智通财经APP获悉，默沙东（MSD）(MRK.US)今日宣布启动EXPrESSIVE临床3期项目，评估其在研口服每月一次小分子疗法MK-8527，用于HIV暴露前预防（PrEP）的安全性和有效性。其中，EXPrESSIVE-11（MK-8527-011）试验预计于2025年8月开始招募受试者，该试验旨在评估MK-8527在HIV-1暴露风险较高人群中的安全性和有效性。而与盖茨基金会（Gates Foundation）合作开展的EXPrESSIVE-10（MK-8527-010）试验则将评估MK-8527在撒哈拉以南非洲地区女性及青春期女孩中的安全性和有效性，预计将在未来几个月内启动受试者招募。
默沙东决定启动3期临床试验项目，依据是一项双盲、多中心2期临床试验（MK-8527-007）的结果。该研究评估了MK-8527的安全性和药代动力学，共招募了350名年龄在18至65岁之间、HIV-1暴露风险较低的受试者。这些受试者按2：2：2：1比例随机分组，接受每月一次口服MK-8527（3毫克、6毫克或12毫克）或安慰剂，持续6个月。试验中，MK-8527各剂量组与安慰剂组的不良事件发生率相近，且实验室检测（包括总淋巴细胞计数和CD4阳性T细胞计数）未见具有临床意义的变化。MK-8527及其活性形式MK-8527-TP的药代动力学数据支持其作为每月一次口服PrEP选择的持续开发。
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