IDDF2024-ABS-0266 Efficacy and safety at 96 weeks of bulevirtide 2mg or 10 mg monotherapy for chronic hepatitis D (CHD): results from an interim analysis of a phase 3 randomized study

<h3>Background</h3> Bulevirtide (BLV) is conditionally approved in the EU for the treatment of chronic hepatitis D (CHD) based on surrogate endpoint results. Virologic responders (VR) to HDV therapy are defined as achieving undetectability or a ≥2-log10 IU/mL decline in HDV RNA from baseline (BL). However, it is unclear if patients who are early virologic nonresponders (NR) will benefit from continued therapy. <h3>Methods</h3> MYR301 is a randomized study: BLV 2mg (Arm B) and BLV 10mg (Arm C) for 144W. Results from participants on treatment at 96W from Arm B + C were included in this analysis. Rates of participants achieving biochemical response (alanine transaminase [ALT] within normal limits [WNL]) were compared between NR, PR, and VR. <h3>Results</h3> Baseline characteristics were similar between groups and included: mean (SD) age 41.8 (8.4) years, 57% males, 83% White, 47% with compensated cirrhosis, mean (SD) HDV RNA 5.05 (1.34) log<sub>10</sub> IU/mL, mean (SD) ALT 110.9 (69.0) U/L, mean (SD) LS of 15 (8.9) kPa; and 61% were on concomitant nucleos(t)ide analogues therapy. Of 150 patients, 143 (95%) completed 96 weeks of treatment. Week 96 efficacy responses were improved vs. Week 48 (IDDF2024-ABS-0266 Table 1). At Week 96, similar combined responses were seen in arms B and C. Viral and biochemical responses were also similar among arms B and C. BLV were safe and well tolerated; there were no drug discontinuations, serious AE (SAE) or deaths attributed to BLV. Increases in bile acids without a correlation to pruritus or other symptoms were noted with BLV treatment. Injection site reactions occurred in a higher proportion receiving 10 mg/d dosing. <h3>Conclusions</h3> Most patients who were PR (75%) and a considerable portion who were NR (43%) to BLV at 24W achieved VR by W96, with ALT improvements occurring in all groups, including those who remained NR.

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Published
2024-08-01
DOI
https://doi.org/10.1136/gutjnl-2024-iddf.192
Primary Topic
Hepatitis C virus research
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article
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article

IDDF2024-ABS-0266 Efficacy and safety at 96 weeks of bulevirtide 2mg or 10 mg monotherapy for chronic hepatitis D (CHD): results from an interim analysis of a phase 3 randomized study

Vladimir Chulanov, Markus Cornberg, Anu Osinusi, Dmitry Manuilov et al.
Hepatitis C virus research
article

IDDF2024-ABS-0266 Efficacy and safety at 96 weeks of bulevirtide 2mg or 10 mg monotherapy for chronic hepatitis D (CHD): results from an interim analysis of a phase 3 randomized study

Vladimir Chulanov, Markus Cornberg, Anu Osinusi, Dmitry Manuilov, Julian Schulze zur Wiesch, Antje Blank, Pavel Bogomolov, Renée-Claude Mercier, Tatyana Stepanova, Nina Mamonova, Soo Aleman, Stefan Zeuzem, Olga Sagalova, John F. Flaherty, Natalia Geyvandova, Pietro Andreoné, Heiner H. Wedemeyer, Maurizia Rossana Brunetto, Audrey Lau, Qi An, Pietro Lampertico, Viacheslav Morozov, Jacques Yu
article en

Abstract

<h3>Background</h3> Bulevirtide (BLV) is conditionally approved in the EU for the treatment of chronic hepatitis D (CHD) based on surrogate endpoint results. Virologic responders (VR) to HDV therapy are defined as achieving undetectability or a ≥2-log10 IU/mL decline in HDV RNA from baseline (BL). However, it is unclear if patients who are early virologic nonresponders (NR) will benefit from continued therapy. <h3>Methods</h3> MYR301 is a randomized study: BLV 2mg (Arm B) and BLV 10mg (Arm C) for 144W. Results from participants on treatment at 96W from Arm B + C were included in this analysis. Rates of participants achieving biochemical response (alanine transaminase [ALT] within normal limits [WNL]) were compared between NR, PR, and VR. <h3>Results</h3> Baseline characteristics were similar between groups and included: mean (SD) age 41.8 (8.4) years, 57% males, 83% White, 47% with compensated cirrhosis, mean (SD) HDV RNA 5.05 (1.34) log<sub>10</sub> IU/mL, mean (SD) ALT 110.9 (69.0) U/L, mean (SD) LS of 15 (8.9) kPa; and 61% were on concomitant nucleos(t)ide analogues therapy. Of 150 patients, 143 (95%) completed 96 weeks of treatment. Week 96 efficacy responses were improved vs. Week 48 (IDDF2024-ABS-0266 Table 1). At Week 96, similar combined responses were seen in arms B and C. Viral and biochemical responses were also similar among arms B and C. BLV were safe and well tolerated; there were no drug discontinuations, serious AE (SAE) or deaths attributed to BLV. Increases in bile acids without a correlation to pruritus or other symptoms were noted with BLV treatment. Injection site reactions occurred in a higher proportion receiving 10 mg/d dosing. <h3>Conclusions</h3> Most patients who were PR (75%) and a considerable portion who were NR (43%) to BLV at 24W achieved VR by W96, with ALT improvements occurring in all groups, including those who remained NR.

University of Pisa (IT), Goethe University Frankfurt (DE), University of Modena and Reggio Emilia (IT), Karolinska University Hospital (SE), Universität Hamburg (DE), Analogic (United States) (US), University of Milan (IT), Heidelberg University (DE), University Hospital Heidelberg (DE), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), Karolinska Institutet (SE), Medizinische Hochschule Hannover (DE), Ospedale Maggiore (IT), Stavropol Regional Clinical Oncology Center (RU), Modern Electron (United States) (US), Ural State Medical University (RU), University Medical Center Hamburg-Eppendorf (DE), Ministry of Health of the Russian Federation (RU), Moscow Regional Research Institute of Obstetrics and Gynecology (RU), University Hospital Frankfurt (DE), Gilead Sciences (United States) (US), Regional Clinical Research (US), Ural research Institute of Phthisiopulmonology (RU), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Azienda Ospedaliera Universitaria Pisana (IT)
Good health and well-being
Openalex Percentile: Top 78%
Hepatitis C virus research
DOISourceOpenAlex
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