Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
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.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Makinson Alain, Bani-Sadr Firouze, Palich Romain, Montès Brigitte, Maillard Anne, Duvivier Claudine, Rey David, Becker Agathe, Hocqueloux Laurent, Raffi François, Dat’AIDS Study Group
Аннотация
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.
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.