Switch to Bictegravir/Tenofovir Alafenamide/Emtrictabine or Dolutegravir + Tenofovir Disoproxil Fumarate/Emtrictabine in Virologically Suppressed People With HIV: Outcomes in Real-world Setting With and Without Tenofovir Resistance.

BACKGROUND

We evaluated whether switching to bictegravir/tenofovir alafenamide/emtrictabine (BIC/TAF/FTC) or dolutegravir (DTG)/tenofovir disoproxil fumarate (TDF)/FTC in people with human immunodeficiency virus (PWH) with virological success increased risks of virological failure (VF), and if VF was driven by tenofovir resistance.

METHODS

Analysis embedded in the French national Dat'AIDS cohort (NCT02898987) of all PWH followed after 1 January 2014, with no history of DTG and BIC exposure or resistance, and with a viral load <50 copies/mL for more than 12 months. Switchers changed their antiretroviral regimen to BIC/TAF/FTC or DTG + TDF/FTC. VF defined as 1 value >200 copies/mL. Marginal structural models compared VF in switchers and nonswitchers, emulating a target trial. A multivariate Cox model assessed tenofovir resistance with VF in switchers only.

RESULTS

There was a total of 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 nonswitchers. After weighing, switching was associated with a nonsignificant risk of VF (hazard ratio [HR] 1.29; 95% CI: .97-1.7) (P = .08). Presence of possible resistance and resistance to tenofovir (ANRS resistance algorithm) was not associated with VF (HR 1.12; 95% CI: .82-1.5; P = .47) In switchers only, tenofovir resistance was not associated with VF (HR 1.04; 95% CI: .47-2.33), nor was M184V or M184I mutations (HR 0.98; 95% CI: .5-2.1).

CONCLUSIONS

In a real-world setting, switching to BIC/TAF/FTC or DTG + TDF/FTC in PWH with virological success was associated with a nonsignificant 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.