Methods
INFECTIOUS DISEASE
This is an open-label, prospective, single-center, randomized trial enrolling PLWH seen for care at the Infectious Disease Clinic of Azienda Ospedaliero-Universitaria Policlinico of Modena, Italy. The study, with EudraCT Number 2018-003458-26, was approved by the local Ethical Committee with Authorization Number AOU 0010923/19 on April 4, 2019, and AIFA Authorization Number AIFA/SC/P/33830 on March 25, 2019.Participants who had a suppressed HIV-RNA ≤50 copies/mL on a 3DR ART regimen for >12 months without any previous failure (previous switches to any other 3DRs with HIV-RNA ≤50 copies/mL were allowed), after providing written informed consent, were randomized 1:1 by means of simple randomization either to switch to B/F/TAF or DTG/3TC and were subsequently followed up for 48 weeks. Concealment of allocation was guaranteed using opaque envelopes so that random assignment was not revealed to the recruiters until participants had passed all screening tests and were deemed to be eligible. Participants have been enrolled over a period of 18 months. Other key inclusion criteria were as follows: i) age ≥18 years; ii) the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures; and iii) no history of viral blips or virological failure prior to enrolment. Virological failure after randomization was defined as a confirmed virological rebound of HIV-1 RNA ≥ 50 copies/mL at two consecutive visits. Since at the time of enrollment there were still concerns about dolutegravir safety in pregnancy, female participants who were pregnant or planning pregnancy were excluded. More details about inclusion and exclusion criteria are included in Supplementary Annex 1.