Hep B Blog

Buyer Beware: When Someone Claims to Have a Hepatitis B Cure, It’s a Counterfeit Drug

Image courtesy of africa, at FreeDigitalPhotos.net
Image courtesy of africa, at FreeDigitalPhotos.net

Twenty years ago when I found out my daughter had chronic hepatitis B, I would’ve purchased any drug I could find to cure her.  I asked her doctor if she could join a pediatric clinical trial for lamivudine. I just wanted her cured as soon as possible. Fortunately, cooler heads prevailed.

My daughter didn’t need treatment then, and she doesn’t need it today. Her doctor was wise enough not to try an antiviral with an unknown track record that was later found to cause high rates of drug resistance. It would have caused more harm than good.

When we want hard to believe in something—especially a medicine that is advertised to cure hepatitis B–we end up listening to our hearts and not our heads.

Many people touched by hepatitis B around the world don’t have an expert to be the voice of reason and wisdom when they hear about false, counterfeit, or untried treatments for hepatitis B. Sadly, there is a steady increase in false marketing claims on Facebook and other websites using testimonials and marketing ploys to sell a counterfeit hepatitis B cure to we who are vulnerable, frightened, and desperate for a quick cure.

We at the Hepatitis B Foundation know this all too well. The public can post on our Facebook and blog pages. Often, unscrupulous people pitching ineffective cures will try to post a personal claim endorsing some doctor’s or herbalist’s new cure. Here’s a recent, verbatim example of a post to our Facebook page:

“Just wanna express my moment of joy for (having) been cured from the deadly HEPATITIS B.  I have been infected with the Disease over three years and already lost hope (because) I have already tried so many ANTIVIRAL treatment…. one day while making more research online, I came across a testimony of a patients Dr … cured from GENITAL HERPES and I decided to give the said doctor a call….”

As you might expect, the writer claims to have been miraculously cured by the doctor using an antiviral drug called hepantivir, for example. But this drug has no scientific credentials. It has never been studied or tested or reported on in medical journals. But “experts” promise it will cure hepatitis B for $800.

We at the foundation remove these posts as soon as we discover them. These herbal supplements and counterfeit drugs can look very official, with medical-sounding names and packaged to appear like true pharmaceutical products.  The advertising often features a photo of a doctor to appeal to a local audience. But they’re fake, and some of these “products” can even make you sicker than before you started the alleged, miracle drug.

In 2013, a study by the United Nations Office on Drugs and Crime that focused on Africa and South-East Asia suggested the counterfeit drug market in Africa was worth about $4 billion (USD).  A report found that in 2009, in Nigeria, 60 out of 225 (27 percent) antimalarial medications failed chemical analysis, and in Ghana, 14 out of 17 (82 percent) antimalarial drugs followed suit.

Their deceit is cruel and criminal, especially when it targets frightened people who may have no access to treatments or advice. In the U.S., drugs must be approved by the U.S. Food and Drug Administration. To win that approval, randomized, clinical trials that compare outcomes of treated patients to untreated patients (the control group), are needed to prove a drug actually does helps people. This is the gold standard of medical evidence.

That careful FDA review does not, however, apply to herbal supplements. One day, some of these supplements may indeed be found to have beneficial effects to protect the liver against hepatitis B after rigorous study and experiments. But that research hasn’t happened yet.

The U.S. National Institutes for Health has published a directory about what scientific research has discovered about common herbal supplements. Probably the most popular herbal supplement pitched as a liver remedy is milk thistle, and its extract silymarin. The NIH milk thistle report found, “Previous laboratory studies suggested that milk thistle may benefit the liver by protecting and promoting the growth of liver cells, fighting oxidation (a chemical process that can damage cells), and inhibiting inflammation. However, results from small clinical trials of milk thistle for liver diseases have been mixed, and two rigorously designed studies found no benefit.”

A true scientific evaluation is what we need to hear, even when we desperately want milk thistle or another supplement to be the cure. There is no magic bullet that is going to cure hepatitis B. It is a complex infection with no cure at this time. Experts are making great strides and hope to find a cure in the next few years, but now, this is the time to let our heads make healthcare decisions, instead of our vulnerable and hopeful hearts.

