Heplisav-B Hepatitis B Vaccine

Dynavax Announces Final Immunogenicity and Interim Safety Results from Clinical Trial Evaluating HEPLISAV-B in Patients Undergoi

A California-based biopharmaceutical company announced immunogenicity and safety results of the ongoing clinical trial evaluating HEPLISAV-B®, a Hepatitis B Vaccine (HVB) in patients undergoing hemodialysis.

Dynavax Technologies Corporation published final immunogenicity data in 119 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) undergoing hemodialysis, demonstrated a seroprotection rate of 89.3 percent with high levels of anti-HBs antibodies, which are critical to maintaining protection in patients undergoing hemodialysis.

And, the interim safety data showed HEPLISAV-B was well tolerated, and no safety concerns were observed. Full safety data are expected by the end of 2021.

HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist adjuvant CpG 1018 to enhance the immune response.

HEPLISAV-B is indicated to prevent infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Robert Janssen, M.D., Chief Medical Officer at Dynavax, stated in a press release, "We believe the 4-dose regimen of HEPLISAV-B, we are evaluating in this study, can provide an important hepatitis B vaccination alternative for patients undergoing hemodialysis by delivering high levels of protection with fewer doses compared to the current standard of care which requires up to 8 injections to complete the regimen."

The study, HBV-24, is designed to evaluate the immunogenicity of HEPLISAV-B at study week 20 and safety over the 68-week study duration. The safety and effectiveness of HEPLISAV-B have not been established in adults on hemodialysis.

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer, and death. HBV is 50 to 100 times more infectious than HIV, and there is no cure for hepatitis B, says the U.S. CDC.

In adults, hepatitis B is spread through contact with infected blood and unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations, and travel to certain areas.

Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis. And for people age 60 and older with diabetes at their physician's discretion.

The company says, ‘do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines.

PrecisionVaccinations publishes research-based vaccine news.

Sub Title:

Dynavax Technologies HEPLISAV-B is an adult hepatitis B vaccine

References:

CDC: Hepatitis

Heplisav-B Hepatitis B Vaccine

HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis

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Hepatitis B Vaccine Reports Similar Acute Myocardial Infarction Rate

Don Hackett — Tue, 03 Dec 2019 21:43:54 +0000

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Dynavax Announces HEPLISAV-B Post-Marketing Requirement Interim Report Completed

A California based biopharmaceutical company announced that it has filed a report on a cumulative analysis of its post-marketing study of the Hepatitis B Vaccine HEPLISAV-B for review by the U.S. Food and Drug Administration (FDA).

This Dynavax Technologies Corporation study is assessing the rates of occurrence of acute myocardial infarction (AMI) in persons receiving HEPLISAV-B compared with Engerix-B.

The interim report assessed unadjudicated events of AMI. The event rates in this interim analysis were found to be similar between the 2 treatment arms.

And, the independent data monitoring committee concurred that this analysis showed no evidence of an increase in AMI events in the HEPLISAV-B arm.

The study was initiated in August 2018 and will continue through November 2020. Final study results will be reported upon study completion.

This post-marketing study requirement is related to FDA approval of HEPLISAV-B on November 9, 2017.

“These results reinforce our previous clinical data regarding the safety of HEPLISAV-B and support our confidence that HEPLISAV-B can be the emerging standard of care for preventing hepatitis B infection in adults,” commented Robert Janssen, M.D., Chief Medical Officer, in a related press release.

“We are pleased to collaborate with Kaiser Permanente Southern California for their rigorous conduct of this study, and look forward to a scientific presentation of the final data at an appropriate forum in the future.”

Dynavax previously announced the complete accrual of more than 30,000 patients who received HEPLISAV-B and more than 30,000 patients who received Engerix-B in the ongoing post-marketing study.

HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response.

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer, and death. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person.

The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%). And, do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

The Centers for Disease Control and Prevention (CDC) recommends vaccination for those at high-risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.

Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 years with diabetes as soon as possible after their diagnosis, and for people age 60 years and older with diabetes at their physician's discretion.

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines. For more information, visit www.dynavax.com.

Hepatitis B vaccine news published by Precision Vaccinations

Sub Title:

Dynavax HEPLISAV-B hepatitis B vaccine completes post marketing study

References:

FDA: BLA APPROVAL

Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

CDC: Hepatitis B Questions and Answers for the Public

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Adult Immunization Schedule Updated

Don Hackett — Wed, 21 Aug 2019 20:25:39 +0000

Every year in the United States, thousands of adults become seriously ill and are hospitalized because of diseases that vaccines can help prevent.

The need for vaccines does not go away with age. In fact, there are specific ages in your adult life when vaccinations are recommended.

Immunization guidelines for adults are routinely updated when the US Food and Drug Administration (FDA) makes changes.

According to a JAMA article published on August 19, 2019, there have been 2 important vaccines approved by the FDA for adults, which are as follows:

Shingrix

Shingrix, a herpes zoster vaccine containing a specific protein subunit of the virus (recombinant glycoprotein E) with a novel adjuvant (an added substance that enhances or prolongs the immunologic response). Shingrix, a new recombinant herpes zoster vaccine approved by the FDA on October 20, 2017, is more efficacious than the older live-attenuated Zostavax (efficacy of >90% vs 51%, respectively).
The ACIP recommends Shingrix over Zostavax for all immunocompetent persons, for those with chronic medical conditions (eg, chronic kidney disease, diabetes, chronic lung disease), and for persons aged 50 years or older receiving low-dose immunosuppressive therapy (at 0 months and at 2-6 months), including those who previously received Zostavax (at ≥2 months after dose) or had a prior episode of shingles.
A recent study showed Shingrix reduced the incidence of herpes zoster in adults who had undergone autologous hematologic stem cell transplantation. Testing for varicella-zoster antibody prior to vaccination is not recommended.

Heplisav-B

Heplisav-B, a single-antigen recombinant hepatitis B vaccine with a novel adjuvant. In 2017, the recombinant hepatitis B vaccine (HBV), Heplisav-B, was approved by the FDA for adults aged 18 years or older.
It is a combination of HBV surface antigen (HBsAg; 20 µg) and Dynavax’s proprietary TLR9 agonist (a synthetic cytidine-phosphate-guanosine oligonucleotide, CpG 1018 adjuvant) and was designed to stimulate a directed immune response to HBsAg.
Heplisav-B is administered as a 2-dose series at 0 month and at 1 month. Currently, the ACIP does not endorse one hepatitis B vaccine over another; however, Heplisav-B requires only 2-doses and evidence suggests it is more immunogenic.

The vaccines you need as an adult are determined by many factors including your age, lifestyle, health condition, and which vaccines you’ve received during your life.

The 2019 adult vaccination schedule can be found here.

The FDA says ‘talk to your healthcare professional about which vaccines are right for you.’

The corresponding author for this JAMA article is Beverly E. Sha, MD, Rush University Medical Center, Division of Infectious Diseases, 600 S Paulina, Ste 140-143, Chicago, IL 60612 (beverly_sha@rush.edu).

Sub Title:

Shingrix and Heplisav-B vaccines now recommended for adults

Reference:

Adult Immunization Update

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Protecting Pregnant Women & Infants With Hepatitis B Vaccines

Don Hackett — Thu, 01 Aug 2019 19:10:24 +0000

Reviewer:

John Paul Sanchez, PharmD

The US Preventive Services Task Force (USPSTF) reaffirmed its previous conclusion that there is convincing evidence that screening for the Hepatitis B virus (HBV) infection in pregnant women provides substantial benefit.

This USPSTF statement was published on July 30, 2019, saying there is adequate evidence that serologic testing for hepatitis B surface antigen accurately identifies HBV infections.

This means testing for the hepatitis B surface antigen (HBsAg) should be ordered at the 1st prenatal visit.

