Pharma Exec Details Hepatitis B Progress, New HBV

VBI Vaccines’s PreHevbrio [Hepatitis B Vaccine (Recombinant)], the only approved 3-antigen hepatitis B vaccine for adults, is now commercially available in the U.S. after approval by the FDA late last year.

VBI Vaccines’s PreHevbrio [Hepatitis B Vaccine (Recombinant)], the only approved 3-antigen hepatitis B vaccine (HBV) for adults, is now commercially available in the U.S. after approval by the FDA late last year.

VBI is working with a network of wholesalers, distributors, group purchasing organizations, and federal accounts to enable broad access to PreHevbrio, VBI said in a news release.

Managed Healthcare Executive® talked with Jeff Baxter, president and CEO of VBI, to find out more about the vaccine and its unique qualities.

MHE: Please explain the significance of PreHevbrio being available as the only approved 3-antigen HBV vaccine for adults.

Baxter: In comparison with other approved hepatitis B vaccines, which contain only the single S-antigen, PreHevbrio presents the three surface antigens of the HBV virion — S, Pre-S1, and Pre-S2 — and is adjuvanted with the same adjuvant, alum, used in the most widely used single-antigen HBV vaccine, Engerix-B.

In pivotal clinical studies, we were able to demonstrate that more adults who were vaccinated with PreHevbrio achieved seroprotection (defined as achievement of anti-HBs titers ≥10 mIU/mL) than Engerix-B. Notably, in the older and more difficult to protect population of adults ages 45 and older, PreHevbrio elicited statistically significantly higher seroprotection rates compared with Engerix-B.

MHE: How much overall healthcare savings do you expect after the launch of PreHevbrio?

Baxter: The wholesale acquisition cost (WAC) of PreHevbrio is set at $64.75. This price point makes PreHevbrio a highly cost-effective new option for healthcare providers as they work to protect their adult patients.

The total estimated hospitalization costs associated with HBV in the U.S. is about $1.3 billion each year. Despite being a vaccine-preventable disease, the U.S. adult HBV vaccination rate has remained persistently low, at around only 25%.

With new recommendations from the CDC’s Advisory Committee on Immunization Practices (ACIP) for adult HBV vaccination (which moved to a universal recommendation for adults age 19-59), and with new cost-effective tools, including PreHevbrio, we hope to see a substantial impact on the medical and economic burden of HBV over the coming years.

MHE: There is a lot of momentum around the fight against Hepatitis B currently. Please explain some of the most important developments.

Baxter: On the public health side, there are revised guidelines for adult vaccination. In November 2021, the CDC’s ACIP unanimously voted to change the adult HBV vaccine recommendation from a risk-based one to a universal one for adults age 19-59.

There is also re-emphasis on key HBV prevention and reduction goals in notable action plans. In 2020, the US Department of Health and Human Services released both the Viral Hepatitis National Strategic Plan for the U.S. (2021-2025) and Healthy People 2030, both of which include HBV targets around reduction of acute HBV infections, increasing awareness of infection status, and reduction of HBV-related deaths.

Additionally, the World Health Organization has adopted the goal of eliminating HBV by 2030, globally, which they have defined as a 90% decrease in infection rates.

Similarly, scientific consensus is that a functional cure for chronic HBV infections is within reach (note: there is no cure today). In partnership with Brii Biosciences, our immunotherapeutic candidate, VBI-2601, is currently in two phase 2 studies in the Asia-Pacific and Greater China regions, being assessed as a potential component of a function cure.

Eradication of hepatitis B will require improvements in both prevention and treatment efforts, and we are committed to being part of that fight from both sides.

MHE: How does PreHevbrio differ from other HBVs on the market?

Baxter: PreHevbrio is scientifically differentiated from all other available HBV vaccines. As mentioned, PreHevbrio is the only 3-antigen HBV vaccine whereas all other HBV vaccines only express the single S antigen of the hepatitis B virus.

Additionally, PreHevbrio is derived from mammalian cells compared to a yeast-cell derivation, as with all other approved HBV vaccines. We believe that the combination of the three surface antigens, plus the mammalian cell derivation, results in a close mimic of the hepatitis B virion as found in nature.