Study of Rapid Restarting of Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Adults Living with HIV After Treatment Breaks

What this Trial Is About

Researchers are studying rapid reinitiation of antiretroviral therapy ART with bictegraviremtricitabinetenofovir alafenamide BFTAF in people living with HIV who have interrupted their treatment for at least 12 weeks. The trial aims to evaluate the safety and effectiveness of starting BFTAF on the same day participants return to care. This approach addresses challenges that cause delays in restarting treatment, such as waiting for lab results and multiple medical visits, which may discourage people from resuming care. Participants will receive open-label BFTAF tablets once daily for either 24 or 48 weeks, depending on their viral load at baseline. Those with HIV-1 RNA levels above 50 copiesmL will be treated for 48 weeks, while those with suppressed viral loads below 50 copiesmL will receive 24 weeks of treatment. Treatment begins immediately during the initial visit without waiting for baseline lab results, allowing for rapid reinitiation. The study includes two cohorts based on viral load and optional interviews to understand reasons for treatment interruption and reinitiation. During the study, participants will be monitored through clinical assessments, viral load measurements, CD4 cell counts, safety evaluations, and adherence tracking. Patient-reported outcomes will also be collected to capture experiences with the therapy and treatment satisfaction. Follow-up lasts up to 48 weeks for viremic participants and 24 weeks for suppressed participants, with interviews conducted by teleconference at weeks 4 and 24. The research team will measure how many participants achieve viral suppression and remain engaged in care.

REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE