A common question among people living with hepatitis B and their families is, “What happened to the cure for hepatitis B?” You can find answers in a new commentary by Dr. Timothy Block, HBF president and co-founder; Dr. Chari Cohen, senior vice president; and Maureen Kamischke, our director of international engagement.
The Hepatitis B Foundation’s Commentaries on the Cure is a new series written by hepatitis B experts. The series will feature thoughts and updates about the progress being made towards a cure for hepatitis B. Many of you have been awaiting a cure for years, and we understand that the wait can be frustrating. In addition to providing a look into the drug development process, we hope this series will serve as a source of information and hope for individuals living with hepatitis B.
Over the last 10 years, great strides have been made in hepatitis B cure research. The number of therapies in clinical trial stages has more than doubled, and four potential treatments for hepatitis Delta are in development! We believe that at least a “functional” cure is on it’s way, but it is extremely difficult to predict when one will be available. According to the Pharmaceutical Research and Manufacturers of America, it takes an average of 12-15 years to bring a drug from research to market. New treatments must undergo a rigorous testing process to ensure that it is both safe and effective for a large population. This process is extremely expensive – costing around $800 million USD per drug – and can be influenced by numerous factors, such as the number of volunteers for a clinical trial.
In recent years, we have seen an increase in interest and investments in a cure for hepatitis B, but more funding and support are needed to complete the journey. The Hepatitis B Foundation will continue to give the hepatitis B community a platform to share their voice, and advocate for the resources needed for the cure.
The Hepatitis B Foundation is thrilled to announce the addition of a new clinical trials search tool to our website! People around the world can now easily search for clinical trial opportunities on the Hepatitis B Foundation website. Created by Antidote – a company that designs technologies to link patients with scientific opportunities – the new tool filters through all of the trials listed in the U.S. National Library of Medicine’s database of private and publicly funded studies. Searching for clinical trials can be time-consuming and confusing to navigate, but this resource eases the process by finding the best trials for you based upon a series of questions.
You can now search for hepatitis B, hepatitisD and liver cancerclinical trials with a few simple clicks! Clinical trials are a series of research phases that a new drug must go through in order to be approved for widespread use. They are an essential to proving that a treatment is safe and effective for the larger population. Generally, these trials take 10-15 years to go from the laboratory to the public, but delays in finding or retaining enough volunteers can extend the process.
Diverse participationinclinical trials is needed to make sure that a treatment is effective for all groups. Research diversity matters greatly for several reasons. Studies have shown that different races and ethnicities may respond differently to a certain medication. In addition, researchers need to examine the impact of the medication on the populations that will eventually use them. According to data from the U.S. Food and Drug Administration (US FDA), individuals from Africa and Asia or of African and Asian descent consistently remain underrepresented in clinical trials; these populations are also disproportionately impacted by hepatitis B. If these groups are underrepresented in trials for hepatitis B treatments, new drugs may not be as effective in these communities, or there may be side effects that researchers were not aware of.
How Our Clinical Trials Finder Works
Using our Clinical Trial Finder takes just a few minutes. After clicking the ‘search’ button, the user will answer a series of questions of general demographic and health questions to determine what trials are near you and you fit the criteria for. You will be able to view the available trials at any point while answering questions, but answering all of the questions will give you the best results. You will also have the option to leave your email to receive personalized trial alerts for new trials that you are eligible for in your area! The new tool is designed to match those who wish to join a clinical trial to the best option for them; it is not designed to benefit any company.
Benefits of Participating in Clinical Trials
While participating in clinical trials helps drug developers, it can also provide major benefits to the participant as well! Blood work, treatments, and monitoring – which can be expensive – are often provided for free to those who are eligible for the duration of their participation in the study. Volunteers can also potentially benefit from the latest medical advancements and developments!
Help Improve the Future of Clinical Trials
5You can also help improve the future of drug development and clinical trials by taking our patientengagement survey! The survey, which takes approximately 20-25 minutes to complete, will be made available for use by the US FDA and drug development researchers to help clinical trial development for future hepatitis B therapies. All survey responses are anonymous.
