Bulevirtide is an entry inhibitor used for the treatment of chronic hepatitis D virus (HDV) infection.
Bulevirtide functions by blocking the sodium taurocholate cotransporting polypeptide (NTCP), the receptor for both hepatitis B virus (HBV) and HDV entry into hepatocytes.
By this blocking mechanism it prevents the viruses from entering liver cells and reducing viral replication and liver inflammation.
Bulevirtide is for the treatment of chronic HDV infection, particularly in patients with compensated liver disease.
The typical dosage is 2 mg administered subcutaneously once daily.
Bulevirtide significantly reduces HDV RNA levels and normalizes alanine aminotransferase (ALT) levels in a substantial proportion of patients.
In a phase 2 trial, 54% to 77% of patients treated with bulevirtide achieved a significant decline in HDV RNA levels at 24 weeks, compared to only 4% in the control group treated with tenofovir disoproxil fumarate alone.
Overall, bulevirtide represents a significant advancement in the management of chronic HDV.
A virologic response, defined as undetectable level of HD RNA during treatment occurs in only 12% and 20% of patients treated with the 2 mg daily dose received for 48 and 96 weeks of therapy, respectively.
The incidence of virologic relapse is high after the treatment discontinuation.
The most common side effects include raised levels of bile salts in the blood and reactions at the site of injection.
The combination of Bulevirtide plus peginterferon alpha 2A was superior to Bulevirtide monotherapy with regard to undetectable HD RNA level at 24 weeks after the end of treatment.