Botswana Harvard School of Public Health AIDS Initiative Partnership, Gaborone, Botswana.
BMC Infect Dis. 2014 Jun 17;14:331. doi: 10.1186/1471-2334-14-331.
A subset of HIV-1 infected patients starting highly active antiretroviral treatment (HAART) experience suboptimal CD4 response (SCR) despite virologic suppression. We studied the rate of and risk factors for SCR among women starting HAART in the ACTG A5208 study conducted in 7 African countries. 741 HAART-naive women with screening CD4 count <200 cells/μL were randomized to start HAART with Tenofovir/Emtricitabine plus either Nevirapine or Lopinavir/Ritonavir.
This analysis includes the 625 women who remained on-study through 48 weeks without experiencing protocol-defined virologic failure. We defined SCR as<100 CD4 cells/μL increase from baseline and absolute CD4 cell count<350 cells/μL, both at 48 weeks after HAART initiation.
The baseline characteristics for the 625 women prior to HAART initiation were: median age 33 years, screening CD4 count 134 cells/μL, and HIV-1 RNA 5.1 log10 copies/mL; 184 (29%) were WHO Stage 3 or 4.Seventy one (11%) of these 625 women experienced SCR. Baseline factors independently associated with increased odds of SCR included older age, lower HIV-1 RNA, positive Hepatitis B surface antigen, and site location. At 96 weeks, only 6% of the SCR group had CD4 ≥ 350 cells/μL compared with 67% in the non SCR group.
After starting HAART, 11% of women with virologic suppression through 48 weeks experienced SCR. These patients were also less likely to achieve CD4 ≥ 350 cells/μL by 96 weeks. The underlying causes and long term clinical implications of SCR deserve further investigation.
Clinicaltrials.gov Identifier: NCT00089505.
尽管病毒得到抑制，但开始高效抗逆转录病毒治疗（HAART）的 HIV-1 感染患者中存在亚组人群会出现 CD4 反应不佳（SCR）。我们研究了在非洲 7 个国家进行的 ACTG A5208 研究中开始 HAART 的女性中 SCR 的发生率和风险因素。741 名筛查时 CD4 计数<200 个细胞/μL 的 HAART 初治患者被随机分配接受富马酸替诺福韦二吡呋酯/恩曲他滨联合奈韦拉平或洛匹那韦/利托那韦治疗。
本分析包括在没有经历方案定义的病毒学失败的情况下，通过 48 周研究的 625 名女性。我们将 SCR 定义为 HAART 起始后 48 周时，从基线时 CD4 计数增加<100 个细胞/μL 和绝对 CD4 细胞计数<350 个细胞/μL。
在开始 HAART 之前，625 名女性的基线特征为：中位年龄 33 岁，筛查时 CD4 计数 134 个细胞/μL，HIV-1 RNA 为 5.1 log10 拷贝/mL；184 名（29%）为 WHO 分期 3 或 4 期。这些 625 名女性中有 71 名（11%）发生了 SCR。与 SCR 组相比，发生 SCR 的基线因素包括年龄较大、HIV-1 RNA 较低、乙型肝炎表面抗原阳性和研究地点。在 96 周时，SCR 组只有 6%的患者 CD4≥350 个细胞/μL，而非 SCR 组为 67%。
在开始 HAART 后，48 周时病毒学抑制的女性中有 11%发生了 SCR。这些患者在 96 周时也更不可能达到 CD4≥350 个细胞/μL。SCR 的潜在原因及其对长期临床的影响值得进一步研究。
Clinicaltrials.gov 标识符：NCT00089505。
