Interferon-α 2b plus ribavirin in patients with chronic hepatitis C after liver transplantation:: A randomized study
Interferon-α 2b plus ribavirin in patients with chronic hepatitis C after liver transplantation:: A randomized study
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DOI：
10.1053/gast.2003.50095
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发表时间：
2003-03-01
期刊：
影响因子：
29.4
通讯作者：
Trepo, C
中科院分区：
文献类型：
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作者：
Samuel, D;Bizollon, T;Trepo, C
背景与目的：肝移植术后丙型肝炎病毒（HCV）再感染是一种常见的并发症，可导致慢性肝炎和肝硬化。在这种情况下使用抗病毒治疗仍然存在争议。本研究旨在评估干扰素α-2b联合利巴韦林治疗肝移植术后复发性丙型肝炎的安全性和有效性。研究方法：复发性慢性丙型肝炎的移植受者被随机分为两组，一组不接受治疗，另一组接受干扰素α-2b（3 MU，每周3次）加1000-1200 mg/天利巴韦林治疗1年。治疗结束后随访6个月。主要终点是治疗结束后6个月HCV RNA的丢失。结果：52例患者被随机分组（治疗组，28例;安慰剂组，24例）。16例患者退出研究; 12例（43%）来自治疗组（主要是贫血[7例患者]），4例（17%）来自对照组。在治疗组中，9例患者（32%）在治疗结束时和6例患者（21.4%）在随访期结束时血清HCV RNA检测不到，而对照组中没有患者在任何时间点丢失HCV RNA（P = 0.036在随访结束时）。然而，没有显著的组织学改善。结论：干扰素α-2b联合利巴韦林在21%的复发性丙型肝炎移植受者中诱导了持续的病毒学应答。然而，43%的患者因不良事件（主要是严重贫血）而停止治疗。需要探索使用低剂量利巴韦林进行治疗的策略。
Background & Aims: Hepatitis C virus (HCV) reinfection after liver transplantation is frequent and leads to chronic hepatitis and cirrhosis. The use of antiviral therapy in this situation remains controversial. This study aimed to assess the safety and efficacy of interferon alfa-2b plus ribavirin for recurrent hepatitis C following liver transplantation. Methods: Transplant recipients with recurrent chronic hepatitis C were randomized to receive either no treatment or therapy with interferon alfa-2b (3 MU 3 times a week) plus 1000-1200 mg/day ribavirin for 1 year. Patients were followed up for 6 months after the end of treatment. The primary end point was loss of HCV RNA 6 months after the end of treatment. Results: Fifty-two patients were randomized (treatment, 28; placebo, 24). Sixteen patients were withdrawn from the study; 12 (43%) were from the treated group (mainly for anemia [7 patients]) and 4 (17%) from the control group. In the treated group, serum HCV RNA was undetectable in 9 patients (32%) at the end of treatment and 6 (21.4%) at the end of the follow-up period, whereas no patient in the control group lost HCV RNA at any point (P = 0.036 at the end of follow-up). However, there was no significant histologic improvement. Conclusions: The combination of interferon alfa-2b plus ribavirin induced a sustained virologic response in 21% of transplant recipients with recurrent hepatitis C. However, 43% discontinued therapy due to adverse events (primarily severe anemia). Strategies to enable treatment with lower doses of ribavirin need to be explored.