Additionally, women with unknown HBsAg status or with new or continuing risk factors for a viral infection of the liver should be screened at the time of admission to a hospital or other delivery setting, says the USPSTF.

And, the USPSTF found limited evidence on the harms of screening for HBV infection in pregnant women. But, the potential harms of HBV screening is small based on the high accuracy of screening and the low likelihood of harms from preventive interventions.

In addition, there is evidence that over time, a perinatal transmission has decreased among women and infants enrolled in case-management, providing an overall substantial health benefit.

Furthermore, the USPSTF found adequate evidence that vaccination of all infants against HBV infection and providing postexposure prophylaxis with hepatitis B immune globulin (HBIG) at birth to infants of mothers infected with HBV substantially reduce the risk for acquisition of HBV infection in infants.

This new USPSTF statement is important since in the USA, estimates of chronic HBV infection range from approximately 850 ,000 to more than 2 million cases. In 2016, a total of 3,218 cases of acute hepatitis B were reported to the US Centers for Disease Control and Prevention (CDC).

In the United States, the most prevalent cases of HBV infection are chronic infections from exposure occurring in infancy or childhood.

>> Private hepatitis screening at Ulta Labs <<

Another major risk factor for HBV infection is country of origin. In the United States, adults with HBV born in high-prevalence countries were commonly infected during birth.

In US-born children, the primary source of infection is vertical transmission at birth. According to the CDC, 800 to 1000 cases of perinatal transmission (3.8% of infants born to HBV-positive women) occurred yearly from 2000 to 2009.

Since 1998, rates of maternal HBV infection have increased annually by 5.5 percent. Older maternal age, race/ethnicity (non-Hispanic black and Asian populations), lower education, higher poverty levels, and lack of insurance coverage are risk factors for HBV infection among women.

Persons infected with HBV during infancy or childhood are more likely to develop chronic HBV infection and have poor long-term health outcomes compared with persons infected later in life.

Acute HBV infections progress to chronic disease in 80 to 90 percent of infected infants, 30 percent of acute infections progress before age 6 years, and less than 1 to 12 percent of acute infections progress in older children or adults.

Hepatitis B vaccine news

“Hepatitis isn’t a disease we hear about often, but it’s still prevalent despite being preventable. Hepatitis B vaccinations are recommended for children, but adults that did not receive the vaccines in childhood may still be at risk,” said Holly Hawbaker, Pharm D Candidate, Intern for Brookshires Grocery Company.

“Patients should talk to their doctor or pharmacist to determine if they’re at risk for hepatitis, and if they are, they can receive the appropriate hepatitis vaccine.”

The CDC is sharing this 5-minute online assessment which offers a personalized report on hepatitis testing and vaccination recommendations.

The CDC said online on July 3, 2019, the ‘best way to prevent hepatitis B is by getting vaccinated. The hepatitis B vaccine is safe and effective. Completing the series of shots is needed for full protection.’

In the USA, there are 3 single-antigen vaccines and 2 combination HBV vaccines available:

Single-antigen hepatitis B vaccines: ENGERIX-B, RECOMBIVAX HB, and HEPLISAV-B

Combination vaccines: PEDIARIX and TWINRIX

To schedule a vaccination appointment at a local healthcare provider, please click here. And, vaccine financial support programs can be found at Vaccine Discounts.

Any vaccine can cause a side effect, which should be reported to a healthcare provider or the CDC.

Sub Title:

Hepatitis B virus vaccines stimulate natural immune systems to protect against the virus

References:

Hepatitis B Virus Infection in Pregnant Women: Screening

Screening for Hepatitis B Virus Infection in Pregnant Women US Preventive Services Task Force Reaffirmation Recommendation

CDC:Hepatitis B Questions and Answers for the Public

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Hepatitis B Infections Impact ‘Other’ Cancers Too

Don Hackett — Wed, 19 Jun 2019 16:50:04 +0000

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Associations Between Hepatitis B Virus Infection and Risk of All Cancer Types

A new study reported that a Hepatitis B virus (HBV) infection was associated with the risk of non-liver cancer, especially digestive system cancers.

