HEPLISAV-B Post-Marketing Observational Study Results Presented at 2021 Annual Conference on Vaccinology Research (ACVR)
The post-marketing observational, non-inferiority surveillance study (HBV-25) evaluated the occurrence of AMI in approximately 31,000 patients who received HEPLISAV-B® and approximately 38,000 patients who received Engerix-B. The AMI rate per 1000 person years was 1.67 for HEPLISAV-B and 1.86 for Engerix-B. The hazard ratio comparing the rate of AMI in the HEPLISAV-B group with the Engerix-B group was 0.92 with a 95% confidence interval of 0.63 to 1.32. The upper bound of the 95% confidence interval of the hazard ratio comparing the rate of AMI in the HEPLISAV-B group to the Engerix-B group was less than 2.0, meeting the primary endpoint. Thus, these results provide evidence there is no increased risk of AMI associated with vaccination with HEPLISAV-B compared to Engerix-B. The study was conducted by
"These results reinforce our previous clinical data regarding the safety of HEPLISAV-B and support our confidence in its ability to prevent hepatitis B infection in adults," commented
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About the Annual Conference on Vaccinology Research (ACVR)
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Please see Important Safety Information below.
For more information about HEPLISAV-B, visit http://heplisavb.com
About Hepatitis B
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,i and transmission is on the rise. 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
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with
Indication and Use
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
Important Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).
For full Prescribing Information for HEPLISAV-B, click here.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the observational comparative study. These forward-looking statements are based upon management's current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events may differ materially from those anticipated in such forward-looking statements due to various risks and uncertainties inherent in our business, including, without limitation; the risk that prescribers and other key decision-makers at potential purchasing entities may not make the decision to switch to or continue prescribing HEPLISAV-B; risks related to market adoption and competing therapies; and risks related to whether payors will cover and provide timely and adequate reimbursement for HEPLISAV-B. These and other risks are described in the "Risk Factors" section of our most recent periodic report, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the
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i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.
iii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.