Hep B Blog

Monthly Archives: August 2019

HDV, Hepatitis Delta (HDV), Living with Hepatitis B

Printable Hepatitis Delta Fact Sheets for At-Risk Populations (Available in 5 Languages!)

 

Hepatitis delta is estimated to affect 15-20 million people globally who are also living with hepatitis B. Hepatitis delta’s geographic distribution is not uniform, and does not always follow regions of highest hepatitis B prevalence. Although more recent data is sparse, regions of higher coinfection are thought to be in Mongolia, Eastern Europe (particularly Romania, Russia, Georgia, Turkey), Pakistan, the Middle East and the Amazonian River Basin. The American Association for the Study of Liver Diseases (AASLD) recommends that hepatitis B patients from these areas be tested for hepatitis delta. If you are a community member or community health worker or physician, please utilize our printable fact sheets to help raise awareness about hepatitis B and delta!

Fact sheets are available in 5 languages, including English, Mongolian, Romanian, Russian and Spanish!

English for Patients    English for Providers

Mongolian for Patients   Mongolian for Providers

Romanian for Patients   Romanian for Providers

Russian for Patients   Russian for Providers

Spanish for Patients   Spanish for Providers

For more information on hepatitis B and delta coinfection, visit www.hepdconnect.org or contact us at connect@hepdconnect.org.

HBV, Hepatitis B Advocacy, Hepatitis B Treatment, Liver Health, Living with Hepatitis B

CVS Caremark : Re-Add Vemlidy To Your Formulary

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 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.

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.
What’s Next:
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 for a 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.

Taking Action

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!

Uncategorized

The Global Need for Hepatitis B Immunization

In the United States, August is National Immunization Awareness Month (NIAM)! During this time, health care providers, educators, and advocates use their resources to inform the public about the safety and importance of vaccines. NIAM was established by the Centers for Disease Control and Prevention (CDC) to encourage individuals of all ages to stay up-to-date with their vaccines and make sure that they are protected. The modern hepatitis B vaccine has been widely used – with over 1 billion doses given – since it was created in 1985, and has been proven to be one of the safest and most effective vaccines in the world. So why do we need to promote the hepatitis B vaccine during NIAM? 

United States: 

On a national level, vaccination rates for hepatitis B are far below where they should be despite being the most effective way to prevent transmission. In the United States, while 91% of children complete the hepatitis B vaccine series, only 64% of children who are born in hospitals are given the hepatitis B birth dose (first dose of the vaccine) as recommended by the CDC – which means that there is much room for improvement. And without the follow-up doses, children are still vulnerable to potential exposures; one dose of the vaccine is not enough. 

Adults in the United States have extremely low rates of vaccination, primarily because many were born before the vaccine became a healthcare standard and mandated for school. According to the CDC, just 25% of adults have received all three doses. Coupled with the recent increase in injection drug use, low vaccination rates among adults have been driving a rise in acute hepatitis B cases across the nation. The good news is that adults can be fully vaccinated with just 2 doses of the Heplisav-B vaccine! This new vaccine has proven to be highly effective and can be completed in just one month.  

Globally: 

Internationally, vaccine rates differ from country to country due to issues with storage, access, affordability, general awareness and priorities. In July 2019, the World Health Organization (WHO) announced that 189 countries now provide the vaccine for infants on a national level, but the global coverage of the birth dose is just 42%. The birth dose is significant for a number of reasons. Ninety percent of babies and up to 50% of young children will progress to chronic hepatitis B if they are infected. Since only 10% of the 292 million chronically infected individuals know about their infection, there is the potential for friends or family members to unknowingly transmit the virus to an infant or young child. In addition, a mother who is unaware of her status has the potential to pass the virus to her newborn via the delivery process. The birth dose significantly lowers the risk of transmission in both of the previous scenarios. That is why it is critical pregnant women are tested early in their pregnancy so they are aware of their infection and can ensure the birth dose is available.

In some countries, the pentavalent vaccine is offered. This vaccine protects against five diseases, including hepatitis B. However, it cannot be administered until the baby is at least 6 weeks old, which leaves a gap in the baby’s protection. The monovalent hepatitis B vaccine should be given to all infants in order to make sure they are covered during this vulnerable time period. It is especially important for infants born to hepatitis B surface antigen positive  (HBsAg +) mothers to receive the monovalent vaccine within 12-24 hours of birth to prevent transmission. 

Vaccines are also essential for healthcare workers. WHO estimates that out of the 3 million healthcare workers who are exposed to bloodborne diseases a year, approximately 2 million of those exposures are to hepatitis B. These exposures, which largely occur in countries where hepatitis B is common, put unvaccinated healthcare workers at risk. International recommendations list hepatitis B as one of the essential vaccines  for health occupations. WHO also reports that unsanitary healthcare practices, such as reusing sharp objects that have not been sterilized following proper infection control practices, were responsible for nearly 2 million hepatitis B infections globally in 2010. Infections from an accidental exposure can easily be avoided with the vaccine!

