Mater Olbia Hospital, Olbia, Italy.
Fondazione Policlinico Agostino Gemelli IRCCS, UOC Malattie Infettive, Roma, Italy.
AIDS Res Hum Retroviruses. 2021 Jun;37(6):429-432. doi: 10.1089/AID.2020.0219. Epub 2020 Dec 30.
We tried to investigate and compare the safety of a dual therapy (DT) with dolutegravir+lamivudine (DTG +3TC) versus bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). We performed a retrospective analysis in a cohort of virologically suppressed HIV+ pts switching to DT or BIC in our center. Primary endpoint was to evaluate time to treatment discontinuation (TD) for any cause. Survival analysis was employed to determine time to TD and its predictors were analyzed by Cox regression. Moreover, we collected viro-immunological parameters as well as markers of renal function and lipid profile at baseline and after 24 weeks and assessed changes through nonparametric tests. We analyzed 476 patients: 350 starting a DT and 126 starting BIC. Overall, we registered 21 TD: 15 in the DT group during 170 patient-years of follow-up (PYFU) (a rate of 8.8 per 100 PYFU) and 6 in the BIC one during 48 PYFU (12.5 per 100 PYFU). Estimated probabilities of maintaining study regimen after 24 weeks were 95.5% [standard deviation (SD) ±1.1] in the DT group and 94.9% (SD ±2.0) in the BIC group, with no significant differences between them (log-rank = .639). Concerning metabolic profile, in the DT group, after 24 weeks, triglycerides decreased significantly (median change -14 mg/dL, < .001), whereas high-density lipoprotein cholesterol increased (+3 mg/dL, = .031). In the BIC group, meanwhile, we observed a significant decrease in low-density lipoprotein cholesterol after 24 weeks (-13 mg/dL, = .026). Both optimization strategies showed high tolerability in the short term in experienced pts, with few differences between them. Further studies are needed to properly assess the matter.
我们试图研究和比较双药治疗（DT）与多替拉韦+拉米夫定（DTG+3TC）和比克替拉韦/恩曲他滨/丙酚替诺福韦（BIC/FTC/TAF）的安全性。我们对在我院接受 DT 或 BIC 转换治疗的病毒学抑制 HIV+患者进行了回顾性分析。主要终点是评估任何原因导致的治疗停药（TD）时间。生存分析用于确定 TD 时间，并用 Cox 回归分析其预测因素。此外，我们收集了基线和 24 周后的病毒学、免疫学参数以及肾功能和血脂谱标志物，并通过非参数检验评估变化。我们分析了 476 例患者：350 例开始 DT，126 例开始 BIC。总的来说，我们记录了 21 例 TD：DT 组在 170 患者年的随访（PYFU）中发生 15 例（每 100 PYFU 8.8 例），BIC 组在 48 PYFU 中发生 6 例（每 100 PYFU 12.5 例）。DT 组在 24 周后维持研究方案的估计概率为 95.5%（标准偏差（SD）±1.1），BIC 组为 94.9%（SD±2.0），两组间无显著差异（对数秩检验=0.639）。关于代谢谱，在 DT 组中，24 周后甘油三酯显著下降（中位数变化-14mg/dL， < 0.001），高密度脂蛋白胆固醇增加（+3mg/dL， = 0.031）。而在 BIC 组中，24 周后低密度脂蛋白胆固醇显著下降（-13mg/dL， = 0.026）。两种优化策略在经验丰富的患者中短期显示出较高的耐受性，且两者之间差异较小。需要进一步的研究来正确评估这一问题。
