with chronic hepatitis B is exposed to someone with hepatitis D. This is called a superinfection, and in 90 percent of cases, people with chronic hepatitis B will also develop chronic hepatitis D.

Who is at risk of hepatitis D? Anyone with chronic hepatitis B who themselves or their family comes from Sub-Saharan Africa, China, Russia, Middle East, Mongolia, Romania, Georgia, Turkey, Pakistan and the Amazonian River Basin should be tested. Hepatitis D rates in some of these countries can reach up to 30 percent in people infected with chronic hepatitis B.

Banner CurveWhat medical conditions suggest hepatitis D? Anyone with chronic hepatitis B who is not responding to antiviral treatment, or who has signs of liver damage even though they have a low viral load (HBV DNA below 2,000 IU/mL) should be tested. Fatty liver disease (caused by obesity) and liver damage from alcohol or environmental toxins should be ruled out before testing for hepatitis D.
Often, people with hepatitis D have low viral loads (even if they are hepatitis B “e” antigen HBeAg-positive), but they have signs of liver damage, including elevated liver enzyme (ALT/SGPT) levels.

Do hepatitis B antivirals work against hepatitis D? No. The hepatitis D virus (HDV) is structurally different from the hepatitis B virus (HBV) and does not respond to tenofovir and entecavir used to treat hepatitis B. Hepatitis B antivirals will lower HBV DNA, but they don’t reduce HBsAg, which HDV need to thrive and reproduce.

How is hepatitis D treated? The only proven hepatitis D treatment is pegylated interferon. Interferon cures hepatitis D 15 to 25 percent of the time after one year of treatment. Once interferon clears hepatitis D, doctors treat patients who continue to be infected with HBV with antivirals. There are dozens of research companies now looking into hepatitis D treatment, and if researchers can find a cure for hepatitis B that eradicates HBsAg, it will also be effective against hepatitis D.

How should people with hepatitis D be monitored? According to Dr. Gish, doctors should:

  • Monitor patients’ ALT/SGPT and liver function at least every six months
  • Perform an ultrasound of the liver and conduct a liver cancer biomarker panel (including AFP, AFPL3% and DCP) every six months;
  • And, perform viral load (HBV DNA) and HDV RNA testing every six months.

How is hepatitis D prevented? The hepatitis B vaccine prevents hepatitis D infection, as does use of safe sex and safe injection practices. According to Dr. Gish, all hepatitis B-positive pregnant women should be tested for hepatitis D if they or their families are from a country with high rates of hepatitis D, or if they have signs of liver damage — even if they do not come from a region with high hepatitis D rates.

If a pregnant woman is infected with either hepatitis B and/or hepatitis D, immunizing her newborn with the first dose of the hepatitis B vaccine within 12 hours of birth and giving the baby a dose of HBIG (hepatitis B antibodies) will prevent both infections.

Bottom line, if you are infected with chronic hepatitis B, you should be tested for hepatitis D if:

  • You or your family comes from a region with high rates of hepatitis D; and/or
  • You have a low viral load, but you continue to have signs of liver damage, indicated by elevated ALT/SGPT or an ultrasound exam of your liver, if your doctor has ruled out fatty liver, NASH or alcohol-related liver damage.

Talk to your doctor about getting tested. Click here for a hepatitis D fact sheet to give to your doctor and click here for a patient-oriented fact sheet. An affordable hepatitis D test has recently become available in the U.S. For more information, click here.

  • Find answers to frequently-asked-questions about hepatitis D here.
  • To watch the webinar featuring Dr. Gish discussing the hidden, hepatitis D epidemic, click here.

When Can Hepatitis B Patients Stop Taking Antivirals? Experts Finally Have Some Answers

Image courtesy of foto76 at FreeDigitalPhotos.net
Image courtesy of foto76 at FreeDigitalPhotos.net

By Christine Kukka

With the help of antivirals, many patients today have undetectable viral load (HBV DNA), a relatively healthy liver and cleared the hepatitis B “e” antigen (HBeAg). So when can they consider stopping their daily entecavir or tenofovir pill?

For years, experts have admitted the endgame of antiviral treatment has been “ill-defined.” While antivirals reduce viral load and the risk of liver damage, they rarely cure people. Recently, after years of observing patients and with the help of better diagnostic tools, experts are getting better at identifying when might be safe to stop.

Historically, in addition to reducing viral load to undetectable levels, the goals of antiviral treatment were:

  • Triggering HBeAg seroconversion: About 21 percent of HBeAg-positive patients with liver damage treated with either tenofovir or entecavir for 12 months are able to lose the hepatitis B “e” antigen (HBeAg) and develop the “e” antibody (HBeAb). This HBeAg “seroconversion” indicates the immune system is fighting the infection and slowing viral replication.
  • And reducing liver damage and even clearing the hepatitis B surface antigen (HBsAg): About 1-3 percent of patients treated with antivirals lose HBsAg after years of treatment. This is called a “functional cure.” Unfortunately, if you have HBeAg-negative hepatitis B, only 1-2 percent of you will lose HBsAg after five to eight years of antiviral treatment.*

If you are among the lucky few who achieve HBeAg seroconversion or clear HBsAg, when is it safe to stop your daily antiviral? Here are the newest guidelines detailing when it may be safe to stop from the 2017 European Association for the Study of the Liver (EASL).

Image courtesy of Taoty at FreeDigitalPhotos.net
Image courtesy of Taoty at FreeDigitalPhotos.net

When is it safe to stop antivirals after you’ve achieved HBeAg seroconversion? Stop too early, and HBeAg can reappear. EASL recommend non-cirrhotic patients who experience HBeAg seroconversion and continue to have undetectable HBV DNA for 12 months longer can stop antivirals, as long as there is frequent monitoring after.

When is it safe to stop if you have HBeAg-negative hepatitis B and have undetectable viral load after years of antiviral treatment? EASL guidelines say non-cirrhotic, HBeAg-negative patients who have had at least three years of antiviral treatment, undetectable viral load and no signs of liver damage can stop treatment, as long as there is frequent follow-up monitoring.

When is it safe to stop antivirals if you’ve lost HBsAg? EASL recommends stopping antivirals after losing HBsAg, even if a patient does not develop the hepatitis B surface antibody (HBsAb). Recently, experts have decided that patients who lose HBsAg may be “functionally” cured, even if no surface antibodies appear.

Researchers also have a new way to determine if it’s safe for patients who had HBeAg seroconversion to stop antivirals – by measuring their HBsAg levels. The lower your HBsAg levels, the more likely you are to maintain HBeAg seroconversion after you stop antivirals.

For example, patients may be HBeAg-negative and have no signs of liver damage, but if their HBsAg levels remain high, these patients remain at risk of reactivation and should continue antiviral treatment. (Read more about HBsAg quantification testing here.)

These antiviral “stopping rules” are still in development and are still frustratingly vague for many patients, but slowly researchers are developing tools and compiling more research in order to develop better guidelines when it’s safe to stop the daily antiviral treatment plan.

 *The statistics and recommendations cited are found at EASL2017 Clinical Practice Guidelines.

Join a Twitter Chat: National Organizations Share Highlights From Hepatitis Awareness Month and Strategies for Successful Events

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Join Hep B United, the National Viral Hepatitis Roundtable, NASTAD and CDC’s Division of Viral Hepatitis for a Twitter #HepChat at 2 p.m. (EST) Thursday, June 8. The chat will highlight Hepatitis Awareness Month outreach events and allow hepatitis B and C partner organizations to share their successes, challenges and lessons learned from their efforts.

Continue reading "Join a Twitter Chat: National Organizations Share Highlights From Hepatitis Awareness Month and Strategies for Successful Events"

Ten Things Women and Mothers Can Do to Combat Hepatitis B

Image courtesy of David Castillo Dominici at FreeDigitalPhotos.net.
Image courtesy of David Castillo Dominici at FreeDigitalPhotos.net.

By Christine Kukka

Don’t know your hepatitis B status? Get tested. An estimated 75 percent of people with chronic hepatitis B don’t know they’re infected. Unfortunately, many doctors won’t test you for hepatitis B unless you request the test. If you or your parents come from a country with high rates of hepatitis B, or if you’ve been sexually active or have other risk factors , get tested. It could save your life.

Get tested for sexually-transmitted infections (STIs). More than half of us will have an STI in our lifetime, and in the U.S. about half of new hepatitis B infections are sexually-transmitted. Many doctors don’t test for STIs. In a national survey of U.S. physicians, fewer than one-third routinely screened patients for STIs. To make matters worse, many women are afraid to talk to doctors about their sexual history and STI risk. Be brave, ask your doctor to test you for STIs and hepatitis B if you think you are at risk.

Photo by Amanda Mills of CDC.
Photo by Amanda Mills of CDC.

Get immunized against hepatitis B. Not sure if you’ve been immunized during childhood? Tell your healthcare provider and get tested and immunized. Even you were vaccinated in the past, getting a second vaccine series won’t harm you. If your partner has hepatitis B, getting vaccinated is critical to protect your health. Practice safe sex until you have received all three shots. About one to two months after your third shot, get tested for the hepatitis B surface antibody (called titers). If you have at least 10 mIU/mL of surface antibodies, you are permanently protected against this serious liver disease.

Infected? In Love? Disclose. When you disclose your hepatitis B status before sex – even if it’s safe sex with a condom – you don’t jeopardize your partner’s health or his/her trust in you. Talking about hepatitis B helps reduce the stigma surrounding this infection and may prompt the person to get vaccinated. How do you tell a potential partner that you have hepatitis B? Calmly and carefully. Do some research so you have a thorough understanding about hepatitis B, which will make it easier for you to calmly explain it. The more you know, the less you fear, and the more comfortable you will be in dispelling their fears and conveying a sense of truth and integrity.

Insist on sterile medical and tattoo equipment. Hepatitis B can live for several days on hard surfaces, including improperly-sterilized and re-used syringes and other medical devices. Whether you’re going for a tattoo or to a dentist or doctor’s office, it is your right to insist that all equipment is brand new (ask to see it removed from protective packaging) and properly sterilized. Visit a licensed, professional tattoo parlor and make sure all tattoo equipment has been sterilized and that needles come out of new packages.

Image courtesy of patrisyu at FreeDigitalPhotos.net
Image courtesy of patrisyu at FreeDigitalPhotos.net

Infected and pregnant? Protect your baby from hepatitis B.

  • Make sure your newborn gets the hepatitis B vaccine within 12 hours of birth. Nearly all hepatitis B-infected women will pass the infection onto their children during delivery, but you can stop that infection cycle. In about 90 percent of cases, immediate immunization will prevent infection. In some countries, it may be difficult to get just the single hepatitis B vaccine dose, but if you are able to immunize your baby at birth, you will have protected your child against a potentially dangerous liver disease. If you live in an area where HBIG (hepatitis B antibodies) is available, make sure your newborn is also given a dose of HBIG at birth, this adds another layer of protection against infection.
  • Get your viral load (HBV DNA) tested early in your pregnancy. Some women with high viral loads (exceeding 200,000 IU/mL or 1 million copies/mL) are at high risk of infecting their newborns, even if the baby receives the first vaccine dose within 12 hours of birth. Ask your doctor to test your viral load, if it’s high, medical guidelines recommend treatment with the antiviral tenofovir during the last three months of your pregnancy to lower your viral load. If you doctor doesn’t test your viral load, be assertive and ask for the test.
  • Breastfeeding is OK, even if you have hepatitis B. If you’re infected with hepatitis B, you can safely breastfeed your baby, as long as the baby was vaccinated against hepatitis B at birth.
Maureen and her two daughters
Maureen and her two daughters

Your children infected? Don’t wait to start talking to them about hepatitis B. You need to start talking to them about germs and how to keep themselves and others safe when they’re young. (Listen to Jin’s Story #justB You about growing up with hepatitis B.) This conversation will be one of the hardest discussions you will ever have with your child, and you’ll be talking about it often in the years ahead, but you can do it!

To hear how other mothers handled talking about hepatitis B with their children, visit our Storytelling page and click on Maureen’s Story #justB Brave  and Maureen K’s Story #just B Assertive  to hear how these mothers navigated issues of disclosure and stigma with their daughters.

 Talk to your children about sex and safe sex practices. It’s critical to educate young people about sexual health and STIs. If we want our sons and daughters to feel empowered to take care of their sexual health, we have to change the culture that dictates the way we talk – or don’t talk – about sex. That means removing denial, uncertainty and shame so we have better conversations about sexual health, sexual assault prevention and STIs. It’s also important to encourage our children to have frank sexual health discussions with one another.

Take care of your health, get monitored regularly: It is important to get your hepatitis B monitored regularly – at least every year and more often if you have liver damage. Women living with hepatitis B tend to have lower rates of liver damage than men because estrogen appears to help protect the liver. But even if we lead a healthy lifestyle and avoid alcohol and cigarettes, as we age our immune system weakens and our viral load (HBV DNA) can start to rise. There is no cure yet for hepatitis B, but there are effective drugs that lower viral load and reduce the risk of liver damage.

Renseley and her husband.
Renseley and her husband.

Be happy. A mother or woman who is well rested, enjoys a healthy diet, gets plenty of exercise, has good relationships with friends and family members and knows how to ask for help when she needs it, is far better equipped to be happy and be the best mother she can be. It isn’t selfish to take care of yourself. Tough times happen, and sometimes a friend or family member may need us, and we will need to be strong during difficult times. If we take care of ourselves and ask for help, in the long run happiness will prevail. For a profile in joy and courage while fighting hepatitis B in her family, watch Renseley’s Story #justB Strong.

The Hepatitis B Foundation recently launched its storytelling campaign, sharing the stories of people affected by hepatitis B. Join a Twitter interview including Maureen K, parent of a daughter with hepatitis B, at 2 p.m. (EST), Tuesday, May 16, hosted by the Hepatitis B Foundation and StoryCenter. Click here for more information.

How to Find a Liver Specialist Who Really Knows Hepatitis B

Image courtesy of stockimages at FreeDigitalPhotos.net
Image courtesy of stockimages at FreeDigitalPhotos.net

By Christine Kukka

If you have chronic hepatitis B or are newly-diagnosed, it’s important to see a liver specialist who has experience with hepatitis B.

Having a specialist with hepatitis B expertise on your team not only safeguards your health, it also lessens the stress of having a chronic liver disease. “My specialist gave me all the possible scenarios, but most importantly, he gave me my life back,” one hepatitis B patient recalled.

When first diagnosed, it’s often a primary health provider (PCP) or for children a pediatrician who gets the test results and calls to break the news. Doctors may run additional blood tests and/or immediately refer you to a liver specialist. They may recommend a specialist who accepts your insurance or practices in the same healthcare system, but you may have to do some research to find the best specialist to treat your hepatitis B.

There are two types of specialists who treat liver diseases:

  • A gastroenterologist is an internist who has trained in digestive disorders including the liver, but how much liver expertise a gastroenterologist (GI doctor) has varies based on their training. It’s important to find out if they specialize in liver diseases.
  • A hepatologist is a physician who specializes in the liver. This doctor has the most expertise and should be up-to-date about new treatments and clinical trials. But not all hepatologists have treated hepatitis B. Many will have treated hepatitis C, but not hepatitis B, so you need to ask.

Tips for finding a specialist:

  • Are they in the Hepatitis B Foundation directory? The foundation has a Physician Directory of liver specialists who treat hepatitis B around the world. These doctors have voluntarily signed up  for the database. It is not an exhaustive list, there may be hepatitis B specialists in your area who have not yet joined the directory.
  • Call the practice ahead of time and ask questions. How many hepatitis B patients have they treated? Do they participate in any clinical trials?  Are they aware of current monitoring and treatment guidelines for hepatitis B?
  • What’s the doctor’s reputation? Does anyone in your community see a liver specialist for viral hepatitis? Whom do they recommend?
  • Will you actually see the specialist or an assistant? Do you see a specialist only if there is a need for treatment? If you go to a teaching hospital, do you see the doctor or an intern, fellow or resident?

You are entering into a long-term relationship with someone who may care for you for many years. You need their expertise, but you also need to feel comfortable working with them. Do they listen when you speak and make eye contact? Trust and rapport are very critical.

“It’s really important that they don’t judge me,” one hepatitis B patient explained.  Another patient said that finding a doctor who spoke his language, or had an assistant who was fluent in his language, helped immensely.

Once you identify a specialist, here are some questions to ask:

  • Is the specialist accepting new patients? How long do you have to wait to get an appointment?
  • What hospital or lab do they use, and are they convenient for you? It’s important for you to always use the same lab so you have consistent results that allow apples-to-apples comparisons.
  • Will the doctor call you with the results or will a nurse or other assistant communicate with you?
  • What would you like your care plan to be? Will you go for blood tests and then see the specialist? Typically, hepatitis B patients get blood tests once or twice a year to monitor their liver, unless they are undergoing treatment.

How to design a long-distance care plan if the specialist is far away:  Sometimes, the best hepatitis B specialist is a few hours-drive from where you live, but distance doesn’t have to be a deal breaker. Many people see a specialist for a first visit, and afterwards simply have their PCPs or local labs email lab results to the specialist. For this remote healthcare relationship to work, your PCP needs to be willing to partner with the specialist. Also, your specialist needs to be open to telephone consultations with you as needed.

Technology matters. Sharing medical records and lab tests electronically make a remote relationship work smoothly. If there are firewalls between practices, find out how to ensure your PCP and specialist share your medical records. Be prepared, you may have to be the conduit if the two healthcare systems don’t talk to each other.

Insurance and cost: Ideally, the hepatitis B specialist closest to you accepts your insurance or is in your provider network. That doesn’t always happen so finding out the charges in advance is important.

  • Will the specialist bill your insurance or will you need to pay the fee upfront and manage the insurance reimbursement yourself?
  • How much do you have to pay out-of-pocket if the specialist is outside your network, or if you are not insured? Some specialists charge a lower fee to uninsured patients. You may be able to have an annual consultation with a specialist and bring your lab results.

One hepatitis B patient reported he was not entirely happy with the specialist his PCP referred him to. “At the time, I had great insurance so all the tests he ordered weren’t a lot of money out-of-pocket,” he said. “But then I changed jobs and I couldn’t afford all of his tests, and he wanted me to go on treatment though my lab reports didn’t justify it.

“I went looking for a new one and found one in the Hepatitis B Foundation’s website,” he said. “I had to drive farther to see him, but his knowledge and patience were very comforting and he spoke my primary language. He really helped me regain confidence in life. ”

Prepare for your visit: Before you see the specialist, put together a list of questions (see sample questions) and have your lab reports available — either bring hard copies or call ahead of time to make sure the doctor has access to your latest labs and medical records.

After you meet with your specialist, take some time to reflect. Are you happy with the doctor? Did he or she communicate well? Are you clear about what you need to do in the weeks and months ahead to take charge of your health? If the answer is yes, congratulations, you have assembled a good healthcare team.

Iron Overload Affects More Than the Irish, People with Hepatitis B-Related Liver Damage Need to Be Tested

Image courtesy of zole4 at FreeDigitalPhotos.net.
Image courtesy of zole4 at FreeDigitalPhotos.net.

By Christine Kukka

Iron is crucial to our health, but too much iron – called iron overload – can put us at risk of liver damage and other health problems, especially if we have hepatitis B-related liver disease and/or we’re Irish.

Irish and hepatitis B are not normally two words you hear in the same sentence, but both populations may need to be careful about how much iron they eat.

  • A liver inflamed or damaged by a chronic hepatitis B infection or other causes doesn’t process or store liver effectively and the excess iron accelerates liver damage and causes a host of other medical problems.
  • If you’re Irish or of northern European ancestry, one in eight of you have a genetic predisposition for hereditary hemochromatosis (HH) – commonly called the Celtic Curse — that occurs when the body doesn’t process or store iron properly, leading to a four-fold increase in iron absorption.
  • If you’re Irish and have chronic hepatitis B, you may want to celebrate St. Patrick’s Day with a trip to your doctor for a simple blood test for ferritin (iron) and transferrin saturation. If they’re elevated, your doctor may order a gene test to see if you have HH.

The relationship between iron overload and hepatitis B has been problematic, or as researchers like to say, “not well defined.”

Our liver is the body’s major storage organ for iron. About one-third of the iron we consume is stored in liver cells, which play a major role in recycling iron and synthesizing transferrin (the main transporting protein) and ferritin (the major storage protein) from iron.

Image courtesy of Stuart Miles at FreeDigitalPhotos.net.
Image courtesy of Stuart Miles at FreeDigitalPhotos.net.

When our livers are damaged or inflamed from hepatitis B, the Celtic Curse, fatty liver or alcohol, they don’t synthesize iron well, leading to excessive iron deposits in the liver which leads to more liver damage, including inflammation, fibrosis and even liver cancer.  In some hepatitis C patients, iron overload was found to reduce the effectiveness of antiviral treatment in some patients.

Researchers often found elevated iron levels in hepatitis B patients and suspected chronic hepatitis B could lead to iron overload. Recently, new research has discovered it’s the inflammation or liver damage from hepatitis B that causes iron problems. People with “inactive” hepatitis B with no signs of liver damage usually do not experience iron overload.

“Our data clearly indicate that hepatitis B-related liver injury, but not direct chronic hepatitis B infection, is likely responsible for the changes in the serum iron markers,” researchers concluded in a report on this topic published in the European Journal of Gastroenterology & Hepatology.

Hepatitis B Foundation Medical Director Robert Gish believes that iron overload is a “non-issue” for hepatitis B patients. However, he does have his patients get a transferrin saturation test. (A score of 20 percent indicates iron deficiency while a score exceeding 50 percent suggests iron overload.)

Many foods in our diet are rich in iron, including iron-fortified cereals, breads and pastas and meat including beef, pork, poultry and seafood.

According to experts, unless we have severe liver damage (often indicated by elevated liver enzymes (ALT/SGPT) or an ultrasound), we don’t need to restrict our consumption of foods rich in iron.

But if we do have liver damage and/or are Irish, it might be worth a conversation with our doctor. When we have excess iron, it is usually not detected by a complete blood count (CBC), hemoglobin, or hematocrit, test, it requires the transferrin saturation test.

Symptoms to watch for include fatigue, joint pain, abdominal pain, irregular heartbeat, skin color changes, irregular menstrual cycles, loss of libido and impotence, bone density changes, depression, anxiety, muscle pain, brain fog, chronic diarrhea, diabetes, liver damage and headaches.

For more information on HH, visit the website of the American Hemochromatosis Society.

Doctors Get a New Tool to Improve Hepatitis B Treatment and Monitoring

Photo courtesy of CDC.
Photo courtesy of CDC.

By Christine Kukka

A recently-approved test now allows doctors to measure exactly how much hepatitis B surface antigen (HBsAg) people with chronic hepatitis B have in their blood; so why should patients get this test and how will it help the millions of people around the world infected with hepatitis B?

According to experts, including the Hepatitis B Foundation’s Medical Director Robert Gish, knowing a patient’s HBsAg levels gives doctors:

  • A better understanding of what stage of hepatitis B a patient is in;
  • A more accurate assessment of a patient’s liver cancer risk; and
  • Essential information to judge if it’s time to start or stop treatment.

And in the future, this test may be critical to finding a cure.

Don’t labs already test for HBsAg? HBsAg, the protein that makes up the surface of the virus, is what labs look for in a blood sample to determine if a person is currently infected with hepatitis B.

