Pilot study of a novel short-cycle antiretroviral treatment interruption strategy: 48-week results of the five-days-on, two-days-off (FOTO) study
Pilot study of a novel short-cycle antiretroviral treatment interruption strategy: 48-week results of the five-days-on, two-days-off (FOTO) study
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DOI：
10.1310/hct0801-19
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发表时间：
2007-01-01
影响因子：
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通讯作者：
Morse, Gene D.
中科院分区：
文献类型：
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作者：
Cohen, Calvin J.;Colson, Amy E.;Morse, Gene D.
目的：与每日终生抗逆转录病毒治疗(ART)相关的挑战激发了人们对替代治疗计划的兴趣，包括对病毒学抑制和足够的CD4(+)T细胞计数的患者进行有计划的周期性中断治疗。方法：我们对一种新的短周期治疗中断策略进行了为期48周的开放标签、单臂、前瞻性先导性研究。在登记后，30名有持续病毒抑制史的HIV+患者每天接受抗逆转录病毒治疗，将他们的每周治疗计划改为连续治疗5天(通常是周一至周五)，然后休息2天(5次开启、2次关闭或FOTO治疗时间表)。结果：在24周和48周时，AS处理分析显示，26/29名受试者(89.6%)保持了病毒学抑制，其中100%的受试者服用了以依法韦仑为基础的方案。参与者很好地遵守了FOTO治疗计划，并表示与每日ART治疗方案相比，FOTO治疗方案更倾向于FOTO治疗方案。结论：如果得到验证，采用以efavirenz为基础的方案的FOTO治疗策略可以避免在较长周期的结构化治疗中断中出现的病毒血症，但仍可改善与目前治疗HIV感染的日常ART方案相关的许多问题，包括治疗成本高和在许多患者中导致不稳定坚持并最终治疗失败的服药疲劳。
Purpose: The challenges associated with daily lifelong antiretroviral therapy (ART) have stimulated interest in alternative treatment schedules, including planned, cyclical interruptions of therapy in patients with virologic suppression and sufficient CD4(+) T-cell counts. Method: We conducted a 48-week, open-label, single-arm, prospective pilot study of a novel short-cycle treatment interruption strategy. Upon enrollment, 30 HIV+ individuals with a history of durable viral suppression on daily ART changed their weekly treatment schedule to 5 consecutive days on treatment (typically Monday through Friday) followed by 2 days off treatment (five-on, two-off, or FOTO treatment schedule). Results: At 24 and 48 weeks, as-treated analysis revealed that virologic suppression was maintained in 26/29 subjects (89.6%), including 100% of subjects taking efavirenz-based regimens. Participants adhered well to the FOTO treatment schedule and expressed a strong preference for the FOTO treatment schedule compared to daily ART Conclusion: If validated, the FOTO treatment strategy with efavirenz-based regimens could avoid the viremia witnessed in longer cycle structured treatment interruptions yet still ameliorate a number of problems associated with the current paradigm of daily ART for HIV infection, including the high cost of therapy and the pill fatigue that, in many patients, leads to erratic adherence and ultimately treatment failure.