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Synonyms: BLV | formerly Myrcludex B | Hepcludex®
bulevirtide is an approved drug (EMA (2020), UK HMRA (2021))
Compound class:
Peptide or derivative
Comment: Bulevirtide is a lipopeptide antiviral agent. It blocks entry of the hepatitis-causing viruses HBV and HDV into hepatocytes [1]. The peptide structure of bulevirtide is derived from the pre-S1 domain of the large envelope protein of HBV surface antigen (HBsAg) [4], that binds to the heoatocyte expressed surface protein sodium/bile acid and sulphated solute cotransporter 1 (NTCP; SLC10A1) to mediate viral entry into host cells. Bulevirtide functionally blocks this entry process [3].
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| No information available. |
Summary of Clinical Use  |
| Bulevirtide is being evaluated as a treatment for chronic hepatitis D infection with the aim of reducing HDV-mediated acceleration of HBV-associated liver disease progression. Treatment of chronic HDV infection with bulevirtide was granted EMA orphan designation in 2015, and was fully approved by the EMA for this indication in 2020 [2]. As of June 2023, it is not approved by the FDA. |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT03852719 | Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD) | Phase 3 Interventional | Gilead Sciences | 5 | |
| NCT05760300 | A Multiple-Dose Study of Bulevirtide in Participants With Normal and Impaired Renal Function | Phase 1 Interventional | Gilead Sciences | ||
| NCT05718700 | Study of Bulevirtide in Participants With Chronic Hepatitis D Infection | Observational [Patient Registry] | Gilead Sciences | ||
| External links |
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For extended ADME data see the following: Electronic Medicines Compendium (eMC) European Medicines Agency (EMA) |
