Wednesday, July 17, 2024

Injection For Hepatitis B Treatment

Who Should Not Get The Hepatitis B Vaccine

Hepatitis B symptoms, treatment and prevention

Hepatitis B is a safe vaccine that does not contain a live virus.

However, there are some circumstances in which doctors advise against getting the HBV vaccine.

You should not receive the hepatitis B vaccine if:

  • youve had a serious allergic reaction to a previous dose of the hepatitis B vaccine
  • you have a history of hypersensitivity to yeast or any other HBV vaccine components

Informed Consent And Ethical Evaluations

All procedures used were in accordance with the ethical standards of the responsible committee on human experimentation and with the Helsinki Declaration of 1964, as revised in 2008. Informed consent for the observational process was obtained from all patients before inclusion in the study. The observational protocol was approved by the institutional review board or ethics committee before study initiation.

Cases And Clusters Of Potential Public Health Importance

Jurisdictions should review and analyze hepatitis B data regularly to identify cases and clusters of hepatitis B that merit further investigation. When resources are limited, these should be prioritized for investigation based on the degree of public health importance. The following are examples of high priority cases and clusters:

  • People of childbearing age who are or have the potential to become pregnant, indicating the potential for perinatal transmission
  • Children 24 months of age to detect perinatal transmission
  • People in age and demographic groups for whom infection may be acute due to recent transmission, including those
  • 70 years of age
  • People who were previously vaccinated to characterize possible vaccine failures
  • People born after 1990 to distinguish between failure of vaccine and failure to vaccinate
  • People receiving hemodialysis with evidence of acute hepatitis B
  • People lacking typical behavioral risk behaviors or exposures for hepatitis B who have evidence of acute infection to identify other potential causes of HBV transmission
  • People with other indicator of possible acute or recent infection, including those
  • with elevated ALT or jaundice
  • with positive immunoglobulin class M antibody to hepatitis B core antigen
  • with recent or current IDU history
  • who were tested at locations frequented by people at high-risk for acute infection or
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    Us Food And Drug Administration Approves Vemlidy For Treatment Of Chronic Hepatitis B Virus Infection In Pediatric Patients

    Approval Expands on Previous FDA Approval of Vemlidy in Adults Living With This Chronic Liver Disease

    Efficacy and Safety of Once-Daily Vemlidy Demonstrated in Individuals 12 Years of Age and Older

    Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved the supplemental new drug application for Vemlidy ® 25 mg tablets as a once-daily treatment for chronic hepatitis B virus infection in pediatric patients 12 years of age and older with compensated liver disease.

    Vemlidy is a novel, targeted prodrug of tenofovir that was previously approved by the FDA in 2016 as a once-daily treatment for adults with chronic HBV infection with compensated liver disease. It is recommended as a preferred or first-line treatment for adults with chronic HBV with compensated liver disease in guidelines from the American Association for the Study of Liver Diseases and European Association for the Study of the Liver . 1,2

    Vemlidy’s approval in this pediatric patient population is supported by 24-week data from a Phase 2 clinical trial comparing treatment with Vemlidy 25 mg to placebo among 70 treatment-naïve and treatment-experienced patients aged 12 to less than 18 years weighing at least 35 kg. The study met its primary endpoint of percentage of patients with HBV DNA levels below 20 IU/mL at 24 weeks of therapy overall, 21% of subjects treated with Vemlidy 25 mg achieved HBV DNA

    U.S. IMPORTANT SAFETY INFORMATION AND INDICATION FOR THE USE OF VEMLIDY

    Is Hepatitis B Preventable

    Hepatitis B Vaccine (rDNA) (100IU) INJECTION, 1 Inj In 1 Vial ...

    Chronic hepatitis B infection affects at least 250 million people worldwide, causing over 880,000 deaths annually. It is also the major cause of liver cancer, the second leading cause of cancer-related deaths in the United States.

    Unlike its cousin hepatitis C, hepatitis B can be prevented with vaccines. If you are accidentally exposed to the virus, there are also drug therapies you can takeâcalled postexposure prophylaxisâto avert the infection.

    Recommended Reading: Hepatitis B Can Cause Liver Cancer

    Hepatitis B Vaccination In Pregnancy

    Hepatitis B infection in pregnant women may result in severe disease for the mother and chronic infection for the baby.

    This is why the hepatitis B vaccine is recommended for pregnant women who are in a high-risk category.

    There’s no evidence of any risk from vaccinating pregnant or breastfeeding women against hepatitis B.

    And, as it’s an inactivated vaccine, the risk to the unborn baby is likely to be negligible .

