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Phase 3 Clinical Trials Opening for Hepatitis Delta Patients

Phase 3 clinical trials have been announced for two drugs, Lonafarnib and Myrcludex (Bulevirtide) for the treatment of hepatitis B and delta coinfection.

Phase 3 studies compare new possible treatments to the current standard treatment, to see if it is more effective and/or safer than the current standard of care. Phase 3 studies are randomized control trials, which means that patients will be assigned to one of several different treatment groups. These studies usually evaluate the new treatment over a long period of time but special designations by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), such as Fast Track, Orphan Drug, Breakthrough Therapy Designations and PRIME eligibility status will speed up this process and bring these drugs to approval more quickly. Because the only currently approved treatment for hepatitis delta is pegylated interferon, which is often less than 30% effective, there is an unmet need for faster development of more treatment options.

Phase 3 clinical trials for Lonafarnib are currently recruiting hepatitis B and delta coinfected patients in the United States. Ninety-two international trial site locations have also been announced and will take place in Belgium, Bulgaria, Canada, France, Germany, Greece, Israel, Italy, Republic of Moldova, New Zealand, Pakistan, Romania, Span, Switzerland, Taiwan, Turkey, United Kingdom and Vietnam. This clinical trial, run by Eiger Biopharmaceuticals, will test the new drug Lonafarnib in combination with other treatments. For more information about the study, visit www.D-LIVRstudy.com or clinicaltrials.gov.

Bulevirtide, made by MYR-GmbH Pharmaceuticals, has also announced that its phase 3 clinical trials will be opening in 2019. Trial site locations have not been announced yet. For more information about this study, visit clinicaltrials.gov.Click here for more information on locating additional clinical trials. If you are considering joining a clinical trial, discussing it with your liver specialist can be helpful in determining if joining a trial may be right for you.

It is very important for hepatitis B and delta patients to be managed by a doctor, preferably a liver specialist, who is familiar with managing hepatitis B and delta coinfection. For assistance in locating a specialist near you, please visit our Physician Directory page. For additional questions, please visit www.hepdconnect.org or email connect@hepdconnect.org.

Hemochromatosis: Treatment, the Liver, and Hepatitis B

Genetic conditions can be an unfortunate part of life, but with information and support, some can be managed. By sharing your family health history and learning about genetic disorders that run in the family, measures can be taken to prevent damage and help your loved ones stay healthy!

Hereditary hemochromatosis is one of the most common genetic disorders. The Centers for Disease Control and Prevention (CDC) reports that approximately 80-90% of hemochromatosis cases are from the hereditary form of the condition1. Due to a mutation in the HFE gene, the body begins to produce too much iron – a process

Northern European Countries

called iron overload. Iron overload can cause complications in the liver, heart, and pancreas2. According to the National Organization for Rare Disorders (NORD), hereditary hemochromatosis has several names that all refer to the same disorder: bronze diabetes, classic hemochromatosis, hemochromatosis type I, hemosiderosis, HFE-related hemochromatosis, HH, and primary hemochromatosis. The two non-hereditary forms of hemochromatosis are secondary hemochromatosis and neonatal hemochromatosis. Both are considered to be rare. Although the hereditary form is common, the exact number of patients worldwide is unknown. Globally, it is estimated that 1 in 227 individuals of Northern European descent is living with hemochromatosis. In the U.S, an estimated 1 million individuals are impacted as well 2

Not everyone who has the mutant gene develops hemochromatosis. These individuals are known as “carriers”; they can pass the gene on without suffering from the symptoms. Symptoms include joint pain, fatigue, abdominal pain, unexplained weight loss, and a bronze or grey skin color. For most patients, symptoms do not appear until middle age (40-60) because it takes time for the iron to build up in the body. Males tend to be affected more often than women and experience symptoms at a younger age as well 3,2. Some carriers for the mutant gene may develop a more severe version of the disorder called juvenile hemochromatosis. With juvenile hemochromatosis, patients experience an excessive amount of iron overload that can lead to liver and heart damage between the ages of 15 and 30.

Hemochromatosis, the Liver, and Hepatitis B

While the body needs a certain amount of iron to function, iron overload can be dangerous.  Hemochromatosis can lead to two major liver issues: hepatomegaly and cirrhosis. Hepatomegaly is the enlargement of the liver and cirrhosis is the scarring of the liver. Both issues can impair the liver’s ability to function and filter out toxins that enter the body. They can also increase a person’s risk of developing liver cancer. Recently, two major studies by the University of Exeter and the U.K. University of Connecticut, and the U.S. National Institute on Aging have found that a person living with hemochromatosis has four times the risk of developing a liver disease than a person who is living with the disorder.

For individuals living with hepatitis B, it is extremely important to understand any behaviors or conditions that may have a negative impact on your liver. Since one liver disease can increase your risk of another liver disease, it is important to identify the disorder as early as possible, especially if you have any of the following risk factors:

Risk Factors for Hereditary Hemochromatosis:

  • Men or postmenopausal women
  • Of Northern European descent
  • Having a relative with hemochromatosis

Risk Factors for Secondary Hemochromatosis:

  • Alcoholism
  • Family history of diabetes, heart disease, or liver disease
  • Taking iron or vitamin C supplements

Hepatitis B patients do not have an increased risk of developing hemochromatosis4. However, if you have any of the above risk factors, it is important to get tested. Hemochromatosis can easily be identified by a comprehensive look at a person’s family health history, a physical exam, and a simple blood sample. Your doctor will then use the blood sample to run a series of tests that may include transferrin saturation (TS), serum ferritin, or liver function tests. In certain cases, the doctor may also perform genetic testing to see if the mutant HFE gene is present.

