Division of Infectious Diseases, the First Hospital of Changsha, Changsha, Hunan, China.
Yidu Cloud Technology, Shanghai, China.
BMC Infect Dis. 2023 Jun 12;23(1):396. doi: 10.1186/s12879-023-08359-w.
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.
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.
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.
Compared with BIC/FTC/TAF, EFV + TDF + 3TC patients were significantly more likely to discontinue the first-line treatment in Hunan Province in China.
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。
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。
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。
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。