Evolution of the HALT-C trial: pegylated interferon as maintenance therapy for chronic hepatitis C in previous interferon nonresponders
Evolution of the HALT-C trial: pegylated interferon as maintenance therapy for chronic hepatitis C in previous interferon nonresponders
复制标题
DOI：
10.1016/j.cct.2004.08.003
复制
发表时间：
2004-10-01
期刊：
影响因子：
--
通讯作者：
Everhart, JE
中科院分区：
文献类型：
--
作者：
Lee, WM;Dienstag, JL;Everhart, JE
丙型肝炎抗病毒长期治疗肝硬化（HALT-C）试验旨在确定维持干扰素治疗是否可以减缓在先前干扰素治疗期间未能根除丙型肝炎病毒（HCV）的患者（无反应）的疾病进展。选择了十个临床站点、一个病毒学检测中心和一个数据协调中心（DCC）合作设计和实施最终方案。符合条件的患者先前已接受干扰素治疗至少12周，联合或不联合另一种抗病毒药物利巴韦林，但仍有持续性病毒血症。由于患者之前接受过各种治疗，并且作为入组的一项益处，我们将长效聚乙二醇化干扰素α -2a加利巴韦林的先导期纳入研究设计，该组合被认为更有效，但在试验开始时未获得食品和药物管理局的批准。如果患者在这种引入治疗20周后未能从血液中清除病毒，他们将在第24周进入主要试验，并随机接受低剂量的聚乙二醇化干扰素每周单独治疗或在另外的3年半内不接受进一步治疗。最初的方案后来在三个方面进行了修改，以改善入组情况，并适应美国食品和药物管理局对引入疗法的批准，包括允许患者在完成类似引入疗法的治疗后直接进入研究的随机部分。该方案在坚持研究的原始目标及其完整性的同时，提高了入组率。(C) 2004爱思唯尔公司版权所有。
The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial was designed to determine whether maintenance interferon therapy could slow disease progression in patients who had failed to eradicate hepatitis C virus (HCV) during prior interferon treatment (nonresponders). Ten clinical sites, a virological testing center, and a data coordinating center (DCC) were selected to collaborate in the design and implementation of the final protocol. Eligible patients had been treated previously with interferon for at least 12 weeks, with or without another antiviral, ribavirin, but still had persistent viremia. Because patients had received a variety of prior treatments, and as a perceived benefit of enrollment, we incorporated a Lead-in period of treatment with long-acting pegylated interferon alfa-2a plus ribavirin into the study design, a combination believed to be more effective but not approved by the Food and Drug Administration at the Trial's inception. If patients failed to achieve clearance of virus from the blood after 20 weeks of this Lead-in therapy, they were entered into the main trial at week 24 and randomized to receive either a lower dose of pegylated interferon weekly alone or no further therapy for an additional 3 1/2 years. The original protocol was amended later in three respects to improve enrollment and to adapt to Food and Drug Administration approval of the Lead-in therapy, including allowing patients to proceed directly to the randomized part of the study if treatment resembling the Lead-in had been completed. The protocol changes enhanced enrollment while upholding the original goals of the study and its integrity. (C) 2004 Elsevier Inc. All rights reserved.