Bictegravir/emtricitabine/tenofovir alafenamide as first-line treatment in naïve HIV patients in a rapid-initiation model of care: BIC-NOW clinical trial Hidalgo Tenorio, Carmen Sequera, Sergio Vivancos, Maria Jesus Vinuesa, David Collado, Antonio De los Santos, Ignacio Sorni, Patricia Cabello Clotet, Noemi Montero, Marta Ramos Font, Carlos Terron, Alberto Galindo, Maria Jose Martinez, Onofre Ryan, Pablo Omar-Mohamed, Mohamed Albendin Iglesias, Helena Javier, Rosario López Ruz, Miguel Ángel Romero, Alberto Garcia Vallecillos, Coral Objective: Multiple strategies have been utilised to reduce the incidence of HIV, including PrEP and rapid antiretroviral therapy initiation. The study objectives were to evaluate the efficacy, safety, satisfaction, treatment adherence, and system retention obtained with rapid initiation of bicte- gravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in naïve patients. Methods: This phase IV, multicenter, open-label, single-arm, 48-week clinical trial enrolled patients be- tween January 2020 and June 2022. Adherence to treatment was evaluated with the SMAQ questionnaire and patient satisfaction with the EQ-5D. Results: Two hundred eight participants were enrolled with mean age of 35.6 years; 87.6% were males; mean CD4 count was 393.5 cells/uL ( < 200 cells/uL in 22.1%); viral load log was 5.6 (VL > 100 000 cop/mL in 43.3%); 22.6% had AIDS, and 4.3% were coinfected with HBV. BIC/FTC/TAF was initiated on the day of their first visit to the HIV specialist in 98.6% of participants, and 9.6% were lost to follow-up. The efficacy at week 48 was 84.1 % by intention-to- treat (ITT), 94.6% by modified ITT, and 98.3% by per protocol analysis. The regimen was discontinued in two subjects (0.9%) during week 1 for grade 3 adverse events. Treatment adherence (weeks 4 [90%, IQR: 80–99%] vs. 4 8 [90%, IQR: 80–95%; P = 0.4 9]) and patient satisfaction (weeks 4 [90%, IQR: 80–99%] vs. 48 [90%, IQR: 80–95 P = 0.49]) rates were very high over the 48- week study period. 2024-05-06T06:18:04Z 2024-05-06T06:18:04Z 2024 journal article International Journal of Antimicrobial Agents 63 (2024) 107164 [https://doi.org/10.1016/j.ijantimicag.2024.107164] https://hdl.handle.net/10481/91377 10.1016/j.ijantimicag.2024.107164 eng http://creativecommons.org/licenses/by-nc-nd/3.0/ open access Creative Commons Attribution-NonCommercial-NoDerivs 3.0 License Elsevier