The Hepatitis B Vaccine
Getting the hepatitis B vaccine is one of the most effective ways to prevent hepatitis B. Its usually administered in two, three, or four doses. In many countries, infants receive their first dose of the vaccine at birth.
The Centers for Disease Control and Prevention recommends that infants receive their first dose of the vaccine at birth and finish all doses at 6 to 18 months old.
The CDC also recommends all children under the age of 19 years old be vaccinated if they havent already received the vaccination.
Adults can also get the hepatitis B vaccine. The vaccine is generally recommended if you have an increased risk of contracting the virus. Some of these risk factors include:
- traveling to or living in a region where hepatitis B is common
- being sexually active with more than one partner or with a partner who has hepatitis B
- working in a medical setting or other workplaces where youre exposed to bodily fluids
- using intravenous drugs and sharing drug equipment
- having chronic liver disease, a human immunodeficiency virus infection, a hepatitis C infection, diabetes, or kidney disease on dialysis
If youve been exposed to the hepatitis B virus and havent been vaccinated, try to see a doctor right away. They can administer the first dose of the vaccine, though youll need to follow up to receive the remaining doses over the next few months.
They may also prescribe a medication called
Hbv Polymerase Inhibitors: Nucleoside And Nucleotide Analogues
As described earlier, hepadnavirus polymerase plays an important role in genome replication. Similar to the HIV virus, viral reverse transcriptase is a good target for inhibiting viral replication. Nucleoside analogues are chemically synthesized selective competitive inhibitors of HBV polymerase. These agents are incorporated into the viral DNA strand, resulting in chain termination. Nucleoside analogues may interfere with the synthesis of the negative DNA strand by reverse transcription, synthesis of the positive DNA strand, and possibly cccDNA formation in newly infected cells . These agents are orally administered and therefore, adherence to the prescribed treatment regimen is better than IFN-based therapy. However, the drawback with these agents as compared to finite therapy with IFN-based regimen is that therapy is usually required for several years. Prolonged use of these agents is challenging due to the development of drug resistance.
Key Points To Remember
- Some people with chronic hepatitis B don’t develop serious problems and can live active, full lives without treatment. But others may develop severe liver damage. If this happens, you may need a liver transplant.
- Treatment may not be an option for everyone who has hepatitis B, because antiviral medicines cost a lot and may not work for everyone.
- Experts recommend antiviral medicines if you have high levels of both the hepatitis B virus and liver enzymes in your blood for at least 6 months or if you have liver disease.
- Some antiviral medicines that stop or slow the growth of the hepatitis B virus can have serious long-term side effects. And some can make you feel sick while you are taking them.
- You may not need to take antiviral medicines if you have normal or only slightly higher-than-normal levels of liver enzymes in your blood and a biopsy shows no signs of liver damage.
- People who have had an organ transplant or who drink too much alcohol or use illegal drugs may not be able to take some antiviral medicines.
- You will probably need to take medicine for many years. And you’ll need to have regular exams and blood tests to see if the virus is still active in your body and to find out how well your liver is working.
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Pivotal Trials And Open
The efficacy and safety of VEMLIDY 25 mg once daily in the treatment of CHB in adults with compensated liver disease were evaluated in 2 randomized, double-blind, active-controlled, noninferiority trials: Trial 108 and Trial 110 .
The primary endpoint for both studies was HBV DNA < 29 IU/mL and noninferiority to tenofovir disoproxil fumarate at Week 48.
Additional efficacy endpoints evaluated at Week 48, Week 96, and Week 144 for both studies include:
- Proportion of patients with HBV DNA < 29 IU/mL
- Alanine aminotransferase normalization
- Hepatitis B surface antigen loss and seroconversion
Hepatitis B envelope antigen loss and seroconversion were also assessed in Trial 110.
The original protocol was amended to extend the double-blind phase from 96 weeks to 144 weeks. However, before implementation of the amendment protocol, 540 patients entered the open-label phase at Week 96 .
At Week 144, all 1137 remaining HBeAg and HBeAg+ patients entered the open-label VEMLIDY phase for an extension trial that is still ongoing.
