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在中国湖南省新开始接受治疗的 HIV-1 患者中,比克替拉韦/恩曲他滨/丙酚替诺福韦和依非韦伦+拉米夫定+富马酸替诺福韦二吡呋酯的治疗持续时间。

Treatment persistence of bictegravir/emtricitabine/tenofovir alafenamide and efavirenz + lamivudine + tenofovir disoproxil among HIV-1 patients newly starting treatment in Hunan Province in China.

机构信息

Division of Infectious Diseases, the First Hospital of Changsha, Changsha, Hunan, China.

Yidu Cloud Technology, Shanghai, China.

出版信息

BMC Infect Dis. 2023 Jun 12;23(1):396. doi: 10.1186/s12879-023-08359-w.

Abstract

BACKGROUND

Though bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF) have been regulatory approved and included in the National Reimbursement Drug List in China, due to the affordability concern, generic version of efavirenz + lamivudine + tenofovir (EFV + 3TC + TDF) is still recommended as the first-line therapy in the clinical guideline and widely used in clinical practice. The aim of the study is to assess the persistence with first-line BIC/TAF/TAF and EFV + 3TC + TDF in newly treated HIV-1 patients in the real-world setting in Hunan Province in China.

METHODS

A retrospective analysis of the medical records of HIV patients initiating first-line antiretroviral therapy in the First Hospital of Changsha in January 1st, 2021-July 31st, 2022 was conducted. Persistence was assessed as the number of days on the therapy from the index until treatment discontinuation or end of data availability. Kaplan-Meier Curves and Cox Proportional Hazard models were used to evaluate the discontinuation rates. Subgroup analysis was performed excluding BIC/FTC/TAF patients with treatment discontinuation due to economic reason, and EFV + 3TC + TDF patients with a viral load > 500,000 copies/mL.

RESULTS

A total of 310 eligible patients were included in the study, with 244 and 66 patients in the BIC/FTC/TAF group and EFV + 3TC + TDF group, respectively. Compared with EFV + 3TC + TDF patients, BIC/FTC/TAF patients were older, more living in the capital city currently, and had significantly higher total cholesterol and low-density level (all p < 0.05). No significant difference was shown in the time to discontinuation between BIC/FTC/TAF patients and EFV + 3TC + TDF patients. After excluding BIC/FTC/TAF patients with treatment discontinuation due to economic reason, EFV + 3TC + TDF group were shown to have a significantly higher risk of discontinuation than BIC/FTC/TAF group (hazard ratio [HR] = 11.1, 95% confidence interval [CI] = 1.3-93.2). After further removing the EFV + 3TC + TDF patients with a viral load > 500,000 copies/mL, the analysis showed similar results (HR = 10.1, 95% CI = 1.2-84.1). 79.4% of the EFV + 3TC + TDF patients discontinued treatment due to clinical reasons, while 83.3% of the BIC/FTC/TAF patients discontinued treatment due to economic reasons.

CONCLUSIONS

Compared with BIC/FTC/TAF, EFV + TDF + 3TC patients were significantly more likely to discontinue the first-line treatment in Hunan Province in China.

摘要

背景

尽管比克替拉韦/恩曲他滨/替诺福韦(BIC/FTC/TAF)已在监管方面获得批准并被纳入中国国家医保药品目录,但由于负担能力的问题,依非韦伦+拉米夫定+替诺福韦(EFV+3TC+TDF)的仿制药仍被推荐作为临床指南中的一线治疗药物,并在临床实践中广泛使用。本研究的目的是评估在中国湖南省新接受 HIV-1 治疗的患者在真实环境中使用一线 BIC/TAF/TAF 和 EFV+3TC+TDF 的持续性。

方法

对 2021 年 1 月 1 日至 2022 年 7 月 31 日期间在长沙市第一医院首次接受一线抗逆转录病毒治疗的 HIV 患者的病历进行回顾性分析。从指数日到治疗停止或数据可用结束的治疗天数评估持续性。采用 Kaplan-Meier 曲线和 Cox 比例风险模型评估停药率。对排除因经济原因而停止 BIC/FTC/TAF 治疗和 EFV+3TC+TDF 治疗且病毒载量>500,000 拷贝/ml 的患者进行亚组分析。

结果

共纳入 310 例符合条件的患者,其中 BIC/FTC/TAF 组和 EFV+3TC+TDF 组分别为 244 例和 66 例。与 EFV+3TC+TDF 组相比,BIC/FTC/TAF 组患者年龄更大,目前更多居住在省会城市,总胆固醇和低密度脂蛋白水平显著更高(均 P<0.05)。BIC/FTC/TAF 组和 EFV+3TC+TDF 组的停药时间无显著差异。排除因经济原因停止 BIC/FTC/TAF 治疗的患者后,EFV+3TC+TDF 组停药风险显著高于 BIC/FTC/TAF 组(风险比[HR]=11.1,95%置信区间[CI]=1.3-93.2)。进一步排除 EFV+3TC+TDF 组病毒载量>500,000 拷贝/ml 的患者后,分析结果相似(HR=10.1,95%CI=1.2-84.1)。EFV+3TC+TDF 组 79.4%的患者因临床原因停止治疗,而 BIC/FTC/TAF 组 83.3%的患者因经济原因停止治疗。

结论

与 BIC/FTC/TAF 相比,EFV+TDF+3TC 组在中国湖南省更有可能停止一线治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b643/10258991/987ee90439e9/12879_2023_8359_Figa_HTML.jpg

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