Sribenjalux Wantin, Nuntawit Tharatorn, Meesing Atibordee, Chetchotisakd Ploenchan
Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Faculty of Medicine, 37690Khon Kaen University, Khon Kaen, Thailand.
Research and Diagnostic Center for Emerging Infectious Diseases (RCEID), 37690Khon Kaen University, Khon Kaen, Thailand.
Int J STD AIDS. 2023 Feb;34(2):98-107. doi: 10.1177/09564624221137972. Epub 2022 Nov 15.
A ritonavir-boosted protease inhibitor (PI)-based antiretroviral therapy (ART) regimen can cause abnormal lipid levels and increased incidence of cardiovascular disease. Switching to a dolutegravir (DTG)-based regimen has been shown to improve blood lipid levels, but data in the Thai population are limited.
A prospective cohort study was conducted at Srinagarind Hospital between April 28, 2021, and April 30, 2022. Patients were eligible if they (1) were over 18 years of age, 2) had received a ritonavir-boosted PI-based regimen for at least three months, and 3) had documented plasma HIV RNA levels below 50 copies/mL within six months before the enrollment. All eligible patients included in the study switched from a ritonavir-boosted PI-based ART regimen to a DTG-based regimen. The primary outcome was changes in low-density lipoprotein cholesterol (LDL-C) levels from baseline to week 24.
Forty-six eligible patients were enrolled, 71.7% of whom were male, with a mean age of 49.4 years. Mean body weight was 62.7 kg and body mass index (BMI) was 22.86 kg/m. The majority of patients had been on a regimen of boosted atazanavir (ATV/r; 60.9%), followed by boosted lopinavir (LPV/r; 37.0%). Six patients were withdrawn from the study. At week 24 after switching to DTG, LDL-C was significantly lower than at baseline, with a difference of -15.1 mg/dL (95% confidence interval [CI; -23.3 to -6.8]; -value < 0.001), as were total cholesterol and triglycerides, with differences of -22.1 mg/dL (95% CI [-33.3 to -10.8]; -value <0.001) and -67.7 mg/dL, (95% CI [-88.3 to -47.0]; -value 0.001), respectively. There were no significant changes in body weight (0.51 kg; 95% CI [-0.37 to 1.38]; -value 0.251) or BMI (0.17 kg/m; 95% CI [-0.14 to 0.48]; -value 0.284) from baseline to week 24. In addition, 39 of 40 patients (97.5%) maintained virological suppression (HIV RNA <50 copies/mL), with only one patient (2.5%) developing virological failure. Three grade 3 adverse events were observed.
Switching from a boosted PI-based ART regimen to a DTG-based regimen in people living with HIV/AIDS who had attained prior virological suppression resulted in a significant reduction in total cholesterol, LDL-C, and triglyceride levels, but did not increase the patient's body weight at 24 weeks of follow-up. Furthermore, the DTG-based regimen was also highly effective in maintaining virological suppression.
Thai Clinical Trials Registry, TCTR20210625004.
基于利托那韦增强型蛋白酶抑制剂（PI）的抗逆转录病毒疗法（ART）方案可导致血脂异常和心血管疾病发病率增加。已证明改用基于多替拉韦（DTG）的方案可改善血脂水平，但泰国人群的数据有限。
于2021年4月28日至2022年4月30日在诗里拉吉医院进行了一项前瞻性队列研究。符合条件的患者需满足以下条件：（1）年龄超过18岁；（2）接受基于利托那韦增强型PI的方案至少三个月；（3）在入组前六个月内记录的血浆HIV RNA水平低于50拷贝/毫升。纳入研究的所有符合条件的患者均从基于利托那韦增强型PI的ART方案改为基于DTG的方案。主要结局是从基线到第24周低密度脂蛋白胆固醇（LDL-C）水平的变化。
46名符合条件的患者入组，其中71.7%为男性，平均年龄49.4岁。平均体重为62.7千克，体重指数（BMI）为22.86千克/平方米。大多数患者接受过增强型阿扎那韦（ATV/r；60.9%）方案，其次是增强型洛匹那韦（LPV/r；37.0%）方案。6名患者退出研究。改用DTG后第24周，LDL-C显著低于基线，差值为-15.1毫克/分升（95%置信区间[CI]：-23.3至-6.8；P值<0.001），总胆固醇和甘油三酯也是如此，差值分别为-22.1毫克/分升（95%CI[-33.3至-10.8]；P值<0.001）和-67.7毫克/分升（95%CI[-88.3至-47.0]；P值0.001）。从基线到第24周，体重（0.51千克；95%CI[-0.37至1.38]；P值0.251）或BMI（0.17千克/平方米；95%CI[-0.14至0.48]；P值0.284）无显著变化。此外，40名患者中有39名（97.5%）维持病毒学抑制（HIV RNA<50拷贝/毫升），只有1名患者（2.5%）发生病毒学失败。观察到3例3级不良事件。
在先前已实现病毒学抑制的HIV/AIDS患者中，从基于增强型PI的ART方案改为基于DTG的方案可使总胆固醇、LDL-C和甘油三酯水平显著降低，但在随访24周时未增加患者体重。此外，基于DTG的方案在维持病毒学抑制方面也非常有效。
泰国临床试验注册中心，TCTR20210625004。