The 5-year data is not presented in the VEMLIDY label.
Can Hepatitis B Be Prevented
The best way to prevent hepatitis B is to get the hepatitis B vaccine.
You can also reduce your chance of hepatitis B infection by:
- Not sharing drug needles or other drug materials
- Wearing gloves if you have to touch another persons blood or open sores
- Making sure your tattoo artist or body piercer uses sterile tools
- Not sharing personal items, such as toothbrushes, razors, or nail clippers
- Using a latex condom during sex. If your or your partner is allergic to latex, you can use polyurethane condoms.
If you think you have been in contact with the hepatitis B virus, see your health care provider right away. Your provider may give you a dose of the hepatitis B vaccine to prevent infection. In some cases, your provider may also give you a medicine called hepatitis B immune globulin . You need to get the vaccine and the HBIG as soon as possible after coming into contact with the virus. It is best if you can get them within 24 hours.
National Institute of Diabetes and Digestive and Kidney Diseases
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What Do I Need To Know About Having Hepatitis B
If you have chronic hepatitis B, getting the right medical care can help you stay healthy. Taking good care of your liver is important. Talk with your doctor before you take any prescription medication, over-the-counter drugs, vitamins, or nutritional supplements to make sure they wont hurt your liver. You should also stay away from alcohol, because drinking can damage your liver.
What Else Do You Need To Make Your Decision
Check the facts
- True That’s right. Experts recommend antiviral medicines if you have high levels of both the hepatitis B virus and liver enzymes in your blood for at least 6 months or if you have liver disease.
- False Sorry, that’s not right. Experts recommend antiviral medicines if you have high levels of both the hepatitis B virus and liver enzymes in your blood for at least 6 months or if you have liver disease.
- I’m not sure It may help to go back and read “Get the Facts.” Experts recommend antiviral medicines if you have liver disease or high levels of the hepatitis B virus and liver enzymes in your blood.
- True That’s right. There are medicines that stop or slow the growth of the hepatitis B virus, but some of them can have serious side effects. Some people stop taking their medicines because they feel too sick to finish them.
- False Sorry, that’s not right. There are medicines that stop or slow the growth of the hepatitis B virus, but some of them can have serious side effects. Some people stop taking their medicines because they feel too sick to finish them.
- I’m not sure It may help to go back and read “Get the Facts.” Some of these medicines can have serious side effects. Some people stop taking their medicines because they feel too sick to finish them.
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Hepatitis B And Pregnancy
Because their immune systems arent fully developed, infants and young children are more likely to develop chronic hepatitis B, so its important to limit their exposure to the virus. All expecting women should be screened for hepatitis B. If a high viral load is detected through testing, your doctor will initiate treatment during your third trimester to reduce the likelihood that your baby will contract the disease during delivery.
Additionally, the infants of mothers with hepatitis B should receive the hepatitis B vaccination series and immune globulins at birth so they do not develop hepatitis B.
What Treatments Are Available For Chronic Hepatitis B
Hepatitis B treatment is based on the results of blood tests, age, and the degree of scarring in the liver. Hepatitis B treatment is recommended for patients with very active virus and an inflamed liver. People with chronic hepatitis B and cirrhosis also may be candidates for treatment.
Treatment involves taking an oral antiviral medication. In some cases, injections may be used.
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American Association For The Study Of Liver Diseases Recommendations
The 2016 AASLD guidelines for the treatment of chronic hepatitis B as well as select recommendations from the 2018 AASLD guidance update on the prevention, diagnosis, and treatment of chronic hepatitis B are outlined below and in the Guidelines section.
The AASLD does not recommend antiviral therapy in individuals with all of the following, regardless of HBeAg status or age :
- No clinical evidence of cirrhosis
- Persistently normal ALT levels
- Low levels of HBV DNA replication . ]
Adults with immune-active chronic hepatitis B infection
Administer antiviral therapy to lower the risk of morbidity and mortality associated with chronic hepatitis B infection.
The recommended initial agent for adults is PEG-IFN, entecavir, or tenofovir.
Adults with immune-tolerant chronic hepatitis B infection
Antiviral therapy is not recommended.
