Once-a-day highly active antiretroviral therapy in treatment-naive HIV-1-infected adults in Senegal
Once-a-day highly active antiretroviral therapy in treatment-naive HIV-1-infected adults in Senegal
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DOI：
10.1097/00002030-200305020-00010
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发表时间：
2003-05-02
期刊：
影响因子：
3.8
通讯作者：
Ndoye, I
中科院分区：
文献类型：
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作者：
Landman, R;Schiemann, R;Ndoye, I
目的：研究一种每日一次的高效抗逆转录病毒治疗方案在塞内加尔成人中的有效性、依从性和耐受性。设计和方法：在一项前瞻性、开放标签的单臂研究中，40名未接受治疗的HIV-1感染患者每天睡前服用以下三种药物：地丹诺辛、拉米夫定和依法韦连兹。主要终点是6个月时血浆HIV-1RNA低于500拷贝/毫升的患者的百分比。结果：85%的患者处于疾病预防控制中心B期或C期，基线时血浆HIV RNA水平为5.4+/-0.4log(10)Copies/ml。6个月时血浆HIV-1RNA低于500拷贝/ml的患者比例为95%[95%可信区间(CI)，83-99]。3、6、9、12、15个月血浆HIV-1RNA低于50拷贝/ml的比例分别为26%(n=39；95%CI，12~39)、78%(n=40；95%CI，65~90)、70%(n=40；95%CI，56~84)、77%(n=39；95%CI，~90)和69%(n=39；95%CI，55~84)。治疗前CD_4细胞计数为164+/-75x10(6)/L，15个月时平均升高199+/-101x10(6)/L。根据血药浓度和问卷调查结果，依从性良好。结论：在非洲晚期HIV感染患者中，每日一次的地达诺辛、拉米夫定和法韦伦兹方案安全、易用，并显示出强大的抗逆转录病毒和免疫学作用。(C)2003年，里平科特·威廉姆斯·威尔金斯。
Objectives: To study the effectiveness, adherence and tolerance of a once-a-day highly active antiretroviral therapy regimen in adults in Senegal.Design and methods: In a prospective, open-label one-arm study, 40 treatment-naive HIV-1-infected patients took the following three drugs once a day at bedtime: didanosine, lamivudine and efavirenz. The primary endpoint was the percentage of patients with plasma HIV-1 RNA below 500 copies/ml at 6 months. The analysis was done on an intent-to treat basis.Results: Eighty-five per cent of patients were at Centers for Disease Control and Prevention stage B or C and the plasma HIV RNA level was 5.4+/-0.4 log(10) copies/ml at baseline. The percentage of patients with plasma HIV-1 RNA below 500 copies/ml at 6 months was 95% [95% confidence interval (CI), 83-99]. The proportions of patients with plasma HIV-1 RNA below 50 copies/ml at months 3, 6, 9, 12 and 15 were 26% (n=39; 95% CI, 12-39), 78% (n=40; 95% CI, 65-90), 70% (n=40; 95% CI, 56-84), 77% (n=39; 95% CI, 64-90) and 69% (n=39; 95% CI, 55-84), respectively. The CD4 cell count was 164+/-75x10(6)/l at baseline and increased by a mean of 199+/-101x10(6)/l at month 15. Permanent treatment discontinuation was never necessary for serious adverse effects. Adherence was excellent, as shown by plasma drug concentrations and according to the results of the questionnaire.Conclusions: The once-daily regimen of didanosine, lamivudine and efavirenz was safe, easy-to-take and demonstrated strong antiretroviral and immunologic effects in African patients with advanced HIV infection. (C) 2003 Lippincott Williams Wilkins.