Kabaçam Gökhan, Dalekos George N, Çakaloğlu Yılmaz, Zachou Kalliopi, Bock Thomas, Erhardt Andreas, Zeuzem Stefan, Tabak Fehmi, Yalçin Kendal, Bozdayi A Mithat, Dienes Hans P, Bozkaya Hakan, Manns Michael, Wedemeyer Heiner, Yurdaydin Cihan
Ankara University, School of Medicine, Department of Gastroenterology, Ankara, Turkey.
Turk J Gastroenterol. 2012;23(5):560-8. doi: 10.4318/tjg.2012.0538.
BACKGROUND/AIMS: The safety and efficacy of interferons in advanced delta hepatitis have not been explored. The aim of this subanalysis of a multicenter clinical trial was to compare the efficacy and safety of 48 weeks of pegylated interferon alpha-2a (180 μg weekly) with or without adefovir (10 mg daily) in patients with chronic delta hepatitis-induced advanced liver disease and in those with non-advanced liver disease.
Thirty-one patients with advanced and 27 patients with non-advanced liver disease were assessed. Patients were considered to have advanced liver disease when biopsy disclosed a fibrosis score of ≥4 according to Ishak or when imaging studies were indicative of cirrhosis. Virologic response, defined as achievement of undetectable hepatitis D virus RNA, was assessed at the end of treatment and end of 24 weeks of treatment-free follow-up.
Patients with advanced disease had lower hepatitis D virus RNA levels and platelet counts (p=0.014 and p=0.0015, respectively). End of treatment and end of follow-up virologic responses in patients with advanced vs. non-advanced liver disease were similar (29% vs. 19% and 32% vs 23%). Proportion of adverse events did not differ between groups except that thrombocytopenia was noted more often in the advanced liver disease group. Further, four cases of clinically important adverse events including two cases of hepatic decompensation and one case of tuberculosis reactivation occurred in the advanced liver disease group.
Pegylated interferon is as effective in patients with advanced liver disease due to chronic delta hepatitis as in patients with non-advanced liver disease, but patients should be monitored closely for clinically important side effects.
背景/目的：干扰素在晚期丁型肝炎中的安全性和有效性尚未得到研究。这项多中心临床试验的亚分析旨在比较聚乙二醇化干扰素α-2a（每周180μg）联合或不联合阿德福韦（每日10mg）治疗48周对慢性丁型肝炎所致晚期肝病患者和非晚期肝病患者的疗效和安全性。
评估了31例晚期肝病患者和27例非晚期肝病患者。当活检显示根据Ishak纤维化评分≥4或影像学检查提示肝硬化时，患者被认为患有晚期肝病。在治疗结束时和停药随访24周结束时评估病毒学应答，定义为实现无法检测到丁型肝炎病毒RNA。
晚期疾病患者的丁型肝炎病毒RNA水平和血小板计数较低（分别为p=0.014和p=0.0015）。晚期肝病患者与非晚期肝病患者在治疗结束时和随访结束时的病毒学应答相似（分别为29%对19%和32%对23%）。除晚期肝病组血小板减少症更常见外，两组不良事件发生率无差异。此外，晚期肝病组发生了4例具有临床意义的不良事件，包括2例肝失代偿和1例结核复发。
聚乙二醇化干扰素对慢性丁型肝炎所致晚期肝病患者的疗效与非晚期肝病患者相似，但应密切监测患者是否出现具有临床意义的副作用。
