HIV-1 RNA levels and the development of clinical disease. North American Lamivudine HIV Working Group.
HIV-1 RNA levels and the development of clinical disease. North American Lamivudine HIV Working Group.
复制标题
HIV-1 RNA 水平与临床疾病的发展。
DOI：
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发表时间：
1996
期刊：
影响因子：
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通讯作者：
Andrew M. Hill
中科院分区：
文献类型：
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作者：
A. Phillips;J. Eron;J. Bartlett;M. Rubin;Judy Johnson;Sharon Price;P. Self;Andrew M. Hill
目的
在接受抗逆转录病毒治疗的患者中，评估HIV RNA水平对预测临床疾病的预后价值，而不依赖于CD 4淋巴细胞计数。
设计
来自两项拉米夫定治疗试验的HIV感染患者队列
患者
在北美NUCA 3001和NUCA 3002拉米夫定试验中随机分配的620例患者，在中心实验室测量HIV RNA水平（中位数，每例患者7次测量）和CD 4计数（中位数，每例患者13次计数）。基线时患者处于1993年疾病控制和预防中心（CDC）A期（n = 439）、B期（n = 135）或C期（n = 46）。
观察指标
对于基线时处于CDC A期的患者，我们考虑了HIV RNA水平和CD 4计数预测CDC B或C期疾病发展的能力。采用考克斯比例风险模型。在第二次分析中，考虑了基线时无艾滋病的患者，终点为艾滋病（CDC C期）。
结果
患者的初始CD 4计数范围（5-95%百分位数）为104至529 × 10（6）/l（中位数，274 × 10（6）/l），HIV RNA水平为1900至339680拷贝/ml（中位数，44240拷贝/ml）。对于第一项分析，以CDC B或C期疾病为终点，最近的HIV RNA水平和CD 4计数均预测临床疾病的发展[HIV RNA的相对危险度（RH），HIV RNA每10倍差异为1.96; 95%置信区间（CI），1.41-2.73; P = 0.0001; RH组CD 4计数为1.82/2倍差异（95%CI 1.27-2.56，P = 0.0009）。当HIV RNA和CD 4计数均被纳入多元回归模型时，两种标志物提供的信息均超过另一种（HIV RNA的RH，1.75; 95% CI，1.23-2.50; P = 0.002; CD 4计数的RH，1.40; 95% CI，0.95-2.07; P = 0.09）。在第二项分析中，以AIDS为终点，HIV RNA水平（P = 0.02）和CD 4计数（P = 0.004）与临床进展独立相关。调整治疗组后，这些结果基本不变（齐多夫定/拉米夫定vs对照组）。
结论
HIV RNA水平显示出预测临床疾病发展的能力，因此在患者监测中除了CD 4计数外可能也很重要。
OBJECTIVE
To assess the prognostic value of HIV RNA levels for predicting clinical disease independently of the CD4 lymphocyte count in patients on antiretroviral therapy.
DESIGN
Cohort of HIV-infected patients from two trials of lamivudine therapy.
PATIENTS
For 620 patients randomized in the North American NUCA3001 and NUCA3002 trials of lamivudine, HIV RNA levels were measured (median, seven measures per patient) and CD4 counts were assessed at a central laboratory (median, 13 counts per patient). Patients were in the 1993 Centers for Disease Control and Prevention (CDC) stages A (n = 439), B (n = 135) or C (n = 46) at baseline.
OUTCOME MEASURES
For patients who were in CDC stage A at baseline we considered the ability of HIV RNA levels and CD4 counts to predict the development of CDC stage B or C disease. A Cox proportional hazards model was used. In a second analysis, patients who were AIDS-free at baseline were considered, and the endpoint was AIDS (CDC stage C).
RESULTS
Patients' initial CD4 counts ranged (5-95% centiles) from 104 to 529 x 10(6)/l (median, 274 x 10(6)/l) and HIV RNA levels from 1900 to 339680 copies/ml (median, 44240 copies/ml). For the first analysis, with CDC stage B or C disease as endpoint, both the most recent HIV RNA level and CD4 count predicted the development of clinical disease [relative hazard (RH) for HIV RNA, 1.96 per 10-fold difference in HIV RNA; 95% confidence interval (CI), 1.41-2.73; P = 0.0001; and RH for CD4 count, 1.82 per twofold difference in CD4 count; 95% CI, 1.27-2.56; P = 0.0009]. When both HIV RNA and CD4 count were included in a multiple regression model, both markers provided information additional to that given by the other (RH for HIV RNA, 1.75; 95% CI, 1.23-2.50; P = 0.002; and RH for CD4 count, 1.40; 95% CI, 0.95-2.07; P = 0.09). In the second analysis, with AIDS as endpoint, both HIV RNA level (P = 0.02) and CD4 count (P = 0.004) were independently associated with clinical progression. These results were essentially unchanged after adjustment for treatment arm (zidovudine/lamivudine versus control arms).
CONCLUSION
The HIV RNA level shows ability to predict the development of clinical disease and may thus be of importance in addition to the CD4 count in patient monitoring.