This is important news since HBV infections affect more than 2 billion people worldwide.

This cohort study of 496,732 Chinese individuals was published in JAMA on June 14, 2019, concluded that hepatitis B surface antigen (HBsAg) seropositivity was associated with the risk of hepatocellular carcinoma, stomach cancer, colorectal cancer, oral cancer, pancreatic cancer, and lymphoma.

Additionally, the association between HBsAg seropositivity and stomach cancer was further replicated in 2 other small Chinese studies, in which more sensitive assays for HBsAg detection were used.

These tissue-based experiments validated the occurrence of HBV expression in cancer cells located in the stomach and pancreas, but not in lung cancer cells.

"This study provides compelling evidence for the association between HBV infection and all types of cancer," the authors wrote, suggesting a potential role of HBV in the oncogenesis of non-liver cancers.

“This study presents striking new evidence for the increased risk of non-liver cancers in people with chronic HBV. Although we have a safe and effective treatment to prevent the spread of HBV, the vaccines still remain on the shelf,” said Ravi Prasad, Pharm D Candidate, an intern for Brookshire Grocery Company.

“The results of this study indicate that we have the tools to prevent horrendous diseases like stomach cancer, oral cancer, colorectal cancer, pancreatic cancer, and lymphoma. Preventing and testing for HBV is indispensable and should be a priority among health care providers around the world.”

Hepatitis B virus has been implicated in the cause of up to 80 percent of hepatocellular carcinoma (HCC) cases, which frequently occurs in Chinese and African populations.

The virus optimizes its life cycle to allow for long-term persistence in liver tissue by establishing a plasmid-like covalently closed circular DNA form.

Chronic HBV infection persisting in liver tissue is associated with increased chronic oxidative damage in hepatocytes, immune-mediated inflammation of the liver, and development of cancer, says the Centers for Disease Control and Prevention (CDC).

Recent hepatitis B vaccine news:

Hepatitis B is transmitted when blood, semen, or other body fluids from a person infected with the Hepatitis B virus enters the body of someone who is not infected. This can happen through sexual contact; sharing needles, syringes, or other drug-injection equipment; or from mother to baby at birth.

>>> Private hepatitis screening at Ulta Labs <<<

For some people, hepatitis B is an acute, or short-term, illness but for others, it can become a long-term, chronic infection.

The risk for chronic infection is related to age at infection: approximately 90 percent of infected infants become chronically infected, compared with 2–6 percent of adults, says the CDC.

Sub Title:

Hepatitis B vaccines are known as the first anti-cancer vaccine

References:

Risk of all-type cancer, hepatocellular carcinoma, non-Hodgkin lymphoma and pancreatic cancer in patients infected with HBV

Chronic hepatitis infection is associated with extrahepatic cancer development: a nationwide population-based study in Taiwan

CDC: Hepatitis B

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Hepatitis B Vaccine Study Launches for Dialysis Patients

Don Hackett — Sun, 19 May 2019 13:51:23 +0000

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Dynavax Announces First Patient Enrolled in Study of HEPLISAV-B® in Adults With End-Stage Renal Disease

A biopharmaceutical company announced the enrollment of the 1st of 100 patients in the company’s open-label, single-arm clinical study of HEPLISAV-B in adults with end-stage renal disease who are initiating or undergoing hemodialysis.

There is no cure for hepatitis B, but effective vaccination can prevent the disease.

The primary endpoints of this phase 1 study, NCT03934736, are to evaluate the immunogenicity induced by HEPLISAV-B at week 20, as measured by seroprotection rate and to evaluate the safety of HEPLISAV-B with respect to clinically significant adverse events.

This time frame is important since Hepatitis B has a long incubation period.

HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like receptor (TLR), 9 agonist, to enhance the immune response.

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer, and death. The hepatitis B virus is 50 to 100 times more infectious than HIV, and transmission is on the rise.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person.