Treatment

Treatment for hemochromatosis is available! Based up tests results, family history, medical history, and the appearance of symptoms, the doctor may suggest a few different treatment methods. In therapeutic phlebotomy – the most common treatment method – a patient undergoes regular blood draw to lower the amount of iron in the body. This method is effective, affordable, and typically lasts for an extended period of time. Through iron chelation therapy, patients can either receive an injection or orally consume a medication that will lower the amount of iron in your blood. Finally, some doctors may suggest changes to your diet, such as eating less vitamin C, avoiding alcohol and shellfish, and not taking iron supplements. Dietary changes are mainly used to prevent liver damage.

For more information on HH, you can visit the National Heart, Lung, and Blood Institute.

References:

  1. Grosse, S. (2017). A New Public Health Assessment of the Disease Burden of Hereditary Hemochromatosis: How Clinically Actionable is C282Y Homozygosity? [Blog]. Retrieved from https://blogs-origin.cdc.gov/genomics/2017/08/16/a-new-public-health-assessment/
  2. National Organization for Rare Disorders. (2019). Classic Hereditary Hemochromatosis. Retrieved from https://rarediseases.org/rare-diseases/classic-hereditary-hemochromatosis/#general-discussion
  3. National Institute of Diabetes and Digestive and Kidney Diseases. (2019). Hemochromatosis. Retrieved from https://www.niddk.nih.gov/health-information/liver-disease/hemochromatosis
  4. Beaton, M., & Adams, P. (2007). The Myths and Realities of Hemochromatosis. Canadian Journal Of Gastroenterology, 21(2), 101-104. doi: 10.1155/2007/619401

Patient Perspective: Living with Chronic Hepatitis B & Fighting it On All Fronts

 

This post is by guest blogger Mariam. Mariam works at a charity cancer hospital and is interested in philosophy. She is currently learning french and enjoys spending time by herself and the mountains. 

When you are first told that you have a chronic disease that is treatable but has no cure, you are suddenly confronted with an enemy on multiple fronts—you have to fight it within your body, inside your mind, your heart and in the outside world. Chronic hepatitis B: nearly 15 million people are living with it in Pakistan. In the world, 292 million people are silently suffering from this , and most are unaware (which is 9 out of 10 people globally). It is a tragedy that 2 out of 3 liver-related deaths are caused by this infection which is preventable and treatable. There are many reasons why this disease is prevalent in a developing country like Pakistan that lacks a proper healthcare system; where there are no pregnancy screenings or an effective mechanism to ensure babies are vaccinated against this. It’s an infection that can be transferred through blood (most commonly from an infected mother to her baby during delivery)  and sexual intercourse and  so it is not difficult to understand how this disease travels from one generation to another, silently. Elimination of viral hepatitis by 2030 is one of the millennium goals of the World Health Organization, but we cannot achieve this without dedicated efforts by all the stakeholders that include health-care professionals, patients, media, and policy-makers. I am primarily interested in sharing the patient’s perspective, in hopes that it will encourage others to fight this epidemic.

A Patient’s Point of View

The fact it’s a chronic illness means you are in for the long haul and you have to be prepared to take care of yourself by regular monitoring/medications (depending on what stage you are at) for the rest of your life. One can argue that’s bad but it’s not a big deal as we have people who suffer from high blood pressure, bad eyesight, or diabetes and they also have to regularly take care of themselves. The problem is that hepatitis B is an infectious disease, a fact that contributes towards stigma surrounding its diagnosis. Suffering from flu makes me feel like a hazard to others. Having an infection that I cannot get rid-off certainly makes me feel bad and, in a way, dirty. I have to be cautious and aware that my blood is hazardous for others and I have to be constantly aware of all the possibilities I can be harmful and ways to prevent it. It’s a progressive disease which can be treated at a certain point, so when you go to follow-up appointments, you feel like a ticking bomb is inside you and you need to be able to identify the period when the bomb goes off so you can treat the damage. Because current hepatitis B medications are most effective when there are signs of liver damage, the treatment is often only given during this phase. The inherent uncertainty makes you hate hepatitis B.

