在 SENSE 随机、双盲试验中，初治患者中依发韦仑与依曲韦林的血脂谱。

Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial.

机构信息

First Department of Internal Medicine, University Hospital of Cologne, Cologne, Germany.

出版信息

J Antimicrob Chemother. 2012 Mar;67(3):685-90. doi: 10.1093/jac/dkr533. Epub 2011 Dec 29.

DOI:10.1093/jac/dkr533

PMID:22210755

Abstract

BACKGROUND

Etravirine is approved for use in treatment-experienced patients at a dose of 200 mg twice daily. Efavirenz has been associated with greater increases in serum lipids compared with other non-nucleosides in randomized trials of first-line treatment.

METHODS

In this double-blind, placebo-controlled trial, 157 treatment-naive patients with HIV RNA >5000 copies/mL were randomized 1:1 to either 400 mg of etravirine once daily (n=79) or 600 mg of efavirenz once daily (n=78) plus two nucleoside analogues (either abacavir/lamivudine, zidovudine/lamivudine or tenofovir/emtricitabine) for 48 weeks. Lipids were measured under fasting conditions at baseline and all visits to Week 48. Clinicaltrials.gov identifier: NCT00903682.

RESULTS

Overall, the patients had a median baseline CD4 count of 302 cells/mm(3) (range 74-722) and a median HIV RNA of 4.8 log(10) copies/mL (range 3.5-6.6). Both the non-nucleosides and the nucleoside analogues used caused changes in serum lipids. In the efavirenz arm, patients showed significantly larger increases in high-density lipoprotein (HDL) (+0.15 mmol/L, P=0.004), low-density lipoprotein (LDL) (+0.35 mmol/L, P=0.005), total cholesterol (+0.61 mmol/L, P<0.0001) and triglycerides (+0.33 mmol/L, P=0.03) at Week 48 compared with the etravirine arm. Across the two arms, patients taking abacavir/lamivudine showed greater increases in total cholesterol (+0.47 mmol/L, P=0.005) compared with patients taking tenofovir/emtricitabine. There were fewer grade 3/4 elevations in total cholesterol, LDL and triglycerides in the etravirine arm (2 patients, 1 patient and 0 patients, respectively) versus the efavirenz arm (8 patients, 6 patients and 2 patients, respectively).

CONCLUSIONS

In the SENSE trial, first-line treatment with 400 mg of etravirine once daily plus two nucleoside analogues led to fewer grade 3 or 4 lipid elevations compared with efavirenz plus two nucleoside analogues.

摘要

背景

依曲韦林的批准剂量为 200 毫克，每日两次，适用于治疗经验丰富的患者。依非韦伦与其他非核苷类药物相比，在一线治疗的随机试验中与血清脂质升高的相关性更大。

方法

在这项双盲、安慰剂对照试验中，157 名 HIV RNA >5000 拷贝/ml 的初治患者以 1:1 的比例随机分为每日一次服用 400 毫克依曲韦林（n=79）或每日一次服用 600 毫克依非韦伦（n=78），同时加用两种核苷类似物（阿巴卡韦/拉米夫定、齐多夫定/拉米夫定或替诺福韦/恩曲他滨），疗程为 48 周。在基线和第 48 周所有访视时，空腹状态下检测血脂。Clinicaltrials.gov 标识符：NCT00903682。

结果

总体而言，患者的中位基线 CD4 计数为 302 个细胞/mm3（范围为 74-722），HIV RNA 中位数为 4.8 log10 拷贝/ml（范围为 3.5-6.6）。非核苷类药物和核苷类似物均导致血清脂质发生变化。在依非韦伦组中，患者的高密度脂蛋白（HDL）增加显著（+0.15mmol/L，P=0.004），低密度脂蛋白（LDL）增加（+0.35mmol/L，P=0.005），总胆固醇增加（+0.61mmol/L，P<0.0001），三酰甘油增加（+0.33mmol/L，P=0.03），与依曲韦林组相比，在第 48 周时。在这两个治疗组中，服用阿巴卡韦/拉米夫定的患者总胆固醇升高幅度更大（+0.47mmol/L，P=0.005），而服用替诺福韦/恩曲他滨的患者总胆固醇升高幅度较小。依曲韦林组（分别有 2 例、1 例和 0 例患者出现 3/4 级总胆固醇、LDL 和三酰甘油升高）的总胆固醇、LDL 和三酰甘油 3/4 级升高的患者少于依非韦伦组（分别有 8 例、6 例和 2 例患者）。