Benini Federica, Distefano Luciana, Baisini Ornella, Pigozzi Marie Graciella, Lanzini Alberto
Department of Internal Medicine, Spedali Civili and Medical School, Brescia, Italy.
Curr Ther Res Clin Exp. 2003 Mar;64(3):140-50. doi: 10.1016/S0011-393X(03)00024-9.
In chronic hepatitis C virus (HCV) infection, interferon (IFN) monotherapy usually is carried out at doses of 3 to 6 million units (MU) 3 times per week, but treatment efficacy is low.
The aim of our study was to assess the efficacy and tolerability of IFN-alfa2b in combination with ribavirin in relapsers and nonresponders to high-dose IFN treatment (5 to 6 MU 3 times per week). We measured the biochemical and virologic responses to treatment and the risk for relapse during the 24 weeks following the end of treatment.
Patients with chronic HCV infection (relapsers and nonresponders to a previous treatment with high-dose IFN) received IFN-alfa2b, 3 MU 3 times per week, and ribavirin, 1000 or 1200 mg/d for 24 or 48 weeks. The patients were then followed up for an additional 24 weeks. Sustained response was defined as normal serum alanine aminotransferase (ALT) level and undetectable HCV RNA 24 weeks after treatment was stopped.
Forty-three patients (32 men, 11 women; mean [SD] age, 45 [2] years; 10 relapsers, 33 nonresponders) were included in the study. Four patients were withdrawn from the study at week 4 of treatment because of treatment-related adverse events, and 1 dropped out. At the end of the treatment period, normalization of serum ALT levels and undetectable HCV RNA levels were seen in 58.1% and 30.2% of patients, respectively. No significant difference in virologic response at the end of treatment was found between nonresponders (10/33 [30.3%]) to previous IFN therapy and relapsers (3/10 [30.0%]). At the end of follow-up, 3 (7.0%) treated patients had sustained response (2 nonresponders to the first IFN course and 1 relapser). All of the patients with sustained response were treated for 24 weeks.
Based on the results of our study, combination therapy with IFN-alfa and ribavirin may be of value in a limited number of patients with chronic HCV infection who do not respond to, or relapse after, a first course of treatment with high-dose IFN monotherapy.
在慢性丙型肝炎病毒（HCV）感染中，干扰素（IFN）单药治疗通常以每周3次、每次300万至600万单位（MU）的剂量进行，但治疗效果较低。
我们研究的目的是评估α-干扰素2b联合利巴韦林对高剂量IFN治疗（每周3次、每次500万至600万MU）的复发者和无反应者的疗效和耐受性。我们测量了治疗的生化和病毒学反应以及治疗结束后24周内的复发风险。
慢性HCV感染患者（复发者和既往高剂量IFN治疗的无反应者）接受α-干扰素2b，每周3次、每次300万MU，以及利巴韦林，1000或1200mg/d，持续24或48周。然后对患者进行另外24周的随访。持续应答定义为治疗停止后24周血清丙氨酸氨基转移酶（ALT）水平正常且HCV RNA检测不到。
43例患者（32例男性，11例女性；平均[标准差]年龄，45[2]岁；10例复发者，33例无反应者）纳入研究。4例患者因治疗相关不良事件在治疗第4周退出研究，1例退出。在治疗期结束时，分别有58.1%和30.2%的患者血清ALT水平正常且HCV RNA水平检测不到。既往IFN治疗的无反应者（10/33[30.3%]）和复发者（3/10[30.0%]）在治疗结束时的病毒学反应无显著差异。在随访结束时，3例（7.0%）接受治疗的患者有持续应答（2例对第一个IFN疗程无反应者和1例复发者）。所有有持续应答的患者均接受了24周治疗。
根据我们的研究结果，α-干扰素和利巴韦林联合治疗可能对有限数量的慢性HCV感染患者有价值，这些患者对高剂量IFN单药治疗的第一个疗程无反应或复发。
