Abbas Zaigham, Memon Mohammad S, Mithani Hammad, Jafri Wasim, Hamid Saeed
Department of Medicine, The Aga Khan University Hospital, Karachi, Pakistan.
Antivir Ther. 2014;19(5):463-8. doi: 10.3851/IMP2728. Epub 2014 Jan 14.
Published experience of treating chronic hepatitis D patients with pegylated interferon (PEG-IFN)-α 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.
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.
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).
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.
聚乙二醇干扰素（PEG-IFN）-α治疗慢性丁型肝炎患者的已发表经验有限。本研究的目的是在现实世界的临床试验环境之外，确定初治患者接受48周PEG-IFN治疗的疗效。
慢性丁型肝炎患者接受PEG-IFN治疗。主要终点是治疗后24周时HDV RNA持续清除且丙氨酸氨基转移酶（ALT）正常。
接受PEG-IFN治疗的患者总数为104例；男性91例，平均年龄±标准差为30.1±10.0岁（范围15 - 55岁）。41例患者存在肝硬化。在意向性分析中，44例（42.3%）患者实现了治疗结束时的病毒学应答（ETR），38例（35%）患者ALT恢复正常，23例（22.1%）患者实现了联合应答。治疗后24周时，24例（23.1%）患者实现了病毒学和生化应答的持续病毒学应答（SVR），13例（12.5%）患者实现了联合应答的SVR。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）。此时可检测到的HDV RNA对治疗后6个月可检测到的RNA的阳性预测值为0.95（范围0.85 - 0.99）。治疗结束时的生物学应答，即治疗结束时ALT正常，也是ETR和SVR的预测指标（分别为P = 0.004和P = 0.041）。
PEG-IFN治疗丁型肝炎的疗效有限。治疗24周时可检测到的HDV RNA是SVR失败的预测指标。