Additionally, the U.S. Preventive Services Task Force has issued a recommendation which reaffirms there is ‘convincing evidence that screening for hepatitis B virus (HBV) infection in pregnant women to avoid transmitting the disease to their future children.’

“Although vaccination to prevent hepatitis B infection has been standard practice for decades for dialysis patients, there remains a need to provide improved overall protection safely through a greater and more durable antibody response,” said Robert Janssen, M.D., chief medical officer of Dynavax.

“We’re hopeful that this patient population may benefit from this new and shortened dosing schedule as compared to currently approved treatments.”

The Centers for Disease Control and Prevention (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.

Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.

About 1.2 million people in the United States are infected with hepatitis B, says the CDC.

Hepatitis B tests can be ordered online from UltaLabs.

For more information, visit HEPLISAV-B.

Sub Title:

Dynavax Heplisav-B is an adult hepatitis B vaccine combining hepatitis B surface antigen with Toll-like receptor 9 agonist to enhance the immune response

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All Pregnant Women Should Be Screened for Hepatitis B

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Clinical Trials

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Hepatitis B Vaccine Candidate For Long-Term Immunological Cure Doses 1st Patient

Don Hackett — Thu, 31 Jan 2019 14:03:32 +0000

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Dicerna Announces Dosing of First Volunteer in Phase 1 Clinical Trial of DCR-HBVS Designed for the Treatment of Chronic HepB

Dicerna Pharmaceuticals announced the dosing of the 1st participant in its Phase 1 clinical trial of DCR-HBVS, an investigational GalXCTM-based therapy for the treatment of chronic hepatitis B virus (HBV) infection in adults.

DCR-HBVS is comprised of a single GalXC molecule that targets HBV messenger RNAs (mRNAs) within the hepatitis B surface antigen (HBsAg) gene sequence region.

Current therapies for HBV, such as nucleoside analogs and pegylated interferon, aim to suppress the virus.

However, although these treatments can provide long-term viral suppression if taken continuously, they rarely lead to a long-term immunological cure.

By contrast, DCR-HBVS targets HBV messenger RNA (mRNA) and leads to greater than 99 percent reduction in circulating HBsAg, as observed in mouse models of HBV infection.

These data suggest that DCR-HBVS may induce long-term clearance of intrahepatic and serum HBsAg, as well as sustained HBV DNA suppression.

Dicerna anticipates publishing data from the DCR-HBVS-101 study in the second half of 2019.

Preclinical studies with a standard mouse model of HBV infection showed DCR-HBVS led to greater than 99 percent reduction in circulating HBsAg, suggesting superior HBsAg suppression (both in magnitude and duration of suppression), compared to targeting within the X gene sequence region.

“RNAi-based therapy has the potential to change the treatment paradigm for patients with chronic HBV infection. By silencing not only the S antigen but also other viral genes, through a powerful and long-acting mechanism,” said principal investigator Edward Gane, MBCHB, M.D., deputy director and hepatologist of the New Zealand Liver Transplant Unit at Auckland City Hospital and clinical professor of Medicine at theUniversity of Auckland School of Medicine.

“RNAi-based therapy could tip the balance toward allowing the patient’s own immune system to mount an effective immune response.”

“This approach could help eradicate HBV and remove the need for life-long therapy.”

Chronic HBV infection, a condition characterized by the presence of the HBV surface antigen for 6 months or more, claims approximately 780,000 lives annually.

An estimated 650,000 of these deaths are caused by cirrhosis and liver cancer as a result of chronic hepatitis B, and 130,000 of these deaths result from complications associated with acute disease, according to the World Health Organization (WHO).

A vaccine against hepatitis B has been available since 1982. The vaccine is 95 percent effective in preventing infection and the development of chronic disease and liver cancer due to hepatitis B.

Currently, there are 3 single-antigen vaccines and 2 combination HBV vaccines available in the USA:

Single-antigen hepatitis B vaccines:

Combination vaccines:

To schedule a vaccination appointment at a local pharmacy, please click here.

