多替拉韦钠联合拉米夫定双药方案治疗初治高病毒载量 HIV-1 感染患者:来自真实世界的初步数据。

Dolutegravir Plus Lamivudine Dual-Drug Regimen in Treatment-Naive HIV-1-Infected Patients With High-Level Viral Load: Preliminary Data From the Real World.

机构信息

Department of Infectious Diseases, National Clinical Research Center for Infectious Disease, State Key Discipline of Infectious Disease, Shenzhen Third People's Hospital, Second Hospital Affiliated to Southern University of Science and Technology, Shenzhen, Guangdong, China.

出版信息

J Acquir Immune Defic Syndr. 2022 Oct 1;91(S1):S16-S19. doi: 10.1097/QAI.0000000000003053.

Abstract

BACKGROUND

Some inpatients with HIV-RNA ≥500,000 copies/mL in China need to use 2-drug regimen for some reasons, although limited data are available for dolutegravir plus lamivudine (3TC) in those patients with ultra-high viral loads.

METHODS

We conducted a single-center retrospective-prospective study in China and enrolled 42 ART-naive HIV-infected inpatients who use a once-daily 2-drug regimen because of various reasons (drug interaction, renal impairment, age, and other related comorbidities).They were divided into 2 groups, low viral load group (baseline viral load <500,000 copies/mL, n = 20) and high viral load group (baseline viral load ≥500,000 copies/mL, n = 22). All patients were followed up for 48 weeks.

RESULTS

The median of baseline viral load was 5.74 log10 copies/mL and CD4+ T-cell count was 59 cells/μL. At week 48, there was no significant difference (P = 0.598) in proportions of participants with HIV-1 RNA <50 copies/mL [90%, 95% confidence interval (CI) (75.6% to 104.4%) in low viral load groups vs 95.5%, 95% CI (86.0% to 104.9%) in high viral load groups]. No differences were found in mean increase of CD4+ T-cell count from baseline between 2 groups (218 ± 122 vs 265 ± 127 cells/μL, P = 0.245). There is no grade 3 or higher treatment-related adverse events and none discontinued treatment because of adverse events.

CONCLUSIONS

The results of our study in real world support dolutegravir + 3TC dual regimen as a promising therapy option for treatment-naive HIV-infected patient with baseline viral load ≥500,000 copies/mL.

摘要

背景

在中国,一些 HIV-RNA≥500,000 拷贝/mL 的住院患者由于某些原因需要使用 2 种药物治疗方案,尽管对于基线病毒载量超高的患者,使用多拉韦林加拉米夫定(3TC)的有限数据可用。

方法

我们在中国进行了一项单中心回顾性前瞻性研究,共纳入 42 名因药物相互作用、肾功能损害、年龄和其他相关合并症等各种原因而使用每日一次 2 种药物治疗方案的初治 HIV 感染住院患者。他们被分为两组,低病毒载量组(基线病毒载量<500,000 拷贝/mL,n=20)和高病毒载量组(基线病毒载量≥500,000 拷贝/mL,n=22)。所有患者均随访 48 周。

结果

基线病毒载量中位数为 5.74log10 拷贝/mL,CD4+T 细胞计数为 59 个/μL。第 48 周时,两组 HIV-1 RNA<50 拷贝/mL 的参与者比例无显著差异(P=0.598)[低病毒载量组为 90%(75.6%104.4%),高病毒载量组为 95.5%(86.0%104.9%)]。两组从基线开始 CD4+T 细胞计数平均增加量无差异(218±122 与 265±127 个/μL,P=0.245)。无 3 级或更高级别的治疗相关不良事件,也无因不良事件而停止治疗的患者。

结论

本真实世界研究结果支持多拉韦林+3TC 双药治疗方案作为一种有前途的治疗选择,适用于基线病毒载量≥500,000 拷贝/mL 的初治 HIV 感染患者。

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