Suppression of HIV in the first 12 months of antiretroviral therapy: a comparative analysis of dolutegravir- and efavirenz-based regimens

ABSTRACT Objective To compare viral suppression in treatment-naïve adults starting antiretroviral therapy with dolutegravir (50mg)- and efavirenz (600mg)-based regimens. Methods We analyzed secondary data from Brazilian health information systems of people living with human immunodeficiency virus who started antiretroviral therapy between 2015 and 2017 in Minas Gerais, Brazil. The outcome was viral suppression, defined as the achievement of the first viral load <50 copies/mL within 12 months after initiating antiretroviral therapy. This outcome was also compared with viral load <1,000 copies/mL and analyzed in two scenarios: intention-to-treat versus per-protocol. Time to viral suppression and adjusted odds ratio accompanied by 95% confidence intervals were estimated. Results Of the 2,599 participants enrolled, 77.5% were men, and the median age was 34 years. In the intention-to-treat analysis, viral suppression was 58.1% for efavirenz and 76.7% for dolutegravir. People living with HIV on dolutegravir-based regimen were more likely to achieve viral suppression (aOR: 2.44; 95%CI: 2.01-2.95) and had a shorter median time to viral suppression (p<0.0001). Antiretroviral therapy initiation within <120 days, baseline CD4⁺T-cells ≥200 cells/mm3, and viral load <100,000 copies/mL had higher odds of viral suppression. According to the per-protocol analysis, viral suppression ≥90% was observed by considering viral load <1,000 copies/mL. Conclusion Our study demonstrated that viral suppression improved after introducing dolutegravir, although the proportion of patients with viral load <50 copies/mL was lower than expected. Improved access to routine viral load examinations and continuous surveillance of the effectiveness of antiretroviral therapy should be considered.

摘要
研究目的：比较初治成人分别接受基于多替拉韦（dolutegravir，50mg）与依非韦伦（efavirenz，600mg）的抗反转录病毒治疗（antiretroviral therapy, ART）方案后的病毒抑制情况。
研究方法：本研究分析了巴西米纳斯吉拉斯州2015至2017年间启动抗反转录病毒治疗的人类免疫缺陷病毒（human immunodeficiency virus, HIV）感染者的巴西卫生信息系统二级数据。研究结局为病毒抑制，定义为启动抗反转录病毒治疗后12个月内首次实现病毒载量＜50 copies/mL；同时以病毒载量＜1000 copies/mL作为替代结局，并在意向治疗（intention-to-treat, ITT）与符合方案（per-protocol, PP）两种分析场景下进行比较。本研究估算了病毒抑制所需时间、校正比值比（adjusted odds ratio, aOR）及其95%置信区间（confidence interval, CI）。
研究结果：本研究纳入的2599名受试者中，77.5%为男性，中位年龄为34岁。在意向治疗分析中，依非韦伦组的病毒抑制率（病毒载量＜50 copies/mL）为58.1%，多替拉韦组为76.7%。接受基于多替拉韦治疗方案的HIV感染者更易实现病毒抑制（校正比值比：2.44；95%CI：2.01~2.95），且病毒抑制的中位时间更短（p＜0.0001）。在启动抗反转录病毒治疗前120天内开始治疗、基线CD4⁺T细胞≥200 cells/mm³以及基线病毒载量＜100000 copies/mL的患者，病毒抑制的比值比更高。符合方案分析结果显示，当以病毒载量＜1000 copies/mL为判定标准时，病毒抑制率≥90%。
研究结论：本研究证实，引入多替拉韦治疗后病毒抑制情况得到改善，但病毒载量＜50 copies/mL的患者比例低于预期。临床实践中应考虑优化常规病毒载量检测的可及性，并持续开展抗反转录病毒治疗有效性的监测工作。