FDA Approves Heplisav-B for Prevention of Hepatitis B in Adults

DynavaxTechnologies Corporation reported that the U.S. Food and Drug Administration has authorized for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older HEPLISAV-B. For adults, in more than 25 years and the only two-dose hepatitis B vaccine.HEPLISAV-B is the first new hepatitis B vaccine in the U.S

Hepatitis B is a highly infectious and potentially deadly virus affecting a wide range of adults. There is no treatment for hepatitis B, and infections originate. A new case of acute hepatitis B in 2015 has increased more than 20%. Hepatitis B can be prevented by effective vaccination. At present, hepatitis B vaccines require 3 shots over a six-month period. Nonetheless, about half of adults fail to complete the sequence within one year.

William Schaffner, MD, Professor of Preventive Medicine at Vanderbilt University Medical Center said “in adults, prevention of hepatitis B by vaccination is more important than ever given the rise in the rate of infections. Many of the adults remain at the risk of unprotected against this virus. Two dose programs with higher rates of protection, along with another strategy, which may help us move to the goal close of getting rid of hepatitis B as a public health problem in the United States.”

To enhance the immune response combination of hepatitis B surface antigen with Dynavax’s proprietary Toll-like receptor 9 agonists for Heplisav-B. Heplisav-B approval was based on data from nearly 10,000 adults who received Heplisav-B from three phase 3 noninferiority trials. The pivotal studies compared over one-month Heplisav-B administered in two doses to Engerix-B (GlaxoSmithKline) administered in three doses over six-month schedule.

Phase 3 trials results, 6,665 participants included, statistically which shows that Heplisav-B demonstrated a higher rate of protection of 95% compared with 81% for Engerix-B significantly. In a subgroup study analysis with type-2 diabetes of 961 participants, statistically, Heplisav-B indicated a 90% higher rate of protection compared to 65% for Engerix-B significantly. In three clinical trials, the most common localized reaction was a pain at the injection site (23% to 39%). The most common systemic reactions were headache (8% to 17%) and fatigue (11% to 17%).

In the United States, Dynavax expects to launch Heplisav-B in the first quarter of 2018. In preparation for Heplisav-B, to meet anticipated demand Dynavax has been building commercial infrastructure and optimizing manufacturing processes.

Additional Information:

What is Hepatitis B:

Hepatitis B is a viral disease of the liver infection caused by the hepatitis B virus that’s easily preventable by a vaccine if it is not vaccinated that becomes chronic and lead to cirrhosis, liver cancer, and death. The hepatitis B virus is 50 to 100 times more infectious than human immunodeficiency virus. In adults, hepatitis B is spread by exposure to infected bodily fluids and through unprotected sex with an infected person.

Signs and Symptoms:

Abdominal pain and dark urine and yellowing of the eyes. In children, they don’t experience any symptoms. Cancer or scarring and liver failure can occur in chronic cases.

Vaccination:

The CDC recommends vaccination for those at high risk for infection due to their jobs, living situations, travel to certain areas and lifestyle. Because people with diabetes are particularly susceptible to infection, for adults 19 to 59 years of age as soon as possible after their diagnosis the CDC recommends vaccination with diabetes, and for people 60 and older with diabetes at their physician’s discretion.

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