基线 CD4(+)T 细胞计数对中国 HIV/AIDS 患者应用奈韦拉平为基础的高效抗逆转录病毒治疗疗效的影响：一项前瞻性、多中心研究。

Impact of baseline CD4(+) T cell counts on the efficacy of nevirapine-based highly active antiretroviral therapy in Chinese HIV/AIDS patients: a prospective, multicentric study.

机构信息

Department of Infectious Diseases, Peking Union Medical College Hospital, Beijing 100730, China.

出版信息

Chin Med J (Engl). 2009 Oct 20;122(20):2497-502.

DOI:

PMID:20079166

Abstract

BACKGROUND

CD4(+) T cell counts have been used as the indicator of human immunodeficiency virus type 1 (HIV-1) disease progression and thereby to determine when to start highly active antiretroviral therapy (HAART). Whether and how the baseline CD4(+) T cell count affects the immunological and viral responses or adverse reactions to nevirapine (NVP)-containing HAART in Chinese HIV-1 infected adults remain to be characterized.

METHODS

One hundred and ninety-eight HIV-seropositive antiretroviral therapy (ART)-naive subjects were enrolled into a prospective study from 2005 to 2007. Data were analyzed by groups based on baseline CD4(+) T cell counts either between 100 - 200 cells/microl or 201 - 350 cells/microl. Viral responses, immunologic responses and adverse events were monitored at baseline and at weeks 4, 12, 24, 36, 52, 68, 84, 100.

RESULTS

Eighty-six and 112 subjects ranged their CD4(+) T cell counts 100 - 200 cells/microl and 201 - 350 cells/microl, respectively. The pre-HAART viral load in CD4 201 - 350 cells/microl group was significantly lower than that in CD4 100 - 200 cells/microl group (P = 0.000). After treatment, no significant differences were observed between these two groups either in the plasma viral load (pVL) or in the viral response rate calculated as the percentage of pVL less than 50 copies/ml or less than 400 copies/ml. The CD4(+) T cell counts were statistically higher in the 201 - 350 group during the entire follow-ups (P < 0.01) though CD4(+) T cell count increases were similar in these two groups. After 100-week treatment, the median of CD4(+) T cell counts were increased to 331 cells/microl for CD4 100 - 200 cells/microl group and to 462 cells/microl for CD4 201 - 350 cells/microl group. Only a slightly higher incidence of nausea was observed in CD4 201 - 350 cells/microl group (P = 0.05) among all adverse reactions, including rash and liver function abnormality.

CONCLUSIONS

The pVLs and viral response rates are unlikely to be associated with the baseline CD4(+) T cell counts. Initiating HAART in Chinese HIV-1 infected patients with higher baseline CD4(+) T cell counts could result in higher total CD4(+) T cell counts thereby achieve a better immune recovery. These results support current guidelines to start HAART at a threshold of 350 cells/microl.

摘要

背景

CD4(+) T 细胞计数一直被用作人类免疫缺陷病毒 1 型（HIV-1）疾病进展的指标，从而确定何时开始高效抗逆转录病毒治疗（HAART）。在中国 HIV-1 感染的成年人中，基线 CD4(+) T 细胞计数是否以及如何影响对含奈韦拉平（NVP）的 HAART 的免疫和病毒反应或不良反应仍有待描述。

方法

198 名 HIV 血清阳性、接受抗逆转录病毒治疗（ART）的初治患者于 2005 年至 2007 年期间入组一项前瞻性研究。根据基线 CD4(+) T 细胞计数在 100-200 个细胞/微升或 201-350 个细胞/微升之间，将数据分为两组进行分析。在基线和第 4、12、24、36、52、68、84、100 周时监测病毒反应、免疫反应和不良事件。

结果

86 名和 112 名受试者的 CD4(+) T 细胞计数分别在 100-200 个细胞/微升和 201-350 个细胞/微升范围内。CD4 201-350 细胞/微升组的预 HAART 病毒载量明显低于 CD4 100-200 细胞/微升组（P=0.000）。治疗后，两组之间血浆病毒载量（pVL）或计算的病毒反应率（pVL 小于 50 拷贝/ml 或小于 400 拷贝/ml 的百分比）均无显著差异。在整个随访期间，CD4 201-350 组的 CD4(+) T 细胞计数明显更高（P<0.01），尽管两组的 CD4(+) T 细胞计数增加相似。治疗 100 周后，CD4 100-200 细胞/微升组的 CD4(+) T 细胞计数中位数增加至 331 个细胞/微升，CD4 201-350 细胞/微升组增加至 462 个细胞/微升。在所有不良反应中，包括皮疹和肝功能异常，仅观察到 CD4 201-350 细胞/微升组的恶心发生率略有升高（P=0.05）。

结论

pVL 和病毒反应率与基线 CD4(+) T 细胞计数无明显相关性。在中国 HIV-1 感染患者中，以较高的基线 CD4(+) T 细胞计数启动 HAART 可能会导致更高的总 CD4(+) T 细胞计数，从而实现更好的免疫恢复。这些结果支持当前以 350 个细胞/微升为阈值开始 HAART 的指南。