MYR301 is a completed, multicentre, open-label, randomised, Phase 3 study in adults with chronic HDV infection with or without cirrhosis (n=150).1
The primary objective of this study was to evaluate the safety and efficacy of HEPCLUDEX® for treatment of chronic HDV in comparison to delayed treatment. The study commenced in April 2019 and was completed in August 2024.2
Adapted from Wedemeyer H, et al. 2023.4
Participants were adults with HDV, with or without compensated cirrhosis (CTP ≤6), ALT >1× to <10× ULN and no HCV or uncontrolled HIV co-infection.
aDelayed treatment arm did not receive HDV treatment through Week 48.1
bNucleos(t)ide analogues for the treatment of underlying HBV infection were given to most patients in the MYR301 study.1
c2 mg of HEPCLUDEX® (bulevirtide) is the licensed dosage. Results will not be shown for the study arm with the unlicensed bulevirtide dose.
Primary endpoint1
• A combined response of undetectable HDV RNAa or decrease of ≥2 log10 IU/mL from baseline and ALT normalisationb at 48 weeks.
Selected secondary endpoints1,2
• Undetectable HDV RNAa at Week 48.
• ALT normalisationb at Week 48.
• Sustained virologic responses at Weeks 24 and 48 (undetectable RNA 24 and 48 weeks after end of treatment).
• Change in liver stiffness (transient elastography) at Weeks 48, 96, 144, 192 and 240.
aUndetectable HDV RNA defined as HDV RNA concentration below the limit of detection (LOD; 6 IU/mL).1
bALT normalisation defined as ALT values within the normal range: Russian sites, ≤31 U/L for females and ≤41 U/L for males; all other sites, ≤34 U/L for females and ≤49 U/L for males.1
Primary endpoint: Percentage of patients with the combined response of undetectable HDV RNAc or ≥2 log10 IU/mL decrease from baseline and ALT normalisationb at Week 48.
Adapted from Wedemeyer H, et al. 2023;3 Wedemeyer H, et al. 20214 and Lampertico P, et al. 2022.5
Improvements of combined response rate was sustained with bulevirtide 2 mg at Week 96 vs. Week 48.3
aSignificance defined relative to comparator arm of delayed treatment.
bALT normalisation defined as ALT values within the normal range: Russian sites, ≤31 U/L for females and ≤41 U/L for males; all other sites, ≤34 U/L for females and ≤49 U/L for males.1
cUndetectable HDV RNA defined as HDV RNA concentration below the limit of detection (LOD; 6 IU/mL).1
dDelayed treatment defined as patients who did not receive HDV treatment until Week 48. Patients in the delayed treatment arm received 10 mg of bulevirtide after Week 48.1
Percentage of patients with undetectable HDV RNAa at Week 48.
Adapted from Wedemeyer H, et al. 2023;3 Lampertico P, et al. 20225 and Wedemeyer H, et al. 2021.6
HDV RNA decline and virologic responsed was sustained with bulevirtide 2 mg at Week 96 vs. Week 48.3
aUndetectable HDV RNA defined as HDV RNA concentration below the limit of detection (LOD; 6 IU/mL).
bDelayed treatment defined as patients who did not receive HDV treatment until Week 48. Patients in the delayed treatment arm received 10 mg of bulevirtide after Week 48.1
cP=0.41 for the difference from delayed treatment group.1
dVirologic response defined as undetectable HDV RNA or a decline by ≥2 log10 IU/mL from baseline.1
Secondary endpoint: Percentage of patients with ALT normalisationa at Week 48
Adapted from Wedemeyer H, et al. 2023;3 Lampertico P, et al. 20225 and Wedemeyer H, et al. 2021.6
Improvement in ALT normalisationb was sustained with bulevirtide 2 mg at Week 96 vs. Week 48.3
aALT normalisation defined as ALT values within the normal range: Russian sites, ≤31 U/L for females and ≤41 U/L for males; all other sites, ≤34 U/L for females and ≤49 U/L for males.1
bDelayed treatment defined as patients who did not receive HDV treatment until Week 48. Patients in the delayed treatment arm received 10 mg of bulevirtide after Week 48.1
MYR301 ongoing Phase 3 study additional analysis: Evaluation of the efficacy of continued bulevirtide 2 mg monotherapyc in patients who were not virologic responders after 24 weeks of treatment
Adapted from Lampertico P, et al. 2023.7
Results shown are for 100% of participants at Weeks 24, 48 and 96. Percentages have been calculated from patient numbers and have been rounded where necessary, meaning that the total may not equal 100%.
aSuboptimal virologic responders were categorised as virologic non-responders or partial responders. Virologic non-response was defined as an HDV RNA decline of <1 log10 IU/mL from baseline. Partial response was defined as an HDV RNA decline of ≥1 but ≤2 log10 IU/mL from baseline.7
bVirologic response defined as undetectable HDV RNA or a decline by ≥2 log10 IU/mL from baseline.7
cData shown are for patients in the 2 mg bulevirtide treatment arm only.
ALT = alanine aminotransferase; CI = confidence interval; CTP = Child-Turcotte-Pugh; HCV = hepatitis C virus; HDV = hepatitis D virus; HIV = human immunodeficiency virus; IU = international units; LOD = limit of detection; qd = once daily; RNA = ribonucleic acid; sc = subcutaneous; ULN = upper limit of normal.
UKI-HPX-0038
Date of preparation May 2025
