Bourlière Marc, Ouzan Denis, Rosenheim Michel, Doffoël Michel, Marcellin Patrick, Pawlotsky Jean-Michel, Salomon Laurence, Fagnani Francis, Rouanet Stéphanie, Pinta Alexandrina, Vray Muriel
Service d'Hépato-Gastroentérologie, Hôpital Saint-Joseph, Marseille, France.
Antivir Ther. 2012;17(1):101-10. doi: 10.3851/IMP1935.
The aim of this study was to document in real life the characteristics and management of hepatitis C patients treated with pegylated interferon-α2a and ribavirin, and the efficacy of treatment (sustained virological response [SVR]).
This observational study enrolled hepatitis C patients initiating pegylated interferon-α2a and ribavirin treatment.
A total of 2,066 patients were included, of which 70% were treatment-naive, 53% had genotype (G) 1 and 38% G2 or G3 infection, and 35% had an F3-F4 Metavir score. In total, 18% of patients treated for 24 weeks and 39% of patients treated for 48 weeks prematurely stopped treatment, mainly because of side effects. The SVR rate (intent-to-treat population) was 39%: 43% in naive patients and 31% in treatment-failure patients. In the complete case analysis population, this was 49%: 54% in naive patients and 37% in treatment-failure patients. Among naive patients, the SVR rate was 42% in G1 carriers and 69% in G2 or G3 carriers. The SVR rate was 69% in naive G1 patients without fibrosis (F0; versus 44% in F1-F2 versus 31% in F3-F4; P<0.001). In naive patients, G2 or G3, low viral load (<800,000 IU/ml) and age ≤40 years were predictive factors for SVR. In treatment-failure patients, low viral load, no or low fibrosis stage (F0-F1) and no treatment modification were predictive factors of SVR.
In patients treated in a real-life setting, adherence to therapy, SVR rates, predictive factors of SVR and safety results were close to those observed in randomized trials. A high SVR in G1 naive patients with no fibrosis warrants further study and might suggest earlier treatment.
本研究旨在实际记录接受聚乙二醇化干扰素-α2a和利巴韦林治疗的丙型肝炎患者的特征、治疗情况以及治疗效果（持续病毒学应答[SVR]）。
这项观察性研究纳入了开始接受聚乙二醇化干扰素-α2a和利巴韦林治疗的丙型肝炎患者。
共纳入2066例患者，其中70%为初治患者，53%感染基因型（G）1型，38%感染G2或G3型，35%的患者Metavir评分处于F3 - F4级。总体而言，接受24周治疗的患者中有18%、接受48周治疗的患者中有39%提前终止治疗，主要原因是出现副作用。SVR率（意向性治疗人群）为39%：初治患者中为43%，治疗失败患者中为31%。在完整病例分析人群中，这一比例为49%：初治患者中为54%，治疗失败患者中为37%。在初治患者中G1型携带者的SVR率为42%，G2或G3型携带者为69%。初治G1型无纤维化（F0）患者的SVR率为69%（F1 - F2患者为44%，F3 - F4患者为31%；P<0.001）。在初治患者中，G2或G3型、低病毒载量（<800,000 IU/ml）以及年龄≤40岁是SVR的预测因素。在治疗失败患者中，低病毒载量、无或低纤维化分期（F0 - F1）以及未调整治疗方案是SVR的预测因素。
在实际临床治疗的患者中，治疗依从性、SVR率、SVR的预测因素以及安全性结果与随机试验中观察到的情况相近。G1型无纤维化初治患者的高SVR率值得进一步研究，可能提示应更早进行治疗。