NIAM is a reminder that a vaccine is only effective at preventing disease when it is used widely. Governments, healthcare providers, and individuals all play an important role in ensuring that people of all ages – especially high-risk individuals – are protected. You can do your part today by asking your doctor for the 3-panel hepatitis B blood test. If your results come back negative (HBsAg -, HBsAb -, and HBcAb -), ask them to begin the vaccination series! In two or three simple doses, you can be protected from the largest risk factor for liver disease and liver cancer!

About Hepatitis B, Hepatitis B Prevention

Hepatitis B is NOT A Genetic Disease – And Here’s Why

There are many misconceptions about the hepatitis B virus. One recurring one is the myth that hepatitis B is a genetic or hereditary disease. The belief is that because multiple family members can be infected by hepatitis B, it must be a virus that runs in families. This is not true. Hepatitis B is NOT genetic. Hepatitis B is spread through direct contact with infected blood. Although transmission can occur a number of different ways, it does not happen at conception or while the child is developing in the uterus. 

Let’s start by breaking down what it means for something to be genetic or hereditary: 

A genetic disease is caused by an error in a person’s genes and is   carried by an individual in their genes. This type of disease may be passed on to a person’s child (which means it is hereditary) or it can occur spontaneously as a result of a gene mutation while a child is growing in the womb. Genes – which make up each of our unique DNA strands – are passed on to a child from both the mother and the father. Therefore, if a mother or father carries a certain hereditary disease or genetic trait, such as brown hair or green eyes, the child has the ability to have that as well. 

Hepatitis B is not a genetic disease because it does not exist in a person’s genes. It is not carried in the egg of a woman or the sperm of a man. The hepatitis B virus exists in the liver cells and circulates in the bloodstream. Unlike a genetic disease, a person is not born with the hepatitis B virus already in their bodies. Instead, the virus is passed from mother to baby during childbirth through infected blood passing from the mother to the child during the physical delivery process. If a pregnant woman tests positive for hepatitis B, she can pass the virus to her newborn through infected blood and tiny tears in the skin that occur during childbirth. Oftentimes, these tears are unable to be seen by the human eye but can still allow for the virus to pass through and make direct contact with mucous membranes (“wet skin”) of the eyes, ears, nose, and mouth of the infant

A number of different factors play a role in determining if a newborn will contract hepatitis B from their mother: the mother’s viral load levels, the mother’s knowledge of her infection, and if the newborn receives post-exposure prophylaxis. Post-exposure prophylaxis is the key to preventing mother-to-child transmission and consists of two parts: the first dose of the hepatitis B vaccine and hepatitis B immunoglobulin (HBIG). Both shots need to be administered 1) in two different limbs and 2) within 12 hours of birth in order to be as effective as possible. Once the shots have been given, the infant should complete the standard hepatitis B vaccine schedule in order to ensure that they are protected for life! *Please note that HBIG is not recommended by WHO, so it may not be recommended or available in all countries.

Commonly Asked Questions: 

It can be difficult to understand facts when they do not align with what you have been told for many years, so we’ve answered some of the most common responses to our information below: 

  1.  If it is not genetic, how is it sexually transmitted? 

 This question goes back to the topic of genes. A genetic disease differs from a sexually transmitted disease because of where the virus is hosted during transmission from one individual to another. A genetic disease is given to a person via cellular DNA while a baby is developing in the mother’s womb. Sexual transmission occurs because the virus is present in blood and sexual fluids and can be transmitted through very tiny, microscopic tears as a result of sexual intercourse.

2.  If it’s not genetic, why do multiple members of my family have it? 

Families tend to share objects – and that’s okay! However, sharp objects like earrings and body jewelry or personal care items like razors, nail clippers, or toothbrushes, can make tiny, microscopic cuts and abrasions in our skin that bleed. Sometimes, we don’t even notice! When a family member uses an object with trace amounts of infected blood and they also have a wound, such as a mouth sore,  cut, or freshly shaved skin, the virus can spread to the uninfected individual. Because hepatitis B is so infectious (at least 50 times more infectious than HIV!), even small amounts of infected blood can cause a person to become infected. Therefore, it is recommended that personal items and sharp objects are not shared – even between family members, or ensure all family members are properly vaccinated for hepatitis B and confirm they are protected

Accidents also occur frequently in households, and sometimes blood is spilled. The virus can live on surfaces outside of the body, so it is essential to properly clean up any blood spills. The key to safely cleaning up blood and killing the virus is to wear gloves and use a fresh diluted bleach solution of 1 part bleach mixed with 9 parts water. 

It’s extremely important to note that infected blood must come into contact with uninfected blood or a mucous membrane for transmission to occur. A person cannot become infected from skin-to-skin contact such as shaking hands or hugging, sharing utensils or food prepared by an infected individual, or even kissing.

Prevention: 

The best thing to remember is that hepatitis B is preventable, even if a child is born to a mother living with chronic hepatitis B! Always remember to wash your hands thoroughly with soap and hot water after any possible exposure to blood. In addition, any family members and loved ones who test negative for the hepatitis B surface antigen (HBsAg) and did not recover from a past infection (HBcAb total negative) should get vaccinated to prevent any possible transmission. The vaccine is one of the most effective vaccines in the world! 

Baruch S. Blumberg Institute