The CDC Vaccine Price List provides current vaccine contract prices and general information, and vaccine discounts can be found here.

Vaccines, like any medicine, can have side effects, says the CDC. You are encouraged to report negative side effects of vaccines to the FDA or CDC.

Dicerna Pharmaceuticals, Inc., is a biopharmaceutical company focused on the discovery and development of innovative, subcutaneously delivered RNAi-based therapeutics for the treatment of diseases involving the liver, including rare diseases, chronic liver diseases, cardiovascular diseases, and viral infectious diseases.

Sub Title:

DCR-HBVS vaccine candidate may induce long-term clearance of intrahepatic and serum HBsAg, as well as sustained HBV DNA suppression

References:

Hepatitis B VIS

Disease Burden from Viral Hepatitis A, B, and C in the United States

42% of Hepatitis B Patients May Also Have Hepatitis D

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All Pregnant Women Should Be Screened for Hepatitis B

Don Hackett — Mon, 14 Jan 2019 22:40:00 +0000

Reviewer:

John Paul Sanchez, PharmD

The U.S. Preventive Services Task Force (USPSTF) has issued a ‘draft’ recommendation which reaffirms its 2009 conclusion that there is ‘convincing evidence that screening for hepatitis B virus (HBV) infection in pregnant women provides substantial benefit.’

This USPSTF recommendation has an ‘A’ rating and says pregnant women should be screened for hepatitis B at their first prenatal visit to avoid transmitting the disease to their future children.

This is important news since only 84–88 percent of pregnant women are screened for HBV infection, says the Centers for Disease Control and Prevention (CDC).

When babies become infected with hepatitis B from their mothers, they have a 90 percent chance of developing lifelong chronic infections, such as liver disease and liver cancer, says the CDC.

Screening for hepatitis B in pregnancy has been a standard of care for more than 30 years.

Task Force member Melissa A Simon, M.D., M.P.H, said in a press release, “Since 1998, rates of maternal hepatitis B virus have increased annually by 5.5 percent.”

“With early screening, we can treat pregnant individuals and substantially reduce transmission of the virus to their babies.”

“In children, the primary source of hepatitis B infection is transmission at birth from an infected mother,” added Task Force member Alex Kemper, M.D., M.P.H., M.S.

“But we know that screening for hepatitis B in pregnant women can keep babies from getting the virus and prevent the onset of potentially lifelong serious health problems.”

Hepatitis B is a viral infection of the liver that can cause a number of chronic conditions, such as liver disease or liver cancer. About 1.2 million people in the United States are infected with hepatitis B, says the CDC.

To prevent pregnant women with hepatitis B from transmitting it to their baby, there is an effective vaccine and preventive medication that can be given to the infant within 12 hours of birth.

Preventing perinatal HBV transmission is an integral part of the national strategy to eliminate hepatitis B in the United States, says the CDC.

This draft is available for public comment through February 4, 2019.

Sub Title:

Preventing perinatal Hepatitis B transmission is an integral part of the national strategy to eliminate hepatitis B

References:

Hepatitis B Virus Infection in Pregnant Women: Screening

Screening for hepatitis B virus infection in pregnancy: U.S. Preventive Services Task Force reaffirmation recommendation

Who should get vaccinated against hepatitis B?

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42% of Hepatitis B Patients May Also Have Hepatitis D

Don Hackett — Mon, 14 Jan 2019 18:59:34 +0000

Reviewer:

John Paul Sanchez, PharmD

A recent Johns Hopkins University study reported that the prevalence of hepatitis D is “significantly higher” than previously acknowledged.

This new study found 42 percent of adults with hepatitis B virus were coinfected with hepatitis D.

And, most of these individuals were unaware of their hepatitis D infection, since the hepatitis D virus is uncommon in the United States, says the Centers for Disease Control and Prevention (CDC).

It’s so uncommon, the CDC does not report on the number of hepatitis D cases.

