III期ARTISTRY-2研究达主要终点，吉利德新型HIV二联疗法展现潜力

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12月15日，吉利德宣布III期ARTISTRY-2研究取得积极顶线结果。该双盲试验评估了病毒学抑制的HIV成人患者从比克替拉韦50mg/恩曲他滨200mg/丙酚替诺福韦25mg片剂（BIKTARVY®，B/F/TAF）转换为比克替拉韦75mg/来那卡帕韦50mg固定剂量复方制剂（BIC/LEN）后的治疗反应。研究结果显示，BIC/LEN的疗效在统计学上非劣于BIKTARVY。吉利德计划将...

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href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251218071039a6afa5d0&s=b><strong>药事纵横</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>12月15日，吉利德宣布III期ARTISTRY-2研究取得积极顶线结果。该双盲试验评估了病毒学抑制的HIV成人患者从比克替拉韦50mg/恩曲他滨200mg/丙酚替诺福韦25mg片剂（BIKTARVY®，B/F/TAF）转换为比克替拉韦75mg/来那卡帕韦50mg固定剂量复方制剂（BIC/LEN）后的治疗反应。研究结果显示，BIC/LEN的疗效在统计学上非劣于BIKTARVY。吉利德计划将...</p>\n\n<a 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INNOVATION \"I\" (SGD) ACC","LU1839511570.USD":"WELLS FARGO GLOBAL FACTOR ENHANCED EQUITY \"I\" (USD) ACC","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","BK4585":"ETF&股票定投概念"},"translate_title":"Phase III ARTISTRY-2 study reached primary endpoint, Gilead's new HIV dual therapy showed potential","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"III":1.5,"GILD":0.9},"content_text":"12月15日，吉利德宣布III期ARTISTRY-2研究取得积极顶线结果。该双盲试验评估了病毒学抑制的HIV成人患者从比克替拉韦50mg/恩曲他滨200mg/丙酚替诺福韦25mg片剂（BIKTARVY®，B/F/TAF）转换为比克替拉韦75mg/来那卡帕韦50mg固定剂量复方制剂（BIC/LEN）后的治疗反应。研究结果显示，BIC/LEN的疗效在统计学上非劣于BIKTARVY。吉利德计划将ARTISTRY研究的III期结果提交给监管机构，并将在未来的科学大会上公布详细数据。在ARTISTRY-2研究中，每日一次的单片复方方案BIC/LEN达到了主要成功标准，其疗效非劣于BIKTARVY。主要疗效终点为第48周时HIV-1 RNA≥50拷贝/mL的参与者百分比，依据FDA快照算法定义。该创新组合总体耐受性良好，试验期间未发现新的或显著的安全问题。该研究方案结合了比克替拉韦——一种被全球指南推荐的具有高耐药屏障的整合酶链转移抑制剂（INSTI），以及来那卡帕韦——一种首创的衣壳抑制剂，与其他现有药物类别无交叉耐药性。比克替拉韦与来那卡帕韦的单片复方方案有望进一步变革HIV治疗格局，为病毒学抑制的HIV感染者提供一种基于最新药物研发成果的治疗选择。ARTISTRY-2（NCT06333808）是一项多中心、双盲、随机III期临床试验，旨在评估每日一次比克替拉韦/来那卡帕韦复方方案与BIKTARVY在病毒学抑制的HIV感染者中的安全性与疗效。参与者在接受BIKTARVY治疗的基础上，以2:1比例随机转换为BIC/LEN或继续原方案。主要终点为第48周时HIV-1 RNA≥50拷贝/mL的患者比例，依据FDA快照算法评估。关键次要终点包括第48周时病毒学抑制（HIV RNA <50拷贝/mL）比例、CD4细胞计数较基线的变化，以及治疗期间出现的不良事件（TEAE）比例。“HIV治疗领域正在不断演进。作为HIV防治共同体的一员，我们必须面向未来，开发更具个性化的治疗方案，以满足HIV感染者的多样化需求与偏好，”吉利德科学公司病毒治疗领域临床开发高级副总裁Jared Baeten医学博士表示，“这些数据支持BIC/LEN作为病毒学抑制HIV成人患者的一项有意义的新治疗选择。我们期待在明年公布ARTISTRY-1与ARTISTRY-2两项III期研究的完整数据，并提交监管机构审批。”ARTISTRY-2的研究结果将与III期ARTISTRY-1（NCT05502341）研究的发现共同构成监管申报的基础。吉利德已于2025年11月公布了ARTISTRY-1的顶线结果，显示BIC/LEN组合耐受性良好，在疗效上非劣于多片式抗反转录病毒治疗方案。目前，比克替拉韦与来那卡帕韦的联合用药方案仍处于研究阶段，尚未在全球任何国家获批。该组合的安全性与有效性尚未获得美国FDA的确认。目前尚无治愈HIV或艾滋病的方法。关于比克替拉韦比克替拉韦是一种被全球指南推荐的整合酶链转移抑制剂（INSTI），具有高耐药屏障。INSTI是一类通过靶向病毒整合酶发挥作用的抗反转录病毒药物。比克替拉韦需与其他抗反转录病毒药物联合使用，用于HIV治疗。关于来那卡帕韦来那卡帕韦已在多个国家获批用于HIV暴露前预防（PrEP），以降低高风险成人和青少年通过性行为感染HIV的风险。该药物也已在多国获批与其他抗反转录病毒药物联合使用，用于治疗多重耐药HIV感染。来那卡帕韦通过多阶段机制作用于HIV生命周期，不同于目前获批的其他抗反转录病毒药物类别。大多数抗反转录病毒药物仅作用于病毒复制的一个阶段，而来那卡帕韦设计用于在多个阶段抑制HIV，并在体外研究中未表现出与其他药物类别的交叉耐药性。来那卡帕韦正在被评估作为长效治疗选择，参与吉利德HIV预防和治疗研究项目中多个正在进行和计划中的早期及晚期临床研究。该药物被开发为未来HIV疗法的基础，旨在提供多种剂型的长效口服和注射方案，既可联合使用，也可作为单药治疗，以满足HIV感染者和受影响社区的个体化需求与偏好。来源：gilead官网","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 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