A Randomized Trial to Compare Dolutegravir Plus Boosted Darunavir Versus Recommended Standard of Care Antiretroviral Regimens in People With HIV-1, Whose First-line Non-nucleoside Reverse Transcriptase Inhibitor Therapy Has Failed: Final 96-week Results of the D2EFT Study

作者：Phyo Pyae Nyein, Margaret Borok, Nnakelu Eriobu, Richard Kaplan, Nagalingeswaran Kumarasamy, Anchalee Avihingsanon, Marcelo Losso, Iskandar Azwa, Muhammad Karyana, Sounkalo Dao, Mohamed Cissé, Jaime Andrade‐Villanueva, Sergio Lupo, Sandra Wagner Cardoso, Evy Yunihastuti, Yanri Wijayanti Subronto, Munawaroh Fitriah, Sudirman Katu, Dannae Brown, Emmanuelle Papot, Jolie Hutchinson, Anthony D. Kelleher, Josh Hanson, Nila J. Dharan, Kathy Petoumenos, Gail Matthews, the D2EFT Study Team, Marcelo Losso, Sergio Lupo, A.M. Solari, Silvina Tavella, D. James Cooper, Sean Emery, Mark N. Polizzotto, Anthony Kelleher, Matthew Law, Gail V Matthews, Beatriz Grinsztejn, Marcelo Wolff, Otto Sussmann, Mohamed Cissé, Selvamuthu Poongulali, Usman Hadi, Sudirman Katu, Yanri Wijayanti Subronto, Evy Yunihastuti, Iskandar Azwa, Ting Soo, Sounkalo Dao, Juan Luis Mosqueda Gómez, Juan Sierra Madero, Jaime Andrade‐Villanueva, Nnakelu Eriobu, Jaclyn Ann, Richard Kaplan, Lerato Mohapi, Anchalee Avihingsanon, Ploenchan, Suwimon Khusuwan, Weerawat Manosuthi, Margaret Borok · 发表于：Clinical Infectious Diseases · 年份：2025 · DOI：10.1093/cid/ciaf346 · 被引用次数：2 · 研究领域：HIV/AIDS drug development and treatment、HIV/AIDS Research and Interventions、HIV-related health complications and treatments

BACKGROUND: Longer-term outcome data following second-line antiretroviral therapy initiation in resource-limited settings is limited, especially in regions where genotypic resistance is inaccessible. This analysis evaluated extended efficacy and tolerability data from the D2EFT study. METHODS: D2EFT is a completed, multicenter, phase IIIB/IV, randomized, open-label trial in 14 low- and middle-income countries. People with human immunodeficiency virus (HIV) who had failed first-line non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens were switched to 1 of ritonavir-boosted darunavir plus 2 nucleoside reverse transcriptase inhibitors (DRV/r + 2NRTIs), ritonavir-boosted darunavir plus dolutegravir (DTG + DRV/r), or dolutegravir with tenofovir disoproxil fumarate plus either lamivudine or emtricitabine (DTG + TDF/XTC), with or without pre-switch genotyping. Here we report virological suppression at 96 weeks, defined as HIV RNA <50 copies/mL in a modified intention-to-treat population. RESULTS: Between November 2017 and January 2022, 1190 participants were screened, 828 were randomized, and 826 were included in the analysis. At week 96, the proportions of participants with HIV RNA <50 copies/mL were 191/251 (76.1%) in DRV/r + 2NRTIs, 215/251 (85.7%) in DTG + DRV/r, and 231/283 (81.6%) in DTG + TDF/XTC. The treatment differences (95% confidence intervals [CIs]) in proportions achieving virological suppression were 9.6% (2.7, 16.4) in DTG + DRV/r and 9.0% (1.4, 16....