Fighting Discrimination and Stigma

Living in a conservative society, if you are one of the few fortunate ones aware of your diagnosis, how do you deal with it? I kept it to myself because I did not want people to define me through my illness. I did not tell my parents or friends because I did not want them to see me as ill or worse, to pity me. I needed time to process it without having to deal with other’s opinions and judgments. Three years ago, I was diagnosed with hepatitis B during regular pre-employment screening. I did not even know anything about this disease. I had a biopsy to determine the stage of the disease. Then I went to a few follow-ups. Unfortunately, after a while, I stopped because I did not want to think about this illness. I wanted to forget about it so I tucked it away, in the farthest corner of my mind. I did not know many people with whom I felt safe talking about this. Until one day, I was at a fundraising event for a charity cancer hospital where I got the chance to sit with a doctor. He was a stranger and a doctor, so in a way I felt safe telling him why I’m so interested in trying to understand where my country stands in the fight against hepatitis B—I told him I was diagnosed with it. At one point he asked me if I’m on treatment,  and I honestly told him I am supposed to be on follow-up. He said, “What do you mean, supposed to be?” That slight hint of disappointment made me feel I failed in taking care of myself. It’s easier to sound irrational inside your head but when you share it out loud, it does not feel nice. He told me that first, I need to sort out myself before trying to make a difference in the world of hepatitis B. I am grateful for the brief discussion with him which gave me the courage to think about re-scheduling my long overdue follow-up appointment. It gave me the clarity that I wanted to share my story with others in hopes that those who are fighting hepatitis know they are not alone. Sharing my story also helps me feel that I am not alone either.

I feel it is very important to fight the stigma surrounding hepatitis. Only then we will be able to talk about it and bust the myths. Only then we will be able to discuss ways to fight it on the ground. It is common in a conservative society to put a label on you as defective and exclude you from everything. For instance, marriage is still, by large, the union in this culture after which people have sexual intercourse and have kids; both occasions that can be possible causes of transmission of this virus. If, before marriage, a person is aware of their diagnosis, they can ensure that their partner is vaccinated and safe. However, in this society, there is also a prevalent culture of arranged marriage which makes this whole discussion almost impossible because so-called “perfection” is demanded. I wonder if submitting your hepatitis status with a marriage certificate was compulsory, would it help in data collection and early detection of this disease or would it encourage stereotyping. What if it was possible to vaccinate every child who starts school to be vaccinated against hepatitis B? After all, mandatory vaccinations are common in other countries. But what about children who can’t afford to go to a school? Can we link hepatitis B vaccination confirmation mandatory with every birth certification? This works in many other countries that vaccinate every baby born – we need to able to fight hepatitis B with a strong response such as this.

I also have an obsession with trying to understand this virus that is sharing my body. So my brain imagined a story to help understand how the chronic hepatitis B works. There are the good guys (liver cells) and bad guys (virus) who grew up together quite happily. Until one day, the good guys realized that these other guys are not from amongst us, let’s kill them. There is a battle and then there is collateral damage. What I want to understand is, if the bad guys aren’t harming the good guys, then why does the body start fighting them? And what is the purpose of their existence if they are not bad guys by default? Perhaps one day someone will help answer my questions. Until then, I’ll try to focus on the inevitable fight.

 

Where Can I Order Hepatitis Delta Testing?

By Sierra Pellechio, BS, CHES, Hepatitis Delta Connect Program Manager

Historically, testing for hepatitis delta has been difficult to access and often not commercially available. With the rise in awareness about hepatitis B and delta coinfection, more tests are beginning to be offered by multiple labs for clinicians in the United States looking to test their patients. Because hepatitis delta can only infect people who also have hepatitis B, the Hepatitis B Foundation’s medical director and leading hepatologist Dr. Robert Gish recommends testing all hepatitis B patients for hepatitis delta. “Screening all hepatitis B patients will allow a better understanding of hepatitis delta prevalence and its impact on outcomes and will identify patients who can be offered treatment within or outside clinical trials.”

The first step in diagnosing an infection is the HDV antibody total (anti-HDV) test. Patients who have recovered from or are currently infected will be positive for the anti-HDV and will present high titers in later stages of acute infection and persist in cases of chronic infection. If the HDV antibody total test is positive, it should be followed by the HDV RNA (PCR) test to confirm an active infection. If this test is negative, a current infection is unlikely.

Testing hepatitis B patients for hepatitis delta is important because when people with hepatitis B are exposed to the hepatitis delta virus, 90% will develop a chronic infection1. Coinfection will alter treatment and management plans, because antivirals effective on hepatitis B do not control hepatitis delta2. While the standard treatment of interferon is less than 30% effective in controlling coinfection, there are new drugs in development. With two of these drugs set to enter phase 3 clinical trials in 2019, it is more important than ever to identify coinfected patients and connect patients into clinical trials.

Until recently, only the anti-HDV test was widely available in the United States. In February 2019, Quest Diagnostics began offering HDV RNA testing, making it easier for patients and their physicians to access this more detailed level of testing. A complete list of labs offering testing is below.

Quest Diagnostics (US)

Tests Offered:

ARUP Laboratories (US) 

Tests Offered:

Cambridge Biomedical (US, Limited States)

Tests Offered:

Mayo Clinic Laboratories (US)

Tests Offered:

Viracor (US)

Tests Offered:

Centers for Disease Control and Prevention (CDC) (US & International)

Tests Offered:

  • HDV Antibody Total
  • HDV RNA
  • Genotyping

Disclaimer: This may not be a comprehensive list of all available labs offering testing.

Please note, if you are a patient in the U.S. and wish to be tested for hepatitis delta, these tests must be ordered through a clinician.

It is very important for coinfected patients to be managed by a liver specialist who is familiar with managing coinfected patients. For assistance in locating a specialist near you, please visit our Physician Directory page. For additional questions, please visit www.hepdconnect.org, email connect@hepdconnect.org, or call our hotline at 215-489-4900.

