New Vaccine for Hepatitis B Gets FDA Approval

Two-dose vaccine for the prevention of hepatitis B in adults.

The Food and Drug Administration (FDA) has approved Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted]; Dynavax) for the prevention of infection caused by all known subtypes of hepatitis B virus. Heplisav-B is approved for use in adults 18 years of age and older.

Infection with hepatitis B virus can have serious consequences including massive hepatic necrosis and chronic active hepatitis. Chronically infected patients are at risk for cirrhosis and hepatocellular carcinoma.

Heplisav-B is administered by intramuscular injection in two doses one month apart. “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 William Schaffner, MD, professor of Preventive Medicine, Vanderbilt University Medical Center. 

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The approval of Heplisav-B was based on data from three Phase 3 non-inferiority trials involving close to 10,000 adults who received the vaccine. Results from the largest study (n=6,665) showed that compared to Engerix-B,  Heplisav-B demonstrated a statistically significantly higher rate of protection (95% vs. 81%). In a subgroup analysis of participants with type 2 diabetes (n=961), Heplisav-B provided a statistically significantly higher rate of protection compared to Engerix-B (90% vs. 65%). 

Heplisav-B is expected to be available in the first quarter of 2018. Each 0.5mL dose is formulated to contain 20mcg of HBsAg and 3000mcg of CpG 1018 adjuvant. 

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