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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
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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治疗中断作为免疫疗法中病毒对照的读出的风险

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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：虽然分析治疗中断被用作艾滋病毒感染中的免疫治疗剂的策略，但它可能对研究参与者带来风险。使用来自抗逆转录病毒治疗策略的策略（ SMART）与匹配的资格标准进行研究。分析了利用AGS-004-001研究的资格标准和治疗停止规则的智能研究人口对智能研究人口的回顾性亚组分析。 AGS-004-001研究的关键纳入标准应用于智能研究的参与者收集的数据。药物保护臂440中有4,720个，病毒抑制臂436含量为AGS-004-001夹杂项标准，并用于智能亚组分析。在随机化后的前16周进入智能研究，亚组中没有死亡。药物保护亚组中有两种艾滋病相关事件，其中一个在病毒抑制亚组中，使艾滋病相关事件的总体风险为每100人（0.005％）和每100人（0.002％）两个子组分别。在药物保护亚组和4/436受试者中有6/440名受试者（1.4％）在病毒抑制亚组中经历2年级不良事件。这些结果表明，评估免疫基因的抗病毒活性的高度选择性，密切监测研究中的分析治疗中断应该是至少16周的可接受的策略。

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