Treatment of chronic hepatitis delta with pegylated interferon-α2b

Treatment of chronic hepatitis delta with pegylated interferon-α2b
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DOI:
10.1111/j.1478-3231.2006.01279.x
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发表时间:
2006-09-01
影响因子:
6.7
通讯作者:
Haeussinger, Dieter
Haeussinger, Dieter
中科院分区:
医学2区
文献类型:
--
作者:
Erhardt, Andreas;Gerlich, Wolfram;Haeussinger, Dieter

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背景/目标:慢性丁型肝炎是一种难以治疗的疾病,本试验旨在研究聚乙二醇干扰素α 2b治疗慢性丁型肝炎的疗效和耐受性。方法:12例慢性丁型肝炎患者前瞻性接受1.5 μ g/kg PEG-IFN-α 2b治疗48周,随访24周。持续应答(SR)定义为治疗后6个月时逆转录-聚合酶链反应检测不到丁型肝炎病毒(HDV)RNA和丙氨酸转氨酶(ALT)正常化。研究包括HDV RNA动力学、B型肝炎病毒(HBV)和HDV基因型测定和组织学评价。结果:12例患者中有2例(17%)实现了SR。第6个月HDV RNA下降小于3 log的阴性预测值为100%。6个月时HDV RNA下降超过3 log的阳性预测值为67%。治疗结束时,在应答者和非应答者中观察到ALT显著降低。Ishak组织学评分在基线时相当,在随访结束时,应答者与无应答者相比显著改善(13.5 vs. 8.0; P < 0.02)。结论:目前的研究表明,聚乙二醇干扰素-α 2b是一种有前途的治疗慢性丁型肝炎的选择。治疗6个月时HDV RNA下降小于3个对数,可以确定无应答者。
Background/Aims: Chronic hepatitis D is difficult to treat. The present pilot study investigated the efficacy and tolerability of pegylated (PEG)-interferon (IFN)-alpha 2b in chronic hepatitis D. Methods: Twelve patients with chronic hepatitis D were prospectively treated with 1.5 mu g/kg PEG-IFN-alpha 2b for 48 weeks and followed for 24 weeks. Sustained response (SR) was defined as undetectable hepatitis delta virus (HDV) RNA by reverse transcriptase-polymerase chain reaction and normalization of alanine aminotransferase (ALT) at 6 months after treatment. Investigations included HDV RNA kinetics, determination of hepatitis B virus (HBV) and HDV genotypes and histological evaluation. Results: An SR was achieved in two out of 12 of patients (17%). The negative predictive value of a less than 3 log HDV RNA decrease at month 6 was 100%. The positive predictive value of a more than 3 log HDV RNA decrease at month 6 was 67%. A marked ALT reduction at the end of treatment was observed in responders and nonresponders. Ishak histological score was comparable at baseline and significantly improved in responders compared with nonresponders at the end of follow-up (13.5 vs. 8.0; P < 0.02). Conclusions: The present study indicates that PEG-IFN-alpha 2b is a promising treatment option in chronic hepatitis D. Nonresponders could be identified by a less than 3 log decrease of HDV RNA at 6 months of treatment.