Federico Alessandro, Masarone Mario, Romano Marco, Dallio Marcello, Rosato Valerio, Persico Marcello
Department of Clinical and Experimental Medicine, Division of Hepatogastroenterology, Second University of Naples, Naples, Italy.
Department of Internal Medicine and Hepatology, Internal Medicine and Hepatology Unit, University of Salerno, Salerno, Italy.
Hepat Mon. 2015 Jun 23;15(6):e18640. doi: 10.5812/hepatmon.15(6)2015.18640. eCollection 2015 Jun.
Standard [i.e. pegylated interferon (Peg-IFN) + ribavirin] treatment of hepatitis C virus (HCV)-related chronic hepatitis is associated with a sustained virological response (SVR) in 50 - 90% of patients. A rapid virological response (RVR) (i.e. negative HCV-RNA after 4 weeks of treatment) predicts SVR in almost 90% of patients.
The main aim of this study was to assess the strength of RVR, as a predictive factor of antiviral treatment response.
Using univariate and multivariate analysis, we retrospectively evaluated biochemical, metabolic, genetic and viral variables that might affect both RVR and SVR to Peg-IFN plus ribavirin, in 315 consecutive outpatients affected by HCV-related chronic hepatitis.
At univariate analysis, staging, body mass index, RVR, genotype and viral load were significantly related to SVR (P < 0.001). At multivariate analysis, RVR and genotype remained significant (P < 0.00001). The RVR had a predictive value of 83%. At univariate and multivariate analyses, diabetes (P = 0.003), genotype 2 (P = 0.000) and HCV-RNA values (P = 0.016) were independent predictors of RVR, even though at multivariate analyses, only genotype 2 was significantly related to RVR. When we stratified patients, according to genotype, no laboratory or clinical factors were predictive of RVR in genotype 1 patients at either univariate or multivariate analysis. In genotype 2 patients, staging (P = 0.029) and diabetes (P = 0.001) were the only significant predictors of RVR at univariate analyses, whereas no factor was independently related to RVR, at multivariate analysis.
The RVR is the strongest factor of SVR and infection with HCV genotype 2 is significantly associated with RVR. Neither biochemical and/or metabolic factors seem to exert influence on RVR.
丙型肝炎病毒（HCV）相关慢性肝炎的标准治疗（即聚乙二醇化干扰素（Peg-IFN）+利巴韦林）可使50%至90%的患者获得持续病毒学应答（SVR）。快速病毒学应答（RVR）（即治疗4周后HCV-RNA呈阴性）可预测近90%的患者获得SVR。
本研究的主要目的是评估RVR作为抗病毒治疗反应预测因素的强度。
我们采用单因素和多因素分析，对315例连续的HCV相关慢性肝炎门诊患者进行回顾性评估，这些患者的生化、代谢、遗传和病毒学变量可能影响对Peg-IFN加利巴韦林的RVR和SVR。
单因素分析时，分期、体重指数、RVR、基因型和病毒载量与SVR显著相关（P<0.001）。多因素分析时，RVR和基因型仍具有显著性（P<0.00001）。RVR的预测价值为83%。单因素和多因素分析时，糖尿病（P=0.003）、2型基因型（P=0.000）和HCV-RNA值（P=0.016）是RVR的独立预测因素，尽管多因素分析时，只有2型基因型与RVR显著相关。当我们根据基因型对患者进行分层时，单因素或多因素分析中，1型基因型患者的RVR均无实验室或临床因素可预测。在2型基因型患者中，单因素分析时，分期（P=0.029）和糖尿病（P=0.001）是RVR的唯一显著预测因素，而多因素分析时，无因素与RVR独立相关。
RVR是SVR的最强因素，HCV 2型感染与RVR显著相关。生化和/或代谢因素似乎均不对RVR产生影响。
