Nair Satheesh, Lipscomb Jeannie, Eason James
Division of Gastroenterology and Hepatology, Ochsner Clinic Foundation, New Orleans, LA, USA.
Transplantation. 2008 Aug 15;86(3):418-22. doi: 10.1097/TP.0b013e31817c1543.
In this article, we explore the virological response to two types of interferon based treatment in recurrent hepatitis C virus in liver recipients who received thymoglobulin induction.
Fifty consecutive patients were randomized to receive PEG interferon alpha 2b (1.0 microg/kg per week), ribavirin (800 mg/d) plus amantadine (200 mg/d), or PEG interferon alpha 2b (1.0 microg/kg per week) plus ribavirin (800 mg/d). The primary endpoint was absence of hepatitis C virus RNA 6 months posttreatment. The secondary endpoint was change in fibrosis at 1 year.
Only 30 patients completed 1 year of treatment. In an intention to treat analysis, the sustained virological response (SVR) rate was 26% in I/R/A group and 50% in I/R group. By per protocol, the overall SVR rate was 57%. Fibrosis progression by at least one stage was noted in 37% patients. Twenty-nine percent of patients who achieved SVR had shown fibrosis progression by at least one stage whereas 46% nonresponders showed fibrosis progression (P=NS).
This is the first study exploring the efficacy of pegylated interferon-based antiviral treatment in patients who received a steroid-free protocol. Our data is encouraging and shows that if liver transplant recipients can tolerate treatment for 1 year there is a reasonable chance of SVR.
在本文中,我们探讨了在接受胸腺球蛋白诱导治疗的肝移植受者中,两种基于干扰素的治疗方法对复发性丙型肝炎病毒的病毒学反应。
连续50例患者被随机分为接受聚乙二醇干扰素α-2b(每周1.0μg/kg)、利巴韦林(800mg/d)加金刚烷胺(200mg/d),或聚乙二醇干扰素α-2b(每周1.0μg/kg)加利巴韦林(800mg/d)。主要终点是治疗后6个月丙型肝炎病毒RNA检测不到。次要终点是1年后纤维化的变化。
只有30例患者完成了1年的治疗。在意向性分析中,I/R/A组的持续病毒学应答(SVR)率为26%,I/R组为50%。根据方案分析,总体SVR率为57%。37%的患者出现至少一个阶段的纤维化进展。达到SVR的患者中有29%显示至少一个阶段的纤维化进展,而无应答者中有46%显示纤维化进展(P=无统计学意义)。
这是第一项探讨基于聚乙二醇干扰素的抗病毒治疗在接受无类固醇方案患者中的疗效的研究。我们的数据令人鼓舞,表明如果肝移植受者能够耐受1年的治疗,就有合理的机会实现SVR。