In January of 2020, the Centers for Medicare and Medicaid Services (CMS) proposed a new rule that could increase the out-of-pocket costs for people who take prescription medication for hepatitis B in the U.S. The proposed rule states that health insurance companies would be able to collect patient coinsurance through pharmaceutical manufacturer financial assistance. However, the insurance companies will be allowed to disregard any coinsurance paid with copay assistance when calculating how much the patient has paid toward their deductible and annual out-of-pocket (OOP) limit.
This proposal – titled 2021 Notice of Benefit and Payment Parameters – reverses a recent ruling that would have required health insurance companies to count the value of manufacturer copay assistance toward an enrollee’s annual deductible and OOP limit in most circumstances1. This rule acknowledged that manufacturer copay assistance helps lessen the financial burden of medications for patients. In the US, prescription drugs can be extremely costly, making manufacturer’s copay assistance programs necessary for many patients. For example, brand name treatments are often expensive in order to help pharmaceutical companies earn back the costs of the research and time spent making the medication. Sometimes, the brand name treatments are the only ones that are available, like Vemlidy, or the only version that a person can take. A reversal of the rule would mean that hepatitis B patients and those living with other chronic illnesses may have to pay a larger amount of out-of-pocket costs for their medications.
To understand the significance of this change, we first need to understand what a copay accumulator is.
What is a Copay Accumulator Program and How Does It Work?
A copay accumulator – or accumulator adjustment program – is a strategy used by insurance companies and Pharmacy BenefitsManagers (PBMs) that stop manufacturer copay assistance coupons from counting towards two things: 1) the deductible and 2) the maximum out-of-pocket spending. What does this mean?
Previously, a person could receive financial assistance from companies that make a drug, and that would count towards their deductible and/or out-of-pocket costs, depending upon the insurance plan. Pharmaceutical companies often provide financial assistance (such as a co-pay card) to help underinsured individuals afford expensive medications. This means that the person paying for the drug would end up saving money, often thousands of dollars.
Why Is This an Issue?
As the AIDS Institute explains it, “ … the trend in health insurance benefit design is to shift more of the cost of health care to patients through high deductibles and coinsurance rates …In order to afford the medicine they need, patients increasingly rely on manufacturer copay assistance.” With copay accumulators, the individuals who need assistance the most will be unable to receive it, and will end up paying more for their treatments.
As shown in the above image, with a copay accumulator program – meaning her manufacturer’s assistance is no longer counted toward her out-of-pocket limit- the consumer ends up paying more, while the insurance company is able to reduce the amount they are paying.
Copay accumulator programs are making life-saving treatments increasingly inaccessible. Research shows that the more out-of-pocket costs a person has to pay, the more likely they are to abandon their medication. Once on a hepatitis B medication, stopping suddenly or only taking it once in a while can cause flares and lead to an even higher risk of liver damage.
In the United States, many of those who are living with hepatitis B come from underserved populations with limited access to healthcare. Oftentimes, cultural differences and language barriers can make it difficult to access and utilize the services they need. Now, copay accumulators are making the navigation process even more complex and placing a higher cost burden on patients.
1The rule required insurance companies to count manufacturer copay assistance toward a patient’s deductible and OOP limit for all brand name drugs for which there is no generic alternative and in cases where the patient gained access to the brand name drug through an insurance plan’s appeals or exceptions process.
Ensuring that people with hepatitis B have access to affordable medications is one of our top priorities. If you or someone you know is currently prescribed Vemlidy (tenofovir alafenamide), entecavir, or tenofovir, we have important news that could help make your medications more affordable.
Vemlidy will once again be covered under CVS Caremark
The Hepatitis B Foundation, along with our network of patients, providers and partners, has successfully advocated for improved access to the hepatitis B medication Vemlidy in the US! In July 2019 CVS Caremark – one of the nation’s leading pharmacy benefit managers – stopped providing coverage for Vemlidy. This decision impacted thousands of Americans who rely on this life-saving drug to manage their hepatitis B.
Thanks in part to our advocacy, the company announced last week that they will resume coverage of Vemlidy for their plan members as early as October 2019! In addition, Gilead Sciences, the manufacturer of Vemlidy, is offering increased patient assistance for patients until the coverage takes effect.
