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Bepirovirsen sodium is an investigational antisense oligonucleotide, a type of medicine built from nucleic acids that is designed to interfere with viral genetic material. It is being developed for chronic hepatitis B virus (HBV) infection.[2] The substance is not authorised as a medicine in the product records of the EU Clinical Trials Information System.[1] The product is supplied by GlaxoSmithKline Research & Development Limited.[1]
Bepirovirsen is a potential first-in-class antisense oligonucleotide that targets all hepatitis B virus messenger RNA and acts to decrease levels of viral proteins.[2] By reducing viral proteins, including hepatitis B surface antigen (HBsAg), the treatment aims to help the immune system clear the virus. The goal of treatment is a functional cure, defined as sustained undetectable levels of HBV DNA and HBsAg in the blood, with or without protective antibodies against HBsAg.[2]
Bepirovirsen sodium is given as a solution for injection in a pre-filled syringe and is administered by subcutaneous use, meaning it is injected under the skin.[1] In the Phase 2b B-Clear study, participants received weekly subcutaneous injections of bepirovirsen 300 mg for 24 weeks, with other groups receiving different schedules.[2]
One trial of bepirovirsen sodium is authorised in the EU Clinical Trials Information System. It is a Phase 2, multicenter, randomised, double-blind, placebo-controlled study in 150 participants with HIV and chronic hepatitis B who are on antiretroviral treatment.[1] The trial assesses 24 weeks of treatment with bepirovirsen, including loading doses, followed by 36 weeks off treatment.[1]
The main measure is the percentage of participants achieving HBsAg not detected and HBV DNA below the lower limit of quantification at 36 weeks after the scheduled end of study treatment, in the absence of rescue medication.[1] Participants in the trial have a baseline HBsAg level of 3000 IU/mL or less.[1]
In an earlier Phase 2b study called B-Clear, 457 people with chronic hepatitis B received bepirovirsen. Among those who received bepirovirsen 300 mg weekly for 24 weeks, 9% of participants taking nucleoside/nucleotide analogue therapy and 10% of those not taking it achieved loss of HBsAg and HBV DNA sustained for 24 weeks after the last dose.[2]
The available source does not report side effects of bepirovirsen sodium in detail.
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