摘要
目的 评估真实世界中达到病毒抑制的人类免疫缺陷病毒(human immunodeficiency virus,HIV)感染/艾滋病(acquired immunodeficiency syndrome,AIDS)患者转换为多替拉韦/拉米夫定(dolutegravir/lamivudine,DTG/3TC)复方单片制剂的疗效及安全性.方法 纳入2021年6月1日至2022年6月1日在郑州市第六人民医院门诊长期随访的HIV得到有效抑制并在研究期间抗病毒方案转换为DTG/3TC方案的HIV/AIDS患者79例,收集转换治疗方案前及治疗期间T淋巴细胞亚群、HIV RNA、血脂水平以及肾功能等检测指标,记录不良事件的发生情况.结果 79例转换治疗方案患者以中年男性为主,有30.4％的患者合并非艾滋病定义性疾病.前3位转换治疗方案原因分别是:简化方案,改善耐受性、药物不良反应、合并非艾滋病定义性疾病.48周病毒持续抑制率为100％,CD4+T淋巴细胞计数较基线变化差异无统计学意义(P>0.05);转换治疗方案48周后高密度脂蛋白、血肌酐、血糖、体质量升高,肾小球滤过率和尿微量白蛋白水平下降,差异均有统计学意义(P均<0.05).有5例患者因血脂异常转换为DTG/3TC方案,转换治疗方案48周后总胆固醇明显下降(P<0.05).有13例患者因肾毒性转换为DTG/3TC方案,转换治疗方案48周后血肌酐、肾小球滤过率、尿微量白蛋白的变化差异无统计学意义(P均>0.05).结论 达到病毒抑制的患者转换为DTG/3TC方案后能持续抑制病毒、安全性及耐受性好,特别是对于合并非艾滋病定义性疾病、出现肾毒性及血脂异常的患者,DTG/3TC方案是很好的优化治疗方案选择之一.
Abstract
Objective To evaluate the efficacy and safety of converting HIV/AIDS patients with viral suppression to single-tablet regiments dolutegravir/lamivudine (DTG/3TC) in the real world. Methods From June 1,2021 to June 1,2022,HIV/AIDS patients with long-term follow-up in the outpatient department of our hospital,who were effectively viral suppressed and converted to DTG/3TC during the study period were enrolled. The results of T lymphocyte subsets,HIV RNA,blood lipid,renal function and other indicators were collected before and during the conversion,and the occurrence of adverse events was recorded. Results This study included 79 patients with conversion treatment,which is given priority to with middle-aged men,30.4％ of patients with non-AIDS-defining-diseases. Top 3 reasons for conversion were:to simplify the regimen and improve the tolerability,side effects of medications,complicated with non-AIDS-defining diseases. Forty-eight weeks after conversion therapy,the sustained viral suppression rate was 100％ in 79 patients,and there was no significant differences in CD4+T lymphocyte count compared to baseline (P>0.05). Following 48 weeks of conversion therapy high-density lipoprotein-cholesterol,serum creatinine,blood glucose,body weight increased,estimated glomerular filtration rate and urine microalbumin decreased,and the differences were statistically significant (P<0.05). Five patients were converted to DTG/3TC because of dyslipidemia,total cholesterol decreased significantly after 48 weeks of conversion therapy (P<0.05). Thirteen patients were converted to DTG/3TC due to nephrotoxicity,and there were no significant differences in serum creatinine,estimated glomerular filtration rate,urinary microalbumin after 48 weeks of conversion therapy (P>0.05). Conclusion Conversion to DTG/3TC can achieve sustained viral suppression in patients who have achieved virological suppression,with good safety and tolerance,especially for complex patients with non-AIDS-defining-diseases,nephrotoxicity and dyslipidemia,which is one of the best optimized treatment options.
基金项目
河南省科技攻关项目(指导立项)(2023)(232102310014)
河南省重点研发与推广专项(科技攻关)(2023)(232102311081)
维普
万方数据