The AASLD suggests obtaining ALT levels at least every 6 months to monitor for potential transition to immune-active or -inactive chronic hepatitis B.
For select patients older than 40 years, the AASLD suggests antiviral therapy in the setting of normal ALT levels, elevated HBV DNA , and significant necroinflammation or fibrosis on liver biopsy specimens.
Adults with HBeAg-positive immune-active chronic hepatitis B who seroconvert to anti-HBe on nucleoside analog therapy
Adults with HBeAg-negative immune-active chronic HBV infection
Children with chronic hepatitis B infection
Individuals with HBV and HCV coinfection
Individuals with HBV and HIV coinfection
Whats The Prognosis For Hepatitis B
Your doctor will know youâve recovered when you no longer have symptoms and blood tests show:
- Your liver is working normally.
- You have hepatitis B surface antibody.
But some people don’t get rid of the infection. If you have it for more than 6 months, youâre whatâs called a carrier, even if you donât have symptoms. This means you can give the disease to someone else through:
- Unprotected sex
- Contact with your blood or an open sore
- Sharing needles or syringes
Doctors donât know why, but the disease does go away in a small number of carriers. For others, it becomes whatâs known as chronic. That means you have an ongoing liver infection. It can lead to cirrhosis, or hardening of the organ. It scars over and stops working. Some people also get liver cancer.
If youâre a carrier or are infected with hepatitis B, donât donate blood, plasma, body organs, tissue, or sperm. Tell anyone you could infect — whether itâs a sex partner, your doctor, or your dentist — that you have it.
CDC: âHepatitis B Questions and Answers for Health Professionals,â âHepatitis B Questions and Answers for the Public.â
Mayo Clinic: âHepatitis B.â
UpToDate: âHepatitis B virus: Screening and diagnosis.â
HealthyPeople.gov: âHepatitis B in Pregnant Women: Screening.â
Annals of Internal Medicine: âScreening for Hepatitis B Virus Infection in Nonpregnant Adolescents and Adults: U.S. Preventive Services Task Force Recommendation Statement.â
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Low Response Rates And Nonresponders
Low vaccination response rates have been associated with obesity, smoking, immunosuppression , and advanced age. Approximately 25-50% of persons who initially do not have a vaccine response will show a response to one additional vaccine dose, and 50-75% of individuals will have a response to a fourth higher dose of Engerix B or Recombivax HB, or a second 3-dose series.
Postvaccine antibody titers do not need to be obtained in routine vaccinations of children or adults. It is recommended that testing for anti-HBs be obtained 4-12 weeks after vaccination in the following groups :
- Immunocompromised patients, including those on hemodialysis, HIV patients, and others
- Infants born to HBsAg-positive mothers
- Healthcare professionals
- Sexual partners of HBsAg-positive patients
Nonresponders, should be revaccinated with another series of 3-dose hepatitis B vaccine. Consider delaying revaccination for several months after initiation of antiretroviral therapy in patients with CD4 counts below 200 cells/mm3 or those with symptomatic HIV disease. The delay in these individuals is an attempt to maximize the antibody response to the vaccine.
Do not defer vaccination in pregnant patients or patients who are unlikely to achieve an increased CD4 count. Individuals at increased risk of severe complications due to HBV infection include those unlikely to achieve CD4 counts of 200 cells/mm3 or above after antiretroviral therapy and HIV-infected pregnant women.
National Institutes Of Health Recommendations
The National Institutes of Health recommends nucleoside therapy for the treatment of patients with acute liver failure, as well as cirrhotic patients who are HBV DNA positive and those with clinical complications, cirrhosis or advanced fibrosis with positive serum HBV DNA, or reactivation of chronic HBV during or after chemotherapy or immunosuppression. In addition, immunoglobulin and vaccination should be administered to newborns born to women positive for hepatitis B surface antigen .
In general, for hepatitis B e antigen -positive patients with evidence of chronic HBV disease, treatment is advised when the HBV DNA level is at or above 20,000 IU/mL and when serum ALT is elevated for 3-6 months.
