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  • IDDF2024-ABS-0269 Results from an integrated analysis at week 96: continued treatment of early virologic non-responder or partial responders with bulevirtide monotherapy for chronic hepatitis d leads to improvement in virologic and biochemical responses

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Clinical Hepatology
IDDF2024-ABS-0269 Results from an integrated analysis at week 96: continued treatment of early virologic non-responder or partial responders with bulevirtide monotherapy for chronic hepatitis d leads to improvement in virologic and biochemical responses
  1. Jacques Yu1,
  2. Pietro Lampertico2,
  3. Heiner Wedemeyer3,
  4. Maurizia Brunetto4,
  5. Pavel Bogomolov5,
  6. Tatyana Stepanova6,
  7. Mark Bourliere7,
  8. Helène Fontaine8,
  9. Grace Chee8,
  10. Dmitry Manuilov8,
  11. Qi An8,
  12. Audrey Lau8,
  13. Ben Da8,
  14. John Flaherty8,
  15. Renee-Claude Mercier8,
  16. Carrie Frenette8,
  17. Anu Osinusi8,
  18. George Gherlan9,
  19. Adrian Streinu-Cercel10,
  20. Stefan Zeuzem11,
  21. Markus Cornberg3,
  22. Dominique Roulot12,
  23. Fabien Zoulim13,
  24. Soo Aleman14,
  25. Tarik Asselah15
  1. 1Gilead Sciences, Hong Kong
  2. 2Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, ‘A.M. e A. Migliavacca’ Center for the Study of Liver Disease, Università degli Studi di Milano, Italy
  3. 3Medizinische Hochschule Hannover, Germany
  4. 4Hepatology Unit, University Hospital of Pisa, Italy
  5. 5Moscow Regional Research Clinical Institute Named After M. F. Vladimirsky, Russia
  6. 6Clinic of Modern Medicine, Russia
  7. 7Hôpital Saint Joseph, France
  8. 8Gilead Sciences, USA
  9. 9‘Carol Davila’ University of Medicine and Pharmacy, Dr. Victor Babes Foundation, Romania
  10. 10Matei Bals National Institute of Infectious Diseases, Romania
  11. 11University Hospital Frankfurt, Frankfurt am Main, Germany
  12. 12Université Sorbonne Paris Nord, France
  13. 13Hospital Croix Rousee, France
  14. 14Karolinska University Hospital/Karolinska Institutet, Sweden
  15. 15Hôpital Beaujon, Université de Paris, France

Abstract

Background Bulevirtide (BLV) is approved in Europe for the treatment of chronic hepatitis D (CHD). Optimal BLV monotherapy duration for CHD is unknown). This analysis evaluated BLV monotherapy in pts without VR after 24W.

Methods Results from pts who completed BLV monotherapy for 96W in the Phase 3 (MYR301) and Phase 2 (MYR204) studies were included. NR and PR were defined as HDV RNA declines of <1 log10 IU/mL and ≥1 but <2 log10 IU/mL, respectively. Rates of biochemical response (alanine aminotransferase [ALT] within normal limits [WNL]) were compared.

Results At W24, 65% pts had VR (58% with ALT WNL), 24% had PR (56% with ALT WNL), and 11% had NR (13% with ALT WNL) (IDDF2024-ABS-0269 Table 1).

View this table:
Abstract IDDF2024-ABS-0269 Table 1

Shift Table for Virologic Response at Week 24 vs Responses at Weeks 48 and 96

View this table:
Abstract IDDF2024-ABS-0269 Table 2

Progression of ALT & HDV RNA Among Those Who Were NR or PR at Week 24

Conclusions Of 49 pts without VR at W24, the majority with PR and nearly half with NR were able to achieve VR at W96. ALT improved in all viral-response groups, including those with NR.

https://doi.org/10.1136/gutjnl-2024-IDDF.194

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