What’s next: If you or a loved one are taking Vemlidy and have a CVS Caremark prescription plan, the date that coverage will resume depends on your plan type. On October 1, 2019, Vemlidy will be processed for those under the Advanced Control Specialty Formulary. For those with a Value Formulary, Vemlidy will be covered beginning on January 1, 2020.
To offset the costs, until January 1, 2020, Gilead Sciences will provide $1,000 a month (for up to $5,000) to offset the costs of treatment. Those interested can go to Gilead’s website and apply fora co-pay card ; insurance is not needed.
Low-cost options for patients on entecavir and tenofovir
n June 2019, the Hepatitis B Foundation partnered with Rx Outreach , a nonprofit mail order pharmacy, to offer two of the most common hepatitis B medications at low cost to eligible patients.
Eligible individuals can get a 30-day supply of tenofovir for $25 or a entecavir for $45. Eligibility is based upon household income, not on insurance status or prescription drug coverage. Our partnership with Rx Outreach will help to fill a gap in access to affordable medication and help to lessen the burden of one of the many forms of discrimination that those living with hepatitis B must face.
UPDATE:The Hepatitis B Foundation and Hep B United, along with our network of patients, providers and partners, has successfully advocated for improved access to the hepatitis B medication Vemlidy in the US.! In July 2019 CVS Caremark – a subsidiary of CVS Health and one of the nation’s leadingpharmacy benefit managers–stopped providing coverage for Vemlidy. This decision impacted thousands of Americans who rely on this life-saving drug to manage their hepatitis B.
Our members took swift action. Together, we sent over 20 letters from partner organizations and gathered over 250 individual signatures for a petition encouraging CVS Caremark to provide coverage for this essential medication.
The company announced last week that they will resume coverage of Vemlidy for their plan members as early as October 2019! Thank you to everyone who helped us to advocate for this important change. We firmly believe that all FDA-approved medications should be available for doctors to prescribe to their patients, and this change will ensure that those on CVS Caremark plans have access to this life-saving drug.
On October 1, 2019, Vemlidy will be processed for those under the Advanced Control Specialty Formulary. For those with a Value Formulary, Vemlidy will be covered beginning on January 1, 2020.
Until January 1st, Gilead Sciences – the creators of Vemlidy – will provide $1,000 a month (for up to $5,000) to offset the costs of treatment. Those interested can go to Gilead’s website and apply fora co-pay card; insurance is not needed.
Thank you to everyone who signed the petition, wrote a letter, or simply shared the information. Because of you, those who rely on Vemlidy now have one less barrier to accessing their needed treatment!
A few months ago, CVS Caremark – a subsidiary of CVS Health – announced their intentions to remove Vemlidy from their list of covered medications, or formulary. With over 2.2 million individuals in the United States living with chronic hepatitis B, this decision impacts thousands of Americans who rely on this life-saving drug to prevent cirrhosis and liver cancer.
CVS Caremark is the second-largest Pharmacy Benefits Manager (PBM) in the United States. As a PBM, Caremark manages prescription drug benefit plans for payers including health insurers and large employers. One of their main tasks is to negotiate drug prices with manufacturers and develop and maintain formularies on behalf of health insurers, which influence which drugs are available to patients on their prescription drug plan and determine out-of-pocket costs. Negotiations between PBMs and drug companies are common. However, they create a dangerous, unstable health and financial situation for those suffering from chronic illnesses.
When it comes to the treatment of chronic illnesses like hepatitis B, medical decisions are best made based upon knowledgeable and informed discussions between the doctor and the patient. After all, doctors have been tracking and monitoring how the virus impacts an individual for many months, if not years, and a patient is aware of how their body reacts to certain medications. CVS Caremark’s decision to remove Vemlidy from their formularies limits the ability of providers to make the best treatment choice for their individual hepatitis B patients.
