这项初步的现实世界研究(RWS)旨在评估抗病毒疗效,安全,2-药物方案(2DR)的可行性,dolutegravir加拉米夫定作为抗逆转录病毒(ARV)初治成人HIV-1在中国西部的初始抗逆转录病毒治疗(ART)。
此RWS包括治疗初治成人,应用2DR的dolutegravir50mg每日一次(QD)加拉米夫定300mgQD,HBsAg阴性,来自中国西部重庆巴南区人民医院的一个单一中心。病毒载量(VL),CD4+T细胞计数,和实验室指标在基线时收集;第4,12和24周,此后每24周收集一次,直至144周.主要终点是第24周时HIV-1RNA<50拷贝/mL的患者比例。
自4月1日起,共有54例接受DTG加3TC的2种药物方案治疗的ART初治患者被纳入本研究,2020年。根据纳入标准的要求,21名患者在筛选时接受了24周的VL测试。输入时的HIV-1RNA中位数为95,700个拷贝/mL(四分位距(IQR):28,300-310,000),基线CD4+细胞计数中位数为249/立方毫米(IQR:118-310)。在第24周,21名参与者中有15名(71.4%)获得了病毒学成功,定义为HIV-1RNA<50拷贝/mL,而基线HIV-1RNA<100,000拷贝/mL的11名参与者中有10名(90.9%)获得病毒学成功,而基线HIV-1RNA≥100,000拷贝/mL的10名参与者中有5名(50%)获得病毒学成功[相对风险(RR)1.818;95%CI1.018-1.927].在CD4+细胞计数≥200细胞/mm3的参与者中,12名参与者中有9名(75%)获得了病毒学成功,而基线CD4+细胞计数<200细胞/mm3的9名参与者中有6名(66.7%)获得了成功(RR1.124;95%CI0.641-1.970)。没有观察到主要的耐受性/毒性问题。
这项现实世界的研究表明,DTG加3TC的2种药物方案可以被认为是中国西部未接受ART治疗的患者的替代方案。尤其是基线时HIV-1RNA小于100,000拷贝/mL,关于病毒载量测试频率的限制和缺乏病毒抗性的HIV基因型测试。
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.