Approximately two billion people worldwide have evidence of past or present infection with hepatitis B virus (HBV), and 350-400 million individuals are chronic carriers (i.e. positive for hepatitis B surface antigen HBsAg). Conventional treatments are based on antiretroviral drugs that require lifelong treatment. Current treatments for chronic HBV infection (NUCs and IFN-a) improve the quality of life and survival of infected patients, but their effects are not sustained (NUC treatment needs to be maintained for life and IFN-a achieves stable HBV suppression in 5-7% of patients). However, a definitive treatment for HBV eradication is not yet available on the market. The global chronic hepatitis B therapeutics market is expected to reach a value of $3 billion by 2024. Activating the immunological mechanisms that allow spontaneous HBV resolution is a sensible strategy for the treatment of chronic HBV infection. Within this project, we undertook to develop an innovative treatment consisting in a single-dose gene therapy-based approach that, when combined with existing and/or upcoming antivirals, aims at inducing a functional cure against chronic hepatitis B.
