Hospital Clinic/Institut d'Investigacions Biomediques August Pi i Suñer, University of Barcelona and ViiV Healthcare, Spain.
Institut national de la santé et de la recherche médicale (INSERM), Sorbonne Université, Institut Pierre Louis d'épidémiologie et de Santé Publique, Unite Medical pour la Recherche Scientifique 1136, Paris, France.
Clin Infect Dis. 2019 Feb 1;68(4):597-606. doi: 10.1093/cid/ciy505.
Both immediate and deferred switching from a ritonavir-boosted protease inhibitor (PI/r)-based regimen to a dolutegravir (DTG)-based regimen may improve lipid profile.
European Network for AIDS Treatment 022 Study (NEAT022) is a European, open-label, randomized trial. Human immunodeficiency virus (HIV)-infected adults aged ≥50 years or with a Framingham score ≥10% were eligible if HIV RNA was <50 copies/mL. Patients were randomized to switch from PI/r to DTG immediately (DTG-I) or to deferred switch at week 48 (DTG-D). Week 96 endpoints were proportion of patients with HIV RNA <50 copies/mL, percentage change of lipid fractions, and adverse events (AEs).
Four hundred fifteen patients were randomized: 205 to DTG-I and 210 DTG-D. The primary objective of noninferiority at week 48 was met. At week 96, treatment success rate was 92.2% in the DTG-I arm and 87% in the DTG-D arm (difference, 5.2% [95% confidence interval, -.6% to 11%]). There were 5 virological failures in the DTG-I arm and 5 (1 while on PI/r and 4 after switching to DTG) in the DTG-D arm without selection of resistance mutations. There was no significant difference in terms of grade 3 or 4 AEs or treatment-modifying AEs. Total cholesterol and other lipid fractions (except high-density lipoprotein) significantly (P < .001) improved both after immediate and deferred switching to DTG overall and regardless of baseline PI/r strata.
Both immediate and deferred switching from a PI/r to a DTG regimen in virologically suppressed HIV-infected patients ≥50 years old or with a Framingham score ≥10% was highly efficacious and well tolerated, and improved the lipid profile.
NCT02098837 and EudraCT: 2013-003704-39.
立即或延迟将基于利托那韦增效的蛋白酶抑制剂（PI/r）方案转换为多替拉韦（DTG）方案，均可能改善血脂状况。
欧洲艾滋病治疗网络 022 研究（NEAT022）是一项欧洲、开放性、随机试验。年龄≥50 岁或 Framingham 评分≥10%的人类免疫缺陷病毒（HIV）感染者，如果 HIV RNA＜50 拷贝/ml，则符合条件。患者被随机分为立即从 PI/r 转换为 DTG（DTG-I）或在第 48 周时延迟转换（DTG-D）。第 96 周的终点是 HIV RNA＜50 拷贝/ml 的患者比例、血脂成分的百分比变化以及不良事件（AE）。
共随机分配了 415 例患者：205 例分到 DTG-I 组，210 例分到 DTG-D 组。第 48 周的非劣效性主要目标得到了满足。第 96 周时，DTG-I 组的治疗成功率为 92.2%，DTG-D 组为 87%（差异为 5.2%[95%置信区间，-.6%至 11%]）。DTG-I 组有 5 例病毒学失败，DTG-D 组有 5 例（1 例在使用 PI/r 时，4 例在转换为 DTG 后），均未发生耐药突变的选择。在 3 级或 4 级 AE 或治疗改变 AE 方面，两组之间无显著差异。总体而言，无论基线 PI/r 分层如何，立即或延迟转换至 DTG 方案后，总胆固醇和其他血脂成分（高密度脂蛋白除外）均显著（P＜0.001）改善。
在病毒学抑制的 HIV 感染患者中，无论基线Framingham 评分≥10%或年龄≥50 岁，立即或延迟将 PI/r 方案转换为 DTG 方案均高度有效且耐受良好，并改善了血脂状况。
NCT02098837 和 EudraCT：2013-003704-39。
