...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Journal of Medical Virology >Assessing risk of a short-term antiretroviral therapy discontinuation as a read-out of viral control in immune-based therapy
【24h】

Assessing risk of a short-term antiretroviral therapy discontinuation as a read-out of viral control in immune-based therapy

机译：评估短期抗逆转录病毒疗法停药的风险，以此作为基于免疫的疗法中病毒控制的一项宣读

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Although analytical treatment interruption is used as a strategy to test immunotherapeutic agents in HIV-infection, it may pose a risk for study participants. The potential risks of short-term interruption of antiretroviral therapy (ART) during treatment with an autologous dendritic cell immune-based therapy (AGS-004-001) were assessed using data from a subgroup of subjects in the strategies for management of antiretroviral therapy (SMART) study with matched eligibility criteria. A retrospective subgroup analysis of the SMART study population using the eligibility criteria and treatment stopping rules of AGS-004-001 study was analyzed. Key inclusion criteria for AGS-004-001 study were applied to the data collected from participants of the SMART study. There were 440 of 2,720 on the drug conservation arm and 436 of 2,752 on the viral suppression arm that matched the AGS-004-001 inclusion criteria and were used in the SMART subgroup analysis. In the first 16 weeks following randomization into the SMART study there were no deaths in either subgroup. There were two AIDS-related events in the drug conservation subgroup and one in the viral suppression subgroup, making the overall risk of AIDS-related events 2 per 100 person years (0.005%) and 1 per 100 person years (0.002%) in the two subgroups, respectively. There were 6/440 subjects (1.4%) in the drug conservation subgroup and 4/436 subjects (0.92%) in the viral suppression subgroup who experienced Grade 2 adverse events. These results demonstrated that analytical treatment interruption within the context of highly selective, closely monitored studies assessing the antiviral activity of immune-based agents should be an acceptable strategy for at least 16 weeks.
机译：尽管分析性治疗中断被用作测试HIV感染中免疫治疗剂的策略，但可能会对研究参与者构成风险。在抗逆转录病毒疗法管理策略中，使用亚组的数据评估了自体基于树突状细胞免疫的疗法（AGS-004-001）治疗期间短期中断抗逆转录病毒疗法（ART）的潜在风险。符合资格标准的SMART研究。使用AGS-004-001研究的入选标准和治疗终止规则，对SMART研究人群进行回顾性亚组分析。 AGS-004-001研究的关键纳入标准适用于从SMART研究参与者收集的数据。符合AGS-004-001纳入标准并用于SMART亚组分析的药物保护分支中有440个，即2,720个，病毒抑制分支中的2,752个，有436个。随机分为SMART研究的前16周，两个亚组均无死亡。药物保存亚组中有2个与艾滋病相关的事件，而病毒抑制组中有1个，使得与艾滋病相关的事件的总风险在每100人年2次（0.005％）和每100人年1次（0.002％）。两个子组。药物保护亚组中有6/440名受试者（1.4％），病毒抑制亚组中有4/436名受试者（0.92％）经历了2级不良事件。这些结果表明，在高度选择性，密切监测的研究中评估分析基于免疫的药物的抗病毒活性的情况下，中断分析治疗应为至少16周的可接受策略。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号