    Factors Used To Determine Whether To Initiate Treatment

    Because of inability to eradicate HBV and the potentially long if not indefinite duration of therapy , treatment is not universally indicated for everyone with chronic HBV, but rather reserved for those who are thought most likely to benefit from the standpoint of disease modification. Conceptually, the clearest indications for treatment are when extensive liver fibrosis has occurred and/or when there is active HBV DNA replication causing ongoing significant hepatic inflammation. The decision to treat persons with chronic HBV therefore typically incorporates the following three factors: cirrhosis status, evidence of hepatic inflammation, as measured by alanine aminotransferase levels or liver biopsy, and ongoing HBV replication as indicated by serum HBV DNA levels. Some guidelines incorporate the HBeAg status as another parameter to consider in deciding whether to initiate HBV treatment.

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    Rare Side Effects After Immunisation

    There is a very rare risk of a serious allergic reaction to any vaccine. This is why you are advised to stay at the clinic or medical surgery for at least 15 minutes following immunisation, in case further treatment is required.

    If you think your child may be having a serious allergic reaction and you are no longer at the clinic where they were immunised, take them immediately to your doctor or to the nearest hospital, or call 000 for an ambulance.

    Another rare side effect is the hypotonic-hyporesponsive episode . If they are experiencing HHE, a baby may be:

    This may occur from one to 48 hours following vaccination. The whole episode may last from a few minutes to 36 hours.

    If you think your child may be having an HHE episode, take them immediately to your doctor or to the nearest hospital.

    Follow-up of children with HHE shows no long-term neurological or other side effects.

    Whats The Prognosis For Hepatitis B

    The Truth about 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.

    Show Sources

    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

    CDC.

    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

    Recommended Reading: Hepatitis B Virus Surface Ab

    Who Should Receive Hepatitis B Vaccination

    • All newborns before hospital discharge. Infants born to hepatitis B-positive women need hepatitis B vaccine and HBIG within 12 hours of birth.
    • All children and adolescents not previously vaccinated.
    • Children born in the U.S. to individuals born in a country with high hepatitis B endemicity.
    • All individuals at risk of hepatitis B infection:
    • Sex partners of hepatitis B-positive persons
    • Sexually active persons who are not in a long-term, mutually monogamous relationship
    • Persons seeking evaluation or treatment for a sexually-transmitted disease
    • Men who have sex with men
    • Persons who inject drugs
    • Household contacts of hepatitis B-positive persons
    • Persons born in countries where hepatitis B infection is endemic should be tested and vaccinated if susceptible
    • International travelers to regions with high or intermediate rates of endemic hepatitis B infection
    • Health care and public safety workers that may be exposed to blood or blood-contaminated body fluids
    • Residents and staff of facilities for developmentally disabled persons, corrections facilities, and other facilities that serve adults at risk for hepatitis B infection
    • Persons with end-stage renal disease, including pre-dialysis, hemodialysis, peritoneal dialysis, and home dialysis patients
    • Persons with chronic liver disease
    • Persons to age 60 years with diabetes
    • Persons with HIV infection
    • All other persons seeking protection from hepatitis B infection.

    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.

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    Why Is The Hepb Vaccine Recommended

    People who dont know they’re infected can spread the hepatitis B virus. So it cant be avoided just by being careful. That’s why health experts recommend that all babies get the vaccine right from birth.

    The HepB injection usually creates long-term immunity. Most infants who get the HepB series are protected from hepatitis B infection beyond childhood, into their adult years.

    Eliminating the risk of infection also decreases risk for cirrhosis of the liver, chronic liver disease, and liver cancer.

    Possible Side Effects Of Hepatitis B Vaccination

    Vaccine, Hepatitis B, Engerix

    You may experience minor side effects following vaccination. Most reactions are mild and last no more than a couple of days and you will recover without any problems.

    Common side effects of hepatitis B vaccines include:

    • pain, redness and swelling at injection site
    • occasionally an injection-site lump

    Talk to your vaccination provider about possible side effects of hepatitis B vaccines, or if you or your child have possible side effects that worry you.

    The Consumer Medicine Information available on the Therapeutic Goods Administration website lists the ingredients and side effects of each vaccine.

    Learn more about the possible side effects of vaccination.

    Recommended Reading: Do I Have Hepatitis B

    Who Should Get The Hbv Vaccine

    The Centers for Disease Control and Prevention recommends that all children and adults up to age 59 should receive the hepatitis B vaccine.

    Infants should get their first hepatitis B vaccine within 24 hours of birth and complete their doses by age 6 to 18 months.

    All unvaccinated children and adults through age 59 should receive the vaccine. Also, unvaccinated adults over the age 60 who are at risk of hepatitis B should get the vaccine.

    Adults over age 60 who are not at risk of hepatitis B may also choose to get the shot.

    Several types of the HBV vaccine are also safe to administer to pregnant women.

    • people who have had more than one sex partner in the last 6 months
    • men who have sex with men
    • people seeking treatment for a sexually transmitted infection
    • people whose partners or household members have hepatitis B
    • people who inject drugs
    • people who live or work in care facilities
    • people who are on dialysis
    • travelers to countries where hepatitis B is common
    • people with chronic liver disease, HIV, or hepatitis C
    • people who are in jail or prison

    People who have diabetes should talk with a healthcare professional about their risk for contracting hepatitis B.

    Approved Drugs For Adults

    There are currently 7 approved drugs in the United States for adults living with chronic hepatitis B infection. These include 5 types of antiviral drugs that are taken as a pill once a day for 1 year or longer. And there are 2 types of immune modulator drugs called interferon that are given as an injection for 6 months to 1 year.

    It is important to know that not everyone needs to be treated. A liver specialist should evaluate your health through a physical exam, blood tests, and an imaging study of your liver . Then you can discuss together whether you are a good candidate for treatment since the approved drugs are most effective when there are signs of active liver disease. In addition, talk to your provider about HBV Clinical Trials since there are several new drugs being tested that are available for infected adults.

    All adults, however, should be seen regularly by a liver specialist whether they are on treatment or not.

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    When To Delay Or Avoid Hepb Immunization

    Doctors delay giving the vaccine to babies who weigh less than 4 pounds, 7 ounces at birth whose mothers do not have the virus in their blood. The baby will get the first dose at 1 month of age or when the baby is discharged from the hospital.

    The vaccine is not recommended if your child:

    • is currently sick, although simple colds or other minor illnesses should not prevent immunization
    • had a serious allergic reaction after an earlier dose of the vaccine or is allergic to baker’s yeast

    How Is A Hepatitis B Vaccine Given

    Treating Hepatitis B – Steven-Huy Han, MD | UCLA Digestive Diseases

    A health care provider gives the hepatitis B vaccine. The vaccine is given as a shot injected into a muscle, usually in the arm for adults and children older than 1 year and in the thigh for infants and children younger than 1 year. Vaccination with a hepatitis B vaccine is usually given as a series of injections over a period of time, depending on the specific brand of the vaccine. Read any printed information that your health care provider gives you about the hepatitis B vaccine.

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    Is There A Cure For Hepatitis B

    The long and short answer is that there is not yet a cure for hepatitis B. Understanding why requires insight into the virus itself and the challenges cure researchers face.

    Hepatitis B is an infectious disease caused by the hepatitis B virus . While most people exposed to hepatitis B will spontaneously clear the virus soon after infection, a proportion will go on to develop a chronic infection.

    Of these, around one in four will develop severe liver complications, including cirrhosis and liver cancer, typically years after the initial infection.

    Efforts to find a cure for hepatitis B have been underway since the virus was first identified by scientists at the National Institutes of Health in 1966. It soon became clear, however, that numerous hurdles would need to be overcome before an actual cure could be achieved. Chief among these are:

    Data Reinforcing Impact Of Bristol Myers Squibb Cardiovascular Portfolio To Be Presented At American Heart Association Scientific Sessions 2022

    Data across VALOR-HCM, EXPLORER-HCM, AUGUSTUS and other studies continue to demonstrate the safety and efficacy of the company’s cardiovascular portfolio

    Bristol Myers Squibb today announced the presentation of research demonstrating the strength of the company’s cardiovascular franchise at the American Heart Association’s annual Scientific Sessions, taking place in-person and virtually November 5-7, 2022. Findings from clinical, patient-reported outcomes and real-world studies will be presented across the cardiovascular portfolio. Notably, one abstract from the CAMZYOS ® development program was accepted as a featured science presentation demonstrating advancements in the treatment of obstructive hypertrophic cardiomyopathy .

    “The AHA annual Scientific Sessions is an important congress for us to share new data that is adding to the growing body of evidence demonstrating the continued positive, long-term impact our treatments are having for cardiovascular patients globally,” said Roland Chen, MD, senior vice president and head of cardiovascular development, Global Drug Development at Bristol Myers Squibb. “We continue to pursue the development of innovative, safe, effective and durable treatment options that improve patients’ lives, and are proud to showcase further analysis from our programs in obstructive hypertrophic cardiomyopathy and thrombosis.”

    Key presentations include:

    Summary of Presentations

    *Sponsored by the Bristol Myers Squibb-Pfizer Alliance

    About CAMZYOS

    $

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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 1 additional vaccine dose, and 50-75% of individuals will have a response to a second 3-dose series.

    It is recommended that testing for anti-HBs be obtained 4-12 weeks following vaccination. Revaccinate nonresponders, 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.

    A combined hepatitis A virus /HBV vaccine is licensed in many countries and offers the advantage of protection against both of these viruses at the same time. The vaccine seems to be safe, although some questions exist regarding neurologic complications.

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