Di Marco V, Almasio P, Vaccaro A, Ferraro D, Parisi P, Cataldo M G, Di Stefano R, Craxì A
Cattedra di Medicina Interna, Istituto di Clinica Medica B, University of Palermo, Italy.
J Hepatol. 2000 Sep;33(3):456-62. doi: 10.1016/s0168-8278(00)80282-2.
BACKGROUND/AIMS: Retreatment of relapses of chronic hepatitis C with a standard regimen of interferon plus ribavirin for 6 months obtains a sustained response in a minority of patients with high viraemia and genotype 1b. We aimed to assess whether increasing the interferon dose and prolonging the time of combined treatment may enhance the effectiveness, and also to evaluate the tolerability, and to identify the determinants of sustained response.
Fifty subjects with chronic hepatitis C who had relapsed after one or more courses of a-interferon monotherapy were randomised to receive alpha2b interferon (6 MU tiw) plus ribavirin (1000-1200 mg daily) for 6 or 12 months. ALT normalisation and serum HCV-RNA clearance at the end of treatment and 6 months after stopping therapy were used as markers for sustained response.
End-of-treatment response was achieved in 48 patients (96%) and 27 (54%) had a complete sustained response. Patients treated for 12 months had a higher rate of sustained response (18/25, 72%; 95% C.I. 0.54-0.89) than those treated for 6 months (9/25, 36%; 95% C.I. 0.17-0.55, p=0.01). Twelve months of therapy was significantly more effective for patients with genotype 1b and baseline serum HCV-RNA greater than 450 000 copies/ml (p=0.005). Seven subjects (14%) discontinued treatment because of side effects. Logistic regression analysis showed 12 months of therapy, young age and low pre-treatment serum HCV-RNA to be independent predictors of sustained response.
Relapsers with genotype 1b and high levels of HCV-RNA will benefit from a 12-month course of 6 MU tiw interferon plus ribavirin, while subjects with genotype 1b and low levels of serum HCV-RNA or with genotype other than 1b may be treated for 6 months.
背景/目的：对于慢性丙型肝炎复发患者，采用标准的干扰素联合利巴韦林方案进行6个月的再治疗，仅少数高病毒血症且基因型为1b的患者能获得持续应答。我们旨在评估增加干扰素剂量并延长联合治疗时间是否可提高疗效，同时评估耐受性，并确定持续应答的决定因素。
50例接受过一个或多个疗程α干扰素单药治疗后复发的慢性丙型肝炎患者，被随机分为接受α2b干扰素（6MU，每周3次）联合利巴韦林（每日1000 - 1200mg）治疗6个月或12个月。以治疗结束时及停药后6个月的ALT正常化和血清HCV - RNA清除作为持续应答的指标。
48例患者（96%）获得治疗结束时应答，27例（54%）有完全持续应答。接受12个月治疗的患者持续应答率（18/25，72%；95%可信区间0.54 - 0.89）高于接受6个月治疗的患者（9/25，3.%；95%可信区间0.17 - 0.55，p = 0.01）。对于基因型为1b且基线血清HCV - RNA大于450 000拷贝/ml的患者，12个月的治疗显著更有效（p = 0.005）。7例患者（14%）因副作用停药。逻辑回归分析显示，12个月的治疗、年轻及治疗前血清HCV - RNA水平低是持续应答的独立预测因素。
基因型为1b且HCV - RNA水平高的复发患者将从6MU每周3次干扰素联合利巴韦林治疗12个月的疗程中获益，而基因型为1b且血清HCV - RNA水平低或基因型非1b的患者可治疗6个月。