Historically, labs determined only if HBsAg was present or not, which is why patients either tested positive or negative for HBsAg. Recently, countries outside the U.S. began measuring HBsAg quantities in blood samples and late last year became available in the U.S. as a federally-approved (CLIA) lab test from Quest Diagnostics.

Hepatitis B Foundation President Timothy Block
Hepatitis B Foundation President Timothy Block

“The strange thing about HBsAg, is that each hepatitis B virus requires only about 100 HBsAg molecules to provide its envelope protein, but the virus produces about 100- to 1 million-times more HBsAg than is needed, leaving millions of HBsAg circulating in the bloodstream,” explained Timothy Block, president of the Hepatitis B Foundation and the Baruch S. Blumberg Institute, the foundation’s research arm.

That over-abundance of HBsAg is why people continue to test positive for HBsAg even if they have an undetectable viral load (HBV DNA).

Why is there so much HBsAg? Researchers, including Block, suspect that in addition to covering the virus’ surface, HBsAg also serves as a decoy to “exhaust” or deflect our immune system’s:

  • T-cells, so they can’t attach to and attack the virus,
  • And B-cells, so they don’t generate the antibodies needed to destroy the viral antigens that make up the virus.

So when HBsAg levels decline–either due to treatment or a strong immune response to the infection–researchers know a patient is on the road to clearing the infection. Bottom line: A low or undetectable HBsAg level means patients are winning the war against hepatitis B and their risk of liver damage is greatly reduced. 

When should doctors measure HBsAg? According to Quest Diagnostics, which created the test, measuring HBsAg levels better identifies which patients are at risk of hepatitis B reactivation.

For example, a patient may be HBeAg-negative and have normal liver enzymes (ALT/SGPT) that indicate a liver is “healthy,” but if HBsAg remain high, doctors know a patient remains at risk of reactivation and hasn’t really entered the safer, “inactive” stage.

Quest maintains that measuring HBsAg and viral load (HBV DNA) together, “…improves the ability to differentiate the phases in HBeAg-negative patients and HBeAg-positive disease and results in a diagnostic accuracy of 70 to 94 percent.

According to Quest, patients with HBV genotype B or C who have low HBV DNA levels (less than 2,000 IU/mL) and HBsAg levels below 1,000 IU/mL have lower risk of liver damage and cancer. In fact, if HBsAg is under 100 IU/mL, patients may be on their way to clearing HBsAg from their blood.

Dr. Robert Gish
Dr. Robert Gish

Knowing for sure when treatment is working: HBsAg levels also reflect the amount of virus protein produced by infected liver cells and if treatment is effectively stopping the virus from producing these proteins. If a patient is treated with pegylated interferon, a decline in HBsAg during the first 12 weeks indicates a successful response to the drug. No change in HBsAg levels indicates interferon will not be effective.

HBsAg changes may also determine if antivirals are working. “In HBeAg-negative patients, low (HBsAg) levels at the end of treatment are associated with sustained virologic response,” Quest officials noted.

If patients have been treated with antivirals for many months or years and achieve undetectable viral load and low HBsAg levels, doctors may consider taking them off the drug.

Dr. Gish considers this new test an essential tool that providers should employ and patients should ask for to get an accurate picture of their infection state and liver cancer risk.

“I use it today to determine when to start treatment, assess a patient’s prognosis while on treatment, enhance patient compliance and determine when treatment can be stopped or should be continued,” he explained. “And this will also be an extremely helpful tool for drug developers in the future to identify promising treatments.”

Because lowering or eradicating HBsAg appears essential to stopping chronic infection and empowering the immune system to fight this complex infection, researchers around the world are working to develop treatments that inhibit HBsAg.

“I am a big believer in finding drugs that suppress HBsAg,” Dr. Block noted. Two of these surface antigen eradicator products are currently in Phase II trials.

Ten Things You Should Know About Hepatitis B and Do in 2017

Image courtesy of krishna arts at FreeDigitalPhotos.net
Image courtesy of krishna arts at FreeDigitalPhotos.net

By Christine Kukka

It’s 2017, and experts around the world continue to study the complex life cycle of the hepatitis B virus in order to find a chink in its armor that will lead to a cure. In 2016, there were successes and disappointments in the research and healthcare arena. Here is what you need to know about hepatitis B in 2017.

If you’re taking tenofovir, ask your doctor about TAF if you’re experiencing kidney problems or bone loss, especially if you’re an older woman. If you’re taking the antiviral tenofovir (Viread) long-term, ask your doctor about replacing it with TAF (Vemlidy). TAF is a reformulated version of tenofovir that delivers the antiviral more effectively to liver cells at a lower dose.  Currently, doctors prescribe either tenofovir or entecavir for liver damage. Entecavir does not cause bone loss, but it doesn’t work in people who have developed drug resistance to lamivudine or adefovir. For them, tenofovir is the only option, but it can cause bone loss and kidney problems when used long-term. With the U.S. Food and Drug’s recent approval of TAF, consumers can now get tenofovir’s robust antiviral activity at a lower dose. Because it’s brand new, your provider may not know about it, so ask about it to see if it would be better for you.

