Department of Gastroenterology and Hepatology, University Hospital Puerta de Hierro Mahadahonda Madrid, Spain.
J Gastroenterol Hepatol. 2012 Nov;27(11):1705-10. doi: 10.1111/j.1440-1746.2012.07214.x.
To evaluate the efficacy and safety of peginterferon α-2a plus ribavirin at standard doses in patients with hepatitis C virus (HVC) genotype 1 infection with persistently normal alanine aminotransferase (ALT) levels.
Patients aged 18 to 65 years were included in this observational, prospective study if they had evidence of a HCV genotype 1 infection. The serum HCV RNA concentration was determined at baseline and week 12. A qualitative HCV RNA test was performed at baseline and at weeks 48 and 72. Liver function tests were performed at each study visit. The primary efficacy measure was the sustained virological response in the intention-to-treat population. Logistic regression analyses were also performed to explore predictors of virological response.
A sustained virological response was observed in 100 of the 175 patients (57%). An early virological response and end-of-treatment response were seen in 159 patients (91%) and 133 patients (76%), respectively. Thirty-seven of the 122 evaluable patients for this outcome (30%) showed a rapid virological response. A higher viral load was a significant predictor for a lack of rapid virological response and lack of sustained virological response. There were not any unexpected safety or tolerability findings.
Our study suggests that the efficacy of the combination of peginterferon α-2a and ribavirin in patients with HCV genotype 1 infection and normal ALT levels is at least similar to that reported in patients with elevated ALT levels.
评估聚乙二醇干扰素 α-2a 联合利巴韦林标准剂量治疗丙型肝炎病毒（HCV）基因型 1 感染、持续正常丙氨酸氨基转移酶（ALT）水平患者的疗效和安全性。
本观察性、前瞻性研究纳入了血清 HCV RNA 浓度证实存在 HCV 基因型 1 感染的 18-65 岁患者。基线和第 12 周测定血清 HCV RNA 浓度，基线和第 48 周、72 周行 HCV RNA 定性检测。每次访视时检测肝功能。主要疗效指标为意向治疗人群中的持续病毒学应答。还进行了 logistic 回归分析，以探索病毒学应答的预测因素。
175 例患者中 100 例（57%）观察到持续病毒学应答。159 例（91%）和 133 例（76%）患者分别出现早期病毒学应答和治疗结束时应答。122 例可评估该结局的患者中，37 例（30%）出现快速病毒学应答。较高的病毒载量是快速病毒学应答缺失和持续病毒学应答缺失的显著预测因素。未发现任何意外的安全性或耐受性问题。
本研究表明，聚乙二醇干扰素 α-2a 联合利巴韦林治疗 HCV 基因型 1 感染、持续正常 ALT 水平的患者的疗效至少与 ALT 升高患者的疗效相似。
