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

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:

• ENGERIX-B
• RECOMBIVAX HB
• HEPLISAV-B

Combination vaccines:

• PEDIARIX
• TWINRIX

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.