It was a pleasure to be able to speak to Prof. Heiner Wedemeyer (Hannover Medical School, Hannover, Germany) about the interim results from the phase 3 MYR301 study investigating bulevirtide monotherapy in patients with chronic hepatitis D.
His abstract entitled ‘Bulevirtide monotherapy at low and high dose in patients with chronic hepatitis delta: 24 weeks interim data of the phase 3 MYR301 study’ was presented at the EASL ILC 2021, 23-26 June.
Questions
- Bulevirtide is the first drug to be approved for the treatment of chronic hepatitis D virus (HDV) in adults with compensated liver disease. Tell us a little about the unmet medical need for patients with HDV? (0:37)
- Could you tell us a little about the rationale for the European Medicine Agency’s conditional approval, and the mechanism of action of bulevirtide? (2:12)
- Could you give us a brief overview of the MYR301 trial, including the overall aim, design and key endpoints measured? (3:11)
- Could you briefly describe what the 24-week interim analysis has demonstrated in terms of clinical efficacy and safety? (5:00)
- What is the clinical significance of these findings? (6:30)
- Are there any other promising therapeutic options for HDV emerging? (7:49)
Disclosures: Prof. Heiner Wedemeyer has served as a clinical trials principal investigator for Abbvie, Altimmune, BMS, Gilead, Janssen, Merck/MSD, MYR GmbH, Novartis, and Transgene; has research grants from Abbvie, Biotest, BMS, Gilead, Merck/MSD, Novartis, and Roche; and advises or is on the speakers’ bureau for Abbott, AbbVie, Altimmune, Biotest, BMS, BTG, Dicerna, Gilead, Janssen, Merck/MSD, MYR GmbH, Novartis, Roche, and Siemens.
Support:Â Interview and filming supported by Touch Medical Media. Interview conducted by Gina Furnival.
Filmed in coverage of the EASL ILC 2021, 23-26 June
