Abstract：
OBJECTIVE: Once-daily treatment of chronic hepatitis delta (CHD) with bulevirtide is well tolerated and associated with significant reductions in HDV RNA in the blood and in biochemical liver disease activity. This study explored the effects of 48-week bulevirtide treatment on health-related quality of life (HRQoL) in patients with CHD.
METHODS: In an open-label, randomised, Phase 3 trial, 150 patients with CHD and compensated liver disease were stratified by liver cirrhosis status and randomised 1:1:1 to no treatment (control), bulevirtide 2 mg/day, or bulevirtide 10 mg/day for 48 weeks. HRQoL was evaluated by the following patient-reported outcome (PRO) instruments at baseline, 24 weeks, and 48 weeks: EQ-5D-3L, Hepatitis Quality of Life Questionnaire (HQLQ), and Fatigue Severity Scale (FSS).
RESULTS: Patient characteristics and HRQoL scores were balanced at baseline between the treatment (2 mg, n = 49; 10 mg, n = 50) and control (n = 51) groups. Patients receiving 2-mg bulevirtide reported significant improvements compared with controls on the HQLQ domains of role physical, hepatitis-specific limitations, and hepatitis-specific health distress. Numerically higher scores for general health, hepatitis-specific limitations, and hepatitis-specific health distress domains were reported by patients with cirrhosis who received bulevirtide vs control. FSS scores remained stable across treatment groups throughout. At week 48, patients in the 2-mg group showed greater mean improvement from baseline in health status compared with controls on the EQ-5D-3L visual analogue scale.
CONCLUSIONS: PROs indicate that 48-week treatment with bulevirtide monotherapy may improve aspects of HRQoL in patients with CHD.
UNASSIGNED: Bulevirtide 2 mg is the only approved treatment for patients with chronic hepatitis delta (CHD) in the EU. Patients with CHD have worse quality of life scores than those with chronic hepatitis B. Bulevirtide treatment for 48 weeks reduced HDV RNA and alanine aminotransferase levels and was well tolerated among patients with CHD. For the first time, this study shows that patients who received bulevirtide therapy for 48 weeks reported improvements in physical and hepatitis-related quality of life domains compared to those who did not receive therapy (control group).
BACKGROUND: ClinicalTrials.gov Identifier, NCT03852719.
METHODS: In an open-label, randomised, Phase 3 trial, 150 patients with CHD and compensated liver disease were stratified by liver cirrhosis status and randomised 1:1:1 to no treatment (control), bulevirtide 2 mg/day, or bulevirtide 10 mg/day for 48 weeks. HRQoL was evaluated by the following patient-reported outcome (PRO) instruments at baseline, 24 weeks, and 48 weeks: EQ-5D-3L, Hepatitis Quality of Life Questionnaire (HQLQ), and Fatigue Severity Scale (FSS).
RESULTS: Patient characteristics and HRQoL scores were balanced at baseline between the treatment (2 mg, n = 49; 10 mg, n = 50) and control (n = 51) groups. Patients receiving 2-mg bulevirtide reported significant improvements compared with controls on the HQLQ domains of role physical, hepatitis-specific limitations, and hepatitis-specific health distress. Numerically higher scores for general health, hepatitis-specific limitations, and hepatitis-specific health distress domains were reported by patients with cirrhosis who received bulevirtide vs control. FSS scores remained stable across treatment groups throughout. At week 48, patients in the 2-mg group showed greater mean improvement from baseline in health status compared with controls on the EQ-5D-3L visual analogue scale.
CONCLUSIONS: PROs indicate that 48-week treatment with bulevirtide monotherapy may improve aspects of HRQoL in patients with CHD.
UNASSIGNED: Bulevirtide 2 mg is the only approved treatment for patients with chronic hepatitis delta (CHD) in the EU. Patients with CHD have worse quality of life scores than those with chronic hepatitis B. Bulevirtide treatment for 48 weeks reduced HDV RNA and alanine aminotransferase levels and was well tolerated among patients with CHD. For the first time, this study shows that patients who received bulevirtide therapy for 48 weeks reported improvements in physical and hepatitis-related quality of life domains compared to those who did not receive therapy (control group).
