Nucleoside Analogues Or Oral Antivirals
Antivirals, or NAs, slow down or stop the hepatitis B virus from reproducing, decreasing the risk of liver damage. Less liver damage occurs when there is less virus present.
People take NAs orally as a pill and experience very few side effects.
First-line treatments, such as Tenofovir disoproxil and entecavir, are potent and effective in suppressing the virus, but they only work for as long as a person takes them. Discontinuing treatment
What Is The Treatment For Hepatitis B
There are no special medicines or antibiotics that can be used to treat a person that is acutely infected once the symptoms appear. Generally, bed rest is all that is needed. Interferon is the most effective treatment for chronic HBV infection and is successful in 25 to 50 percent of cases. Chronic carriers of HBV should avoid drinking alcohol or taking medications which are harmful to the liver, as these actions can make the liver disease worse.
What Are The Types Of Hepatitis B
There are two types of hepatitis B infection: acute and chronic.
An acute infection happens at the beginning, when you first get infected with hepatitis B. Many people are able to clear it from their bodies and recover. In fact, this is true of about 4 in 5 adults who are infected.
If you are not able to clear the infection within six months or longer, you have chronic hepatitis B. It is chronic hepatitis B that leads to inflammation and the serious, and possibly fatal, illnesses of cirrhosis of the liver and liver cancer. Treatment can slow disease progress, reduce the chance of liver cancer and increase your chances of surviving.
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Molecular Mechanisms Of Drug Resistance
Different types of mutations are associated with drug resistance and can emerge during antiviral therapy with nucleoside or nucleotide analogues. Primary mutations typically affect the reverse transcriptase domain of the HBV polymerase, thereby causing steric changes of the polymerase protein that escape the inhibitory effects of the nucleoside analogues . The most relevant hot-spot mutations in the HBV polymerase are displayed in Table 1. However, the polymerase mutants have a dramatically reduced viral replication efficacy in most cases . Secondary compensatory mutations occur in order to restore the viral replication fitness, thereby overcoming deleterious effects of the primary drug-resistant mutations . These mutations are not necessarily located within the enzymatically active sites of the polymerase, but oftentimes stabilize secondary or tertiary viral structures. The eight different HBV genotypes AH partly differ with respect to the position of secondary compensatory mutations and the rate of drug resistance development .
Switch Trial Design: 401816
The efficacy and safety of switching from TDF 300 mg once daily to VEMLIDY 25 mg once daily in virologically suppressed adults with CHB infection were evaluated in a randomized, double-blind, active-controlled trial: Trial 4018 .
Patients must have been taking TDF 300 mg once daily for 12 months, with HBV DNA less than the Lower Limit of Quantitation by local laboratory assessment 12 weeks prior to screening and HBV DNA < 20 IU/mL at screening. Patients were randomized in a 1:1 ratio to either switch to VEMLIDY or stay on TDF . At baseline, the median duration of exposure to TDF prior to the trial was similar in both treatment groups .
The primary endpoint was the proportion of patients with plasma HBV DNA 20 IU/mL at Week 48.
Additional efficacy endpoints included:
- Proportion of patients with HBV DNA < 20 IU/mL
- ALT normal and normalization, HBsAg loss and seroconversion
- HBeAg loss and seroconversion
At Week 48, all patients who were randomized to TDF for the controlled portion of the trial were switched to VEMLIDY for the open-label extension through Week 96.
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Management Of Persons Who Are Hbsag Positive
Recommendations for management of all persons with HBsAg include the following:
When seeking medical or dental care, persons who are HBsAg positive should be advised to inform their health care providers of their HBsAg status so that they can be evaluated and managed. The following are key counseling messages for persons with HBsAg:
- HBV is not usually spread by hugging, coughing, food or water, sharing eating utensils or drinking glasses, or casual contact.
- Persons should not be excluded from work, school, play, childcare, or other settings because they are infected with HBV.
- Involvement with a support group might help patients cope with chronic HBV infection.
- HBV infection is a chronic condition that can be treated, and patients should receive prevention counseling and be evaluated for antiviral treatment.
How Do Doctors Treat The Complications Of Autoimmune Hepatitis
If autoimmune hepatitis leads to cirrhosis, doctors can treat health problems and complications related to cirrhosis with medicines, surgery, and other medical procedures. If you have cirrhosis, you have a greater chance of developing liver cancer. Your doctor may order an ultrasound or other types of imaging tests to check for liver cancer.
If autoimmune hepatitis causes acute liver failure or cirrhosis with liver cancer or liver failure, you may need a liver transplant.