For HBeAg-negative patients with chronic hepatitis B disease, treatment can be administered when the HBV DNA is at or above 2,000 IU/mL and the serum ALT is elevated for 3-6 months.
In patients coinfected with HBV and HIV, initiate therapy against HBV and administer antiretroviral therapy as well.
The NIH also indicates that immediate therapy is not routinely indicated for patients who have the following :
Chronic hepatitis B with high levels of serum HBV DNA but normal serum ALT levels or little activity on liver biopsy
Low levels of or no detectable serum HBV DNA and normal serum ALT levels
Positive serum HBV DNA but not HBsAg , unless the patient is undergoing immunosuppression
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Treatment For People With Hiv And Hepatitis B Co
In the UK, standards for HIV treatment and care are set and monitored by the British HIV Association , the professional association for HIV doctors and other healthcare professionals. The most recent guidelines on HIV and hepatitis co-infection were produced in 2017 .
“The health of your liver should be regularly monitored during HIV and hepatitis B treatment.”
Like everyone else living with HIV, people with HIV and hepatitis B co-infection are advised to start antiretroviral treatment soon after they are diagnosed with HIV. People with co-infection may particularly benefit from early antiretroviral treatment because undetectable HIV viral load and restored immune function are linked to slower liver disease progression.
Guidelines recommend that all people with HIV and hepatitis B co-infection should use combination antiretroviral therapy containing tenofovir plus either lamivudine or emtricitabine. These drugs are active against both HIV and hepatitis B.
The most widely used option is the Truvada pill combining tenofovir and emtricitabine, along with an additional anti-HIV drug from another class. Fixed-dose combination pills for HIV treatment that contain tenofovir and emtricitabine are also active against hepatitis B. Tenofovir alafenamide is easier on the kidneys and bones than tenofovir disoproxil . People who cannot take tenofovir can use entecavir instead, in addition to combination therapy to treat HIV.
Hepatitis B Treatment Outcomes
Effective hepatitis B treatment suppresses hepatitis B virus reproduction, and reducing hepatitis B viral load can reduce inflammation and bring liver enzyme levels back to normal. Less often, treatment can lead to loss of hepatitis B antigens and promote production of antibodies .
The most effective antiviral drugs usually produce low or undetectable hepatitis B viral load in most people who receive treatment. However, people with HBeAg-negative hepatitis B are more likely to respond to treatment. For example, one study found that among HIV-negative people treated with tenofovir, around 95% of HBeAg-negative people and 75% of HBeAg-positive people had undetectable hepatitis B virus DNA after one year. A majority of both groups still had hepatitis B suppression after eight years on treatment.
Most people taking antivirals alone do not experience hepatitis B antigen loss or seroconversion. Pegylated interferon strengthens the immune response against hepatitis B, but usually does not lead to a cure. Some studies show that adding pegylated interferon to antivirals increases the likelihood of these outcomes. For people with co-infection, seroconversion appears to be more likely if they are also on HIV treatment.
How well something works . See also ‘efficacy’.
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Treatment Options For Hepatitis B
People living with chronic hepatitis B infection should expect to live a long and healthy life. There are decisions people can make to protect their livers such as seeing a liver specialist or health care provider regularly, avoiding alcohol and tobacco, and eating healthy foods. There are also approved drugs for both adults and children that control the hepatitis B virus, which helps reduce the risk of developing more serious liver disease, but there is still no complete cure.
Current treatments for hepatitis B fall into two general categories:
- Immune modulator Drugs These are interferon-type drugs that boost the immune system to help get rid of the hepatitis B virus. They are given as a shot over 6 months to 1 year.
- Antiviral Drugs These are drugs that stop or slow down the hepatitis B virus from reproducing, which reduces the inflammation and damage of your liver. These are taken as a pill once a day for at least 1 year and usually longer.
It is important to know that not everyone with chronic hepatitis B infection needs to be treated. This can be difficult to accept when first diagnosed because taking a drug to get rid of the virus seems like the first step to getting better. Current treatments, however, are generally found to be most effective in those who show signs of active liver disease .
Hepatitis B Drug Watch
Visit the HBF Drug Watch for a complete list of the approved treatments for hepatitis B and promising new drugs in development.