Open-Label Randomized Multicenter Selection Study of Once Daily Antiretroviral Treatment Regimen Comparing Ritonavir-Boosted Atazanavir to Efavirenz with Fixed-Dose Abacavir and Lamivudine
Open-Label Randomized Multicenter Selection Study of Once Daily Antiretroviral Treatment Regimen Comparing Ritonavir-Boosted Atazanavir to Efavirenz with Fixed-Dose Abacavir and Lamivudine
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DOI：
10.2169/internalmedicine.50.4572
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发表时间：
2011-01-01
影响因子：
1.2
通讯作者：
Oka, Shinichi
中科院分区：
文献类型：
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作者：
Honda, Miwako;Ishisaka, Michiyo;Oka, Shinichi
背景 日本人和白人患者的抗逆转录病毒药物副作用不同。日本人对依非韦伦的严重中枢神经系统 (CNS) 副作用和对阿巴卡韦的过敏率较低是日本人的特点。 目的 本研究的目的是选择每日一次的治疗方案进行进一步的非劣效研究，比较现行 HIV/AIDS 指南中每日一次的一线抗逆转录病毒治疗方案的病毒学疗效和安全性。 方法 该研究设计是一项随机、开放标签、多中心、选择研究。一只手臂接受依非韦伦治疗，另一只手臂接受利托那韦增强的阿扎那韦治疗。双臂均使用固定剂量拉米夫定加阿巴卡韦。主要终点是 48 周时的病毒学成功率（病毒载量低于 50 拷贝/mL）。对患者进行了长达 96 周的随访，以安全性作为次要终点。临床试验.Gov (NCT 00280969) 和大学医院医疗信息网络 (UMIN000000243)。结果 共有 71 名参与者入组。第 48 周时，两组的病毒学成功率相似 [依非韦伦组 28/36 (77.8%)；依非韦伦组 28/36 (77.8%)；阿扎那韦组 27/35 (77.1%)]，但在第 96 周，依非韦伦组下降至 55.6%，阿扎那韦组下降至 68.8% (p=0.33)。在 96 周的随访中，EFV 组中 52.8% 的患者和 ATV/r 组中 34.3% 的患者总胆固醇达到 220 mg/dL 以上，需要治疗。本研究中截至第96周，没有患者出现心血管并发症。结论 依非韦伦和利托那韦增强的阿扎那韦联合拉米夫定加阿巴卡韦在48周时的疗效无显着差异。安全性评估延长至 96 周，也显示两组没有显着差异。
Background The side-effects of anti-retroviral drugs are different between Japanese and Caucasian patients. Severe central nerve system (CNS) side-effects to efavirenz and low rate of hypersensitivity against abacavir characterize the Japanese.Objective The objective of this study was to select a once daily regimen for further non-inferior study comparing the virological efficacy and safety of the first line once daily antiretroviral treatment regimens in the current HIV/AIDS guideline.Methods The study design was a randomized, open label, multicenter, selection study. One arm was treated with efavirenz and the other with ritonavir-boosted atazanavir. A fixed-dose lamivudine plus abacavir were used in both arms. The primary endpoint was virologic success (viral load less than 50 copies/mL) rate at 48 weeks. Patients were followed-up to 96 weeks with safety as the secondary endpoint. Clinicaltrials.Gov (NCT 00280969) and the University hospital Medical Information Network (UMIN000000243).Results A total of 71 participants were enrolled. Virologic success rates in both arms were similar at week 48 [efavirenz arm 28/36 (77.8%); atazanavir arm 27/35 (77.1%)], but were decreased at week 96 to 55.6% in the efavirenz arm and 68.8% in the atazanavir arm (p=0.33). At the 96-week follow-up, 52.8% of the EFV arm and 34.3% of the ATV/r arm reached total cholesterol more than 220 mg/dL and required treatment. None of the patients developed cardiovascular complications in this study by week 96.Conclusion There was no significant difference in the efficacy of efavirenz and ritonavir-boosted atazanavir combined with lamivudine plus abacavir at 48 weeks. The evaluation of safety was extended to 96 weeks, which also showed no significant difference in both arms.