基于体重的聚乙二醇干扰素α-2b 治疗慢性 delta 肝炎：一项多中心罗马尼亚试验。

Weight-based dosing regimen of peg-interferon α-2b for chronic hepatitis delta: a multicenter Romanian trial.

机构信息

Center for Digestive Diseases and Liver Transplantation, Fundeni Clinical Institute, Bucharest, Romania.

出版信息

J Gastrointestin Liver Dis. 2011 Dec;20(4):377-82.

Abstract

BACKGROUND

Antiviral therapy for chronic hepatitis D (delta) is not yet satisfactory, although it appears to be the only means to alter the progressive natural course of chronic hepatitis D virus (HDV) infection.

AIM

To assess safety and efficacy, evaluated by virological, biochemical and histological end-of-treatment (EOT) and end-of-follow-up (EOF) response to peg-interferon α-2b 1.5 µg/kg body weight weekly in a Romanian cohort of naïve patients with chronic hepatitis delta.

RESULTS

49 Caucasian patients (55.1% men, 44.9% females) with a mean age of 37.95 years received study medication; per-protocol population consisted of 36 subjects. Virological EOT response was present in 33.3% and EOF response was maintained in 25% of patients. 50% of study population showed normalization of ALT level at EOT and 25% at EOF. A combined biochemical and virological response was observed in 19.4% of patients at EOT and in 16.7% at EOF. At baseline, the necroinflammation quantified by histological activity index (HAI) score was 9.72 and the mean fibrosis score was 2.03; there was a significant decrease of HAI score to 7.44 (p=0.01) at EOT, but not for fibrosis score (1.33, p=0.37). However, only 8.3% of patients at EOT and 19.4% at EOF had progressive histological disease.

CONCLUSIONS

Treatment with peg-interferon α-2b succeeded in obtaining a negative HVD RNA in 25% of patients after 104 weeks of follow-up, although combined biochemical and virological response was present in only 16.7%. Necroinflammation decreased significantly in treated patients. Longer treatment periods with pegylated interferon or combination regimen peg interferon-nucleotide analogues should be tested in order to increase efficacy.

摘要

背景

慢性丁型肝炎（delta）的抗病毒治疗尚不尽人意，尽管它似乎是改变慢性丁型肝炎病毒（HDV）感染的进行性自然病程的唯一手段。

目的

评估聚乙二醇干扰素α-2b 1.5μg/kg 体重每周 1 次治疗罗马尼亚初治慢性丁型肝炎患者的安全性和疗效，通过治疗结束（EOT）和随访结束（EOF）时的病毒学、生化学和组织学应答来评估。

结果

49 例高加索患者（55.1%为男性，44.9%为女性），平均年龄为 37.95 岁，接受了研究药物治疗；符合方案人群由 36 例患者组成。33.3%的患者达到了 EOT 时的病毒学应答，25%的患者在 EOF 时维持了应答。50%的研究人群在 EOT 时 ALT 水平正常，25%在 EOF 时正常。19.4%的患者在 EOT 时和 16.7%的患者在 EOF 时出现了生化和病毒学联合应答。基线时，通过组织学活动指数（HAI）评分量化的坏死性炎症为 9.72，纤维化平均评分为 2.03；EOT 时 HAI 评分显著下降至 7.44（p=0.01），但纤维化评分无变化（1.33，p=0.37）。然而，只有 8.3%的 EOT 患者和 19.4%的 EOF 患者发生了进展性组织学疾病。