病毒基因型对慢性丙型肝炎患者干扰素治疗的影响：一项多中心对照研究。

Impact of virus genotype on interferon treatment of patients with chronic hepatitis C: a multicenter controlled study.

作者信息

Xie Yao, Xu Dao-Zhen, Lu Zhi-Meng, Luo Kang-Xian, Jia Ji-Dong, Wang Yu-Ming, Zhao Gui-Zhen, Zhang Shu-Lin, Zhang Da-Zhi

机构信息

Department of Infectious Diseases, Beijing Ditan Hospital, Beijing 100011, China.

出版信息

Hepatobiliary Pancreat Dis Int. 2004 Aug;3(3):369-74.

PMID:15313671

Abstract

BACKGROUND

Some factors have been reported to be associated with a greater likelihood of sustained viral response (SVR) in the interferon (IFN) treatment of chronic hepatitis C. The factors include HCV genotype, HCV RNA level in serum, state of liver disease, baseline body weight, age, sex, and race. The aim of this trial was to investigate the influence of HCV genotype on the IFN treatment of patients with chronic hepatitis C.

METHODS

The genotypes of HCV virus were determined in the patients with chronic hepatitis C from several hospitals of China enrolled into the randomized, opened and controlled trial of Peg-IFN alpha-2a (pegasys) treatment, controlled with IFN-alpha-2a (roferon-A). The serum ALT levels and HCV RNA concentrations of the patients were detected before and at the end of treatment and during the follow-up. The influence of HCV genotype on the IFN treatment of patients with chronic hepatitis C was analyzed in intention-to-treat (ITT) population.

RESULTS

The HCV genotypes of 202 patients were determined. Of these patients, 158(78.22%) were infected with genotype 1 HCV and 44(21.78%) with genotype non-1. The viral response at the end of treatment (ETVR) and sustained viral response (SVR) rates were 53.80% and 25.32% respectively in patients with genotype 1 HCV, but they were 61.36% and 43.18% in patients with genotype non-1. The difference of SVR between patients with genotype 1 HCV and those with genotype non-1 was significant (P=0.021). After being grouped by the used drugs, the ETVR rates of patients infected with genotype 1 and non-1 HCV were 76.83% and 80.95% in the patients treated with pegasys (P=0.686); but their SVR rates were 35.37% and 66.67% (P=0.01). The viral relapse rate of genotype 1 HCV (55.56%) was significantly higher than that of genotype non-1 HCV (23.53%) (P=0.02). In roferon-A group, the ETVR and SVR rates of patients with genotype 1 HCV were 28.95% and 14.47% respectively, which were lower but not more significant than those of patients with genotype non-1 HCV (43.48% and 21.74%). Moreover, the viral relapse rate of genotype 1 HCV (72.73%) was higher but not more significant than that of genotype non-1 HCV (50.00%) (P=0.21).

CONCLUSION

HCV genotype could affect the efficacies, mainly sustained responses, of IFN treatment in patients with chronic hepatitis C, and the effects of IFN are related to drugs and therapeutic course.

摘要

背景

据报道，在慢性丙型肝炎的干扰素（IFN）治疗中，一些因素与持续病毒学应答（SVR）可能性较大相关。这些因素包括丙型肝炎病毒（HCV）基因型、血清中HCV RNA水平、肝脏疾病状态、基线体重、年龄、性别和种族。本试验的目的是研究HCV基因型对慢性丙型肝炎患者IFN治疗的影响。

方法

在中国多家医院纳入的聚乙二醇干扰素α-2a（派罗欣）治疗的随机、开放和对照试验中，对慢性丙型肝炎患者的HCV病毒基因型进行测定，以干扰素α-2a（罗扰素）作为对照。在治疗前、治疗结束时及随访期间检测患者的血清丙氨酸氨基转移酶（ALT）水平和HCV RNA浓度。在意向性治疗（ITT）人群中分析HCV基因型对慢性丙型肝炎患者IFN治疗的影响。

结果

确定了202例患者的HCV基因型。其中，158例（78.22%）感染1型HCV，44例（21.78%）感染非1型HCV。1型HCV患者治疗结束时病毒学应答（ETVR）率和持续病毒学应答（SVR）率分别为53.80%和25.32%，而非1型HCV患者分别为61.36%和43.18%。1型HCV患者与非1型HCV患者的SVR差异有统计学意义（P = 0.021）。按所用药物分组后，接受派罗欣治疗的1型和非1型HCV感染患者的ETVR率分别为76.83%和80.95%（P = 0.686）；但其SVR率分别为35.37%和66.67%（P = 0.01）。1型HCV的病毒复发率（55.56%）显著高于非1型HCV（23.53%）（P = 0.02）。在罗扰素组中，1型HCV患者的ETVR率和SVR率分别为28.95%和14.47%，低于非1型HCV患者（43.48%和21.74%），但差异无统计学意义。此外，1型HCV的病毒复发率（72.73%）高于非1型HCV（50.00%），但差异无统计学意义（P = 0.21）。