Abstract：
OBJECTIVE: Chronic hepatitis D (CHD) is a severe form of chronic viral hepatitis. The estimated HDV prevalence in Spain is around 5% of patients with hepatitis B. Reimbursement of new antiviral therapies (Bulevirtide, BLV) was delayed in our country until February 2024. We aimed to characterize the clinical profile of patients with HDV/HBV infection in Spain and current barriers in their management at the time of BLV approval.
METHODS: Multicenter registry including patients with positive anti-HDV serology actively monitored in 30 Spanish centers. Epidemiological, clinical and virological variables were recorded at the start of follow-up and at the last visit.
RESULTS: We identified 329 anti-HDV patients, 41% were female with median age 51 years. The most common geographical origin was Spain (53%) and East Europe (24%). Patients from Spain were older and had HCV and HIV coinfection probably associated to past drug injection (p<0.01). HDV-RNA was positive in 138 of 221 assessed (62%). Liver cirrhosis was present at diagnosis in 33% and it was more frequent among viremic patients (58% vs 25%, p<0.01). After a median follow-up of 6 (3-12) years, 44 (16%) resolved infection (18 spontaneously and 26 after Peg-INF). An additional 10% of patients developed cirrhosis (n=137) during follow-up (45% had portal hypertension and 14% liver decompensation). Liver disease progression was associated to persisting viremia.
CONCLUSIONS: One-third of the patients with CHD already have cirrhosis at diagnosis. Persistence of positive viremia is associated to rapid liver disease progression. Importantly, barriers to locally determine/quantify HDV-RNA were present.
METHODS: Multicenter registry including patients with positive anti-HDV serology actively monitored in 30 Spanish centers. Epidemiological, clinical and virological variables were recorded at the start of follow-up and at the last visit.
RESULTS: We identified 329 anti-HDV patients, 41% were female with median age 51 years. The most common geographical origin was Spain (53%) and East Europe (24%). Patients from Spain were older and had HCV and HIV coinfection probably associated to past drug injection (p<0.01). HDV-RNA was positive in 138 of 221 assessed (62%). Liver cirrhosis was present at diagnosis in 33% and it was more frequent among viremic patients (58% vs 25%, p<0.01). After a median follow-up of 6 (3-12) years, 44 (16%) resolved infection (18 spontaneously and 26 after Peg-INF). An additional 10% of patients developed cirrhosis (n=137) during follow-up (45% had portal hypertension and 14% liver decompensation). Liver disease progression was associated to persisting viremia.
CONCLUSIONS: One-third of the patients with CHD already have cirrhosis at diagnosis. Persistence of positive viremia is associated to rapid liver disease progression. Importantly, barriers to locally determine/quantify HDV-RNA were present.
摘要：
目的：慢性丁型肝炎（CHD）是慢性病毒性肝炎的一种严重形式。估计西班牙的HDV患病率约为乙型肝炎患者的5％。新的抗病毒疗法（Bulevirtide，BLV)在我国被推迟到2024年2月。我们的目的是在BLV批准时，描述西班牙HDV/HBV感染患者的临床特征及其管理中的当前障碍。
方法：多中心登记，包括在30个西班牙中心积极监测的抗HDV血清学阳性患者。流行病学,在随访开始时和最后一次访视时记录临床和病毒学变量.
结果：我们确定了329名抗HDV患者，41%为女性，平均年龄51岁。最常见的地理起源是西班牙（53％）和东欧（24％）。来自西班牙的患者年龄较大，HCV和HIV合并感染可能与过去的药物注射有关（p<0.01）。HDV-RNA在评估的221个中的138个为阳性(62%)。肝硬化在33％的诊断中存在，并且在病毒血症患者中更常见（58％vs25％，p<0.01)。经过6（3-12）年的中位随访，44（16％）解决了感染（自发18和Peg-INF后26）。另外10％的患者在随访期间发展为肝硬化（n=137）（45％患有门静脉高压症，14％的肝脏代偿失调）。肝脏疾病进展与持续的病毒血症有关。
结论：三分之一的冠心病患者在诊断时已经患有肝硬化。阳性病毒血症的持续与肝脏疾病的快速进展有关。重要的是,存在局部确定/定量HDV-RNA的障碍。
方法：多中心登记，包括在30个西班牙中心积极监测的抗HDV血清学阳性患者。流行病学,在随访开始时和最后一次访视时记录临床和病毒学变量.
结果：我们确定了329名抗HDV患者，41%为女性，平均年龄51岁。最常见的地理起源是西班牙（53％）和东欧（24％）。来自西班牙的患者年龄较大，HCV和HIV合并感染可能与过去的药物注射有关（p<0.01）。HDV-RNA在评估的221个中的138个为阳性(62%)。肝硬化在33％的诊断中存在，并且在病毒血症患者中更常见（58％vs25％，p<0.01)。经过6（3-12）年的中位随访，44（16％）解决了感染（自发18和Peg-INF后26）。另外10％的患者在随访期间发展为肝硬化（n=137）（45％患有门静脉高压症，14％的肝脏代偿失调）。肝脏疾病进展与持续的病毒血症有关。
结论：三分之一的冠心病患者在诊断时已经患有肝硬化。阳性病毒血症的持续与肝脏疾病的快速进展有关。重要的是,存在局部确定/定量HDV-RNA的障碍。
