Department of Infection, Chengdu Public Health Clinical Medical Center, Chengdu, China .
J Acquir Immune Defic Syndr. 2022 Oct 1;91(S1):S1-S7. doi: 10.1097/QAI.0000000000003041.
The application time of dolutegravir (DTG) is relatively short, and the treatment experience is insufficient. Therefore, evidence is required to shed more light on the effectiveness and safety issues of DTG in China.
To assess the effectiveness and safety of a DTG vs. efavirenz (EFV) antiviral regimens (the current mainstream regimen).
This was a retrospective cohort study. Data of people with HIV (PWH), who started initial DTG-based or EFV-based antiretroviral therapy at the Chengdu Public Health Clinical Medical Center from January 2018 to October 2020, were collected. Effectiveness indicators such as CD4+ T-cell recovery and HIV viral suppression, and safety indicators, including blood routine, liver and kidney function, and occurrence of abnormal blood lipids after DTG vs. EFV-based antiviral regimen treatments, were analyzed.
A total of 656 patients were eligible, of which 611 patients were included in the study. Most of the PWHs in our center were young men (86.25%). Nearly one-third of the participants were coinfected with syphilis. The median baseline HIV viral load was 4.70 log10 copies/mL. The median CD4+ T-cell count was 254 cells/mm3. More participants started on EFV-based regimens than DTG-based regimens (82.32% vs. 17.67%). The time to reach the target value (CD4 > 350 cells/mm3) in the DTG group was shorter than that in the EFV group (408 days vs. 522 days), and the percentage of reaching the CD4 target value of the DTG group was higher than that of the EFV group (41.04% vs. 33.76%) in 1 year. The effect of virologic suppression (<50 copies/mL) in the DTG group was superior to that in the EFV group. The use of DTG-containing treatment regimens was significantly related to a quicker virologic suppression (hazard ratio, 1.76; 95% confidence interval of 1.40-2.21, P < 0.0001). The safety data analysis of laboratory indicators showed that there was no significant difference in the incidence of adverse events between the 2 groups.
A DTG-based regimen may be more conducive to the CD4 recovery than the EFV-based regimen. The virologic suppression of the DTG group may be superior to that of the EFV group. DTG-based regimens might be the preferred treatment option for people with HIV for initial HIV treatment.
多拉韦林（DTG）的应用时间相对较短，治疗经验不足。因此，需要有证据来更清楚地了解 DTG 在我国的有效性和安全性问题。
评估 DTG 与依非韦伦（EFV）抗病毒方案（目前的主流方案）的疗效和安全性。
这是一项回顾性队列研究。收集了 2018 年 1 月至 2020 年 10 月在成都市公共卫生临床医疗中心开始初始 DTG 或 EFV 为基础的抗逆转录病毒治疗的 HIV 感染者（PWH）的数据。分析了 CD4+T 细胞恢复和 HIV 病毒抑制等疗效指标，以及 DTG 与 EFV 为基础的抗病毒方案治疗后血常规、肝肾功能和血脂异常发生率等安全性指标。
共纳入 656 名符合条件的患者，其中 611 名患者纳入研究。本中心的 PWH 多为年轻男性（86.25%）。近三分之一的参与者合并梅毒感染。中位基线 HIV 病毒载量为 4.70 log10 拷贝/ml。中位 CD4+T 细胞计数为 254 个/mm3。开始 EFV 为基础的方案治疗的参与者多于 DTG 为基础的方案（82.32% vs. 17.67%）。DTG 组达到目标值（CD4>350 个/mm3）的时间短于 EFV 组（408 天 vs. 522 天），1 年内 DTG 组达到 CD4 目标值的比例高于 EFV 组（41.04% vs. 33.76%）。DTG 组的病毒学抑制（<50 拷贝/ml）效果优于 EFV 组。含 DTG 的治疗方案的使用与更快的病毒学抑制显著相关（风险比，1.76；95%置信区间为 1.40-2.21，P<0.0001）。实验室指标不良事件发生率的安全性数据分析显示，两组间无显著差异。
与 EFV 为基础的方案相比，DTG 为基础的方案可能更有利于 CD4 恢复。DTG 组的病毒学抑制可能优于 EFV 组。DTG 为基础的方案可能是 HIV 初治患者的首选治疗方案。
