Quality of life improves during antiviral therapy with bulevirtide

Abstract

Background and Aims

Hepatitis D virus (HDV) infection is the most severe form of viral hepatitis and has been shown to be associated with reduced quality of life. With the approval of the entry inhibitor bulevirtide, the first specific agent for HDV infection became available. Here, we report data on quality of life (QOL) before and during antiviral therapy with bulevirtide in a single center real-world cohort.

Method

We investigated QOL assessed by the Short Form 36 Health Survey (SF-36) in 25 patients undergoing antiviral treatment with bulevirtide. Surveys were completed before the beginning of antiviral therapy and up to week 152 of treatment as a long-term follow up.

Results

The study cohort included 7 women (28%) and 18 men (72%) with a median age of 46 years. Liver cirrhosis (defined as liver stiffness measurement ≥ 15.2 kPa) was present in 16 patients (64%) at the start of antiviral treatment. During the course of antiviral treatment with bulevirtide, scores for vitality, mental health and bodily pain significantly improved. The physical component score showed a minimal clinically important increase of ≥ 2.5 points in 10 patients (42%) at week 24 and in 6 patients (30% of patients with full data available) at week 48. The mental component score showed a minimal clinically important increase (≥ 2.5 points compared to baseline) in 10 patients (42%) at week 24 and in 12 patients (60%) at week 48. In the patient cohort with an improvement of physical or mental component scores at week 48, a further improvement beyond week 48 was evident in single cases but not in all patients. Importantly, changes of physical or mental component scores were not associated with virological or biochemical responses.

Conclusion

Vitality, mental health and bodily pain improved during BLV treatment. As a sign of the good tolerability of BLV, no significant deteriorations in QOL scores were observed. Findings need to be confirmed and further evaluated in larger cohorts and longer follow-up is needed.

Zusammenfassung

Einleitung

Hepatitis-D-Virus (HDV)-Infektionen gelten als die schwerste Form der Virushepatitiden und gehen nachweislich mit einer reduzierten Lebensqualität einher. Mit der Zulassung des Eintrittsinhibitors Bulevirtid wurde der erste spezifische therapeutische Wirkstoff für HDV-Infektionen verfügbar. Im Folgenden präsentieren wir eine Datenanalyse zur Lebensqualität (QOL) vor und während der antiviralen Therapie mit Bulevirtid in einer real-world-Kohorte an einem hepatologischen Zentrum.

Methodik

Analyse der Lebensqualität von 25 Patienten während einer antiviralen Behandlung mit Bulevirtid anhand des SF-36-Fragebogens (Short Form 36 Health Survey). Es erfolgte eine Analyse der Lebensqualität vor dem Beginn und bis zu Woche 152 der antiviralen Therapie.

Ergebnisse

Die Studienkohorte bestand aus 7 Frauen (28%) und 18 Männern (72%), mit einem medianen Alter von 46 Jahren. 16 der untersuchten Patienten (64%) zeigten zu Beginn der antiviralen Behandlung eine Leberzirrhose (definiert ab einem Schwellenwert von ≥ 15,2 kPa in der transienten Elastografie). Im Verlauf der antiviralen Behandlung mit Bulevirtid verbesserten sich die Werte für Vitalität, psychische Gesundheit und Schmerz. Die körperliche Summenskala wies bei 10 Patienten in Woche 24 (42%) und bei 6 Patienten in Woche 48 (30% der Patienten zu diesem Zeitpunkt) eine minimal-klinisch bedeutsame Steigerung von ≥ 2,5 Punkten auf. Die psychische Summenskala zeigte bei 10 Patienten (42%) in Woche 24 und bei 12 Patienten (60%) in Woche 48 eine minimal-klinisch bedeutsame Steigerung. In dem Teil der Kohorte mit einer Verbesserung der körperlichen oder psychische Summenskala in Woche 48 war in einzelnen Fällen eine weitere Verbesserung über Woche 48 hinaus zu beobachten, jedoch nicht bei allen Patienten. Es zeigte sich kein Zusammenhang zwischen der körperlichen oder psychischen Summenskala und dem virologischen oder biochemischen Ansprechen auf die antivirale Therapie.

Schlussforderung

Die Subskalen Vitalität, psychische Gesundheit und Schmerz zeigten während der Bulevirtid-Therapie eine Verbesserung. Als Zeichen der guten Verträglichkeit von BLV wurden keine signifikanten Verschlechterungen der QOL beobachtet. Größere Kohorten mit einem noch längeren Beobachtungszeitraum erscheinen erforderlich, um die Ergebnisse zu bestätigen und weiterführend zu evaluieren.

Keywords

hepatitis D - bulevirtide - quality of life - SF-36

Schlüsselwörter

Leber - Virushepatitis - Hepatitis D - Bulevirtid - Lebensqualität - SF-36

Publikationsverlauf

Eingereicht: 13. März 2025

Angenommen nach Revision: 11. Juni 2025

Artikel online veröffentlicht:
11. September 2025

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