So be patient. Don’t fall for false promises, even when they’re accompanied by professional-looking photographs and emotional testimonials. If it sounds too good to be true, it probably is.

More information about counterfeit medications:

Quality Matters: Battling the Epidemic of Illegal Online Drug Sellers and Counterfeit Medicines  Of the 35,000-50,000 active online drug sellers, 97 percent do not comply with U.S. laws and 50 percent of medicines sold online are fake or counterfeit, according to the Alliance for Safe Online Pharmacies (ASOP Global), an international non-profit headquartered in Washington, D.C. with operations in Europe and Asia.

These counterfeit medications are often manufactured in unsafe conditions; contain too little, too much or no active pharmaceutical ingredients; and, in many cases, have been found to contain dangerous substances like floor wax, rat poison, concrete, chalk, boric acid, road tar, paint, anti-freeze, and other toxins. This means that consumers worldwide are just a click away from buying products that may cause harm, treatment failure or even death. Read more…

Fight the Fakes Campaign:  Fight the Fakes is a campaign to raise awareness about the dangers of fake medicines. The campaign gives a voice to those who have been personally impacted and shares the stories of those working to put a stop to this threat to public health. It seeks to build a global movement of organizations and individuals who will shine light on the negative impact that fake medicines have on people around the globe and to reduce the negative consequences on individuals worldwide.

As part of this effort, Fight the Fakes is collecting and sharing the stories of those who are impacted by fake medicines and are speaking up. The website also serves as a resource for organizations and individuals who are looking to support this effort by outlining opportunities for action and sharing what others are doing to fight fake medicines.

The Importance of Advocating for Our Health, and Facing Our Fears

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

Early detection of cancer saves lives. Whether it’s breast, liver, or skin cancer, when it’s found and treated early, our survival improves markedly.

But here’s the rub. We intellectually know that early detection works, but performing those self-breast exams or getting screened for liver cancer carries a huge risk – what if something is found?

Every trip to the doctor or lab reminds us of our mortality, especially when we have hepatitis B. We have to take that risk and acknowledge our mortality, even when the healthcare system doesn’t make it easy.

A few months ago, the Hepatitis B Foundation assembled national experts to discuss how well the system worked to identify and treat liver cancer, which is now one of the top causes of cancer deaths. Worldwide, today hepatitis B causes 45 percent of liver cancers.

Their findings, published in the April 2015 issue of the Journal of the National Cancer Institute, paint a dismal picture of a healthcare system that often fails us, our family members, and our friends who live with hepatitis B and are at risk of liver cancer. Not only are providers failing to screen a large percentage of at-risk patients, when they find liver cancer, their treatment is often inadequate and inconsistent across clinics.

Who should be screened for liver cancer? 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.

What is the screening? A semi-annual ultrasound and blood tests to detect liver cancer are recommended, but this approach is only 70 to 80 percent effective in identifying liver cancers. This means 20 to 30 percent of people at risk of cancer won’t get diagnosed. And there are other problems.

A recent, large study of 5,000 insured hepatitis B patients in the U.S. who did not have cirrhosis found that only 6.7 percent of them had been screened properly, based on recommendations, over the four-year study. And these are the patients with insurance who have good access to healthcare. Liver cancer screening among uninsured people is downright abysmal, and usually performed only after liver cancer has progressed to an inoperable and untreatable stage.

About 60 percent received partial screens and 34 percent had not been screened at all. Those least likely to be screened lived in rural areas (where doctors had little hepatitis B expertise and were unfamiliar with current guidelines) or were coinfected with HIV.

While ultrasound exams are affordable, relatively easy to perform and widely available, the success of this screen depends entirely on the operator’s skill and experience. If the operator is having a bad day or is not trained in identifying liver cancers, small nodules or tumors can remain unnoticed, at a time when they’re in the early, treatable stage.