Vemlidy is one of just three first-line hepatitis B treatments. First-line treatments are medications that have been proven to be highly effective with the least amount of side effects. For some individuals, this drug is the best option, as other FDA treatments can increase their risk of kidney disease and bone density loss. Hepatitis B expert and Medical Director of the Hepatitis B Foundation Robert G Gish, MD, notes two separate studies where tenofovir alafenamide (TAF) (Vemlidy) had lower amounts of bone density loss and kidney impairment than tenofovir disoproxil fumarate (entecavir), another first-line treatment. In order to properly help their patients, doctors need to have a full range of tools at their disposal. All FDA approved medications should be available for doctors to choose from.
The Hepatitis B Foundation’s Medical and Scientific Advisory Board is also concerned about the negative health impacts of Caremark’s decision. “TAF is less likely to cause adverse bone mineral density and renal dysfunctions than Tenofovir disoproxil fumarate (TDF). This is true not only for patients at risk of these complications but the overall hepatitis B patient population as demonstrated in clinical studies comparing TAF and TDF. By removing Vemlidy from the formulary plan, CVS Caremark is implementing a significant barrier to thousands of Americans who may need and/or rely on this drug to manage their hepatitis B….We are not advocating that all hepatitis B patients have to be treated with TAF. We believe that this decision should be made by the patient’s doctor with the patient.”
What Does This Mean:
Now that Vemlidy has been removed from Caremark’s list of covered treatments, those living with chronic hepatitis B will either have to pay the full price or switch to another medication. To put this into perspective, the average retail price of Vemlidy is $1,350 USD a month. The average cash price reached $1,650 USD in July. There is no generic version of the drug. Like other hepatitis B treatments, Vemlidy must be taken daily over the course of several years to be effective; an individual paying the average retail price would have to pay approximately $16,200 a year to access their medication.
Others will be forced to change from Vemlidy to a similar treatment that is cheaper, but may be less effective with safety issues. This practice is known as non-medical switching: when insurers or PBMs make changes to a formulary primarily due to financial negotiations with manufacturers, in exchange for greater market share.
According to the Alliance for Patient Access, non-medical switching is associated with poor health outcomes. One of their recent studies found that patients who had been switched off their preferred medication experienced complications from the new medication. One in 10 reported being hospitalized for complications after the switch, approximately 40% stopped taking their medication completely, and 60% reported side effects from the new medication. These complications are extremely dangerous for individuals taking hepatitis B medication, as stopping suddenly and without consulting an expert can cause the virus to flare and increase the risk of liver disease, and liver cancer.
Hep B United (HBU) – a program of the Hepatitis B Foundation and a national coalition of over 40 organizations – has started a petition and will be sending a letter to CVS Caremark.
Individuals can ask CVS Caremark to reinstate Vemlidy by signing this petition! Organizations can add their names to HBU’s official letter commenting on Caremark’s decision. We hope that CVS Caremark will honor their commitment to the health of Americans and add Vemlidy back on their formularies!
Are you a hepatitis B patient living in the United States? Are you taking entecavir or tenofovir disoproxil fumarate (TDF) to help manage your hepatitis B infection? Thanks to the Hepatitis B Foundation’s new strategic partnership with Rx Outreach – America’s largest fully licensed, non-profit, mail order pharmacy and Patient Assistance Program – you may be able to receive your medication for less than 5% of the average retail price!
Each year, we answer thousands of national and international phone calls, emails, and social media messages from people who have been impacted by hepatitis B. Over the past year, we have seen a significant increase in calls regarding access to medication. The majority of those calls have been from people living in the United States. The ability to access medications is more than just having them available at a local pharmacy – it is about the price as well.
In the United States, life-saving generic treatments can cost more than $830 a month on average. As treatments are typically taken for several years after a person begins, paying such high monthly out-of-pocket costs simply isn’t an option for most people. That’s why we partnered with Rx Outreach to increase patient accessibility to life-saving hepatitis B medications.
We believe that affordable treatments should be low-cost and widely available to everyone who needs them. Hepatitis B antiviral treatments need to be taken daily in order to be effective, and a lack of affordable options force some individuals who are living with chronic hepatitis B to avoid diagnosis and treatment, to stop taking medication or to only take it sporadically, which increases their risk of developing cirrhosis or liver cancer. Our new partnership can help eliminate the need for such potentially harmful actions by providing the same medication at a much lower cost than retail pharmacies, pharmaceutical companies, and insurance plans can offer.