References:

  1. Hooks, B., Billings, J., & Herrera, J. (2009). Hepatitis D Virus. Practical Gastroenterology.

2. Farci, P., & Anna Niro, G. (2018). Current and Future Management of Chronic Hepatitis D. Gastroenterology & hepatology, 14(6), 342-35

We Will No Longer Be Invisible

The Hepatitis B Foundation and the Hep B United coalition are excited to partner with the All of Us Research Program, a program funded by the National Institutes of Health (NIH) to advance precision medicine – health care that is tailored to each person. All of Us will enroll and engage 1 million or more people across the country, from all walks of life, to contribute to research that could improve health for generations to come.

We are partnering with All of Us to increase representation of Asian American and Pacific Islander communities in biomedical research. Diversity and inclusion in health research is critical to understanding how certain diseases or treatments affect individuals differently and helping transform health care to be more customized and effective for each person.

In the U.S., over half of the 2.2 million people living with chronic hepatitis B are Asian Americans and Pacific Islanders. Join All of Us to help researchers better understand the causes and risk factors for chronic conditions like hepatitis B and make health equity a reality.

Visit JoinAllofUs.org to learn more about the All of Us Research Program.

Additional resources:

Fact Sheet: All of Us Research Program 

Infographic: All of Us Research Program 

Flyer : How do I sign up for this research program?

Valentine’s Day: Dating, Love, and Hepatitis B

Valentine’s Day is a day of celebration, but it can also bring about worries and stress. Some might feel pressure about buying the right gifts for their loved ones. Maybe you’re wondering if it’s too soon in your relationship to celebrate the holiday. We may not be able to help you figure out what type of candy your partner likes the most, but we can help you navigate the holiday if you or a loved one is living with hepatitis B!

Can my partner and I have sex if one of us is infected and the other is not?

One way that hepatitis B is spread is through unprotected sex. This means that certain precautions need to be taken if your partner is uninfected, has not been vaccinated, or has not completed their vaccine series yet. Precautions include using a condom correctly. Using condoms can also prevent other sexually transmitted infections, like hepatitis C and HIV, that can be harmful to everyone, but especially to those who have chronic hepatitis B. Please keep in mind that certain sexual activities carry higher risks of transmission because of tiny, often microscopic tears in the membrane that may occur and increase the chances of direct blood contact! If you believe your partner has been accidentally exposed, they should contact their doctor or a local physician to begin post-exposure prophylaxis (PEP) as soon as possible. PEP can prevent chronic hepatitis B if caught early enough, so it is very important to inform the doctor of a possible exposure soon after it occurs.

If your partner has already completed the 2 dose (where available) or 3 dose vaccine series, there is nothing to worry about! They are not at risk for transmission! The recommended schedule for the three-dose vaccine consists of a dose at 0, 1 and 6 months, and the two-dose adult vaccine is at 0 and 1 month.  Some individuals may be interested in an accelerated vaccine schedule. Please understand that an accelerated schedule entails four shots, not three. The fourth shot would be administered at one year and would provide long term protection. Those that choose a shortened schedule will not have long term protection from hepatitis B if they do not complete the fourth dose. And your partner should have their blood tested 4 weeks after their last vaccine dose to confirm that they are protected.

I’m scared to tell my partner that I have hepatitis B.

It can be intimidating to tell a person something so personal, especially if you are uncertain about how they will react. However, it is extremely important! Even if you are using condoms, it is necessary to let your partner know your status before becoming intimate. Once you tell them, it will be a huge relief!

So, how can you prepare for the conversation?

  1. Research: hepatitis B can be confusing, so it is important that you both are familiar with the infection, including how it is transmitted! Apart from HBF’s website, the Centers for Disease Control and Prevention (CDC) has great information and handouts (in multiple languages!) on the infection. Consider printing one or two fact sheets out for your partner to look over.
  2. Take a deep breath: Don’t rush into the conversation. Take a moment to think about what you want to say. This will help you to stay calm and allow the conversation to progress. Remember to let your partner talk as well!
  3. Speak confidently: Don’t let hepatitis B speak for you! Let your partner know what you’ve learned about your infection and inform them that you are regularly visiting the doctor to monitor the infection. Speaking confidently can help keep them calm as well, and assure them that there is nothing to worry about!

If they react badly to the news at first, don’t worry! Everybody processes things at different rates and many people fear what they don’t understand. Try giving them some space and let them think about the information they’ve been given. You can also show them Heng’s #justB video; it tells the story of a man who fell in love and married a woman who is living with chronic hepatitis B and how he still supports her today! Also, remind your partner that hepatitis B is vaccine preventable! Three simple shots can protect them for life and they will never have to worry about the risk of transmission again!

Some people will never react kindly to the news, and that’s okay too! It may be disappointing, but don’t let it keep you down! You deserve someone who will accept and love you for who you are! Your chronic hepatitis B infection does not define you; it is just a small part of who you are.

For Partners of Chronic Hepatitis B Patients:

Valentine’s Day is a  time of love, and what better way is there to show love than by being supportive? If your partner is living with hepatitis B, you can show them you care in small ways! Perhaps it’s skipping the alcohol once in a while when you two go out with friends so they don’t feel alone. You can also try cooking healthy meals with them or exercising together a few times a week. Small gestures can say big things!