BACKGROUND: ClinicalTrials.gov Identifier, NCT03852719.
摘要：
目的：每天一次用布莱维肽治疗慢性丁型肝炎（CHD）的耐受性良好，并且与血液和生化肝病活动中HDVRNA的显着降低相关。这项研究探讨了48周的丁韦利肽治疗对冠心病患者健康相关生活质量（HRQoL）的影响。
方法：在开放标签中，随机化，第三阶段试验，150例CHD和代偿性肝病患者按肝硬化状态分层，随机分为1：1：1至无治疗（对照），丁维肽2毫克/天，或丁韦利肽10毫克/天，持续48周。HRQoL在基线时通过以下患者报告结果（PRO）仪器进行评估，24周,48周：EQ-5D-3L，肝炎生活质量问卷（HQLQ），和疲劳严重程度量表（FSS）。
结果：患者特征和HRQoL评分在治疗之间的基线平衡（2mg，n=49；10毫克，n=50）和对照组（n=51）。与对照组相比，接受2-mgbulevirtide的患者在HQLQ领域的身体作用方面有了显着改善，肝炎特异性限制，和肝炎特有的健康困扰。一般健康状况的数值较高，肝炎特异性限制，和肝炎特异性的健康困扰领域报告的肝硬化患者谁接受了bulevirtide与控制.整个治疗组的FSS评分保持稳定。在第48周，在EQ-5D-3L视觉模拟量表上，与对照组相比，2-mg组患者的健康状况从基线平均改善更大。
结论：PROs表明，丁韦韦肽单药治疗48周可以改善冠心病患者的HRQoL。
■Bulevirtide2mg是欧盟唯一批准的慢性丁型肝炎（CHD）患者治疗方法。CHD患者的生活质量评分比慢性乙型肝炎患者更差。丁维肽治疗48周可降低HDVRNA和丙氨酸转氨酶水平，并且在CHD患者中耐受性良好。第一次,这项研究表明,与未接受治疗的患者(对照组)相比,接受丁韦肽治疗48周的患者在身体和肝炎相关生活质量方面均有改善.
背景：ClinicalTrials.gov标识符，NCT03852719。
方法：在开放标签中，随机化，第三阶段试验，150例CHD和代偿性肝病患者按肝硬化状态分层，随机分为1：1：1至无治疗（对照），丁维肽2毫克/天，或丁韦利肽10毫克/天，持续48周。HRQoL在基线时通过以下患者报告结果（PRO）仪器进行评估，24周,48周：EQ-5D-3L，肝炎生活质量问卷（HQLQ），和疲劳严重程度量表（FSS）。
结果：患者特征和HRQoL评分在治疗之间的基线平衡（2mg，n=49；10毫克，n=50）和对照组（n=51）。与对照组相比，接受2-mgbulevirtide的患者在HQLQ领域的身体作用方面有了显着改善，肝炎特异性限制，和肝炎特有的健康困扰。一般健康状况的数值较高，肝炎特异性限制，和肝炎特异性的健康困扰领域报告的肝硬化患者谁接受了bulevirtide与控制.整个治疗组的FSS评分保持稳定。在第48周，在EQ-5D-3L视觉模拟量表上，与对照组相比，2-mg组患者的健康状况从基线平均改善更大。
结论：PROs表明，丁韦韦肽单药治疗48周可以改善冠心病患者的HRQoL。
■Bulevirtide2mg是欧盟唯一批准的慢性丁型肝炎（CHD）患者治疗方法。CHD患者的生活质量评分比慢性乙型肝炎患者更差。丁维肽治疗48周可降低HDVRNA和丙氨酸转氨酶水平，并且在CHD患者中耐受性良好。第一次,这项研究表明,与未接受治疗的患者(对照组)相比,接受丁韦肽治疗48周的患者在身体和肝炎相关生活质量方面均有改善.
背景：ClinicalTrials.gov标识符，NCT03852719。
