Yu Jian-Wu, Wang Gui-Qiang, Sun Li-Jie, Li Xiao-Guang, Li Shu-Chen
Department of Infectious Diseases, Second Affiliated Hospital, Harbin Medical University, Nangang District, Harbin, China.
J Gastroenterol Hepatol. 2007 Jun;22(6):832-6. doi: 10.1111/j.1440-1746.2007.04904.x.
The therapeutic effect of pegylated interferon (peg-IFN)-alpha-2a combination with ribavirin on patients with chronic hepatitis C virus (HCV) infection is dependent on the rapidity of the virological response. The aim of this study was to investigate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) in HCV patients treated with peg-IFN-alpha-2a and ribavirin.
The HCV genotypes of 105 patients with chronic hepatitis C were detected by enzyme-immunoassay. Patients received subcutaneous 180 microg peg-IFN-alpha-2a once weekly plus daily ribavirin. Patients with genotype 1 were treated for 48 weeks and patients with genotype 2 or 3 were treated for 24 weeks. HCV RNA was assessed by qualitative PCR at pretreatment, at weeks 4 and 12 during treatment, and at week 24 of follow-up. Virological response rates at different weeks were investigated, with RVR defined as serum HCV RNA undetectable after 4 weeks and EVR defined as HCV RNA either undetectable or decrease by >or=2 log(10) after 12 weeks. The effects of virological response rates at different weeks on SVR were analyzed.
Of the 105 patients, 44 (41.9%) were genotype 1, 46 (43.8%) were genotype 2, and 15 (14.3%) were genotype 3. RVR rates (19.5%) of patients with genotype 1 were significantly lower than those (60.7%) of genotype 2 or 3 (chi(2) = 16.836, P = 0.000); and EVR rates (73.2%) of patients with genotype 1 were significantly lower than those (96.7%) of genotype 2 or 3 (chi(2) = 12.220, P = 0.000). The SVR rates (86.7%) of patients who had achieved RVR were significantly higher than those (43.9%) of patients who had not achieved RVR (chi(2) = 19.713, P = 0.000). The positive predictive value of RVR in all patients was higher than that of EVR, but there was no significant difference between RVR and EVR. The negative predictive value of RVR in all patients or with genotype 1 was significantly lower than that of EVR. In univariate analysis, HCV RNA level (P = 0.014), genotype (P = 0.001), RVR (P = 0.000) and EVR (P = 0.000) were associated with effect of treatment. However, in stepwise regression analysis, the independent factors associated with effect of antiviral therapy were RVR (OR = 6.501, P = 0.001), EVR (OR = 2.776, P = 0.003) and genotype (OR = 3.061, P = 0.024).
The RVR and EVR rates of patients with genotype 1 were significantly lower than those of patients with genotype 2 or 3. RVR had a similar predictive value as EVR on SVR. Genotype, HCV RNA level, RVR and EVR were associated with SVR. Genotype, RVR and EVR were independent factors for predicting the effect of antiviral therapy.
聚乙二醇化干扰素（peg-IFN）-α-2a联合利巴韦林治疗慢性丙型肝炎病毒（HCV）感染患者的疗效取决于病毒学应答的速度。本研究旨在探讨快速病毒学应答（RVR）和早期病毒学应答（EVR）对接受peg-IFN-α-2a和利巴韦林治疗的HCV患者持续病毒学应答（SVR）的预测价值。
采用酶免疫法检测105例慢性丙型肝炎患者的HCV基因型。患者接受皮下注射180μg peg-IFN-α-2a，每周1次，同时每日口服利巴韦林。基因1型患者治疗48周，基因2型或3型患者治疗24周。在治疗前、治疗第4周和第12周以及随访第24周时通过定性PCR评估HCV RNA。研究不同周时的病毒学应答率，RVR定义为治疗4周后血清HCV RNA检测不到，EVR定义为治疗12周后HCV RNA检测不到或下降≥2 log(10)。分析不同周时病毒学应答率对SVR的影响。
105例患者中，44例（41.9%）为基因1型，46例（43.8%）为基因2型，15例（14.3%）为基因3型。基因1型患者的RVR率（19.5%）显著低于基因2型或3型患者（60.7%）（χ² = 16.836，P = 0.000）；基因1型患者的EVR率（73.2%）显著低于基因2型或3型患者（96.7%）（χ² = 12.220，P = 0.000）。达到RVR的患者的SVR率（86.7%）显著高于未达到RVR的患者（43.9%）（χ² = 19.713，P = 0.000）。RVR在所有患者中的阳性预测价值高于EVR，但RVR与EVR之间无显著差异。RVR在所有患者或基因1型患者中的阴性预测价值显著低于EVR。单因素分析中，HCV RNA水平（P = 0.014）、基因型（P = 0.001）、RVR（P = 0.000）和EVR（P = 0.000）与治疗效果相关。然而，在逐步回归分析中，与抗病毒治疗效果相关的独立因素为RVR（OR = 6.501，P = 0.001）、EVR（OR = 2.776，P = 0.003）和基因型（OR = 3.061，P = 0.024）。
基因1型患者的RVR和EVR率显著低于基因2型或3型患者。RVR对SVR的预测价值与EVR相似。基因型、HCV RNA水平、RVR和EVR与SVR相关。基因型、RVR和EVR是预测抗病毒治疗效果的独立因素。
