Treatment of chronic hepatitis D patients with pegylated interferon: a real-world experience
Treatment of chronic hepatitis D patients with pegylated interferon: a real-world experience
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DOI：
10.3851/imp2728
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发表时间：
2014-01-01
影响因子：
1.2
通讯作者：
Hamid, Saeed
中科院分区：
文献类型：
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作者：
Abbas, Zaigham;Memon, Mohammad S.;Hamid, Saeed
背景：已发表的用聚乙二醇干扰素（PEG-IFN）-α治疗慢性丁型肝炎患者的经验有限。本研究的目的是确定48周的疗效与PEG-IFN治疗初治患者的临床试验设置之外，在真实的world.Methods：慢性丁型肝炎患者进行了治疗与PEG-IFN。主要终点是持续清除HDV RNA和正常的丙氨酸氨基转移酶（ALT）在24周后treatment.Results：与PEG-IFN治疗的患者总数为104，91名男性，平均年龄+/- SD 30.1 +/- 10.0岁（范围15-55）。41例患者出现肝硬化。通过意向治疗分析，44例（42.3%）患者达到治疗结束病毒学应答（ETR），38例（35%）患者ALT正常化，23例（22.1%）患者达到联合应答。在治疗后24周时，在24例（23.1%）患者中观察到病毒学和生化应答的持续病毒学应答（SVR），在13例（12.5%）患者中观察到联合应答。ETR和SVR均与治疗24周时HDV RNA阴性相关（分别为P=0.001和P=0.000）。此时可检测的HDV RNA对治疗后6个月可检测的RNA具有0.95（范围0.85-0.99）的阳性预测值。治疗结束时的生物学反应，即在治疗结束时ALT正常也是ETR和SVR的预测因子（分别为P=0.004和P=0.041）。结论：PEG-IFN治疗丁型肝炎疗效有限。治疗24周时可检测到HDV RNA是SVR失败的预测因子。
Background: Published experience of treating chronic hepatitis D patients with pegylated interferon (PEG-IFN)-alpha is limited. The aim of this study was to determine the efficacy of 48 weeks of treatment with PEG-IFN in naive patients outside the clinical trial setting, in the real world.Methods: Patients with chronic hepatitis D were treated with PEG-IFN. The primary end points were sustained clearance of HDV RNA and normal alanine aminotransferase (ALT) at 24 weeks post-treatment.Results: The total number of patients treated with PEG-IFN was 104; 91 males, mean age +/- sd 30.1 +/- 10.0 years (range 15-55). Cirrhosis was present in 41 patients. With an intention-to-treat analysis, end of treatment virological response (ETR) was achieved in 44 (42.3%), normalization of ALT in 38 (35%) and a combined response in 23 (22.1%) patients. Sustained virological response (SVR) at 24 weeks post-treatment was seen in 24 (23.1%) patients each for the virological and biochemical responses and in 13 (12.5%) as combined response. Both ETR and SVR were associated with a negative HDV RNA at 24 weeks of treatment (P=0.001 and P=0.000, respectively). Detectable HDV RNA at this point had a positive predictive value of 0.95 (range 0.85-0.99) for detectable RNA at 6 months post-treatment. End of treatment biological response, that is, normal ALT at the end of treatment was also a predictor of ETR and SVR (P=0.004 and P=0.041, respectively).Conclusions: Treatment with PEG-IFN for hepatitis D is of limited efficacy. Detectable HDV RNA at 24 weeks of treatment is a predictor for a failed SVR.