Final 192-Week Efficacy and Safety Results of the ADVANCE Trial, Comparing 3 First-line Antiretroviral Regimens

作者：Simiso Sokhela, François Venter, Bronwyn Bosch, Joana Woods, Kaitlyn McCann, Godspower Akpomiemie, Nomathemba Chandiwana, Nkuli Mashabane, Angela Tembo, Bryony Simmons, Samanta Tresha Lalla‐Edward, Mark J. Siedner, Phumla Sinxadi, Lucas E. Hermans, Lee Fairlie, Alinda G. Vos, Elaine J. Abrams, Jennifer Manne‐Goehler, Michelle Moorhouse, Polly Clayden, Shane A. Norris, Ambar Qavi, Matthew Chersich, Masebole Masenya, Natasha Arulappan, Andrew Hill · 发表于：Open Forum Infectious Diseases · 年份：2024 · DOI：10.1093/ofid/ofae007 · 被引用次数：40 · 研究领域：HIV/AIDS drug development and treatment、HIV-related health complications and treatments、HIV/AIDS Research and Interventions

Background: ADVANCE compared 3 World Health Organization-recommended first-line regimens in participants with HIV who were antiretroviral naive. Methods: This randomized, open-label, noninferiority trial enrolled participants living with HIV with no antiretroviral exposure in the previous 6 months to 1 of the following arms: tenofovir alafenamide (TAF) / emtricitabine (FTC) + dolutegravir (DTG) (2 tablets), tenofovir disoproxil fumarate (TDF) / FTC + DTG (2 tablets), or a fixed-dose combination of TDF / FTC / efavirenz (EFV) (1 tablet). We report the final safety and efficacy data up to 192 weeks. Results: Repeat consent from the original 351 participants randomized to each arm was obtained from 230 participants (66%) in the TAF/FTC + DTG arm, 209 (60%) in the TDF/FTC + DTG arm, and 183 (52%) in the TDF/FTC/EFV arm. At 192 weeks, 213 (61%) of the original 351 participants in the TAF/FTC + DTG arm, 195 (56%) in the TDF/FTC + DTG arm, and 172 (49%) in the TDF/FTC/EFV arm had confirmed RNA <50 copies/mL, with low virologic failure in all groups and no significant integrase inhibitor mutations in any arm. Mean weight gain was 8.9 kg (SD, 7.1) in the TAF/FTC + DTG arm, 5.9 kg (SD, 7.1) in the TDF/FTC + DTG arm, and 3.2 kg (SD, 8.1) in the TDF/FTC/EFV arm at 192 weeks from baseline and was greatest among women, those taking TAF, and those with lower baseline CD4 counts. The weight trajectory slowed after week 96. There were few clinical events and minor laboratory changes and diffe...