Eligibility is based upon household income, not on insurance status or prescription drug coverage. To be eligible for Rx Outreach’s pricing, please review the chart below or you can check your eligibility here.If it appears that you do not qualify but you believe that you should, you can also call Rx Outreach and a representative will assist you.
Our partnership with Rx Outreach will help to fill a gap in access to affordable medication and help to lessen the burden of one of the many forms of discrimination that those living with hepatitis B must face. It offers more than 1,000 medication strengths at affordable prices. Since 2010, Rx Outreach has saved people in need more than $662 million on their prescription medication.
People generally think liver cancer is non-treatable and non-curable. But that perception needs to change. Diagnosis and treatment of liver cancer have improved so much in the past 20 years that it can be cured if caught early and managed by an experienced health care team.Liver Cancer Connect’s “Fighting the Doom and Gloom” series explains how the right treatment plan and teamwork offer the best chances for a cure. Continue reading "Fighting the Doom and Gloom: It Takes a Team"→
The hepatitis B virus (HBV) can be transmitted two ways: 1) through direct contact with blood and 2) infected body fluids. Some risks for direct blood contact are obvious, such as touching an open wound to another open wound or cleaning up someone’s blood without any protective gear. However, other methods of blood transmission are harder to catch. Common activities like sharing razors, earrings, or toothbrushes are simple, innocent actions, yet they all have the potential for blood exchange.
Medical and dental procedures are aspects of our lives that we might not think twice about. While beneficial to our health, they also carry the risk of exposure to another person’s blood. Surgeries, shots, and dental activities all use sharp objects that pierce the skin and draw blood. If the tools are not properly sterilized, or cleaned, before they are used on a new patient, the blood that was on the equipment can be transferred to the next patient.
How do I know if medical tools are sterile?Ask! It is your right to know if the equipment that will touch your body has been thoroughly cleaned. In a dentist office, the assistant might unwrap a package of tools in front of you; this typically means that the tools are either new or have been properly cleansed. In a medical setting, needles and surgical equipment might come in packaging as well. If you still are not certain, feel free to ask what the standard cleaning procedures are for the tools being used. The staff will be happy that you are taking your health into your hands!
Why is it important to have sterile tools?Hepatitis B earned the nickname “silent infection” because there are often no symptoms. Those who have been infected may not take the necessary precautions simply because they do not know that they should. They may not even know they are infected! In many cases, medical and dental professionals are unaware when a patient has hepatitis B. Therefore, it is important to make sure that all equipment that is being reused has been sterilized. Although there are no global sterilization standards, many countries and medical facilities around the world – like hospitals, dental offices, and doctor offices – have disinfection guidelines and practices for their equipment.
Tips to Protect Yourself:
Be your own advocate: Ask the dental hygienist, nurse, doctor, acupuncturist or person in charge of your procedure if the tools have been sterilized.
Know where you go: Try to visit medical or dental facilities that you trust and that provide clean, safe environments for any procedures involving blood or body fluids.
Get vaccinated:Hepatitis B is a vaccine preventable disease. After receiving all three doses, most people are protected for life! Check your immunization records to make sure that you have been vaccinated or ask your doctor or local clinic about the vaccine.
Share with caution: Sharing or eating food prepared by someone with hepatitis B is safe, but any activities that may involve direct contact with blood carry a risk. A good guideline is to keep all personal hygiene items personal.
If you think you have been exposed to hepatitis B, it is important to get tested. Visit your doctor or local health clinic to get screened.
If you have been diagnosed with chronic hepatitis B, our Physicians Directory* can help you locate a liver specialist near you. TheWorld Hepatitis Alliancecan also help you find health care services and hepatitis B education in your country.
The Hepatitis B Foundation Liver Specialist Directory is intended for use by the public to assist in locating a liver specialist within a specific state or country. All data is self-reported and is not intended for use by organizations requiring credentialing verification. The HBF does not warrant the accuracy, completeness, timeliness, or appropriateness for a particular purpose of the information contained in the Liver Specialist Directory. The HBF does not endorse the individuals listed in the service, nor does HBF verify medical qualifications, licenses, practice areas or suitability of those listed. In no event shall the HBF be liable to you or anyone else for any decision made or action taken by you based upon the information provided in the service. Note: This is not a physician referral service. The HBF cannot provide referrals to specific physicians nor advice on individual medical problems.
