National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.
AIDS. 2009 Mar 27;23(6):697-700. doi: 10.1097/QAD.0b013e3283262a78.
Most antiretroviral treatment program in resource-limited settings use immunologic or clinical monitoring to measure response to therapy and to decide when to change to a second-line regimen. Our objective was to evaluate immunologic failure criteria against gold standard virologic monitoring.
Observational cohort.
Participants enrolled in an antiretroviral treatment program in rural Uganda who had at least 6 months of follow-up were included in this analysis. Immunologic monitoring was performed by CD4 cell counts every 3 months during the first year, and every 6 months thereafter. HIV-1 viral loads were performed every 6 months.
A total of 1133 participants enrolled in the Rakai Health Sciences Program antiretroviral treatment program between June 2004 and September 2007 were followed for up to 44.4 months (median follow-up 20.2 months; IQR 12.4-29.5 months). WHO immunologic failure criteria were reached by 125 (11.0%) participants. A virologic failure endpoint defined as HIV-1 viral load more than 400 copies/ml on two measurements was reached by 112 participants (9.9%). Only 26 participants (2.3%) experienced both an immunologic and virologic failure endpoint (2 viral load > 400 copies/ml) during follow-up.
Immunologic failure criteria performed poorly in our setting and would have resulted in a substantial proportion of participants with suppressed HIV-1 viral load being switched unnecessarily. These criteria also lacked sensitivity to identify participants failing virologically. Periodic viral load measurements may be a better marker for treatment failure in our setting.
大多数资源有限环境下的抗逆转录病毒治疗方案都使用免疫学或临床监测来衡量治疗反应，并决定何时改用二线治疗方案。我们的目的是评估免疫学失败标准与病毒学监测的金标准相对照的情况。
观察性队列研究。
本分析纳入了在乌干达农村参加抗逆转录病毒治疗项目、至少有 6 个月随访的参与者。免疫监测在第一年每 3 个月进行一次 CD4 细胞计数，此后每 6 个月进行一次。每 6 个月进行一次 HIV-1 病毒载量检测。
2004 年 6 月至 2007 年 9 月期间，共有 1133 名参与者参加了 Rakai 健康科学项目抗逆转录病毒治疗项目，随访时间最长达 44.4 个月（中位数随访时间 20.2 个月；IQR 12.4-29.5 个月）。125 名（11.0%）参与者达到了世卫组织免疫学失败标准。112 名（9.9%）参与者达到了 HIV-1 病毒载量两次测量超过 400 拷贝/ml 的病毒学失败终点。在随访期间，只有 26 名参与者（2.3%）同时经历了免疫学和病毒学失败终点（2 次病毒载量>400 拷贝/ml）。
在我们的研究环境中，免疫学失败标准表现不佳，会导致很大一部分 HIV-1 病毒载量得到抑制的参与者不必要地被转换治疗方案。这些标准也缺乏敏感性来识别病毒学失败的参与者。定期进行病毒载量测量可能是我们研究环境中治疗失败的更好标志物。
