司他夫定、拉米夫定和奈韦拉平简化固定剂量组合（GPO-VIR）治疗晚期HIV感染患者的安全性和有效性：一项为期24周的研究。

Safety and efficacy of a simplified fixed-dose combination of stavudine, lamivudine and nevirapine (GPO-VIR) for the treatment of advanced HIV-infected patients: a 24-week study.

作者信息

Anekthananon Thanomsak, Ratanasuwan Winai, Techasathit Wichai, Sonjai Areeaue, Suwanagool Surapol

机构信息

Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital, Bangkok 10700, Thailand.

出版信息

J Med Assoc Thai. 2004 Jul;87(7):760-7.

PMID:15521230

Abstract

OBJECTIVE

To determine the efficacy and safety of the fixed-dose combination of stavudine (d4T), lamivudine (3TC) and nevirapine (NVP) in the treatment of antiretroviral naive HIV-infected Thai adults.

PATIENTS AND METHOD

An open-label, single arm trial was conducted Baseline clinical assessment and blood test was done on 10, antiretroviral naive HIV-infected patients, who then received a fixed dose combination of d4T, 3TC and NVP (GPO- VIR, Thai Government Pharmaceutical Organization, Bangkok, Thailand). Nevirapine was given as 200 mg once daily for the first 2 weeks. The patients were followed up at 2, 4, 8, 12 and 24 weeks. A CD4 cell count and HIV-RNA assay were done at 12 and 24 weeks.

RESULTS

One hundred and one patients were enrolled The mean baseline CD4 cell count and mean HIV RNA were 58.7 (57.7) cells/mm3 and 5.3 (0.5) log10, copies/mL respectively. At week 24th, the mean decrease in log HIV RNA was 3.6 (0.7) log10 copies/mL [P < 0.001; 95% confidence interval (CI), 2.70-3.03]. Eighty one (80.2%) patients had HIV RNA < 400 copies/mL by intention-to-treat analysis (ITT) and 97.6% had HIV RNA < 400 copies/mL by on-treatment analysis (OT). Sixteen (84.2%) patients with baseline HIV RNA < or = 100,000 copies/mL and 65 (82.3%) patients with baseline HIV RNA > 100,000 copies/mL had viral load < 400 copies/mL by ITT (P = 0.842; 95% CI, -20.9%-16.2%). Sixteen (94.1%) patients with baseline HIV RNA < or = 100,000 copies/mL and 65 (98.5%) patients with baseline HIV RNA > 100,000 copies/mL had viral load < 400 copies/mL by OT (P = 0.295; 95% CI, -25.5%-3.8%). The mean CD4 cell count at week 24 was 155.1 (89.0) cells/mm3 (range 13-402). The mean increase in CD4 cell count from baseline was 96.5 (63.5) cells/ mm3 (P < 0.001). A total of 12% of the patients receiving d4T + 3TC + NVP developed skin rashes. Grade 3 or 4 hepatotoxicity was recognized in 7% of the patients.

CONCLUSION

Fixed-dose combination of d4T + 3 TC + NVP (GPO- VIR) is safe, well tolerated and effective in increasing CD4 cell counts and suppression of HIV RNA at 24 weeks in advanced HIV-infected patients in Thailand.

摘要

目的

确定司他夫定（d4T）、拉米夫定（3TC）和奈韦拉平（NVP）固定剂量组合用于治疗未接受过抗逆转录病毒治疗的泰国成年HIV感染者的疗效和安全性。

患者与方法

开展一项开放标签、单臂试验。对10名未接受过抗逆转录病毒治疗的HIV感染患者进行了基线临床评估和血液检查，随后这些患者接受了d4T、3TC和NVP的固定剂量组合（GPO-VIR，泰国政府制药组织，曼谷，泰国）。奈韦拉平在最初2周内每日一次给予200毫克。在第2、4、8、12和24周对患者进行随访。在第12周和24周进行CD4细胞计数和HIV-RNA检测。

结果

共纳入101名患者。基线时CD4细胞计数平均值和HIV RNA平均值分别为58.7（57.7）个细胞/mm³和5.3（0.5）log₁₀拷贝/mL。在第24周时，HIV RNA log平均值下降3.6（0.7）log₁₀拷贝/mL[P<0.001；95%置信区间（CI），2.70 - 3.03]。通过意向性分析（ITT），81名（80.2%）患者HIV RNA<400拷贝/mL，通过治疗中分析（OT）97.6%的患者HIV RNA<400拷贝/mL。通过ITT，基线HIV RNA≤100,000拷贝/mL的16名（84.2%）患者和基线HIV RNA>100,000拷贝/mL的65名（82.3%）患者病毒载量<400拷贝/mL（P = 0.842；95% CI，-20.9% - 16.2%）。通过OT，基线HIV RNA≤100,000拷贝/mL的16名（94.1%）患者和基线HIV RNA>100,000拷贝/mL的65名（98.5%）患者病毒载量<400拷贝/mL（P = 0.295；95% CI，-25.5% - 3.8%）。第24周时CD4细胞计数平均值为155.1（89.0）个细胞/mm³（范围13 - 402）。CD4细胞计数较基线的平均增加量为96.5（63.5）个细胞/mm³（P<0.001）。接受d4T + 3TC + NVP治疗的患者中共有12%出现皮疹。7% 的患者出现3级或4级肝毒性。