Position of the problem
Hepatitis delta affects approximately 5% of HBsAg positive patients. Pegylated interferon (PEG-IFN), the only treatment available so far, has poor tolerance and efficacy (20-25%). Bulevirtide (BLV), entry inhibitor, in monotherapy or in combination with PEG-IFN, decreases HDV RNA in 2 phase 2 trials. This work presents the efficacy and tolerance data of BLV, in ATU cohort from September 2019 to September 2020
Method
Were included and analyzed 145 HDV patients, presenting F2 fibrosis with increased ALT, F3, or compensated cirrhosis. Patients received BLV 2 mg/d alone or in combination with PEG-IFN, depending on physician’s choice. The primary endpoint (CJP) was a decrease of 2 log10 IU/mL in HDV viral load (CV) at M12.
Results
9/145 patients were cirrhotic. The BLV arm alone (arm 1) included 77 patients, the BLV + IFN arm (arm 2) 56 patients (exclusions of 12 IFN stops). The modifications and treatment discontinuation were numerous (19 and 7 respectively for arm 1, 5 and 14 for arm 2). At M12, 68% of patients in the BLV arm alone reached the CJP, 39% an undetectable viral load, versus 94 and 85% for the BLV + IFN arm. CVs were still down at M12. There were no adverse effects specific to BLV, the elevation of bile salts was without clinical translation.
Conclusion
This first study in a real population, on 145 VHD patients, 63% of whom were cirrhotics, showed a virological response in obtaining an undetectable VL at M12 in 39% of patients in the BLV arm alone, 85% of patients in the BLV + IFN, with CV still decreasing at 12 months of treatment. The tolerance of BLV was good. Further data will help determine the clinical impact of this virological response.
Blandine VAUQUELIN
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