Department of Infection, People's hospital of Chongqing Banan District, Chongqing, China.
Curr HIV Res. 2022;20(3):222-227. doi: 10.2174/1570162X20666220514165728.
This preliminary real-world study (RWS) was designed to evaluate the antiviral efficacy, safety, and feasibility of the 2-drug regimen (2DR), dolutegravir plus lamivudine as the initial antiretroviral therapy (ART) among antiretroviral (ARV)-naïve adults with HIV-1 in West China.
This RWS included the treatment of treatment-naïve adults applying 2DR of dolutegravir 50 mg once daily (QD) plus lamivudine 300mg QD with negative HBsAg from one single center of People's Hospital of Chongqing Banan District in West China. Viral load (VL), CD4+ T-cell count, and laboratory indicators were collected at baseline; weeks 4, 12, and 24, and thereafter every 24 weeks up to 144 weeks. The primary endpoint was the proportion of patients with HIV-1 RNA <50 copies/mL at week 24.
A total of 54 ART-naïve patients were treated with the 2-drug regimen of DTG plus 3TC and were enrolled in this study since April 1st, 2020. Twenty-one patients received 24-week VL tests at screening as required by inclusion criteria. Median HIV-1 RNA at entry was 95,700 copies/ mL (interquartile range (IQR): 28,300-310,000) and the median baseline CD4+ cell count was 249 per cubic millimetre(IQR: 118-310). At week 24, 15 (71.4%) of 21 participants achieved virological success, defined as HIV-1 RNA < 50 copies/mL, while 10 (90.9%) of 11 participants with a baseline HIV-1 RNA < 100,000 copies/mL achieved virological success compared with 5 (50%) of 10 participants with a baseline HIV-1 RNA ≥100,000 copies/mL [Relative Risk (RR) 1.818; 95% CI 1.018-1.927]. In participants with CD4+ cell counts ≥ 200 cells/mm3, 9 (75%) of 12 participants achieved virological success compared with 6 (66.7%) of 9 participants with baseline CD4+ cell count < 200 cells/mm3 achieved it (RR 1.124; 95% CI 0.641-1.970). No major tolerability/toxicity issues were observed.
This real-world study suggested that the 2-drug regimen of DTG plus 3TC could be considered as an alternative for ART-naïve patients in West China, especially with HIV-1 RNA less than 100,000 copies/mL at baseline, regarding the limits of viral load test frequency and the absence of HIV genotypic testing of viral resistance.
本初步真实世界研究（RWS）旨在评估在西中国初治的 HIV-1 成人中，使用二药方案（2DR）即每日一次（QD）50mg 度鲁特韦加 300mg 拉米夫定作为初始抗逆转录病毒治疗（ART）的抗病毒疗效、安全性和可行性。
本 RWS 纳入了来自西中国重庆市巴南区人民医院单一中心的初治成年人应用 2DR 即每日一次 50mg 度鲁特韦加 300mg 拉米夫定（如果 HBsAg 为阴性）进行治疗。在基线时收集病毒载量（VL）、CD4+T 细胞计数和实验室指标；在第 4、12 和 24 周以及此后每 24 周，直至 144 周。主要终点是第 24 周时 HIV-1 RNA <50 拷贝/mL 的患者比例。
自 2020 年 4 月 1 日以来，共有 54 名初治的接受 DTG 加 3TC 二药方案治疗的 ART 患者被纳入本研究。有 21 名患者按纳入标准要求在筛查时接受了 24 周的 VL 检测。入组时 HIV-1 RNA 的中位数为 95,700 拷贝/mL（四分位距（IQR）：28,300-310,000），CD4+细胞计数的中位数为 249 个/立方毫米（IQR：118-310）。在第 24 周时，21 名参与者中有 15 名（71.4%）实现了病毒学成功，定义为 HIV-1 RNA <50 拷贝/mL，而在基线 HIV-1 RNA <100,000 拷贝/mL 的 11 名参与者中有 10 名（90.9%）实现了病毒学成功，与基线 HIV-1 RNA ≥100,000 拷贝/mL 的 10 名参与者中有 5 名（50%）相比（相对风险（RR）1.818；95%CI 1.018-1.927）。在 CD4+细胞计数≥200 个/立方毫米的参与者中，12 名中有 9 名（75%）实现了病毒学成功，与基线 CD4+细胞计数<200 个/立方毫米的 9 名参与者中有 6 名（66.7%）相比（RR 1.124；95%CI 0.641-1.970）。未观察到主要的耐受性/毒性问题。
本真实世界研究表明，对于初治的 HIV-1 成人，尤其是基线 HIV-1 RNA 小于 100,000 拷贝/mL 的患者，DTG 加 3TC 二药方案可作为一种替代 ART 方案，考虑到病毒载量检测频率的限制和缺乏 HIV 耐药基因检测。