What’s the difference: Hepatitis B vs. Hepatitis E

With five different types of viral hepatitis, it can be difficult to understand the differences between them. Some forms of hepatitis get more attention than others, but it is still important to know how they are transmitted, what they do, and the steps that you can take to protect yourself and your liver!

This is the final installment in a three-part series. You can click the links to view more about hepatitis A and hepatitis C.

What is Hepatitis?

Hepatitis means “inflammation of the liver”. A liver can become inflamed for many reasons, such as too much alcohol, physical injury, autoimmune response, or a reaction to bacteria or a virus. The five most common hepatitis viruses are A, B, C, D, and E. Some hepatitis viruses can lead to fibrosis, cirrhosis, liver failure, or even liver cancer. Damage to the liver reduces its ability to function and makes it harder for your body to filter out toxins.

Hepatitis B vs. Hepatitis E

Globally, hepatitis E is a common liver infection. The World Health Organization estimates that 20 million people are infected each year. The virus has 4 known types: genotype 1, genotype 2, genotype 3, and genotype 4. Genotypes 1 and 2 are primarily spread through  fecal-oral transmission or by consuming food or water that has been contaminated and are only found in the human population. Typically, these genotypes are found in Africa, Asia, and Mexico. Poor sanitation and lack of clean water infrastructure contribute to the spread of genotypes 1 and 2.

Image Courtesy of Canva

Genotypes 3 and 4 are found in animal populations and can be passed on to a human if their meat is undercooked and consumed. Pigs, deer, boar, and chickens have all been found to carry the hepatitis E virus, but studies have shown that consuming undercooked infected pig (pork) and wild boar have commonly been the main source of animal-to-human transmission. Although less common, shellfish has also been found to carry the hepatitis E virus as well. Genotypes 3 and 4 are most generally found in China, Taiwan, Japan, and other developed countries.

It is important to remember that hepatitis B is not spread by contaminated food or water. You cannot get hepatitis B by sharing utensils or eating food prepared by someone who is infected. The hepatitis B virus is a blood-borne pathogen, which means that it is only spread through direct blood contact with an infected person’s blood.

Unlike hepatitis B, hepatitis E usually does not progress to a life-long infection. However, the Centers for Disease Control and Prevention (CDC) reports that the number of genotype 3 cases that lead to chronic liver disease are on the rise. In most cases, the infection typically resolves itself after a few weeks. Globally, young people aged 15-40 are considered to be the most at-risk population. Children under 15 generally have no symptoms or develop a mild illness. Young adults will often experience symptoms such as jaundice, vomiting, reduced appetite, and fatigue. At the moment, there are no specific treatment options for hepatitis E. Recommendations include getting plenty of rest and staying hydrated. In extreme cases, hospitalization may be required. Hepatitis E can also lead to fulminant hepatitis, or acute liver failure. Fulminant hepatitis most often occurs with hepatitis E infections in pregnant women and those with weakened immune systems.

Pregnant Women and Hepatitis B/E

Image Courtesy of Canva

Both hepatitis B and E can be transmitted from mother-to-child. This type of transmission is rare for hepatitis E patients but occurs frequently in mothers living with chronic hepatitis B. This is because hepatitis B is a “silent infection”; it often has no symptoms so many mothers do not know that they are infected. It is much less common for hepatitis E to be spread from mother to child because the infection typically resolves itself in 4-6 weeks. The danger with hepatitis E and pregnancy lies within the complications that it can cause. Research has shown that pregnant women have a higher risk of developing fulminant hepatitis than other patients, although more studies need to be conducted to discover the reason why this occurs. Hepatitis E tends to be most dangerous for women in their second and third trimester.  According to the CDC, maternal death rates from hepatitis E can reach 10% – 30% in the final trimester. Mothers can also experience severe illness, premature delivery, and the loss of their pregnancy.

With hepatitis B infection, approximately 90% of infants born to hepatitis B infected mothers will develop chronic hepatitis B and have an increased risk of developing liver disease and liver cancer later in life. This can be avoided, however, if certain precautions are taken once the child has been born!  By making sure the doctor is aware of the mother’s hepatitis B and having the delivery staff administer 1) the first dose of the hepatitis B vaccine and 2) one dose of the Hepatitis B Immune Globulin (HBIG, if available) in the delivery room, the newborn has more than a 95% chance of being protected for life! After the initial shots are given, it is extremely important to follow through with the vaccination schedule for a lifetime of protection.

Prevention

Hepatitis B can be prevented with a 3-dose vaccine or a 2-dose vaccine for adults where available! While you wait to complete the vaccine series, simple steps to prevent transmission include washing your hands thoroughly with hot water and soap, cleaning surfaces that come  into contact with blood with a diluted bleach solution, and not sharing objects that may have trace amounts of blood on them such as razors, toothbrushes, nail clippers and body jewelry. Although there is no vaccine approved for hepatitis E in the United States, there is one available in China. For hepatitis E, genotypes 1 and 2 can be prevented by thoroughly washing your hands after using the bathroom and by boiling water before drinking it. Transmission of genotypes 3 and 4 can be prevented by thoroughly cooking all meat and avoiding undercooked meats. Pregnant women should exercise caution when consuming pork, deer meat, and wild boar.

