Prospective Multicenter Study of Virological Effectiveness and Adherence in HIV-1 Patients Treated with Bictegravir

What this Trial Is About

Researchers are evaluating the effectiveness of the antiretroviral combination therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people living with HIV-1 who face challenges in maintaining treatment adherence. The study focuses on real-life adherence patterns and their impact on viral suppression, aiming to provide data especially for populations usually under-represented in clinical trials, over a two-year inclusion period with usual follow-up. Participants will be adults living with HIV-1 who are currently treated or starting treatment with B/F/TAF. Adherence to therapy will be monitored using electronic medication event monitoring system caps (MEMS caps) and intracellular drug level measurements from dried blood spots. The study will measure virological suppression rates at 6 and 12 months, assess resistance mutations if viral replication occurs, evaluate safety, and monitor quality of life during the follow-up. During the study, participants will use MEMS caps to track medication adherence and provide blood samples for drug level testing. Researchers will evaluate viral load to detect virological failure and check for drug resistance. Safety and quality of life questionnaires will also be completed. The planned follow-up duration for each participant is 12 months, with the study expected to conclude in 2027 after all data is collected and analyzed.

Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir