Switch to BIC/TAF/FTC or DTG + TDF/FTC in virologically suppressed PWH: outcomes in real-world setting with and without tenofovir resistance.

Abstract

We evaluated whether switching to bictegravir/tenofovir alafenamide/emtrictabine (BIC/TAF/FTC) or dolutegravir (DTG)/tenofovir disoproxil fumarate (TDF)/FTC in PWH with virological success increased risks of virological failure (VF). Analysis embedded in the French national Dat'AIDS cohort (NCT02898987) of all PWH followed after 1st January 2014, with no history of DTG and BIC exposure or resistance, and with a viral load < 50 copies/mL for more than twelve months. Switchers changed their antiretroviral regimen to BIC/TAF/FTC or DTG + TDF/FTC. VF defined as one value > 200 copies/mL. Marginal Structural Models compared VF in switchers and non-switchers, emulating a target trial. A multivariate Cox model assessed tenofovir resistance with VF in switchers only. 9827 PWH of whom 1393 (14.2%) switched to BIC/TAF/FTC or DTG + TDF/FTC. We observed 75 (5.4%) VF in switchers and 523 (6.2%) in non-switchers. After weighing, switching was associated with a non-significant risk of VF (HR of 1.29, 95% CI (0.97-1.7) (p=0.08). Presence of possible resistance and resistance to tenofovir (ANRS resistance algorithm) was not associated with VF (HR of 1.12, 95% CI (0.82-1.5), (p=0.47)) In switchers only, tenofovir resistance was not associated with VF (HR: 1.04, 95% CI (0.47-2.33)), nor was M184V or M184I mutations (HR: 0.98, 95% CI (0,5-2,1)). in a real-world setting, switching to BIC/TAF/FTC or DTG + TDF/FTC in PWH with virological success was associated with a non-significant risk of VF, but M184V or M184I mutations and tenofovir resistance had no effect on VF. Most VF were blips or related to unmeasured adherence issues.