Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression

作者：Susan Swindells, Jaime Andrade‐Villanueva, Gary Richmond, Giuliano Rizzardini, Axel Baumgarten, Mar Masiá, Gulam Latiff, Vadim Pokrovsky, Fritz Bredeek, Graham Smith, Pedro Cahn, Kim Ys, Susan L. Ford, Christine L. Talarico, Parul Patel, Vasiliki Chounta, Herta Crauwels, Wim Parys, Simon Vanveggel, Joseph Mrus, Jenny Huang, Conn Harrington, Krischan J Hudson, David A. Margolis, Kimberly Y. Smith, Peter Williams, William Spreen · 发表于：New England Journal of Medicine · 年份：2020 · DOI：10.1056/nejmoa1904398 · 被引用次数：580 · 研究领域：HIV/AIDS drug development and treatment、HIV Research and Treatment、HIV/AIDS Research and Interventions

BACKGROUND: Simplified regimens for the treatment of human immunodeficiency virus type 1 (HIV-1) infection may increase patient satisfaction and facilitate adherence. METHODS: In this phase 3, open-label, multicenter, noninferiority trial involving patients who had had plasma HIV-1 RNA levels of less than 50 copies per milliliter for at least 6 months while taking standard oral antiretroviral therapy, we randomly assigned participants (1:1) to either continue their oral therapy or switch to monthly intramuscular injections of long-acting cabotegravir, an HIV-1 integrase strand-transfer inhibitor, and long-acting rilpivirine, a nonnucleoside reverse-transcriptase inhibitor. The primary end point was the percentage of participants with an HIV-1 RNA level of 50 copies per milliliter or higher at week 48, determined with the use of the Food and Drug Administration snapshot algorithm. RESULTS: Treatment was initiated in 308 participants per group. At week 48, HIV-1 RNA levels of 50 copies per milliliter or higher were found in 5 participants (1.6%) receiving long-acting therapy and in 3 (1.0%) receiving oral therapy (adjusted difference, 0.6 percentage points; 95% confidence interval [CI], -1.2 to 2.5), a result that met the criterion for noninferiority for the primary end point (noninferiority margin, 6 percentage points). An HIV-1 RNA level of less than 50 copies per milliliter at week 48 was found in 92.5% of participants receiving long-acting therapy and in 95.5% of those rece...