And then there’s obesity. Especially in the U.S., many patients with viral hepatitis and/or fatty liver-related cancer are overweight, and obesity reduces the accuracy of ultrasounds.

The advantages of blood tests is they are widely available, relatively affordable, and generally require only a blood sample. The disadvantages is they are not highly accurate, especially when tumors are small (and still treatable). The most well-studied and commonly-used blood test is the alpha fetoprotein (AFP) test, but it is so unreliable that current guidelines says that an ultrasound must be used with it.

You might think with so much stacked against early detection of liver cancer, why bother? Because we owe it to ourselves and our families and friends.

Even when faced with an imperfect healthcare system, we need to overcome our fears, find out our risk factors, and ask for screening even when our doctors fail to recommend it.

The study, Hepatitis-Associated Liver Cancer: Gaps and Opportunities to Improve Care, was written by experts from the Hepatitis B Foundation and its Baruch S. Blumberg Institute, the Alaska Native Tribal Health Consortium’s Liver Disease and Hepatitis Program, Drexel University’s School of Public Health, the Fox Chase Cancer Center, and the University of Toronto.

There’s Hope for a Hepatitis B Cure at the HEP DART 2015 Conference

IMG_1387This year’s  HEP DART conference brought together liver specialists and researchers from around the world to review and brainstorm about the latest research to find a cure for hepatitis B.

Biopharmaceutical companies presented data that showed their cutting-edge treatments, which use micro-RNAs and other innovative approaches to reduce the virus, appear promising. Much of this research, however, is in early, pre-clinical stages and focuses on laboratory-grown liver cells or laboratory animals, though a few are in Phase I and Phase II trials.

Joan Block, co-founder and executive director of the Hepatitis B Foundation, reported the following news in hepatitis B research from the conference, which was held in Hawaii from Dec. 6-10.

HepDart 2015 marks the 20th anniversary of this conference, and about 600 attendees from 20 countries attended. In opening remarks, Dr. Patrick Marcellin of France noted that the cure for hepatitis C is a huge medical breakthrough, now, he noted we are faced with finding a cure for hepatitis B.

This year’s HepDart meeting included nearly two days devoted to hepatitis B drug development—which shows the new momentum around finding a cure hepatitis B by the scientific community. During previous HepDart meetings, there was almost no discussion about new hepatitis B treatment. But this year, there are more than five companies presenting new hepatitis B drug findings, Block reported.

Researchers at the conference continued to lament the lack of resources spent to research and develop a cure for hepatitis B. They noted the U.S. government has spent $17.5 billion treating HIV. A fraction of that has been spent on finding cures for hepatitis B and C, which infects up to 6 million Americans.

Despite the lack of financial investment in finding a cure, Joan Block reports that the consensus at the conference is that a cure is indeed possible. Despite barriers to achieving a cure because of the complexity of the hepatitis B virus, “the feeling is that there are many targets in the life cycle of the virus and that a combination of a direct-acting antiviral along with an immunomodulator (to boost the immune system) will be the most likely route to success,” she reported.

In the short term, experts may be looking at a “functional” cure. For example, some of the new experimental drugs appear to increase the chances of clearing the hepatitis B surface antigen (HBsAg) with a finite duration of treatment. “Although this wouldn’t take care of (lingering) cccDNA or viral integration into liver cells, it would be a significant advance in treatment,” she said.

Day 2 of HepDart focused on targets within the virus, new therapies and possible cures. Experts explored whether any of the new drugs could produce a functional cure (similar to a resolved hepatitis B infection with loss of surface antigen) versus producing a complete cure that totally eradicates the virus from the liver (including cccDNA). Loss of cccDNA is referred to as the holy grail of the HBV cure.

“The parsing of the word ‘cure’ is frustrating to patient advocates,” she reported, “but the feeling is that the hepatitis B virus life cycle is very complex so an incremental or functional approach might be most feasible.

“Everyone wants a complete cure, including the scientists working on hepatitis B,” she noted, “however, a functional cure might be the most realistic goal in the next 10 years.”

