1Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA. David.firstname.lastname@example.org.
2Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA. Christopher.email@example.com.
Hepatitis B virus (HBV) and its satellite virus hepatitis D (HDV) are common worldwide hepatotrophic infections responsible for cirrhosis and hepatocellular carcinoma (HCC). The more common HBV infection has several therapeutic regimens currently available for suppression of viral replication. However, a regimen leading to an effective sustained functional cure is still not available. In contrast, HDV infection, which causes the most severe form of chronic viral hepatitis and an increased rate of HCC, currently has no Food and Drug Administration (FDA)-approved treatment. Bulevirtide is a novel virion entry inhibitor which blocks the virion's hepatocyte pathway of entry, the hepatic sodium/taurocholate cotransporting polypeptide (NTCP) receptor, and is now a promising therapy for both infections. In July 2020 bulevirtide was authorized for use in the E.U. following a positive opinion by the European Medicines Agency (EMA) for the treatment of chronic HDV infection in HDV RNA-positive adult patients with compensated liver disease. In this paper we have examined the studies that led to this approval as well as studies examining the drug's efficacy in treating HBV.