The Journal of infectious diseases · 2025
Impact of Dolutegravir Plus Lamivudine as First-line Antiretroviral Treatment on the Human Immunodeficiency Virus Type 1 Reservoir and Inflammatory Markers in Peripheral Blood.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Bailón Lucía, Puertas Maria C, García-Guerrero Maria C, Moraes-Cardoso Igor, Aparicio Ester, Alarcón-Soto Yovaninna, Rivero Angel, Rosen Elias P, Estes Jacob D, Blanco Julià, Olvera Alex, Mothe Beatriz, Martinez-Picado Javier, Moltó José, DUALITY Study Group
Аннотация
BACKGROUND: To compare the effects of first-line antiretroviral therapy (ART) with dolutegravir plus lamivudine (DTG + 3TC) versus dolutegravir plus emtricitabine/tenofovir alafenamide (DTG + FTC/TAF) on the human immunodeficiency virus type 1 (HIV-1) reservoir and immune activation biomarkers in people with HIV (PWH).
METHODS: DUALITY was a 48-week, single-center, randomized, open-label clinical trial in ART-naive PWH, randomized (1:1) to receive ART with DTG + 3TC (2DR group) or DTG + FTC/TAF (3DR group). We measured total and intact proviral HIV-1 DNA, cell-associated RNA in CD4+ T cells, frequency of HIV-infected CD4+ T cells able to produce p24, plasma soluble inflammatory markers, and activation and exhaustion markers in CD4+ and CD8+ T cells.
RESULTS: Forty-four participants (22 per study arm) were enrolled, with baseline mean (standard deviation) log10 plasma viral load (pVL) 4.4 (0.7) copies/mL and CD4+ T-cell counts of 493 (221) cells/μL. At week 48, all participants had pVL <50 copies/mL at week 48, except for 1 participant in the 2DR group who was resuppressed after treating syphilis. Changes from baseline in reservoir parameters and immune biomarkers were comparable between groups.
CONCLUSIONS: First-line ART with DTG + 3TC showed similar reductions of HIV-1 persistence parameters and immune markers as DTG + FTC/TAF, supporting DTG/3TC among preferred first-line ART options for PWH.
METHODS: DUALITY was a 48-week, single-center, randomized, open-label clinical trial in ART-naive PWH, randomized (1:1) to receive ART with DTG + 3TC (2DR group) or DTG + FTC/TAF (3DR group). We measured total and intact proviral HIV-1 DNA, cell-associated RNA in CD4+ T cells, frequency of HIV-infected CD4+ T cells able to produce p24, plasma soluble inflammatory markers, and activation and exhaustion markers in CD4+ and CD8+ T cells.
RESULTS: Forty-four participants (22 per study arm) were enrolled, with baseline mean (standard deviation) log10 plasma viral load (pVL) 4.4 (0.7) copies/mL and CD4+ T-cell counts of 493 (221) cells/μL. At week 48, all participants had pVL <50 copies/mL at week 48, except for 1 participant in the 2DR group who was resuppressed after treating syphilis. Changes from baseline in reservoir parameters and immune biomarkers were comparable between groups.
CONCLUSIONS: First-line ART with DTG + 3TC showed similar reductions of HIV-1 persistence parameters and immune markers as DTG + FTC/TAF, supporting DTG/3TC among preferred first-line ART options for PWH.