比克替拉韦/来那卡帕韦：一种用于治疗HIV-1感染的二药方案。
完整摘要 · 中文译文
目的：评价比克替拉韦/来那卡帕韦治疗HIV-1感染的疗效和安全性。数据来源：在PubMed和Google Scholar（2016年1月-2026年8月）中使用检索词比克替拉韦和来那卡帕韦进行文献检索。其他数据来源包括近期会议上展示的摘要和处方信息。研究选择和数据提取：所有评估比克替拉韦/来那卡帕韦治疗HIV-1感染疗效和安全性的英文研究均被考虑纳入。数据综合：比克替拉韦是一种成熟的第二代整合酶链转移抑制剂（INSTI），而来那卡帕韦是一种新型衣壳抑制剂。两种抗逆转录病毒药物对HIV-1均具有高度活性。比克替拉韦/来那卡帕韦75 mg/50 mg在两项3期临床试验中显示，从复杂抗逆转录病毒治疗（ART）或比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺转换治疗后安全有效。美国食品药品监督管理局批准该复方制剂用于治疗病毒学抑制稳定、对各自成分无耐药的成人HIV-1感染。该药以单 tablet方案（STR）形式提供，每日口服一次。与现有药物相比对患者护理和临床实践的相关性：比克替拉韦/来那卡帕韦是首个用于治疗HIV-1感染的INSTI-衣壳抑制剂双药STR。该复方制剂可能对希望简化方案的患者和/或不能使用核苷（酸）或非核苷 核苷类逆转录酶抑制剂。它对乙型肝炎病毒合并感染无活性。 结论：比克替拉韦/来那卡韦作为双药方案用于治疗成人HIV-1感染是安全且有效的。
完整摘要 · 英文原文
OBJECTIVE: To evaluate the efficacy and safety of bictegravir/lenacapavir for the treatment of HIV-1 infection. DATA SOURCES: A literature search was conducted in PubMed and Google Scholar (January 2016-August 2026) using the search terms bictegravir and lenacapavir. Other data sources included abstracts presented at recent conferences and the prescribing information. STUDY SELECTION AND DATA EXTRACTION: All English-language studies assessing the efficacy and safety of bictegravir/lenacapavir for the treatment of HIV-1 infection were considered for inclusion. DATA SYNTHESIS: Bictegravir is an established second-generation integrase strand transfer inhibitor (INSTI), whereas lenacapavir is a novel capsid inhibitor. Both antiretrovirals are highly active against HIV-1. Bictegravir/lenacapavir 75 mg/50 mg was shown to be safe and effective in two phase 3 clinical trials after switching from complex antiretroviral therapy (ART) or bictegravir/emtricitabine/tenofovir alafenamide. The Food and Drug Administration approved this combination for the treatment of HIV-1 infection in adults who are virologically suppressed on stable ART with no resistance to the individual components. It is available as a single-tablet regimen (STR) taken orally once daily.Relevance to Patient Care and Clinical Practice in Comparison With Existing Drugs:Bictegravir/lenacapvir is the first INSTI-capsid inhibitor 2-drug STR indicated for the treatment of HIV-1 infection. The combination could be useful for patients who want to simplify their regimen and/or those who cannot use a nucleos(t)ide or a non-nucleoside reverse transcriptase inhibitor. It is not active against hepatitis B virus coinfection. CONCLUSIONS: Bictegravir/lenacapvir is safe and efficacious as a 2-drug regimen for the treatment of adults with HIV-1 infection.