Background: The hepatitis B and D virus (HBV/HDV) hepatocyte entry inhibitor bulevirtide (BLV) has been available in Europe since July 2020, after the registrational trial MYR202. Real-life
data on the efficacy and safety of BLV are sparse. Methods: We have analysed the course of treatment
with BLV (2 mg/day) plus tenofovir disoproxil fumarate (TDF) (245 mg/day) in patients with chronic
hepatitis delta (CHD). Virologic (≥2 log reduction in HDV RNA or suppression of HDV RNA below
the lower limit of detection) and biochemical (normalisation of serum ALT) treatment responses after
24 weeks were defined according to the MYR202 trial. Results: Seven patients were recruited (four
with liver cirrhosis Child–Pugh A). After 24 weeks, a virologic response was observed in five of seven
and a biochemical response was seen in three of six patients with elevated serum ALT at baseline.
Extended treatment data > 48 weeks were available in three cases: two presented with continuous
virologic and biochemical responses and in one individual an HDV-RNA breakthrough was observed.
Adverse effects were not recorded. Conclusions: The first real-life data of the approved dosage of
2 mg of BLV in combination with TDF confirm the safety, tolerability, and efficacy of the registrational
trial MYR202 for a treatment period of 24 weeks and beyond.
| Identifer | oai:union.ndltd.org:DRESDEN/oai:qucosa:de:qucosa:85915 |
| Date | 09 June 2023 |
| Creators | Herta, Toni, Hahn, Magdalena, Maier, Melanie, Fischer, Janett, Niemeyer, Johannes, Hönemann, Mario, Böhlig, Albrecht, Gerhardt, Florian, Schindler, Aaron, Schumacher, Jonas, Berg, Thomas, Wiegand, Johannes, van Bömmel, Florian |
| Publisher | MDPI |
| Source Sets | Hochschulschriftenserver (HSSS) der SLUB Dresden |
| Language | English |
| Detected Language | English |
| Type | info:eu-repo/semantics/publishedVersion, doc-type:article, info:eu-repo/semantics/article, doc-type:Text |
| Rights | info:eu-repo/semantics/openAccess |
| Relation | 517 |
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