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What Other Drugs Will Affect Vemlidy
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Tenofovir can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, high blood pressure, or pain or arthritis .
Many drugs can interact with tenofovir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.
Treatments For Hepatitis B
Hepatitis B usually clears up on its own without treatment. You may be offered medicine to help with the symptoms, such as painkillers or medicines to stop you feeling sick.
Your GP will refer you to see a liver specialist who will check how well your liver is working.
If hepatitis B lasts for over 6 months it is called long-term hepatitis B.
It is usually treated with antivirals and medicine to help relieve symptoms such as itchiness, pain, and sickness. You will also need to see a liver specialist for regular check-ups.
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Exposure To A Source With Unknown Hbsag Status
Unvaccinated persons and persons with previous nonresponse to hepatitis B vaccination who have a discrete, identifiable exposure to blood or body fluids containing blood from a person with unknown HBsAg status should receive the hepatitis B vaccine series, with the first dose initiated as soon as possible after exposure and the series completed according to the age-appropriate dose and schedule. Exposed persons who are not fully vaccinated but started the series should complete the vaccine series. Exposed persons with written documentation of a complete hepatitis B vaccine series who did not receive postvaccination testing require no further treatment.
Who Should Be Vaccinated For Hepatitis B
All newborns should be vaccinated. Also, people who are under 18 who were not vaccinated at birth should also get the vaccine. Other groups who should be sure to be vaccinated are those in certain high-risk categories, such as:
- People who have more than one sexual partner.
- Men who have sex with men.
- Adults with diabetes.
- Sexual partners of infected people and people who share households with infected individuals.
- People who are exposed to blood and other bodily fluids, including healthcare and public safety professionals, and people who work in jails and other places taking care of people who cant take care of themselves.
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Tdf Resistance And Multi
Although there is no signature mutation pattern conferring TDF resistance, cases of insufficient responses to TDF have been reported . Considering the noncross-resistance between ETV and TDF, the use of ETV should be effective in these cases, either as mono- or combination therapy . In vitro data indeed demonstrated that ETV is effective against TDF-resistant strains . The situation might be more complex in patients with multiple drug-resistant mutations due to an extended treatment history. A retrospective European multicenter study revealed that TDF monotherapy induced a potent and long-lasting antiviral response in LMV- and/or ADV-experienced patients with previous treatment failure . Moreover, the combination of ETV and TDF is a highly effective rescue therapy in patients with treatment failure after exposure to multiple drugs .
Screening For Chronic Hepatitis B
Screening can help identify chronic hepatitis B early, so that necessary care, including antiviral therapy and/or surveillance for disease progression, may be considered.12
The USPSTF, CDC, and AASLD recommend screening the following patients5,13-16:
- People born in regions with prevalence of HBV infection 2%
- US-born people not vaccinated as infants whose parents were born in regions with prevalence of HBV infection 8%
- Household and sexual contacts of people with HBV infection
- All pregnant women
- Men who have sex with men
- Injection drug users
- People with certain medical conditions
- Needing immunosuppressive therapy
- Infected with HCV or HIV
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Mechanisms Of Action Of Na And Ifn
NAs inhibit reverse transcription of pregenomic RNA and synthesis of HBV DNA in the cytoplasm and have no direct effect on cccDNA. IFN has both antiviral and immunomodulatory activities, although the precise mechanisms of action remain unclear. Recent studies suggest that IFN may enhance cccDNA degradation and exert epigenetic modification of cccDNA transcription,4 explaining its greater effect on viral protein production and higher rates of HBeAg and hepatitis B surface antigen loss compared to NAs.
Hepatitis B Treatment: Medication
There are five FDA-approved oral medications and one injection available to treat hepatitis B. The newer oral medications are stronger and less likely to develop viral resistance and have very few side effects.
The medication cannot cure the disease, but can help reduce the number of viruses in the body and the risk of complications. You may undergo periodic blood tests to monitor drug resistance and determine whether the medication is having an effect.
