Laguno Montserrat, Cifuentes Carmen, Murillas Javier, Veloso Sergio, Larrousse Maria, Payeras Antoni, Bonet Lucia, Vidal Francese, Milinkovic Ana, Bassa Antoni, Villalonga Concha, Pérez Iñaki, Tural Cristina, Martínez-Rebollar Maria, Calvo Marta, Blanco Jose Luis, Martínez Estaban, Sánchez-Tapias Jose M, Gatell Jose M, Mallolas Jose
Infectious Diseases Service, Hospital Clínic, Barcelona, Spain.
Hepatology. 2009 Jan;49(1):22-31. doi: 10.1002/hep.22598.
Although two pegylated interferons (Peg-IFN) are available to treat chronic hepatitis C virus (HCV) infection, no head-to-head comparative studies have been published. We aim to compare the efficacy and safety of PEG IFN alfa-2b (PEG 2b) versus PEG IFN alfa-2a (PEG 2a), plus ribavirin (RBV). A prospective, randomized, multi-center, open-label clinical trial including 182 human immunodeficiency virus (HIV)-hepatitis C virus (HCV) patients naïve for HCV therapy was performed. Patients were assigned to PEG 2b (80-150 mug/week; n = 96) or PEG 2a (180 mug/week; n = 86), plus RBV (800-1200 mg/day) for 48 weeks. The primary endpoint was sustained virological response (SVR: negative HCV-RNA 24 weeks after completion of treatment). At baseline, both groups were well balanced: 73% male; 63% HCV genotype 1 or [corrected] 4; 29% had fibrosis index of 3 or greater. The overall SVR was 44% (42% PEG 2b versus 46% PEG 2a, P = 0.65). Among genotypes 1 or [corrected] 4, SVRs were 28% versus 32% (P = 0.67) and 62% versus 71% (P = 0.6) in genotypes 2 or [corrected] 3 for PEG 2b and PEG 2a, respectively. Early virological response (EVR; >or=2 log reduction from baseline or negative HCV-RNA at week 12) was 70% in the PEG 2b group and 80% in the PEG 2a group (P = 0.13), reaching a positive predictive value of SVR of 64% and a negative predictive value of 100% in both arms. Side effects were present in 96% of patients but led to treatment discontinuation in 10% of patients (8% on PEG 2b and 13% on PEG 2a, P = 0.47).
In patients with HIV, HCV therapy with PEG 2b or PEG 2a plus RBV had no significant differences in efficacy and safety.
虽然有两种聚乙二醇化干扰素（Peg-IFN）可用于治疗慢性丙型肝炎病毒（HCV）感染，但尚无直接比较的研究发表。我们旨在比较聚乙二醇干扰素α-2b（PEG 2b）与聚乙二醇干扰素α-2a（PEG 2a）联合利巴韦林（RBV）的疗效和安全性。进行了一项前瞻性、随机、多中心、开放标签的临床试验，纳入182例初治的人类免疫缺陷病毒（HIV）-丙型肝炎病毒（HCV）患者。患者被分配至PEG 2b组（80 - 150微克/周；n = 96）或PEG 2a组（180微克/周；n = 86），加用RBV（800 - 1200毫克/天），疗程48周。主要终点为持续病毒学应答（SVR：治疗结束后24周HCV-RNA阴性）。基线时，两组情况均衡：73%为男性；63%为HCV基因1型或[校正后]4型；29%的纤维化指数为3或更高。总体SVR为44%（PEG 2b组为42%，PEG 2a组为46%，P = 0.65）。在基因1型或[校正后]4型中，PEG 2b组和PEG 2a组的SVR分别为28%对32%（P = 0.67），基因2型或[校正后]3型中分别为62%对71%（P = 0.6）。早期病毒学应答（EVR；自基线下降≥2 log或第12周时HCV-RNA阴性）在PEG 2b组为70%，PEG 2a组为80%（P = 0.13），两组中SVR的阳性预测值均为64%，阴性预测值均为100%。96%的患者出现副作用，但仅10% 的患者因副作用停药（PEG 2b组为8%，PEG 2a组为13%，P = 0.47）。
对于HIV合并HCV感染患者，PEG 2b或PEG 2a联合RBV治疗在疗效和安全性方面无显著差异。