Was medical or recreational marijuana just approved in your state? Exercise caution. Many in the hepatitis C community have used medically-prescribed marijuana to ease side effects from interferon for years, so many assume it’s also safe for people with hepatitis B. Unfortunately, there are no studies that conclusively prove its safety. One study  that monitored liver fibrosis in 700 people coinfected with HIV and hepatitis C found, “…no evidence for an association between cannabis (marijuana) smoking and significant liver fibrosis progression in HIV/HCV coinfection.”

But another study  concluded: “Cell culture and animal model studies support that (marijuana) could have a therapeutic effect on liver injury and fibrosis progression. However, three cross-sectional studies in patients with chronic hepatitis C suggest that daily cannabis use is associated with fibrosis and steatosis.”

There is also no information indicating if marijuana is safer when it’s consumed in edibles vs. smoked, though many assume smoking introduces more toxins and chemical to the body. Bottom line: Just because your state approved it doesn’t mean marijuana is safe for you. Talk to your doctor and watch for more studies.

Image courtesy of Nanhatai8 at FreeDigitalPhotos.net.
Image courtesy of Nanhatai8 at FreeDigitalPhotos.net.

Fight for affordable healthcare for all. Newly-elected federal officials are threatening to fundamentally change a variety of healthcare insurance programs serving moderate- and low-income Americans and roll back protections, including mandated coverage of pre-existing conditions like hepatitis B. Many of these programs and coverage mandates have helped people living with hepatitis B get the care and medications they need. If you want these programs and safeguards to remain, you’re going to have to fight for them. Please check the Hep B United’s website regularly to learn about what is happening with hepatitis B on the federal level, and what you can do as an advocate.

Don’t give up hope. We know it’s been a tough year and that some promising drugs that were in clinical trials were shelved, but don’t give in to despair. There are more drugs in the works. Keep checking the Drug Watch page and clinical trials page to learn the latest.

Get monitored regularly. No one likes a blood draw, but it’s important to be tested annually or more often if you have a high viral load and/or signs of liver damage. There may not be a cure yet, but there are effective treatment options. Be brave, protect your health, and go to the lab for your blood test.

Demand to be screened for liver cancer. Some experts say current medical guidelines don’t go far enough to screen us for liver cancer. So take charge of your health and ask for a liver cancer screen, which includes a semi-annual blood test and an ultrasound.  Hepatitis B-infected Asian men (or of Asian descent) over age 40 years and Asian women over age 50 years, patients with a family history of liver cancer, patients with cirrhosis, and Africans over the age of 20 should all be screened. Think you’re not at risk for cancer because you take antivirals? Think again. Antivirals help reduce liver damage, but if you’ve had cirrhosis or are older, the risk of liver cancer remains.

If someone promises a new cure or treatment that sounds too good to be true….it probably is. In our search to be rid of hepatitis B, we may be tempted to yield to clever marketing and try a supplement that promises to cure us. But first, do your homework and practice precaution. To check out an herbal supplement, visit the National Center for Complementary and Integrative Health’s website to see what scientific evidence exists for a supplement and talk to your doctor. There is no magic bullet that will cure hepatitis B. Experts hope to find one soon, but for now be patient and stay skeptical. If you want to safeguard your health, eat healthy foods and avoid alcohol and cigarettes.

Pregnant with hepatitis B? Get your viral load tested and ask your doctor about antivirals. The American Association for the Study of Liver Disease (AASLD) recommends that pregnant women with viral loads (HBV DNA) higher than 200,000 IU/mL (or 1 million copies/mL) receive an antiviral (either tenofovir or telbivudine). The antivirals won’t hurt you or your baby and will reduce the risk that your baby will be infected with hepatitis B to nearly zero, as long as your baby gets the first dose of the hepatitis B vaccine and a dose of HBIG (hepatitis B antibodies) within 12 hours of birth.

Fight discrimination against hepatitis B and know your rights. Hepatitis B should never be a barrier to the education or job you want. Sadly, ignorance and stigma persist. It depends on us, our friends, and our family, to stand up and fight for our civil rights. We can’t back down. If we don’t fight, who will?

Be brave, disclose, and get your friends, family, and lovers screened for hepatitis B and vaccinated. Yes, it will be one of the hardest conversations you will ever have, but if you are infected with hepatitis B, you need to disclose your infection to people who may be at risk. If you just discovered you have chronic hepatitis B, which you may have contracted at birth, you need to tell your siblings and your mother and get them screened and immunized if needed. Dating someone, and about to take the next step? You need to disclose ahead of time and give them information and choices. It builds trust and it’s the right thing to do. You would want the same for yourself. For more on disclosure click here.