I thought hepatitis B was sexually transmitted? I just tested positive, but my partner tested negative, we’ve been together for years, what gives?
This question is a common one. Hepatitis B is indeed easily transmitted sexually, so why do some people — who were not vaccinated — never get hepatitis B from their sexual partners?
It comes down to variables, such as the type of sexual activity you engage in, the viral load (HBV DNA) of the infected partner, and who is on the receiving end of infectious body fluids, especially blood that contains the most virus, and semen.
Having one partner infected, and other not, can add more stress to an already traumatic hepatitis B diagnosis. “It was very confusing and made me question how was it possible I was the only one infected,” said a woman who tested positive while her husband tested negative. “I thought it was possibly a mistake, maybe I was a biological anomaly, which of course I was not.”
Let’s look at the factors that affect who gets infected and who doesn’t when two people have sex.
Viral load: Semen, vaginal fluids and blood all contain the hepatitis B virus (HBV), and the higher the viral load, the more infectious one’s blood and body fluids are. However, having an undetectable viral load doesn’t mean you won’t infect someone during unsafe sex. Even if a man has an undetectable viral load, studies show his semen still contains some HBV and can spread infection, though the risk is lower.
So, the rule here is if a man tests positive for the hepatitis B surface antigen (HBsAg), he must consider himself infectious.
The role of gender: In heterosexual relationships, uninfected women are at higher risk of getting infected by a male partner infected with hepatitis B, than the reverse. Women are on the receiving end of semen, which greatly increases their risk of becoming infected unless a condom is used.
When a woman is infected with hepatitis B, an uninfected man is at risk through direct contact with her vaginal secretions, but that contact is lower-risk than a woman’s direct exposure to infectious semen during intercourse.
However, an infected woman who is menstruating is more likely to spread hepatitis B because blood can contain higher levels of HBV than vaginal secretions. That is why gloves and dental dams are recommended to provide a barrier against exposure.
The type of sexual activity: Certain sexual activities are far more efficient at spreading hepatitis B than others. Oral sex appears to have a lower rate of hepatitis B transmission than vaginal sex. Anal sex carries a very high risk of transmission because of tears in the skin that can occur during penetration, which improves transmission of HBV.
Fingering carries a lesser risk, unless the infected woman is menstruating or a person has bruises or cuts on their hands that allow entry of hepatitis B virus in semen or vaginal fluids, then gloves are recommended.
The “uninfected” partner could already have been infected and cleared hepatitis B: When a person is first diagnosed with hepatitis B, doctors often test his or her partner for only the hepatitis B surface antigen (HBsAg), which indicates a current hepatitis B infection. If they are negative for HBsAg, they are immediately vaccinated.
If the partner isn’t also tested for the hepatitis B surface antibody (anti-HBs or HBsAb), then no one knows if the individual was already protected, either due to recovery from a past hepatitis B infection, or because they had already been vaccinated.
Hepatitis B is not called the “silent” infection for nothing — many people who get hepatitis B never have any symptoms and never realize they were infected. As a result, a wife, husband, partner or lover who tested negative for HBsAg, may actually have been infected in the past and cleared the infection and now has protective hepatitis B surface antibodies to forever safeguard them from infection. If they’re immediately vaccinated and retested after the three-dose vaccination, they will test positive for surface antibodies, without ever knowing that their antibodies resulted from a past infection, not immunization.
Bottom line, if one of you have been diagnosed and the other is not infected, it is unusual but not uncommon. Get tested and immediately vaccinated if the uninfected partner tests negative for the hepatitis B surface antibody.
Take a quiz to find out how much you know about hepatitis B transmission: click here.
Disclaimer: The information provided in this video is not intended to serve as medical advice or endorsement of any product. The Hepatitis B Foundation strongly recommends each person discuss this information and their questions with a qualified health care provider.