Tackling Hepatitis B in Africa: The First Nigerian Hepatitis Summit

This is a guest blog post by Danjuma Adda, MPH, Executive Director of Chargo Care Trust, a non-profit dedicated to helping hepatitis patients in Nigeria. 

In 2016, the World Health Organization (WHO) set targets for the elimination of viral hepatitis as a public health threat by 2030 and provided a global health sector strategy (GHHS) on viral hepatitis for 2016–2021 that has since been adopted and endorsed by 194 countries. Nigeria joined the league of other nations to sign up to the GHSS and was among the few countries in Africa to develop firm goals towards the elimination of viral hepatitis. The goals were mapped out in a comprehensive framework that includes the National Viral Hepatitis Strategic Plan 2016-2020, National Policy for the Control of Viral Hepatitis, and National Guidelines for the Care and Treatment of Viral Hepatitis. An estimated 26 million Nigerians are living with viral hepatitis. A national hepatitis control program was created and a Technical Working Group for the Control of Viral Hepatitis was set up to help address the issues.

Despite these achievements, there has been very little financial assistance or investments by the national government towards the elimination of hepatitis. Gaps like low awareness fueled by myths and misconceptions, lack of available information on hepatitis, poor systems of health, high cost of diagnostic testing and out of pocket expenses for viral hepatitis treatment, low capacity of health care providers, and the proliferation of substandard treatment centres across Nigeria poses a challenge to the elimination goal of hepatitis in the country.

The First Nigerian Hepatitis Summit

To spur action towards hepatitis elimination in Nigeria, hepatitis patient groups and civil society networks organized the first ever Nigeria Hepatitis Summit in December 2018. The groups were led by Danjuma Adda, Executive Director of Chargo Care Trust. The goals of the summit were to:

1. Improve health seeking behavior among Nigerians through disease awareness and, as more people become aware of the disease, help them discover their status and encourage them to seek treatment as appropriate;

2. Increase local and domestic health financing, increase domestic, local responses, and allocate needed funds towards the elimination of the disease as more state governments establish state actions plans;

3. Increase engagement and involvement of the private sector in accelerating the elimination goal of viral hepatitis in Nigeria and;

4. Increase the capacity of health care professionals and improve health care systems to deliver quality viral hepatitis cascade of care in line with WHO and national guidelines.

The summit was held on December 3-4 in Abuja, Federal Capital Territory. Over 200 participants from diverse sectors attended including the:

* WHO’s Nigerian office

* State Directors of Public Health across Ministries of Health

* State HIV/AIDS Program Managers-Hepatitis is domiciled in the State HIV/AIDS programs at both national and state levels.

* Civil society and NGOs from 26 states in Nigeria

* Academia including the Society of Gastroenterologist and Hepatologist in Nigeria (SOGHIN)

* Private sector representatives

* Professional Medical associations

The Society of Gastroenterologist and Hepatologist (SOGHIN) led the technical faculty. SOGHIN made up 70% of the speakers. Other Speakers included: World Health Organization (WHO); World Hepatitis Alliance (WHA); Clinton Health Access Initiative (CHAI); National Primary Health Care Development Agency; Harm Reduction Association of Nigeria; and Representatives of States Ministries of Health.

Outcomes from the Summit

* Increased advocacy at state ministries of health to ensure state governments prioritize hepatitis cascade of care

* The engagement of private institutions to invest in the hepatitis cascade of care

* Efforts to enhance collaboration towards improving hepatitis cascade of care between civil society organizations and state governments

* Increased domestic financing is needed by state governments towards the elimination of viral hepatitis in Nigeria

* The World Hepatitis Alliance (WHA) UK is partnering with CSOs/Patient groups to build advocacy efforts for hepatitis C financing. To this end, WHA is supporting the development of a hepatitis C financing model for the engagement of state governments and private sector players to invest in elimination projects across Nigeria.

Looking Towards the Future

For the first time, government representatives from the state and national ministry of health, patient representatives, and civil society members came together to talk about the burden of viral hepatitis with the common goal of finding solutions to the pandemic. It was evident during the meeting that the lack of commitment and political will by the national government may cause Nigeria to miss the target goal of eliminating viral hepatitis if strong actions are not taken. Viral hepatitis must be recognized as a disease of public health importance in the country.

At the moment, the viral hepatitis cascade of care remains beyond the reach of the majority of Nigerians, fueling the spread of fake and substandard practices and the proliferation of treatment centres around the nation.

Almost everyone in Nigeria is affected by the scourge of viral hepatitis. Brothers, friends, and relatives have been lost to this disease. The conspiracy of silence across the nation and lack of strong will to address the pandemic remains a puzzle that we all need to solve.

Nigeria has what it takes in terms of financial and human resources to be the regional leader in the drive towards the elimination of viral hepatitis in Africa. What it lacks is the political will and commitment of government at all levels and the interest of private sector players to invest in the elimination of viral hepatitis in Nigeria. At the moment, other African countries are overtaking Nigeria on the path towards elimination by launching ambitious plans for their citizens.

If only we can get the attention and support of the private sector players and business moguls in Nigeria, the country will be on track towards the elimination of this disease and surpass the WHO target. If some of the countries wealthiest individuals contributed just a million dollars each to a National Hepatitis Elimination Project, Nigeria would see profound health benefits for the entire nation.

