Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom.
PLoS One. 2012;7(5):e36997. doi: 10.1371/journal.pone.0036997. Epub 2012 May 29.
As antiretroviral treatment (ART) programmes in resource-limited settings mature, more patients are experiencing virological failure. Without resistance testing, deciding who should switch to second-line ART can be difficult. The consequences for second-line outcomes are unclear. In a workplace- and community-based multi-site programme, with 6-monthly virological monitoring, we describe outcomes and predictors of viral suppression on second-line, protease inhibitor-based ART.
We used prospectively collected clinic data from patients commencing first-line ART between 1/1/03 and 31/12/08 to construct a study cohort of patients switched to second-line ART in the presence of a viral load (VL) ≥ 400 copies/ml. Predictors of VL<400 copies/ml within 15 months of switch were assessed using modified Poisson regression to estimate risk ratios.
205 workplace patients (91.7% male; median age 43 yrs) and 212 community patients (38.7% male; median age 36 yrs) switched regimens. At switch compared to community patients, workplace patients had a longer duration of viraemia, higher VL, lower CD4 count, and higher reported non-adherence on first-line ART. Non-adherence was the reported reason for switching in a higher proportion of workplace patients. Following switch, 48.3% (workplace) and 72.0% (community) achieved VL<400, with non-adherence (17.9% vs. 1.4%) and virological rebound (35.6% vs. 13.2% with available measures) reported more commonly in the workplace programme. In adjusted analysis of the workplace programme, lower switch VL and younger age were associated with VL<400. In the community programme, shorter duration of viraemia, higher CD4 count and transfers into programme on ART were associated with VL<400.
High levels of viral suppression on second-line ART can be, but are not always, achieved in multi-site treatment programmes with both individual- and programme-level factors influencing outcomes. Strategies to support both healthcare workers and patients during this switch period need to be evaluated; sub-optimal adherence, particularly in the workplace programme must be addressed.
随着资源有限环境中的抗逆转录病毒治疗(ART)项目的成熟,越来越多的患者出现病毒学失败。如果没有耐药性检测,确定谁应该切换到二线 ART 可能会很困难。二线治疗结果的后果尚不清楚。在一个以工作场所和社区为基础的多地点项目中,我们进行了 6 个月一次的病毒学监测,描述了在存在病毒载量(VL)≥400 拷贝/ml 的情况下,使用基于蛋白酶抑制剂的二线 ART 后的病毒学抑制结果和预测因素。
我们使用前瞻性收集的 2003 年 1 月 1 日至 2008 年 12 月 31 日期间开始接受一线 ART 的患者的临床数据,构建了一个在 VL≥400 拷贝/ml 的情况下切换到二线 ART 的患者队列。使用修正泊松回归来评估 15 个月内 VL<400 拷贝/ml 的预测因素,以估计风险比。
共有 205 名工作场所患者(91.7%为男性;中位年龄 43 岁)和 212 名社区患者(38.7%为男性;中位年龄 36 岁)转换了方案。与社区患者相比,工作场所患者的病毒血症持续时间更长,VL 更高,CD4 计数更低,并且一线 ART 时报告的非依从性更高。工作场所患者的报告理由是更高的非依从性。转换后,工作场所患者中 48.3%(工作场所)和 72.0%(社区)的 VL<400,工作场所方案中报告的非依从性(17.9% vs. 1.4%)和病毒学反弹(35.6% vs. 13.2%,有可用措施)更为常见。在对工作场所方案的调整分析中,较低的切换 VL 和较年轻的年龄与 VL<400 相关。在社区方案中,较短的病毒血症持续时间、较高的 CD4 计数和转用 ART 进入方案与 VL<400 相关。
在具有个体和方案层面因素影响结果的多地点治疗方案中,二线 ART 可以实现高水平的病毒学抑制,但并非总是如此。需要评估支持医护人员和患者在这一转换期的策略;必须解决工作场所方案中较差的依从性问题。