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在一项前瞻性随机多中心试验中,感染丙型肝炎病毒1型的韩国患者接受全剂量或减量(≥全剂量的80%)聚乙二醇化干扰素α-2a治疗,两组的病毒学应答无差异。

The virological response in Koreans infected with HCV genotype 1 did not differ between groups treated with a full dose or reduced dose (≥80 % full dose) of peginterferon alfa-2a: a prospective randomized multicenter trial.

作者信息

Kwon Jung Hyun, Bae Si Hyun, Lee Youn Jae, Lee Jin-Woo, Kim Young Seok, Hwang Jae Seok, Tak Won Young, Jang Jeong Won, Lee Byung Seok, Lee June Sung, Lee Chun Kyon, Baik Soon Koo, Park Neung Hwa, Lee Tae Hee, Kim Dong Joon, Choi Jae-Seok, Shin Jae-Gook, Yim Hyeon Woo

机构信息

Department of Internal Medicine, Incheon St. Mary's Hospital, The Catholic University of Korea, Incheon, Korea.

Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, 505 Banpo-dong, Seocho-gu, Seoul, 137-040, Korea.

出版信息

Hepatol Int. 2013 Oct;7(4):1000-9. doi: 10.1007/s12072-013-9472-x. Epub 2013 Oct 23.

DOI:
10.1007/s12072-013-9472-x
PMID:26202029
Abstract

PURPOSE

A high rate of sustained viral response (SVR) in Koreans with chronic hepatitis C (CHC) is related to a favorable IL28B genotype. We compared two dosing strategies for peginterferon alfa-2a in Koreans with CHC and defined the combined effect of polymorphisms and dosing on the virological response.

METHODS

A total of 178 treatment-naïve patients with CHC genotype 1 were prospectively enrolled. All patients were randomly assigned to treatment with one of two peginterferon alfa-2a regimens: 180 μg per week for 48 weeks (full-dose group) or 180 μg per week during the first 12 weeks followed by 135 μg per week for the next 36 weeks (dose-reduction group). Polymorphisms related to IL28B, ITPA, C20orf194 and SLC29A1 were studied.

RESULTS

SVR rates did not differ between the full-dose and dose-reduction groups (56.5 and 51.2 %, respectively, p = 0.474). The frequency of additional reductions of the peginterferon dose because of adverse events was higher in the full-dose group than in the dose-reduction group. SVR rates in patients homozygous for the IL28B major allele were higher than those in patients for the other IL28B alleles. For patients with unfavorable IL28B genotypes, SVR was less likely to be achieved in the dose-reduction group than in the full-dose group.

CONCLUSIONS

In Koreans with HCV genotype 1, the virological response to treatment did not differ between a full dose and reduced dose (≥80 % of full dose) of peginterferon alfa-2a. However, in the patients with unfavorable IL28B genotypes, the full-dose treatment of peginterferon alfa-2a may be beneficial.

摘要

目的

韩国慢性丙型肝炎(CHC)患者的高持续病毒学应答率(SVR)与有利的IL28B基因型相关。我们比较了聚乙二醇干扰素α-2a在韩国CHC患者中的两种给药策略,并确定了多态性和给药对病毒学应答的联合影响。

方法

前瞻性纳入178例初治CHC 1型患者。所有患者被随机分配接受两种聚乙二醇干扰素α-2a方案之一的治疗:每周180μg,共48周(全剂量组)或前12周每周180μg,随后36周每周135μg(剂量减少组)。研究了与IL28B、ITPA、C20orf194和SLC29A1相关的多态性。

结果

全剂量组和剂量减少组的SVR率无差异(分别为56.5%和51.2%,p = 0.474)。全剂量组因不良事件而额外减少聚乙二醇干扰素剂量的频率高于剂量减少组。IL28B主要等位基因纯合患者的SVR率高于其他IL28B等位基因患者。对于IL28B基因型不利的患者,剂量减少组比全剂量组更难实现SVR。

结论

在韩国HCV 1型患者中,聚乙二醇干扰素α-2a全剂量和减少剂量(≥全剂量的80%)治疗的病毒学应答无差异。然而,对于IL28B基因型不利的患者,聚乙二醇干扰素α-2a全剂量治疗可能有益。

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