IntroductionThe efficacy and safety of ainuovirine+lamivudine+tenofovir (ANV+3TC+TDF) and efavirenz+lamivudine+tenofovir (EFV+3TC+TDF) have been confirmed in previous clinical trials; however, there are no related studies on patient‐reported outcomes. This study aimed to evaluate the effectiveness and safety of these 2 antiretroviral therapy regimens and to understand the patient's symptom experience and subjective experience of sleep quality through patient‐reported outcomes.MethodsThis is a single‐center prospective cohort study with 243 patients evaluated from October 1, 2021 to June 30, 2022. Virological effectiveness and patient‐reported outcomes results were analyzed. The primary endpoint was the proportion of HIV viral load <50 copies/mL (virological suppression rate) at 48 weeks and the changes in the HIV symptom index and Pittsburgh sleep quality index.ResultsThe virological suppression rates in the ANV+3TC+TDF and EFV+3TC+TDF groups were 83.6% (102/122) and 87.6% (106/121), respectively, at 48 weeks. In the ANV+3TC+TDF group, the scores of HIV symptom index and pittsburgh sleep quality index in the 48th week were lower than the baseline level (p < 0.05). Logistic regression results showed that the baseline regimen EFV+3TC+TDF was a risk factor for dizziness/lightheadedness (odds ratio = 3.153, 95% confidence interval: 1.473–6.748, p = 0.003), sadness/depression odds ratio = 2.404, 95% confidence interval:1.188–4.871, p = 0.015), and difficulty sleeping (odds ratio = 2.802, 95% confidence interval: 1.437–5.463, p = 0.002) at 48 weeks.ConclusionsBoth regimens showed good virological effectiveness; however, compared with ANV+3TC+TDF, the EFV+3TC+TDF regimen reduced the prevalence of HIV‐related symptoms.

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新型非核苷逆转录酶抑制剂的临床益处：一项前瞻性队列研究

简介艾诺韦林+拉米夫定+替诺福韦（ANV+3TC+TDF）和依非韦伦+拉米夫定+替诺福韦（EFV+3TC+TDF）的疗效和安全性已在既往临床试验中得到证实；然而，没有关于患者报告结果的相关研究。本研究旨在评估这2种抗逆转录病毒治疗方案的有效性和安全性，并通过患者报告的结果了解患者的症状体验和睡眠质量的主观体验。方法这是一项单中心前瞻性队列研究，自10月1日起对243名患者进行了评估，2021年至2022年6月30日。分析了病毒学有效性和患者报告的结果。主要终点为48周时HIV病毒载量<50拷贝/mL的比例（病毒学抑制率）以及HIV症状指数和匹兹堡睡眠质量指数的变化。 结果ANV+3TC+TDF和EFV的病毒学抑制率48周时+3TC+TDF组分别为83.6%（102/122）和87.6%（106/121）。 ANV+3TC+TDF组中，第48周的HIV症状指数和匹兹堡睡眠质量指数得分均低于基线水平（p< 0.05）。 Logistic 回归结果显示，基线方案 EFV+3TC+TDF 是头晕/头晕的危险因素（比值比 = 3.153，95% 置信区间：1.473–6.748，p= 0.003)，悲伤/抑郁优势比 = 2.404，95% 置信区间：1.188–4.871，p= 0.015）和睡眠困难（比值比 = 2.802，95% 置信区间：1.437–5.463，p= 0.002) 在 48 周时。结论 两种方案均显示出良好的病毒学有效性；然而，与ANV+3TC+TDF相比，EFV+3TC+TDF方案降低了HIV相关症状的患病率。