Bepirovirsen (GSK3228836) in chronic hepatitis B infection: an evaluation of phase II progress

Expert Opin Investig Drugs. 2023 Oct 30. doi: 10.1080/13543784.2023.2277389. Online ahead of print.ABSTRACTINTRODUCTION: Chronic hepatitis B infection is a major global health issue associated with significant liver-related morbidity and mortality. While existing treatments can suppress the virus effectively, they are incapable of inducing functional cure, as defined by hepatitis B surface antigen (HBsAg) seroclearance. Currently, numerous novel compounds are being developed, including bepirovirsen which is an antisense oligonucleotide (ASO).AREAS COVERED: This review summarizes the mechanism of action, pharmacokinetics, clinical efficacy and safety data collected from phase I and II studies of bepirovirsen. The data were extracted from publications relevant to the pivotal trials of bepirovirsen, in either full manuscript or conference abstracts.EXPERTOPINION: Bepirovirsen, a 20-mer ASO, has already entered phase III clinicalevaluation using the optimal dosing regimen of 300 mg subcutaneousinjection weekly for 24 weeks in nucleoside analogue-treatedHBeAg-negative non-cirrhotic patients with low (<3000 IU/mL)baseline HBsAg. The durability and long-term clinical outcomes amongbepirovirsen responders will need to be evaluated. The stop-to-cureapproach in those reaching HBsAg < 100 IU/mL should also beexplored. In the long run, bepirovirsen has the potential tofacilitate viral hepatitis elimination.PMID:37902953 | DOI:10.1080/13543784.2023.2277389
Source: Expert Opinion on Investigational Drugs - Category: Drugs & Pharmacology Authors: Source Type: research