Clinical drug investigation · 2026
The Economic Burden of HDV in Italy: Evaluating the Potential Impact and Effects of Bulevirtide for Chronic HDV Infection.
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Paoletti Martina, Cazzato Daniela, Marcellusi Andrea, Kondili Loreta A, Coppola Nicola, Coco Barbara, Mecozzi Alessandra, Mollea Sara, Kim Chong, Rock Marvin
Аннотация
BACKGROUND AND OBJECTIVES: Chronic hepatitis D is associated with substantial clinical and economic burden due to its progressive course and risk of severe liver-related complications. The aim of this study was to quantify the economic burden of chronic hepatitis D (HDV) in Italy from societal perspectives, and to estimate the clinical and economic consequences associated with bulevirtide, peginterferon alfa (PEG-IFN-α), and best supportive care (BSC) in HDV-RNA-positive adults with compensated liver disease.
METHODS: The economic impact of HDV infection was estimated using a cost-of-illness (COI) analysis, while the costs and effects of introducing bulevirtide were estimated using a cost-and-outcomes analysis (COA). The COA compared two scenarios: a clinical practice scenario that includes PEG-IFN-α and BSC, and a scenario that introduces bulevirtide. The analyses were conducted from the societal perspective; therefore, direct and indirect estimated costs were included. The most relevant outcomes were quality adjusted life years (QALYs) and the number of deaths. Both analyses were carried out on a standardised hypothetical cohort of 1000 HDV-RNA-positive adult patients with compensated liver disease, over 10 years. A deterministic sensitivity analysis (DSA) was conducted to assess parameter uncertainty.
RESULTS: The COI estimated a 10-year economic burden of €34,939,429.41 for the management and treatment of patients with HDV infection in Italy. The COA estimated a total 10-year reduction in disease-related costs of €2,152,752.76 after the introduction of bulevirtide, an increase of 8.26% (+ 366.12) in the number of QALYs gained, and a 12.39% reduction (- 73.67) in the number of deaths.
CONCLUSIONS: Our study suggests that the introduction of bulevirtide may alleviate the clinical and economic burden associated with HDV in Italy, while improving quality of life.
METHODS: The economic impact of HDV infection was estimated using a cost-of-illness (COI) analysis, while the costs and effects of introducing bulevirtide were estimated using a cost-and-outcomes analysis (COA). The COA compared two scenarios: a clinical practice scenario that includes PEG-IFN-α and BSC, and a scenario that introduces bulevirtide. The analyses were conducted from the societal perspective; therefore, direct and indirect estimated costs were included. The most relevant outcomes were quality adjusted life years (QALYs) and the number of deaths. Both analyses were carried out on a standardised hypothetical cohort of 1000 HDV-RNA-positive adult patients with compensated liver disease, over 10 years. A deterministic sensitivity analysis (DSA) was conducted to assess parameter uncertainty.
RESULTS: The COI estimated a 10-year economic burden of €34,939,429.41 for the management and treatment of patients with HDV infection in Italy. The COA estimated a total 10-year reduction in disease-related costs of €2,152,752.76 after the introduction of bulevirtide, an increase of 8.26% (+ 366.12) in the number of QALYs gained, and a 12.39% reduction (- 73.67) in the number of deaths.
CONCLUSIONS: Our study suggests that the introduction of bulevirtide may alleviate the clinical and economic burden associated with HDV in Italy, while improving quality of life.