Which suggests an expanded testing need among people with confirmed hepatitis B, concluded these researchers.

This is important news since there is not a preventive vaccine available for hepatitis D.

This study of Americans over the age of 18 years, between 2011–2016, found the prevalence of hepatitis B surface antigen (HBsAg) was 0.36% overall.

Among adult HBsAg-carriers, 42 percent (95% confidence interval: 29%-56%) had antibodies to hepatitis D virus.

Additionally, this study also found that B/D coinfected adults had 30 percent higher serological markers associated with liver disease.

Previously in 2017, an analysis from two longitudinal patient databases showed an expanding number of newly diagnosed HDV.

"Results from this ICD-10 analysis indicate that only 4.7 percent of chronic HBV patients are tested for HDV co-infection, even though this represents a 30 percent increase in HDV testing in 2016 versus 2012,” said Eduardo B. Martins, MD, Senior Vice President of Liver and Infectious Diseases Development at Eiger BioPharmaceuticals, Inc.

Hepatitis D virus (HDV) only occurs in people who are infected with the hepatitis B virus, because HDV is an incomplete virus that requires the helper function of HBV to replicate, says the CDC.

HDV can be an acute, short-term, infection or a long-term, chronic infection.

Hepatitis D is transmitted through percutaneous or mucosal contact with infectious blood and can be acquired either as a coinfection with HBV or as a superinfection in people with HBV infection.

The CDC says hepatitis D can be prevented in people who are not already infected by hepatitis B, with a hepatitis B vaccine.

In the USA, there are 3 single-antigen vaccines and 2 combination HBV vaccines available:

Single-antigen hepatitis B vaccines:

Combination vaccines:

To schedule a vaccination appointment at a local pharmacy, please click here.

The CDC Vaccine Price List provides current vaccine contract prices and general information, and vaccine discounts can be found here.

Vaccines, like any medicine, can have side effects, says the CDC. You are encouraged to report negative side effects of vaccines to the FDA or CDC.

Sub Title:

Hepatitis D virus can be prevented in people who are not already HBV-infected with hepatitis B vaccination

References:

Prevalence of Hepatitis B and Hepatitis D Virus Infections in the United States, 2011–2016

Disease Burden from Viral Hepatitis A, B, and C in the United States

Hepatitis D Expanding Worldwide

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Heplisav-B Vaccine is Now Recommended for Adults

Don Hackett — Fri, 20 Apr 2018 20:41:21 +0000

Reviewer:

Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant

According to the Advisory Committee on Immunization Practices (ACIP), one hepatitis B vaccine delivers the best prevention from this type of hepatitis.

People with a chronic hepatitis B virus (HBV) infection are at an increased risk for cirrhosis and liver cancer and require medical care.

Hepatitis B vaccination is the primary means of preventing infections and complications caused by HBV, says the ACIP, but vaccinations are not for people who already have Hepatitis B.

The ACIP is now recommending Heplisav-B (HepB-CpG) for adults over the age of 18 years old.

Heplisav-B was approved by the Food and Drug Administration (FDA) during November 2017 and is the 5th inactivated Hepatitis B vaccine currently recommended by the FDA.

Heplisav-B is a yeast-derived vaccine prepared with a novel adjuvant, administered as a 2-dose series, over 1 month. HepB-CpG is available in single-dose 0.5 mL vials.

Each dose contains 20 μg of HBsAg and 3,000 μg of 1018 adjuvant and is formulated without preservatives.

From a clinical review perspective, the seroprotective antibody to hepatitis B surface antigen (anti-HBs) levels were achieved in 90%–100% of subjects receiving Heplisav-B, compared with 70.5%–90.2% of subjects receiving Engerix-B.

To make this recommendation, the ACIP Hepatitis Vaccines Work Group conducted a systematic review of the evidence, including information from:

4 randomized controlled clinical trials assessing prevention of HBV infection, and
6 randomized controlled trials assessing adverse events in adults.

