Z Gastroenterol 2025; 63(08): e556-e557
DOI: 10.1055/s-0045-1810986
Abstracts | DGVS/DGAV
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Infektionen abseits des Üblichen Freitag, 19. September 2025, 16:10 – 17:30, MZF 4

Predictors of undetectable hepatitis delta virus RNA at 48 weeks after end of treatment with bulevirtide monotherapy in the MYR301 study

S Aleman
1   Karolinska University Hospital/Karolinska Institutet, Department of Infectious Diseases, Stockholm, Schweden
,
M Brunetto
2   University Hospital of Pisa, Hepatology Unit, Reference Center of the Tuscany Region for Chronic Liver Disease and Cancer, Pisa, Italien
3   University of Pisa, Department of Clinical and Experimental Medicine, Pisa, Italien
,
A Blank
4   Heidelberg University Hospital, Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Medical Faculty, Heidelberg, Deutschland
,
P Andreone
5   Baggiovara Hospital, Division of Internal Medicine, University of Modena and Reggio Emilia, Modena, Italien
,
P Bogomolov
6   M.F. Vladimirsky Moscow Regional Research and Clinical Institute, Moscow, Russische Föderation
,
V Chulanov
7   Sechenov University, Moscow, Russische Föderation
,
N Mamonova
8   FSBI National Research Medical Center for Phthisiopulmonology and Infectious Diseases of the Ministry of Health of the Russian Federation, Moscow, Russische Föderation
,
N Geyvandova
9   Stavropol Regional Hospital, Stavropol, Russische Föderation
,
V Morozov
10   LLC Medical Company Hepatolog, Samara, Russische Föderation
,
O Sagalova
11   South Ural State Medical University, Chelyabinsk, Russische Föderation
,
T Stepanova
12   LLC Clinic of Modern Medicine, Moscow, Russische Föderation
,
K Deterding
13   Hannover Medical School, Clinic for Gastroenterology, Hepatology, Infectious Diseases, and Endocrinology, Hannover, Deutschland
,
A Lichtman
14   Gilead Sciences, Inc., Foster City, Vereinigte Staaten
,
R-C Mercier
14   Gilead Sciences, Inc., Foster City, Vereinigte Staaten
,
D Manuilov
14   Gilead Sciences, Inc., Foster City, Vereinigte Staaten
,
S Arterburn
14   Gilead Sciences, Inc., Foster City, Vereinigte Staaten
,
J Schulze zur Wiesch
15   University Hospital Hamburg-Eppendorf, Hepatology Outpatient Medical Clinic, Hamburg, Deutschland
,
M Cornberg
13   Hannover Medical School, Clinic for Gastroenterology, Hepatology, Infectious Diseases, and Endocrinology, Hannover, Deutschland
,
S Zeuzem
16   Goethe University Hospital, Frankfurt, Deutschland
,
P Lampertico
17   Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italien
18   University of Milan, CRC “A. M. and A. Migliavacca” Center for Liver Disease, Department of Pathophysiology and Transplantation, Milan, Italien
,
H Wedemeyer
13   Hannover Medical School, Clinic for Gastroenterology, Hepatology, Infectious Diseases, and Endocrinology, Hannover, Deutschland
› Author Affiliations
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    Introduction: In MYR301, a Phase 3 study evaluating bulevirtide (BLV) monotherapy for treatment of chronic hepatitis delta (CHD) for 2–3 years, a subset of patients who achieved undetectable hepatitis delta virus (HDV) RNA by end of treatment (EOT) maintained undetectable viraemia at 48 weeks (W) of follow-up after EOT (FU48).

    Objectives: To evaluate predictors of sustained HDV RNA undetectability through FU48 after 96W or 144W of BLV treatment.

    Methodology: Data were analysed from 149 patients in MYR301 who were randomised to immediate treatment with BLV 2 or 10 mg/d for 144W, or to 48W of no treatment followed by BLV 10 mg/d for 96W. All patients were to be followed through FU48. Logistic regression modelling (adjusted for treatment group) was performed to examine potential predictors of sustained HDV RNA undetectability (defined as less than the lower limit of quantitation [target not detected at FU in patients with available data]) through FU48 in those with undetectable viraemia at EOT.

    Results: Baseline (BL) characteristics were similar across arms. Overall, 65/149 (44%) patients achieved undetectable HDV RNA at EOT, of whom 23/64 (36%) with available FU HDV RNA data had sustained undetectability through FU48. Sustained undetectability rates were higher in the immediate treatment arms vs the delayed treatment arm. BL predictors of sustained undetectability posttreatment (PT) included BL HDV RNA less than a median of 4.5 log10 IU/mL (odds ratio [OR]: 6.2; 95% CI [1.9, 20.8]; P=.003) and lower BL hepatitis B surface antigen (HBsAg) level (OR: 0.3 per log10 IU/mL; 95% CI [0.1, 0.8]; P=.019). On-treatment predictors included greater duration of continuous undetectability at EOT (OR per additional week: 1.0; 95% CI [1.0, 1.1]; P<.0001), HBsAg loss or decrease by≥1 log10 IU/mL (OR: 7.2; 95% CI [1.2, 42.3]; P=.030), and W144 antidrug antibody incidence (OR: 10.2; 95% CI [1.9, 55.7]; P=.008). Proportions of patients with sustained PT undetectability were 9/10 (90%) in those with≥96W of undetectability at EOT, 11/22 (50%) in those with≥48 to<96W, and 3/32 (9%) in those with<48W. BL cirrhosis was not a predictor of sustained PT undetectability; 13/32 (41%) with cirrhosis had sustained undetectability vs 10/32 (31%) without cirrhosis.

    Conclusion: In patients with CHD treated with BLV monotherapy for 96W or 144W, early and sustained HDV RNA undetectability predicted sustained undetectability during FU. Note: PL and HW contributed equally.


     

    Publication History

    Article published online:
    04 September 2025

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