Happy 2017!  Our hope for a cure continues.

As of January 2017, TAF has been approved for hepatitis B treatment in the U.S., Europe and Japan.

Be Brave: Join a Hepatitis B Clinical Trial and Help Find a Cure

Photo courtesy of CDC.
Photo courtesy of CDC.

By Christine Kukka

One of the bravest things people living with hepatitis B can do is participate in a clinical trial  to help find the drug that will one day eradicate the virus that infects more than 240 million worldwide.

There are medical and financial advantages to participating in a trial. We may gain access to a drug that is more effective than what is currently available. We may get free lab tests and medications, and we know we have helped millions of others in the pursuit of a cure.

For example, if you participate in the Hepatitis B Research Network Adult Cohort Study, which is currently collecting data on how hepatitis B affects in 2,500 people in the U.S. and Canada over a five-year period, you helps scientists better understand this disease while getting free annual liver tests.

There are different types of clinical trials, for example some compare the effectiveness of a new drug against current treatments. When TAF, a new formulation of tenofovir, was in clinical trials, one group of patients received TAF and the other received the standard tenofovir drug. Researchers then compared viral loads (HBV DNA) and liver health from the two groups to see if TAF was as effective as tenofovir in lowering viral load and reducing the risk of liver damage.

Other drug trials compare the effectiveness of a new drug against no treatment. In this double-blind study, a control group receives no treatment (a placebo – or sugar pill) and the other group gets the experimental drug. Researchers don’t know until the end of the study which participants received the experimental drug in order to achieve an objective view of a drug’s effectiveness.

Clinical trials are also used to test the accuracy of new monitoring equipment or approaches, or they can help define what screening practices work best in individual immigrant communities.

Photo by Amanda Mills of CDC.
Photo by Amanda Mills of CDC.

They can also assess the effectiveness of herbal supplements and vitamin D in reducing liver damage or help identify when a pregnant woman should receive antivirals to lower her risk of infecting her newborn.

There are drawbacks to clinical trials that participants need to know. While pharmaceutical companies have spent years developing new drugs and testing them in lab animals before they reach human clinical trials, some drugs will not work.

A recent example of this is the Arrowhead Pharmaceutical’s ARC 520, 521 and AAT drugs, which were in clinical trials on 300 people in 17 countries. Last month, Arrowhead halted the trials after test animals that were receiving much higher doses of the drug died.

And, some trial participants risk getting the placebo instead of the experimental drug. In many of these cases, if the “experimental” drug is successful, those who received the placebo eventually gain access to the new drug. Also, these trials take commitment, including your time, travel and perseverance. But one day, these trials will help find a cure, but it can’t happen without the help of people living with hepatitis B.

How do we find a clinical trial? Most hepatitis B trials are managed by clinical researchers who work at universities, large hospitals or pharmaceutical companies. But you do not have to be a patient at one of these institutes to participate in a trial.

Step 1: Talk to your provider at your clinic, primary care office or liver treatment center and tell them you’re interested in participating in a trial. If you find one you think you’d qualify for, show them the information. Your provider can refer you to a trial even if he or she isn’t participating directly in the trial.

Step 2: Your provider can contact the research center on your behalf, submit an intake form for you, and transfer your patient records after you complete a HIPAA form. Your provider can still continue to care for you even if you join a trial.

Step 3: If you qualify, you may have to travel to the research center at least once. After that, your blood tests and any other lab results can be performed locally and sent to the researchers.

Step 4: Do your research before you participate. Ask questions and make sure you understand how the trial will affect your health. If there’s a chance you’ll get the placebo pill, ask what will happen and if you get access to the drug later on. Make sure you get the information in your primary language and that trial doctors are culturally-sensitive. Trust and knowledge is essential.

Below are some resources to help you. If you need more information, contact the foundation at 215-489-4900 (U.S.) or email info@hepb.org.

Where to find a clinical trial

  • Hepatitis B Foundation’s directory  of hepatitis B-related clinical trials: This resource lists hepatitis B-related clinical trials registered with the U.S. National Institutes of Health. These include hepatitis B-related treatment and liver cancer trials for adults and children in the U.S. and around the world. They also include coinfections, hepatitis D and trials investigating ways to prevent mother-to-children transmission of hepatitis B during childbirth. You can also email the foundation for more information at info@hepb.org.
  • The U.S. National Institutes of Health directory of clinical trials. This is a searchable directory of all NIH-approved clinical trials. You can search by condition and location.
  • Center for Information & Study on Clinical Research Participation: This offers a clinical trial database you can search, and the organization will also help you find clinical trials and email or mail you the information.  Call 877-MED HERO. Allow one to two weeks for response.

To watch a webinar about how to participate in a clinical trial, click here.