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Efficacy And Safety Of Available Treatments
Currently, two types of treatment, IFNs and NAs, are approved for chronic HBV infection. The virologic responses to these therapies are summarized in Table Table11.13, 24, 25 Pegylated IFNs have a more convenient dosing schedule and improved efficacy. Among the NAs, entecavir , TDF, and tenofovir alafenamide are preferred because of their potent antiviral activity and high barrier to antiviral resistance. A 1year course of pegylated IFN results in higher rates of HBeAg seroconversion and HBsAg loss than the same duration of ETV, TDF, or TAF therapy in patients who are HBeAgpositive despite lower rates of undetectable HBV DNA . Similarly, in patients who are HBeAgnegative, a 1year course of pegylated IFN results in a higher rate of HBsAg loss than the same duration of ETV, TDF, or TAF therapy despite a lower rate of undetectable HBV DNA . Response to IFN is more durable, and rates of HBeAg and HBsAg loss continue to increase after cessation of treatment, whereas viral relapse is universal when NA is discontinued after 1 year of therapy.
Barriers To Eliminating Hbv
Persistence of cccDNA and its ability to selfreplenish and the lack of direct effects of current therapies on cccDNA account for the difficulty in eliminating cccDNA. There are additional barriers to eliminating HBV. HBV DNA can be integrated into the host genome. Although integrated HBV DNA is often rearranged and/or partially deleted and there is no evidence that it supports the full cycle of HBV replication, recent studies suggest that integrated HBV DNA can be sufficiently intact to support translation of viral proteins, e.g., HBsAg.5 Elimination of integrated HBV DNA will likely require the removal of hepatocytes that harbor these DNA. Control of infections generally requires elimination of the infectious organisms coupled with activation of specific immune responses. Whereas patients who recover from acute HBV infection display rigorous immune responses to multiple HBV epitopes, patients with chronic HBV infection manifest weak immune responses to very few HBV epitopes.6
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Who Are Hepatitis B Carriers
Hepatitis B carriers are people who have the hepatitis B virus in their blood, even though they dont feel sick. Between 6% and 10% of those people whove been infected with the virus will become carriers and can infect others without knowing it. There are over 250 million people in the world who are carriers of HBV, with about 10% to 15% of the total located in India. Children are at the highest risk of becoming carriers. About 9 in 10 babies infected at birth become HBV carriers, and about half of children who are infected between birth and age 5 carry the virus. A blood test can tell you if you are a hepatitis B carrier.
Injections: Interferon And Pegylated Interferon
Pegylated interferon is given as an injection once per week. It can be used alone or with an oral hepatitis B medication. Patients with both chronic hepatitis B and hepatitis D infection may need pegylated interferon alone or combined with an oral hepatitis B pill.
- Pegylated interferon therapy is usually given for 48 weeks.
- Pegylated interferon may cause many side effects, such as flu-like symptoms, rashes, irritability, and depression.
- Side effects to interferon require close monitoring with routine blood tests.
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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.
What Other Problems Can Hepatitis B Cause
In rare cases, acute hepatitis B can cause liver failure.
Chronic hepatitis B can develop into a serious disease that causes long-term health problems such as cirrhosis , liver cancer, and liver failure.
If you have ever had hepatitis B, the virus may become active again, or reactivated, later in life. This could start to damage the liver and cause symptoms.
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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.
Is Hepatitis B Curable
Theres no cure for hepatitis B. The good news is it usually goes away by itself in 4 to 8 weeks. More than 9 out of 10 adults who get hepatitis B totally recover.
However, about 1 in 20 people who get hepatitis B as adults become carriers, which means they have a chronic hepatitis B infection. Carriers are more likely to pass hepatitis B to other people. Most carriers are contagious meaning they can spread hepatitis B for the rest of their lives.
Hepatitis B infections that last a long time may lead to serious liver diseases like cirrhosis and liver cancer. About 1 in 5 people with chronic hepatitis B die from it. There are medicines that can help treat chronic hepatitis B infections.
Most babies who get hepatitis B during birth develop chronic infection, unless they get treated right away. But treatments are almost always effective if your baby gets them quickly. Thats why its important for pregnant people to get tested for hepatitis B.
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What Is Involved In A Liver Transplant
A liver transplant is considered necessary when the liver is damaged and cannot function or in some cases of liver cancer. Your liver is very important. It is responsible for many functions related to making sure that your body stays healthy and is able to digest foods.
You may be eligible for a transplant if you have chronic hepatitis B infection or some of the diseases that may result from it, including liver cancer and cirrhosis. You will have to complete testing and be evaluated before being approved for a transplant. It is likely that you will be placed on a waiting list while an appropriate organ is found.
Donated livers come from two types of donors: living and deceased. Because the liver can regenerate, it is possible to use part of a liver for transplant. The remaining sections in both the donor and the receiver will grow into livers of adequate size.
People who get liver transplants must take anti-rejection drugs for the rest of their lives. These drugs make you more susceptible to infection. However, liver transplants have become more successful over time and continue to improve.