A functional cure means patients will have to take one of the new drugs for only a limited period of time–compared to the current long-term reliance on antivirals that patients take in order to keep their viral loads down and prevent liver damage.

The downside of a functional cure is the potential for reactivation if a person, later in life, needs to take immune-suppressing drugs, such as chemotherapy, to fight cancer. However, this can be managed with antivirals if necessary. This is a similar situation to those who spontaneously recover from an infection.

To underscore the complexity of finding a cure, the image below shows the different targets in the hepatitis B virus life cycle that companies are examining to find a cure.

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There are many promising targets that are being pursued by scientists in academia, NIH, biotech companies and the Hepatitis B Foundation. At this point, the small interfering RNA (siRNA) technology is most advanced. However there are compounds in the pipeline for each category (see below), which is very exciting. Please refer to the Hepatitis B Foundation’s Drug Watch Page for complete list of drugs in development.

“The research work continues,” Joan Block reported, “and there is reason for optimism.”

Dr. Marion Peters - HepDart 2015
Dr. Marion Peters – HepDart 2015

The Hepatitis B Foundation president, Dr. Tim Block chaired a special session at HepDART to discuss what new endpoints will be needed to evaluate the efficacy of the new drugs coming down the pipeline. This will include immunological, virologic, and clinical endpoints for both a functional cure and complete cure.  The clinical endpoint goals might differ based on the phase (immune tolerant, immune active and inactive phase) the patient is in at the time of treatment with these newer agents.

HBF president, Dr. Tim Block
HBF president, Dr. Tim Block

Late breaking update from HepDART!

  • Arrowhead’s hepatitis B surface antigen (HBsAg)-lowering drug (ARC 520) looks promising according to the company’s presentation at HepDart. A single injection of the siRNA first in class type drug lowered HBsAg 10-fold in hepatitis B “e” antigen (HBeAg) positive people. The study was small (a few individuals) but impressive.
  • Arrowhead’s ARC 520 may also be telling us something about chronic HBeAg-positive hepatitis B versus HBeAg-negative hepatitis B. They suggest that the amount of HBsAg in the blood of people with HBeAg-negative hepatitis B may come from “integrated” hepatitis B in the liver, not from “cccDNA.”  This has profound implications for treatment.
  • Novira’s oral drug is a first-in-class capisd inhibitor and was able to lower HBV DNA levels by as much as 100-fold in the small number of people in the initial human trial, according to their presentation at HepDart. Novira was recently acquired by the pharma giant J&J.

“Excitement is really building as the first new hepatitis B drugs come into the clinic,” said Joan Block.

Cold and Flu Season Is Here. If You Live with Hepatitis B, You Need a Flu Shot. Now.

 Image courtesy of Sura Nualpradid at FreeDigitalPhotos.net
Image courtesy of Sura Nualpradid at FreeDigitalPhotos.net

Flu season is here and if you or a family member lives with chronic hepatitis B, it’s time to get a flu shot as soon as possible!

Why? According to an article in the November 2015 issue of the medical journal Vaccine, chronic hepatitis B patients who get a flu shot have a lower rate of flu-related hospitalizations than patients who skip the annual flu vaccine. Continue reading "Cold and Flu Season Is Here. If You Live with Hepatitis B, You Need a Flu Shot. Now."

Is Your Family Getting Together for the Holidays? Time to Discover Your Medical History

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

When we have chronic hepatitis B, knowing our family medical history can give us an inside edge to fight this infection.

Hepatitis B is an infection that often runs in families, and knowing how our parents or grandparents handled this liver disease can give us insider information about our own genetic prospects with hepatitis B.

Experts estimate that more than half of us worldwide became infected at birth. Our mothers may have been infected with hepatitis B and immunization, which can prevent infection if administered within 12 hours of birth, was not available to us as newborns, nor to our mothers or grandmothers. Continue reading "Is Your Family Getting Together for the Holidays? Time to Discover Your Medical History"

New Hepatitis B Treatment Guidelines Revealed at AASLD 2015 Conference

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The American Association for the Study of Liver Disease (AASLD), the organization that defines how doctors should treat hepatitis B and other liver ailments, unveiled new hepatitis B treatment guidelines this week at its annual conference in San Francisco.

