Younossi Z M, Mullen K D, Zakko W, Hodnick S, Brand E, Barnes D S, Carey W D, McCullough A C, Easley K, Boparai N, Gramlich T
Department of Gastroenterology, Biostatistics and Anatomic Pathology, the Cleveland Clinic Foundation, OH, USA.
J Hepatol. 2001 Jan;34(1):128-33. doi: 10.1016/s0168-8278(00)00003-9.
BACKGROUND/AIMS: Interferon-based regimens (alone or with ribavairin) are standard therapies for chronic hepatitis C. The aim of this study was to compare a 24-week regimen of interferon alpha-2b + ribavirin (IFN + RIBA) to interferon alpha-2b + amantadine (IFN + AMANT) in non-responders to previous interferon monotherapy.
In a multi-center, double-blind clinical trial, 118 patients (non-responders to previous interferon monotherapy) were equally randomized into the two arms: interferon alpha-2b (3 MU thrice weekly) and ribavirin (800 mg daily) vs. interferon alpha-2b (3 MU thrice weekly) and amantadine (200 mg daily).
After 24 weeks of therapy, HCV RNA became undetectable in 34.8% (95% CI: 23.7-49.2) of IFN + RIBA and 19.6% (95% CI: 10.6-34.7) of IFN + AMANT (P = 0.10). This response was sustained in 3.9% (95% CI: 1.0-14.9) of IFN + RIBA and 0% of IFN + AMANT (P = 0.16). Ten patients from IFN + AMANT (17%) and 12 patients (20%) from IFN + RIBA were discontinued before completion of therapy. Of these, 7% in IFN + AMANT and 12% in IFN + RIBA were discontinued due to adverse effects.
Re-treatment of interferon non-responders with a 24-week course of IFN + AMANT was not associated with any sustained viral eradication. Although IFN + RIBA in this group was associated with a reasonable end of treatment response, relapses were common and sustained responses were low.
背景/目的：基于干扰素的治疗方案（单独使用或联合利巴韦林）是慢性丙型肝炎的标准疗法。本研究的目的是比较干扰素α-2b + 利巴韦林（IFN + RIBA）的24周治疗方案与干扰素α-2b + 金刚烷胺（IFN + AMANT）在既往干扰素单药治疗无应答者中的疗效。
在一项多中心、双盲临床试验中，118例患者（既往干扰素单药治疗无应答者）被平均随机分为两组：干扰素α-2b（3 MU，每周三次）联合利巴韦林（每日800 mg）与干扰素α-2b（3 MU，每周三次）联合金刚烷胺（每日200 mg）。
治疗24周后，IFN + RIBA组34.8%（95% CI：23.7 - 49.2）的患者HCV RNA检测不到，IFN + AMANT组为19.6%（95% CI：10.6 - 34.7）（P = 0.10）。IFN + RIBA组3.9%（95% CI：1.0 - 14.9）的患者此应答得以维持，IFN + AMANT组为0%（P = 0.16）。IFN + AMANT组有10例患者（17%）和IFN + RIBA组有12例患者（20%）在治疗完成前停药。其中，IFN + AMANT组7%和IFN + RIBA组12%的患者因不良反应停药。
对干扰素无应答者采用24周疗程的IFN + AMANT再治疗未实现任何持续性病毒清除。尽管该组中的IFN + RIBA与合理的治疗结束时应答相关，但复发常见且持续性应答率低。
