A Decade of Bulevirtide Use in Chronic Hepatitis Delta: Real-World Clinical Results

Abstract

Background and Aims: Until recently, the only available treatment option for hepatitis D virus (HDV) was the off-label use of interferon, which is associated with limited efficacy and considerable side effects. The approval of the first HDV-direct antiviral, bulevirtide (BLV), has introduced a targeted therapeutic option for patients with chronic hepatitis delta. We assessed the clinical efficacy of BLV in our HDV patients.

Methods: We conducted a retrospective analysis of all patients diagnosed with HDV infection in our department over the past 10 years. For statistical analysis, we performed multivariate analysis of variance, MANOVA.

Results: 26 patients tested positive for HDV antibodies (17 developed chronic hepatitis delta). Eleven patients received BVD. At treatment initiation, liver cirrhosis was present in three patients in the bulevirtide group (MELD-Na: 9–10; Child-Pugh: 5–7) and in three patients in the no bulevirtide group (MELD-Na: 13–18; Child-Pugh: 5–8). Over 12 months of follow-up, bulevirtide recipients showed reductions in alanine aminotransferase (ALT; mean baseline 88 U/L vs 59 U/L; controls 230 U/L vs 206 U/L; MANOVA between-subject effect: p<0.05), aspartate aminotransferase (AST; 68 U/L vs 56 U/L; controls 208 U/L vs 151 U/L; p<0.05), bilirubin (0.74 mg/dL vs 0.65 mg/dL; controls 1.48 mg/dL vs 1.17 mg/dL; p<0.005), HDV-RNA (1,323,182 copies/mL vs 36,975 copies/mL; controls 416,825 copies/mL vs 17,914,733 copies/mL; p<0.05) a statistically significant time-by-group interaction was found for both Child-Pugh scores (p<0.0001) and MELD-Na scores (p<0.05), indicating improved liver function over time in the BLV group compared to controls. No progression of liver fibrosis was observed.

Conclusions: Bulevirtide is a safe and effective treatment for chronic hepatitis delta in a real-world clinical setting. These findings support its role as a sustainable therapeutic option for patients with HDV infection.