The new guidelines are published here.  Patients should review them and discuss any updates that address their individual conditions with their physicians. Continue reading "New Hepatitis B Treatment Guidelines Revealed at AASLD 2015 Conference"

The Veterans Administration Ignores an Enemy on the Homefront: Hepatitis B

Courtesy of the U.S. Defense Health Agency.
Courtesy of the U.S. Defense Health Agency.

With Veterans Day comes reports about the lack of adequate mental health care for men and women returning from war. There is another, invisible health issue threatening veterans of all ages–hepatitis B.

Few veterans have ever been screened or treated for hepatitis B though their infection rate is four-times the national average.

The percentage of veterans infected with hepatitis B may actually be higher, but no one knows. Only 15 percent of U.S. veterans have ever been screened for hepatitis B. Among the few screened and diagnosed with chronic hepatitis B, only 25 percent have received antiviral treatment and only 13 percent have been screened for liver cancer. Continue reading "The Veterans Administration Ignores an Enemy on the Homefront: Hepatitis B"

The Annual Hepatitis B Check-up: Facing Mortality and a Missing History

Image by worradmu, courtesy of FreeDigitalPhotos.net.
Image by worradmu, courtesy of FreeDigitalPhotos.net.

For more than 20 years, I have accompanied my daughter to her annual hepatitis B check-up with her liver specialist. She is 22 and does not need me to come, but I always go out of habit and love.

After the appointment, we sit eating lunch and I talk about how lucky she is that her liver has been healthy and her viral load undetectable for many years. Recently, she started testing negative for the hepatitis B surface antigen (HBsAg). However, she has never developed hepatitis B surface antibodies. Her immune system has cleaned house, but has lacked the power to produce enough surface antibodies to show up on lab tests and declare her free of infection.

For the second year in a row, her doctor gave her a hepatitis B vaccine shot, an experiment to see if the injection of HBsAg would spur her immune system to generate enough surface antibodies to register in a lab test. Continue reading "The Annual Hepatitis B Check-up: Facing Mortality and a Missing History"

Shop Carefully for the Best Insurance Plan When You Have Hepatitis B

Image courtesy of digitalart at FreeDigitalPhotos.net
Image courtesy of digitalart at FreeDigitalPhotos.net

With the cost of health care and prescription drugs soaring, it’s important to choose health insurance carefully when you take hepatitis B medications and need frequent check-ups and lab tests.

In the next two months, Medicare recipients, people who get insurance through their jobs and consumers buying coverage through the Affordable Care Act (Obamacare) will be selecting insurance plans during open enrollment.

If you take antivirals or interferon and have frequent lab tests and doctor visits, it’s important that you select the plan that:

  • Has your specialist or primary care doctor and lab in its network,
  • And offers the lowest copay for the drugs you need.

Continue reading "Shop Carefully for the Best Insurance Plan When You Have Hepatitis B"

Want to Avoid Liver Cancer? There Are Things You Can Control

Image courtesy of FreeDigitalPhotos.net
Image courtesy of FreeDigitalPhotos.net

We who live with hepatitis B know that avoiding alcohol and cigarettes go a long way toward reducing our risk of liver cancer. But there are new threats emerging. Researchers are finding that obesity, diabetes and developing fatty liver from unhealthy food and a sedentary lifestyle can be just as dangerous to our livers.

In a recent study, published in the Journal of Hepatology, researchers found:

  • If you have chronic hepatitis and are obese with a fatty liver, your liver cancer risk increases 1.5 to 4.5 times
  • And, if you have hepatitis B and diabetes, your liver cancer risk climbs two- to three-fold.

This is a sobering realization that our lifestyle and our weight matter a lot when it comes to how long we will live. We may like to think we won’t develop liver cancer because our viral load is low or our liver tests don’t show any damage, but sitting all day and over-eating are just as dangerous. Continue reading "Want to Avoid Liver Cancer? There Are Things You Can Control"