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Heiner Wedemeyer, EASL ILC 2021: Bulevirtide Phase 3 Hepatitis D Study

Published Online: July 14th 2021

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

  1. 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)
  2. 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)
  3. Could you give us a brief overview of the MYR301 trial, including the overall aim, design and key endpoints measured? (3:11)
  4. Could you briefly describe what the 24-week interim analysis has demonstrated in terms of clinical efficacy and safety? (5:00)
  5. What is the clinical significance of these findings? (6:30)
  6. 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: Interview and filming supported by Touch Medical Media. Interview conducted by Gina Furnival.

Filmed in coverage of the EASL ILC 2021, 23-26 June

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