In order to attract support from partners around the world including pharmaceutical companies, the government of Nigeria must make a bold commitment and investment in addressing the challenge of viral hepatitis for its citizens.

The government of Nigeria must take the first step by making the financial commitment towards provisions for prevention, testing and treatment programs in the country by launching a pragmatic and ambitious Viral Hepatitis Elimination Project with clear targets to reach each year on prevention and treatment, including harm reduction strategies.

What is silymarin (milk thistle), and is it helpful for managing my hepatitis B and D?

 

Silymarin, an herb and extract of milk thistle seeds, is a supplement commonly taken by hepatitis patients across the world, yet its proven benefits remain controversial. It is not a treatment for hepatitis B or D, nor has it been shown to have any effect against fighting the viruses. This herb is believed to have possible benefits on liver health due to its antioxidant and free radical fighting properties, although no studies have found a consistent positive effect on viral load or fibrosis scores 1 .

Silymarin is often taken by patients or suggested by their health care provider during or after interferon treatment ends, presumably with the hope of a protective or anti-inflammatory effect on the liver. But a 2013 study on hepatitis C patients unsuccessfully treated with interferon (the standard treatment for hepatitis B and D coinfection) found no significant difference in silymarin’s ability to lower ALT scores over placebo, a pill with no active drug ingredients 2 . Another 2013 metanalysis reviewed 8 studies which tested silymarin against a placebo and looked for measurable levels of improvement in ALT scores, of which the results were mixed and inconsistent1.

Interestingly, several studies have found improvements in patients’ self-reported patient quality of life after taking silymarin 1 – perhaps due to decreased stress or self-perceived control over their health. However, a 2012 study which randomly assigned patients either silymarin or placebo to measure possible declines in ALT or virus levels, in addition to self-reported quality of life, found little to no improvement in any of these outcomes3 regardless of whether they took milk thistle or a placebo.

As mentioned in our previous blog post, the U.S. National Institutes for Health (NIH) has published a directory of 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.”

The verdict on silymarin? Due to mixed literature and lack of proven improvements, patients should not rely on silymarin as a treatment for hepatitis B or D, and should discuss any new prescription recommendations with their doctor. Silymarin will not counterbalance damage done by hepatitis B or D viruses. While some studies have found silymarin to be well tolerated with low side-effects6, individual reactions can vary. In the U.S., supplements including silymarin are not regulated by the Food and Drug Administration (FDA), making the true contents of supplements unknown. For these reasons, patients should be cautious about supplements and consider additional ways to improve their overall health. Lifestyle changes including eating a nutritious, balanced diet, avoiding alcohol and cigarettes, and getting regular exercise have been repeatedly proven to have the ability to lower ALT and AST numbers4,5. It is understandable why many patients may turn to herbal supplements for possible health benefits, but without more consistent regulation, and proven clinical benefit, investing in overall healthy lifestyle changes may prove most beneficial.

It is very important for hepatitis B and D patients to be managed by a doctor, preferably a liver specialist, who is familiar with managing coinfected patients. For assistance in locating a specialist near you, please visit our Physician Directory page. For additional questions, please visit www.hepdconnect.org or email connect@hepdconnect.org.

Disclaimer: Herbal products are not U.S.FDA approved, and the Hepatitis B Foundation cannot endorse the usage of such products that lack regulation and scientific evidence to deem them both effective and safe.

References

1. Polyak, S. J., Ferenci, P., & Pawlotsky, J. M. (2013). Hepatoprotective and antiviral functions of silymarin components in hepatitis C virus infection. Hepatology (Baltimore, Md.), 57(3), 1262-71.

2. Fried, M. W., Navarro, V. J., Afdhal, N., Belle, S. H., Wahed, A. S., Hawke, R. L., Doo, E., Meyers, C. M., Reddy, K. R., Silymarin in NASH and C Hepatitis (SyNCH) Study Group (2012). Effect of silymarin (milk thistle) on liver disease in patients with chronic hepatitis C unsuccessfully treated with interferon therapy: a randomized controlled trial. JAMA, 308(3), 274-82.

3. Fried MW, Navarro VJ, Afdhal N, et al. Effect of Silymarin (Milk Thistle) on Liver Disease in Patients with Chronic Hepatitis C Unsuccessfully Treated with Interferon Therapy: A Randomized Controlled Trial. JAMA.2012;308(3):274–282. doi:10.1001/jama.2012.8265

4. Rusu, E., Jinga, M., Enache, G., Rusu, F., Dragomir, A. D., Ancuta, I., Draguţ, R., Parpala, C., Nan, R., Sima, I., Ateia, S., Stoica, V., Cheţa, D. M., Radulian, G. (2013). Effects of lifestyle changes including specific dietary intervention and physical activity in the management of patients with chronic hepatitis C–a randomized trial. Nutrition journal, 12, 119.

5. St George A, Bauman A, Johnston A, Farrell G, Chey T, George J Gastroenterol Hepatol. 2009 Mar; 24(3):399-407.

6. Rambaldi, Andrea & P Jacobs, Bradly & Gluud, Christian. (2007). Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases. Cochrane database of systematic reviews (Online).

