Department of Internal Medicine, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
University College London, London, United Kingdom.
PLoS One. 2019 Jan 28;14(1):e0209911. doi: 10.1371/journal.pone.0209911. eCollection 2019.
Comparison of changes in body composition, adipokines and inflammatory markers after initial therapy with a nucleos(t)ide reverse transcriptase inhibitor (N(t)RTI)- sparing or containing regimen are scarce.
Randomised Clinical Trial.
This is the body composition substudy of NEAT 001/ANRS 143, a randomised trial comparing darunavir/ritonavir (DRV/r) plus either raltegravir (RAL) or tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 805 ART naïve HIV-infected adults. The primary endpoint was percentage change in limb fat at week 96. Secondary endpoints were associations among these changes and metabolic markers (IL-6, insulin, leptin, adiponectin, FGF-23).
126 subjects (61 DRV/r + RAL and 65 DRV/r + TDF/FTC) were included. The rate of change in BMI between groups for RAL versus TDF/FTC at week 96 was 1.5% per 48-week period (p = 0.015). The rate of change in limb fat mass, trunk fat mass, total body fat and total lean mass was for RAL versus TDF/FTC at week 96 was 2.5% (p = 0.38), 7.3% ((p = 0.021), 4.9% (p = 0.061) and 1.3% (p = 0.12) respectively. Baseline insulin and leptin levels were correlated with baseline limb fat and trunk fat mass [r = 0.31 (p = 0.0043)/r = 0.28 (p = 0.0011) for limb fat, and r = 0.63 (p<0.0001)/r = 0.50(p<0.0001) for trunk fat]. After adjustment, a 10% faster increase in leptin between baseline and week 48 was associated with a more rapid increase in limb fat at week 48 (0.5% per 48 weeks, p<0.001), total body fat mass (0.6% per 48 weeks, p<0.001), and trunk fat mass (0.3% per 48 weeks, p = 0.0026).
After week 96 a N(t)RTI sparing regimen of DRV/r + RAL produced a numerically greater percentage increase in body composition variables with only change in trunk fat mass and BMI being significant.
初始治疗时使用核苷（酸）逆转录酶抑制剂（N(t)RTI）节约或包含方案后，身体成分、脂肪因子和炎症标志物变化的比较很少。
随机临床试验。
这是 NEAT 001/ANRS 143 的身体成分子研究，该研究比较了初治 HIV 感染成人中，达芦那韦/利托那韦（DRV/r）加拉替拉韦（RAL）或替诺福韦二吡呋酯/恩曲他滨（TDF/FTC）的疗效。主要终点是第 96 周时四肢脂肪百分比的变化。次要终点是这些变化与代谢标志物（IL-6、胰岛素、瘦素、脂联素、FGF-23）之间的关联。
126 名受试者（DRV/r+RAL 组 61 名，DRV/r+TDF/FTC 组 65 名）被纳入研究。96 周时，RAL 组与 TDF/FTC 组的 BMI 变化率为每 48 周 1.5%（p = 0.015）。96 周时，RAL 组与 TDF/FTC 组的四肢脂肪质量、躯干脂肪质量、全身脂肪和全身瘦质量的变化率分别为 2.5%（p = 0.38）、7.3%（p = 0.021）、4.9%（p = 0.061）和 1.3%（p = 0.12）。基线胰岛素和瘦素水平与基线四肢脂肪和躯干脂肪质量相关[r = 0.31（p = 0.0043）/r = 0.28（p = 0.0011）与四肢脂肪，r = 0.63（p<0.0001）/r = 0.50（p<0.0001）与躯干脂肪]。调整后，基线至 48 周时瘦素增加 10%，与 48 周时四肢脂肪增加（每 48 周增加 0.5%，p<0.001）、全身脂肪质量增加（每 48 周增加 0.6%，p<0.001）和躯干脂肪质量增加（每 48 周增加 0.3%，p = 0.0026）相关。
96 周后，DRV/r+RAL 的 N(t)RTI 节约方案使身体成分变量的百分比增加幅度更大，仅躯干脂肪质量和 BMI 的变化有统计学意义。
