基于多替拉韦和利托那韦增强的达芦那韦在治疗已耐受 HIV-1 感染患者中的双药治疗的真实生活研究。
Real-life study of dual therapy based on dolutegravir and ritonavir-boosted darunavir in HIV-1-infected treatment-experienced patients.
机构信息
Department of Infectious Diseases and Hepatology, Medical University of Lodz, Lodz, Poland.
Hospital for Infectious Diseases, HIV Out-Patient Clinic, Warsaw, Poland.
出版信息
PLoS One. 2019 Jan 17;14(1):e0210476. doi: 10.1371/journal.pone.0210476. eCollection 2019.
BACKGROUND
Dual therapy based on dolutegravir and ritonavir-boosted darunavir (DTG/DRV/r) is a combination of well-known drugs with a high genetic barrier to HIV resistance.
METHOD
A retrospective analysis of all HIV-1 infected treatment-experienced patients who switched to DTG/DRV/r from May 2014 till March 2017 in 4 Polish centres-results of a 48-week treatment.
RESULTS
The study group consisted of 59 men and 17 women. Median baseline parameters were: age- 42.7 years, CD4 cells count- 560.5 cells/μl, CD4 cells nadir- 150 cells/μl, number of prior antiretroviral regimens- 3. The introduction of dual therapy was primarily due to virologic failure (30 patients), adverse events on previous regimens (17 patients) and therapy simplification (27 patients). At week 48 the treatment was continued in 70/76 of patients and the median CD4 cells count increased from 560.5 to 641.0 cells/μl. The therapy was discontinued in six patients (1 -virologic failure, 1 -decrease of estimated glomerular filtration rate (eGFR), 1 -myalgia, 3 -lost to follow-up). At week 48 six patients had detectable viremia, but only in one patient viremia was higher than 200 copies/ml. At week 48 the level of serum total cholesterol of the investigated subjects was statistically significantly higher than at the moment of dual therapy introduction (185.8 mg/dl vs. 174.8 mg/dl- p<0.05). However, in patients previously not treated with TDF, there were no changes in lipid parameters during therapy. Proteinuria was observed in 13.2% of patients before the switch to dual therapy and in 7.1% of patients at week 48.
CONCLUSIONS
The investigated dual therapy was effective and safe. The observed increase in lipid parameters only concerned the patients who had used a TDF-based regimen prior to analysed dual treatment.
背景
基于多替拉韦和利托那韦增强的达芦那韦(DTG/DRV/r)的双药治疗是由具有高 HIV 耐药遗传屏障的知名药物组成的组合。
方法
对 2014 年 5 月至 2017 年 3 月期间在波兰 4 个中心接受 DTG/DRV/r 转换治疗的所有 HIV-1 感染的有治疗经验的患者进行回顾性分析-48 周的治疗结果。
结果
研究组包括 59 名男性和 17 名女性。中位基线参数为:年龄-42.7 岁,CD4 细胞计数-560.5 个/μl,CD4 细胞最低点-150 个/μl,既往抗逆转录病毒治疗方案的数量-3。双药治疗的引入主要是由于病毒学失败(30 例)、先前方案的不良反应(17 例)和治疗简化(27 例)。在第 48 周,76 例患者中有 70 例继续治疗,CD4 细胞计数从 560.5 增加到 641.0 个/μl。有 6 例患者(1 例病毒学失败,1 例估算肾小球滤过率(eGFR)下降,1 例肌痛,3 例失访)停止治疗。在第 48 周时,有 6 例患者可检测到病毒血症,但只有 1 例病毒血症高于 200 拷贝/ml。在第 48 周,与双药治疗开始时相比,研究对象的血清总胆固醇水平显著升高(185.8mg/dl 比 174.8mg/dl-p<0.05)。然而,在以前未接受 TDF 治疗的患者中,治疗过程中脂质参数没有变化。在转换为双药治疗前,有 13.2%的患者存在蛋白尿,在第 48 周时,有 7.1%的患者存在蛋白尿。
结论
所研究的双药治疗是有效和安全的。仅观察到脂质参数的增加与接受分析的双治疗前使用 TDF 方案的患者有关。