Abstract：
In China, non-nucleoside reverse transcriptase inhibitors (NNRTIs) are integral to the antiretroviral therapy (ART) regimen for persons living with HIV (PWH), comprising over 80% of such treatments. To broaden treatment options and improve therapeutic effectiveness, Ainuovirine (ANV), a new NNRTI, was authorized for ART in 2021. Nevertheless, the clinical efficacy of ANV and its impact on blood biochemical markers remain somewhat underexplored. This study seeks to evaluate ANV\'s clinical performance in ART and its influence on relevant treatment parameters. A retrospective analysis was performed on 208 patients treated with an ANV-based regimen from July 2021 to July 2023, monitoring indicator changes from baseline to week 24. The primary endpoint was the proportion of participants achieving HIV-1 RNA levels of less than 50 copies/mL by week 24. Secondary endpoints involved assessing variations in CD4+ T cell counts and blood biochemical markers from baseline. These outcomes were also compared with data from 241 patients treated with an Efavirenz (EFV)-based regimen in the same time frame. The findings suggest that the ANV-based regimen is as effective as the EFV-based regimen in viral suppression (p > .05) and offers superior improvements in lipid profiles, liver function, and immune system indicators, alongside fewer adverse reactions. These results affirm ANV\'s efficacy and safety as an antiretroviral therapy option, offering Acquired Immune Deficiency Syndrome patients a wider array of treatment possibilities and the potential for better treatment outcomes.
摘要：
在中国,非核苷类逆转录酶抑制剂（NNRTIs）是HIV/AIDS患者抗逆转录病毒治疗（ART）方案的组成部分，包括超过80%的此类治疗。为了拓宽治疗方案，提高治疗效果，Ainuovirine(ANV),一个新的NNRTI,2021年获得ART授权。然而，ANV的临床疗效及其对血液生化指标的影响仍存在一定程度的不足.本研究旨在评估ANV在ART中的临床表现及其对相关治疗指标的影响。从2021年7月至2023年7月，对208例接受基于ANV的方案治疗的患者进行了回顾性分析，监测从基线到第24周的指标变化。主要终点是到第24周时HIV-1RNA水平低于50拷贝/mL的参与者比例。次要终点涉及评估CD4+T细胞计数和血液生化标志物相对于基线的变化。这些结果还与在相同时间框架内接受基于EFV的方案治疗的241名患者的数据进行了比较。研究结果表明，基于ANV的方案在病毒抑制方面与基于EFV的方案一样有效（P>0.05），并提供了更好的改善血脂谱，肝功能,和免疫系统指标，不良反应较少。这些结果肯定了ANV作为抗逆转录病毒治疗选择的有效性和安全性，为艾滋病患者提供了更广泛的治疗可能性，并有可能获得更好的治疗结果。
