Assistance Publique Hôpitaux de Paris, Hôpital Saint-Louis, Department of Infectious Diseases, University of Paris-Diderot/Paris 7, Paris, France.
J Antimicrob Chemother. 2011 Jan;66(1):184-91. doi: 10.1093/jac/dkq395. Epub 2010 Oct 28.
once-daily combinations of efavirenz and two nucleoside analogues are recommended for the treatment of HIV infection. Long-term efficacy and safety data are scarce for the combination of efavirenz, emtricitabine and didanosine.
the ALIZE ANRS 099 trial enrolled 355 adults with plasma HIV RNA levels of <400 copies/mL under a protease inhibitor-based regimen, who were randomized to remain on this regimen or to switch to a once-daily regimen of emtricitabine, didanosine and efavirenz for 48 weeks. An extended 4 year follow-up was available for the 178 patients who switched to the efavirenz-containing regimen, and assessed plasma HIV RNA levels, CD4 cell counts, safety and tolerability.
after a median follow-up of 42 months, 121 patients (68%) remained on an efavirenz-based regimen, and 62% and 57% had plasma HIV RNA levels of <400 and <50 copies/mL, respectively, in an intent-to-continue analysis with missing data and treatment discontinuation considered as failure. There was a significant increase in CD4 cell count of 41 cells/mm(3). Drug-related adverse events were the main reason for treatment discontinuation in 26 patients (15%), and 15 were reported during the first year of therapy (58%). There was no emergence of clinically defined lipodystrophy, and lipid and glucose profiles were favourable with a significant increase from baseline of high-density lipoprotein cholesterol levels (median increase 12 mg/dL, P < 10(-4)).
a once-daily regimen of emtricitabine, didanosine and efavirenz provided a durable antiretroviral response and was well tolerated through 4 years of therapy.
每日一次的依非韦伦与两种核苷类似物联合治疗方案推荐用于 HIV 感染的治疗。依非韦伦、恩曲他滨和地达诺辛联合治疗方案的长期疗效和安全性数据较为缺乏。
ALIZE ANRS 099 试验纳入了 355 例正在接受基于蛋白酶抑制剂方案治疗、病毒载量<400 拷贝/ml 的成年 HIV 感染者，他们被随机分为继续原方案治疗或转换为依非韦伦、恩曲他滨和地达诺辛每日一次的方案治疗 48 周。对于转换为依非韦伦为基础的治疗方案的 178 例患者，我们进行了为期 4 年的扩展随访，评估了血浆 HIV RNA 水平、CD4 细胞计数、安全性和耐受性。
中位随访 42 个月后，121 例患者（68%）继续使用依非韦伦为基础的方案，意向性继续治疗分析中，62%和 57%的患者血浆 HIV RNA 水平分别<400 和<50 拷贝/ml，失访和治疗失败视为失败。CD4 细胞计数增加了 41 个细胞/mm3。药物相关不良事件是 26 例（15%）患者停药的主要原因，其中 15 例发生在治疗的第一年（58%）。没有出现临床上定义的脂肪营养不良，血脂和血糖谱也较好，高密度脂蛋白胆固醇水平从基线显著升高（中位数增加 12 mg/dL，P<10(-4)）。
恩曲他滨、地达诺辛和依非韦伦每日一次的方案提供了持久的抗病毒反应，在 4 年的治疗中耐受性良好。
