Interferon-alpha therapy for hepatitis C virus infection after liver transplantation.
Interferon-alpha therapy for hepatitis C virus infection after liver transplantation.
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干扰素α治疗肝移植后丙型肝炎病毒感染。
DOI：
10.1002/hep.1840200402
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发表时间：
1994
期刊：
影响因子：
--
通讯作者：
Urdea,M
中科院分区：
文献类型：
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作者：
Wright,TL;Combs,C;Kim,M;Ferrell,L;Bacchetti,P;Ascher,N;Roberts,J;Wilber,J;Sheridan,P;Urdea,M
这项初步研究的目的是评估干扰素-α 2b治疗肝移植受者丙型肝炎病毒感染的安全性和有效性，监测治疗过程中丙型肝炎病毒RNA水平的变化，并确定预测完全缓解的预处理参数。18例有丙型肝炎病毒血症和肝移植后肝炎组织学证据的患者接受300万单位α干扰素治疗，每周3次，至少4个月。治疗前血清转氨酶水平至少为正常上限的1.5倍，无患者合并B型肝炎病毒感染。对治疗的反应定义为治疗结束时天冬氨酸和丙氨酸转氨酶的正常化。5例患者（28%）完全缓解，而13例（72%）一种或两种转氨酶持续升高（无应答者）。在治疗结束时，应答者和无应答者中的丙型肝炎病毒RNA水平均降低（通过Wilcoxon符号秩检验，分别为p= 0.043和0.039）。停止治疗后，转氨酶保持正常的五个应答者中的四个，但血清丙型肝炎病毒RNA水平恢复到治疗前水平的应答者和无应答者。治疗后组织学评分无显著变化。应答者比无应答者更可能具有低治疗前丙型肝炎病毒RNA水平和低血清胆红素（分别为p= 0.0004和0.0077）。应答者倾向于在移植和开始治疗之间具有延长的间隔（通过秩逻辑回归分析，p= 0.10）。副作用导致两名患者提前停止治疗，六名患者减少剂量。在1例患者中观察到可能的排斥反应的组织学证据。我们的结论是，肝酶正常化，可以看到在移植后丙型肝炎病毒感染的干扰素治疗的患者，治疗与丙型肝炎病毒RNA水平下降，无论生化反应。然而，病毒学变化是短暂的。治疗前变量，如丙型肝炎病毒RNA水平和血清胆红素可能有助于选择更可能对治疗有反应的患者和设计未来的对照临床试验。（Hepatology 1994; 20：773-779）。
The aims of this pilot study were to evaluate the safety and efficacy of interferon–α 2b for treatment of hepatitis C virus infection in liver transplant recipients, to monitor changes in hepatitis C virus RNA levels with treatment and to determine pretreatment parameters predictive of a complete response. Eighteen patients with documented hepatitis C virus viremia and histological evidence of hepatitis after liver transplantation received 3 million units of α interferon three times weekly for at least 4 mo. Pretreatment serum aminotransferase levels were at least 1.5 times the upper limit of normal and no patient had concomitant hepatitis B virus infection. Response to therapy was defined as normalization of both aspartate and alanine aminotransferase at the end of treatment. Five patients (28%) had a complete response, whereas 13 (72%) had persistent elevation of one or both aminotransferases (nonresponders). At the end of therapy, hepatitis C virus RNA levels were reduced in both responders and nonresponders (p= 0.043 and 0.039, respectively by Wilcoxon signed rank test). After cessation of treatment, aminotransferases remained normal in four of five responders but serum hepatitis C virus RNA levels returned to pretreatment levels in responders and nonresponders. There was no significant change in histological score with therapy. Responders were more likely than nonresponders to have low pretreatment hepatitis C virus RNA levels and low serum bilirubin (p= 0.0004 and 0.0077, respectively). Responders tended to have a prolonged interval between transplantation and initiation of therapy (p= 0.10 by rank logistic regression analysis). Side effects resulted in early cessation of therapy in two patients and dose reduction in six. Histological evidence of possible rejection was seen in one patient. We conclude that normalization of liver enzymes can be seen in patients with posttransplant hepatitis C virus infection on interferon therapy and that treatment is associated with fall in hepatitis C virus RNA levels, regardless of biochemical response. However, virological changes are transient. Pretreatment variables such as hepatitis C virus RNA levels and serum bilirubin may aid in the selection of patients more likely to respond to therapy and the design of future controlled clinical trials.(Hepatology 1994; 20: 773-779).