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目的探讨河南地区丙型肝炎病毒(hepatitis C virus,HCV)1b亚型干扰素敏感决定区(interferon sensitivity determining region,ISDR)氨基酸序列变异是否影响聚乙二醇干扰素(pegylated interferon,PEG-IFN)联合利巴韦林(ribavirin,RBV)治疗慢性丙型肝炎(chronic hepatitis C,CHC)的抗病毒疗效,评价其预测价值。方法对49例HCV 1b亚型慢性感染者采用PEG-IFN/RBV联合方案治疗48周,并随访24周。定量检测血清HCV-RNA,RT-PCR扩增治疗前血清标本中HCV-ISDR片段并测序,MEGA 4分析氨基酸序列变异度;二分类logistic回归分析各变量与持续病毒学应答(sustained virological response,SVR)之间的关系。结果 SVR率为69.4%(34/49);治疗前血清HCV的ISDR氨基酸序列与HCV J株比较,12例为野生型(未突变),36例为中间型(1~3个突变),1例为突变型(≥4个突变);二分类logistic回归分析显示,影响SVR的主要因素是ISDR氨基酸残基突变(OR=21.505,P=0.001),其次是年龄(OR=0.876,P=0.042);ISDR氨基酸突变数≥2个的CHC组所获得的SVR(13/14)明显高于氨基酸突变数<2个的CHC组(1/15)(P<0.05),年龄≤40岁者SVR(14/17)高于年龄>40岁者(20/32)(P<0.05)。结论河南地区HCV1b亚型ISDR突变型极少;PEG-IFN/RBV联合方案治疗中,对SVR有预测价值的为ISDR氨基酸突变数≥2个和年龄≤40岁。
Objective To investigate whether the amino acid sequence variations of hepatitis C virus (HCV) 1b interferon sensitivity determining region (ISDR) affect the expression of pegylated interferon (PEG-IFN) Antiviral efficacy of ribavirin (RBV) in the treatment of chronic hepatitis C (CHC) was evaluated and its predictive value was evaluated. Methods 49 patients with chronic HCV 1b infection were treated with PEG-IFN / RBV for 48 weeks and were followed up for 24 weeks. Serum HCV-RNA was detected quantitatively. The HCV-ISDR fragments of serum samples were amplified by RT-PCR and sequenced. MEGA 4 was used to analyze the amino acid sequence variation. Logistic regression analysis was used to analyze the relationship between each variable and sustained virological response (SVR )The relationship between. Results The rate of SVR was 69.4% (34/49). Before treatment, the ISDR amino acid sequence of serum HCV was 12 (wild type), 36 intermediate (1 ~ 3 mutation) and 1 Logistic regression analysis showed that the main factors influencing SVR were mutations in amino acid residues of ISDR (OR = 21.505, P = 0.001), followed by age (OR = 0.876, P = 0.042 ). The SVR (13/14) in the CHC group with more than 2 amino acid mutations in ISDR was significantly higher than that in the CHC group (1/15) with amino acid mutations <2 (P <0.05). The SVR (14/17) were higher than those aged> 40 years (20/32) (P <0.05). CONCLUSIONS: There are few ISDR mutations in HCV1b subtype in Henan Province. Among the PEG-IFN / RBV combination regimens, the predictive value for SVR is that the number of ISDR amino acid mutations is ≥2 and the age ≤40 years.