Booster-free anti-retroviral therapy for persons living with HIV and multidrug resistance (B-Free): protocol for a multicentre, multistage, randomised, controlled, non-inferiority trial
The B-Free clinical trial is an investigator-initiated randomized clinical trial funded by the Swiss National Science Foundation and nested in the Swiss HIV Cohort Study. In this article, the authors present the trial and its protocol.
B-Free is a multicenter, randomized, open-label, non-inferiority study that aims to evaluate whether a simplified HIV treatment regimen is as effective as the boosted antiretroviral therapy (ART) that people with HIV who have experienced virological failures are currently taking. The simplified regimen offered in the B-Free trial consists of a combination of doravirine, dolutegravir, and lamivudine (DOR/DTG/3TC).
The study targets individuals who are virologically suppressed on boosted ART regimens but are at risk for drug-drug interactions. Participants are enrolled from HIV cohorts in Switzerland (Swiss HIV Cohort Study), as well as in the Netherlands, and France. Exclusion criteria include major resistance to DTG or DOR or chronic hepatitis B. Participants are randomized to either switch to DOR/DTG/3TC or continue their current boosted ART.
The primary goal of B-Free is to assess the proportion of participants with unsuppressed viral load (HIV-RNA ≥50 cp/mL) after 48 weeks. Secondary outcomes include changes in drug-drug interaction burden, treatment satisfaction, quality of life, mental health, and resistance development.
Furthermore, a qualitative sub-study will explore participant experiences with treatment and clinical research.