What’s the Difference: Hepatitis A vs Hepatitis B

With five different types of viral hepatitis, it can be difficult to understand the differences between them. Some forms of hepatitis get more attention than others, but it is still important to know how they are transmitted, what they do, and the steps that you can take to protect yourself and your liver!

This is part two in a three-part series.

What is Hepatitis?

Hepatitis means “inflammation of the liver”. A liver can become inflamed for many reasons, such as too much alcohol, physical injury, autoimmune response, or a reaction to bacteria or a virus. The five most common hepatitis viruses are A, B, C, D, and E. Some hepatitis viruses can lead to fibrosis, cirrhosis, liver failure, or even liver cancer. Damage to the liver reduces its ability to function and makes it harder for your body to filter out toxins.

Hepatitis A vs. Hepatitis B

While hepatitis A and B both impact the liver, the two viruses differ greatly from one another. Hepatitis B is a blood-borne pathogen; its primary mode of transmission is through direct blood-to-blood contact with an infected person. In contrast, hepatitis A can be spread by fecal-oral transmission or by consuming food or water that has been contaminated. It is important to note that a person cannot contract hepatitis B through casual interactions such as holding hands, sharing a meal with, or eating foods prepared by someone who is infected. There is no need to keep plates and utensils separate. However, hepatitis A can be spread through food that is prepared by an infected person. Hepatitis A is primarily caused by poor sanitation and personal hygiene. Poor sanitation and hygiene can be the result of a lack of essential infrastructure like waste management or clean water systems. It can also result from a lack of education.

Hepatitis A is an acute infection; the virus typically stays in the body for a short amount of time and most people make a full recovery after several weeks. Recently, the United States has seen a rise in hepatitis A infections. The rise is partially attributed to a growing homeless population and increases in injection drug use. You can track hepatitis A outbreaks in the United States by using this map.

Unlike hepatitis B, which rarely has symptoms, people infected with hepatitis A generally develop symptoms four weeks after exposure. However, children under the age of 6 often do not show any symptoms. Oftentimes, an infected adult will experience nausea, vomiting, fever, dark urine, or abdominal pain. Older children and adults with hepatitis A will typically experience jaundice, according to the Centers for Disease Control and Prevention (CDC). Once a person makes a recovery, they cannot be reinfected. Their body develops protective antibodies that will recognize the virus and fight it off if it enters their system again. Hepatitis A rarely causes lasting liver damage, but in a small percentage of individuals, it can cause acute liver failure called fulminant hepatitis. Some people with hepatitis A feel ill enough that they need to be hospitalized to receive fluids and supportive care.

On the other hand, hepatitis B begins as a short-term infection, but in some cases, it can progress into a chronic, or life-long, infection. Chronic hepatitis B is the world’s leading cause of liver cancer and can lead to serious liver diseases such as cirrhosis or liver cancer. Most adults who become infected with hepatitis B develop an acute infection and will make a full recovery in approximately six months. However, about 90% of infected newborns and up to 50% of young children will develop a life-long infection. This is because hepatitis B can be transmitted from an infected mother to her baby due to exposure to her blood. Many infected mothers do not know they are infected and therefore cannot work with their physicians to take the necessary precautions to prevent transmission. It is extremely important for all pregnant women to get tested for the hepatitis B – if they are infected, transmission to their baby can be prevented!

There are vaccines to protect people against both hepatitis A and hepatitis B. If you are unvaccinated and believe that you have been exposed to hepatitis A, you should contact your doctor or local health department to get tested. If you were exposed by consuming contaminated food, the health department can work with you to identify the source of exposure and prevent a potential outbreak. Depending on the situation and when you were exposed, your doctor may administer postexposure prophylaxis (PEP) to help prevent the infection or lessen its impact. For hepatitis A, PEP is given in the form of one dose of the vaccine or immune goblin.

For unvaccinated individuals, PEP is also recommended after a possible exposure to hepatitis B and is usually given as a dose of the vaccine. In certain cases, a physician will recommend that a patient receive both the vaccine and a dose of hepatitis B immune globulin (HBIG) for additional protection. As recommended by the CDC, all infants born to hepatitis B surface antigen positive mothers (HBsAg positive) should receive both a dose of the hepatitis B vaccine and a dose of HBIG within 12 hours of birth in order to prevent transmission. As timing is crucial in the prevention of disease, a healthcare provider should be notified as quickly as possible after a potential exposure.

Prevention

Hepatitis A and B vaccines can protect you for life! The hepatitis A vaccine is given in 2-doses over the span of six months and the hepatitis B vaccine is given in 3-doses over the course of six months; there is even a 2-dose hepatitis B vaccine now available in the U.S.! You can also ask your doctor about getting the combination vaccine for hepatitis A and B together, which will reduce the number of shots you need.

The CDC recommends that people living with chronic hepatitis B also get vaccinated for hepatitis A to protect themselves against another liver infection and potential liver damage. While the hepatitis A vaccine is routinely given to children in the United States, other countries have different vaccine recommendations, so check with your doctor to see if you have been vaccinated. Hepatitis A can also be prevented by good hygiene practices like washing your hands with soap and hot water after using the bathroom or before preparing food, but the best form of prevention is always vaccination!