HERACLIS_BLV_D: Increasing Response Rates During 2-Year Bulevirtide Real-Life Therapy in Chronic Hepatitis D.

DATA AVAILABILITY STATEMENT: The data of this study can be available from the corresponding author upon reasonable request.

BACKGROUND & AIMS: There is still limited real-life data for bulevirtide (BLV) therapy in chronic hepatitis D (CHD). We assessed the efficacy and safety of up to 2-year BLV therapy in CHD patients treated at Greek centres.

METHODS

All patients with CHD starting BLV 2 mg before the approvals of the HERACLIS_BLV_D study were included. All patients were followed according to standard clinical practice. Serum HDV RNA was determined by a polymerase chain reaction assay at a central lab. Virological response (VR) was defined as HDV RNA undetectable or decline > 2 log10 compared to baseline. Biochemical response (BR) was defined as normal ALT.

RESULTS

Seventy-six patients were included (45 with cirrhosis). At 12 and 24 months, rates of VR were 73% and 93%, HDV DNA undetectability 57% and 80.4%, BR 71% and 74%, and combined response (VR + BR) 51% and 74%, respectively. VR response at month 24 was associated with no baseline characteristic, while 24-month HDV RNA undetectability was independently associated with lower baseline HDV RNA (p = 0.019) and platelets (p = 0.045). Both 24-month BR and combined responses were independently associated with lower baseline gamma-glutamyl transpeptidase (p = 0.004) and haemoglobin levels (p = 0.006). There was no drug-related serious adverse event and no patient discontinued BLV due to an adverse event.

CONCLUSIONS

BLV monotherapy is safe and effective for the treatment of CHD patients followed at Greek tertiary liver centres offering increasing rates of VRHDV RNA undetectability and BR or combined response exceeding 90%, 80% and 70%, respectively, at 2 years of therapy.