Safety, Tolerability, and Efficacy of a Dose Reduction Strategy Based on Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-infected Adults

This is a phase IV, unicentric, open, pilot, randomized, controlled trial to evaluate Bictegravir/FTC/TAF. The study will be developed at a single clinical care centre:Hospital Clínic de Barcelona, Barcelona, Spain. The aim of this study is to assess the feasibility of dose redutions of Bictegravir/FTC/TAF in virologically suppressed HIV-infected adults on BETAF once daily. The reduction of drug exposure will have a significant positive impact on parameters reflecting potential toxicities associated with bictegravir or tenofovir.

Inclusion Criteria:Stable and asymptomatic HIV-infected adults (≥18 years) on BETAF once daily for at least the previous 6 months.Plasma HIV-1 RNA less than 50 copies/mL for at least the previous 6 months.CD4 cell counts greater than 350 cells/mL at the time of consideration for the study.Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods.Patients agreed to participate.Exclusion Criteria:Prior virological failure to any antiretroviral regimen or documented.Any diagnosis of psychiatric illness.Alcohol abuse or illicit drug consumption (based on their past medical history and specific questions at the time of recruitment).Patients co-infected with HIV and active hepatitis B or C virus.Any other condition at the doctor's discretion that did not allow ensuring a correct adherence.