Post-licensure surveillance studies pertaining to the use of HepB-CpG will be reviewed by ACIP as they become available, and recommendations will be updated as needed.

Future economic analyses might inform cost-effectiveness considerations of HepB-CpG, including its use among persons at an increased risk for vaccine non-response.

HBV is transmitted through puncture through the skin or direct contact with mucous membranes exposure to infectious blood or body fluids.

HBV is highly infectious, can be transmitted in the absence of visible blood, and remains viable on environmental surfaces for at least 7 days, says the ACIP.

An estimated 248 million people have chronic HBV infection globally.

Which means, HepB vaccines should also be given to those traveling internationally to countries that have high or intermediate levels of endemic HBV infection or countries with HBsAg prevalence of 2% or higher, says the CDC.

The CDC Vaccine Price List provides current HBV vaccine contract prices and general information, and vaccine discounts can be found here.

Vaccines, like any medicine, can have side effects, says the CDC. You are encouraged to report negative side effects of vaccines to the FDA or CDC.

These researchers did not disclose any conflicts on interest: Schillie S, Harris A, Link-Gelles R, Romero J, Ward J, Nelson N. Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant. MMWR Morb Mortal Wkly Rep 2018;67:455–458.

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Heplisav-B vaccine was found to offer greater response than Engerix-B

References:

Infectious Diseases Related to Travel

Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practi

Two-Dose Hep B Vaccine Approved by CDC

HIGHLIGHTS OF PRESCRIBING INFORMATION

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Hepatitis B Vaccine Approved On Third Attempt

Don Hackett — Fri, 10 Nov 2017 13:33:32 +0000

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Compliance With Multiple-Dose Vaccine Schedules Among Older Children, Adolescents, and Adults: Results From a Vaccine Safety Dat

The first hepatitis B vaccine to win the U.S. Food and Drug Administration’s (FDA) approval in 25 years, will launch in early 2018.

The two-dose vaccine, HEPLISAV-B, approval comes after two FDA rejections, first in 2013 and then in 2016.

There is no cure for hepatitis B, but effective vaccination can prevent the disease.

HEPLISAV-B, an adult hepatitis B vaccine, is indicated for active immunization against all known subtypes of hepatitis B virus.

HEPLISAV-B will compete with Engerix-B, which is a three-dose vaccine delivered over a six-month period.

However, almost 50 percent of adults fail to complete the Engerix-B vaccine series within one year, according to previous research.

Results from a Phase 3 trial, which included 6,665 participants, showed that HEPLISAV-B demonstrated a statistically significantly higher rate of protection, 95% compared with 81% for Engerix-B.

Hepatitis B is an extremely infectious and potentially deadly virus affecting a wide range of adults in the United States. There is no cure for hepatitis B, and infections are on the rise.

In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally,according to the Centers for Disease Control and Prevention (CDC).

"Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections," said William Schaffner, M.D., professor of Preventive Medicine, Vanderbilt University Medical Center.

"Too many at-risk adults remain unprotected against this virus. A two-dose schedule with higher rates of protection, along with other strategies, may help us move closer to the goal of eliminating hepatitis B as a public health problem in the United States," said Dr. Schaffner.

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person.

Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.

For full Prescribing Information for HEPLISAV-B, click here.

Most pharmacies offer the hepatitis B vaccine. The price for this vaccine varies by state, and the CDC vaccine price list can be found here.

Vaccine discounts can be found at this page.

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HEPLISAV-B is the only two-dose vaccine for Hepatitis B in adults

References:

Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

Surveillance for Viral Hepatitis – United States, 2015

Hepatitis B FAQs for the Public

Hepatitis B FAQs for Health Professionals

Diabetes and Hepatitis B Vaccination

Dynavax Announces FDA Approval of HEPLISAV-B(TM) for Prevention of Hepatitis B in Adults

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New HepB Vaccine Delivered in Just Two Doses

Don Hackett — Wed, 02 Aug 2017 18:07:44 +0000

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