Efficacy of peginterferon alpha-2b in chronic hepatitis delta:: Relevance of quantitative RT-PCR for follow-up

Efficacy of peginterferon alpha-2b in chronic hepatitis delta:: Relevance of quantitative RT-PCR for follow-up
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DOI:
10.1002/hep.21325
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发表时间:
2006-09-01
期刊:
影响因子:
13.5
通讯作者:
Gault, Elyanne
Gault, Elyanne
中科院分区:
医学1区
文献类型:
--
作者:
Castelnau, Corinne;Le Gal, Frederic;Gault, Elyanne

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丁型肝炎病毒(HDV)可导致感染乙型肝炎病毒的患者出现严重的急性和慢性肝病。高剂量的α干扰素虽然效果不佳,但却是据报道对慢性丁型肝炎有一定疗效的唯一治疗方法。聚乙二醇化干扰素 α (PEG-IFN) 尚未进行评估。通常通过定性检测血清中 HDV-RNA 来监测治疗。在这项研究中,评估了 PEG-IFN 在慢性丁型肝炎中的安全性和有效性,并使用定量 RT-PCR 测定了血清 HDV-RNA 动力学。 14 名慢性丁型肝炎患者在 12 个月期间接受皮下注射 PEG-IFN α-2b(每周 1.5 μg/kg)。在治疗开始时、治疗过程中以及治疗后随访期间(6 至 42 个月(中位 16 个月))对血清 HDV-RNA 进行定量。 PEG-IFN α-2b 耐受性良好,没有引起严重的不良反应。 8 名患者 (57%) 获得了持续的生化反应。治疗结束时,8 名患者 (57%) 达到病毒学应答(HDV-RNA 检测不到)。 6 名患者 (43%) 在整个治疗后随访期间观察到持续的病毒学应答。 HDV-RNA 动力学可预测反应:使用 PEG-IFN 3 个月后,反应组中的 HDV-RNA 水平显着低于无反应组 (P = .018)。治疗 6 个月后,HDV-RNA 阴性可预测持续缓解 (P = .021)。总之,这项初步研究表明 PEG-IFN α-2b 对于治疗慢性丁型肝炎是安全有效的。治疗期间 HDV-RNA 水平的随访可以区分各种病毒学反应,从而改善治疗监测。
Hepatitis delta virus (HDV) can cause severe acute and chronic liver disease in patients infected by hepatitis B virus. Interferon alpha at high doses, although poorly efficient, is the only treatment reported to provide some benefit in chronic hepatitis delta. Pegylated interferon alpha (PEG-IFN) has not yet been evaluated. Treatment is usually monitored by the qualitative detection of HDV-RNA in serum. In this study, safety and efficacy of PEG-IFN were assessed in chronic hepatitis delta, and serum HDV-RNA kinetics were determined using quantitative RT-PCR Fourteen patients with chronic hepatitis delta received subcutaneous PEG-IFN alpha-2b during 12 months (1.5 mu g/kg per week). Serum HDV-RNA was quantified at initiation and during the course of therapy, and during the posttreatment follow-up period, which ranged from 6 to 42 months (median 16 months). PEG-IFN alpha-2b was well tolerated, inducing no serious adverse effect. Sustained biochemical response was obtained in 8 patients (57%). At the end of treatment, 8 patients (57%) had achieved virological response (undetectable HDV-RNA). Sustained virological response throughout the posttreatment follow-up period was observed in 6 patients (43%). HDV-RNA kinetics were predictive of the response: after 3 months of PEG-IFN, HDV-RNA levels were significantly lower in the responders than in the nonresponders group (P = .018). After 6 months of therapy, a negative HDV-RNA was predictive of sustained response (P = .021). In conclusion, this preliminary study indicates that PEG-IFN alpha-2b is safe and efficient for treatment of chronic hepatitis delta. The follow-up of HDV-RNA levels during therapy, which allows the differentiation of various profiles of virological responses, improves treatment monitoring.