在未接受治疗的 HIV-2 感染者中，三联核苷酸逆转录酶抑制剂和利托那韦增强型蛋白酶抑制剂的免疫病毒学反应：ACHIEV2E 协作研究组。

Immunovirological response to triple nucleotide reverse-transcriptase inhibitors and ritonavir-boosted protease inhibitors in treatment-naive HIV-2-infected patients: The ACHIEV2E Collaboration Study Group.

机构信息

INSERM, U, France.

出版信息

Clin Infect Dis. 2011 May;52(10):1257-66. doi: 10.1093/cid/cir123.

DOI:10.1093/cid/cir123

PMID:21507923

Abstract

BACKGROUND

Triple nucleoside reverse-transcriptase inhibitors (NRTIs) are recommended by the World Health Organization as first-line regimen in treatment-naïve HIV-2-infected patients. However, ritonavir-boosted protease inhibitor (PI/r)-containing regimens are frequently prescribed. In the absence of previous randomized trials, we retrospectively compared these regimens in observational cohorts.

METHODS

HIV-2-infected patients from 7 European cohorts who started triple NRTI or PI/r since January 1998 were included. Piecewise linear models were used to estimate CD4 cell count and plasma HIV-2 RNA level slopes, differentiating an early phase (until end of month 3) and a second phase (months 4-12). On-treatment analyses censored data at major treatment modification and systematically at month 12.

RESULTS

Forty-four patients started triple NRTI therapy and 126 started PI/r therapy. Overall, the median CD4 cell count was 191 cells/mm(3) and the median plasma HIV-2 RNA level was ≥2.7 log(10) copies/ml in 61% of the patients at combination antiretroviral therapy (cART) initiation; the median duration of the first cART was 20 months, not differing between groups. PI/r regimens were associated with better CD4 cell count and HIV-2 RNA level outcomes, compared with NRTI regimens. Estimated CD4 cell count slopes were +6 and +12 cells/mm(3)/month during the early phase (P = .22), and -60 cells/mm(3)/year versus +76 cells/mm(3)/year during the second phase (P = .002), for triple NRTI and PI/r, respectively. Estimated mean HIV-2 RNA levels at month 12 in patients with detectable viremia at cART initiation were 4.0 and 2.2 log(10) copies/ml, respectively (P = .005).

CONCLUSIONS

In this observational study, PI/r-containing regimens showed superior efficacy over triple NRTI regimens as first-line therapy in HIV-2-infected patients.

摘要

背景

世界卫生组织建议将三联核苷逆转录酶抑制剂（NRTIs）作为初治 HIV-2 感染患者的一线治疗方案。然而，经常会开利托那韦增效蛋白酶抑制剂（PI/r）为基础的治疗方案。在没有之前的随机试验的情况下，我们在观察队列中对这些方案进行了回顾性比较。

方法

1998 年 1 月以来，来自 7 个欧洲队列的开始使用三联 NRTI 或 PI/r 的 HIV-2 感染者被纳入研究。采用分段线性模型估计 CD4 细胞计数和血浆 HIV-2 RNA 水平斜率，区分早期阶段（直到月末 3 个月）和第二阶段（第 4-12 个月）。治疗期间分析在主要治疗修改时和系统地在第 12 个月时删失数据。

结果

44 例患者开始三联 NRTI 治疗，126 例患者开始 PI/r 治疗。总体而言，61%的患者在开始联合抗逆转录病毒治疗（cART）时的中位 CD4 细胞计数为 191 个细胞/mm³，中位血浆 HIV-2 RNA 水平≥2.7 log（10）拷贝/ml；cART 开始时，第一组 cART 的中位持续时间为 20 个月，两组之间没有差异。与 NRTI 方案相比，PI/r 方案与更好的 CD4 细胞计数和 HIV-2 RNA 水平结局相关。在早期阶段，估计的 CD4 细胞计数斜率分别为+6 和+12 个细胞/mm³/月（P =.22），在第二阶段，分别为-60 和+76 个细胞/mm³/年（P =.002），分别为三联 NRTI 和 PI/r。在 cART 开始时可检测到病毒血症的患者中，估计在第 12 个月时的平均 HIV-2 RNA 水平分别为 4.0 和 2.2 log（10）拷贝/ml（P =.005）。