Peginterferon alfa-2a for hepatitis C after liver transplantation: Two randomized, controlled trials
Peginterferon alfa-2a for hepatitis C after liver transplantation: Two randomized, controlled trials
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DOI：
10.1002/hep.20560
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发表时间：
2005-02-01
期刊：
影响因子：
13.5
通讯作者：
Lopez-Talavera, JC
中科院分区：
文献类型：
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作者：
Chalasani, N;Manzarbeitia, C;Lopez-Talavera, JC
目前对于原位肝移植（OLT）后复发性丙型肝炎尚无有效治疗方法。因此，我们进行了两项随机对照试验（一项预防试验和一项治疗试验），以评估聚乙二醇干扰素 alfa-2a 对接受过 OLT 的患者的安全性和有效性。预防试验招募了 OLT 后 3 周内的 54 名患者，治疗试验招募了 OLT 后 6 至 60 个月的 67 名患者。在每项试验中，患者被随机分配接受每周注射一次 180 壶聚乙二醇干扰素 alfa-2a 的治疗或 48 周内不接受抗病毒治疗，并随后随访 24 周。与未经治疗的对照组相比，聚乙二醇干扰素α-2a治疗的患者丙型肝炎病毒RNA水平显着降低，肝脏组织学特征发生更有利的变化。然而，预防试验中只有 2 名接受治疗的患者 (8%) 和治疗试验中只有 3 名接受治疗的患者 (12%) 达到了持续的病毒学应答。在预防试验中，聚乙二醇干扰素α-2a组中有8名患者（31%）和未治疗组中有9名患者（32%）提前退出；而在治疗试验中，聚乙二醇干扰素α-2a组中有10名患者（30%）和未治疗组中有6名患者（19%）提前退出。在预防（12% vs. 21%；P = .5）和治疗（12% vs. 0%；P = .1）试验中，治疗组和未治疗组的急性排斥反应发生率相似。总之，聚乙二醇干扰素 alfa-2a 治疗 48 周是安全且可耐受的，并且在 OLT 后具有一定疗效。需要进行随机对照研究来确定聚乙二醇干扰素和利巴韦林对接受 OLT 的患者的疗效。
There is currently no effective treatment for recurrent hepatitis C after orthotopic liver transplantation (OLT). We therefore performed two randomized, controlled trials-a prophylaxis trial and a treatment trial-to evaluate the safety and efficacy of peginterferon alfa-2a in patients who had undergone OLT. The prophylaxis trial enrolled 54 patients within 3 weeks after OLT, and the treatment trial enrolled 67 patients 6 to 60 months after OLT. In each trial, patients were randomized to treatment with once weekly injections of 180 jug peginterferon alfa-2a or no antiviral treatment for 48 weeks and were followed up for 24 weeks thereafter. Peginterferon alfa-2a treated patients had significantly lower hepatitis C virus RNA levels and more favorable changes in hepatic histological features compared with untreated controls. However, only 2 treated patients in the prophylaxis trial (8%) and 3 in the treatment trial (12%) achieved a sustained virological response. In the prophylaxis trial, 8 patients (31%) in the peginterferon alfa-2a group and 9 (32%) in the untreated group were withdrawn prematurely; whereas in the treatment trial, 10 patients (30%) in the peginterferon alfa-2a group and 6 (19%) in the untreated group were withdrawn prematurely. The incidence of acute rejection was similar in the treated and untreated groups in both the prophylaxis (12% vs. 21%; P = .5) and treatment (12% vs. 0%; P = .1) trials. In conclusion, peginterferon alfa-2a treatment for 48 weeks is safe and tolerable and offers some efficacy in the post-OLT setting. Randomized controlled studies are needed to establish the efficacy of pegylated interferon and ribavirin in patients who have undergone OLT.