Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2025
Randomized clinical trial to evaluate the longitudinal HIV-1 reservoir and inflammation in treatment-naïve people starting dolutegravir/lamivudine versus dolutegravir plus tenofovir alafenamide/emtricitabine.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование IV фазыНазвание и аннотация: Перевод в очереди
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Saborido-Alconchel Abraham, Serna-Gallego Ana, Trujillo-Rodriguez María, Muñoz-Muela Esperanza, Alvarez-Ríos Ana I, Sotomayor Cesar, Herrero Marta, Lopez-Cortes Luis E, Espinosa Nuria, Raffo-Marquez Miguel, Romero-Palacios Alberto, Mariscal-Vázquez Gabriel, Rivero Antonio, Roca-Oporto Cristina, Gutierrez-Valencia Alicia, Lopez-Cortes Luis F
Аннотация
OBJECTIVE: There is limited evidence on whether dolutegravir/lamivudine (DTG/3TC) reduces the viral reservoir, immune activation, and inflammation as a three-drug regimen. This study aims to clarify possible differences in these outcomes in people with HIV-1 (PHIV) starting DTG plus tenofovir alafenamide/emtricitabine (DTG + TAF/F) versus DTG/3TC.
METHODS: A phase IV, controlled, open-label, multicentre clinical trial in which treatment-naïve PHIV were randomized to DTG + TAF/F or DTG/3TC. The primary endpoint was changes in CD4+ T cells associated with HIV-1-DNA and HIV-1-RNA after 12 and 24 months (Intact Proviral DNA and Intact Viral RNA Assays). Secondary endpoints included immune recovery and changes in T-cell phenotypes and plasma inflammatory markers.
STATISTICS: χ2, Mann-Whitney U test, and general linear model for repeated measures.
RESULTS: Sixty-six participants were randomized, of whom 30 (DTG/3TC) and 29 (DTG + TAF/F) completed follow-up. Overall, the median baseline CD4+/μL count was 401 (293-540), the CD4+/CD8+ ratio 0.47 (0.34-0.76), and the viral load 57 250 copies/mL (16 189-180 500). Results are reported as medians (interquartile ranges) in the DTG + TAF/F and DTG/3TC groups at baseline and month 24, respectively. Intact HIV-1-DNA: 1210 (412-3508) copies/106 CD4+ and 1230 (335-2502), which decreased to 65 (24-236) and 71 (32-110) (F = 0.253; p = 0.691). Total defective HIV-1-DNA: 831 copies/106 CD4+ (315-1636) and 726 (273-1770), decreasing to 143 copies/106 CD4+ (82-368) and 266 (67-353) (F = 1.840, p = 0.201). Similarly, no significant differences were observed between the groups in immune recovery, decrease in activation, proliferation, and exhaustion markers of T cells, as well as in the reduction of plasma levels of interleukin-1β, interleukin-6, tumour necrosis factor-α, interferon-γ, sCD14, and sCD163.
CONCLUSIONS: These data suggest that starting treatment with DTG + TAF/F does not confer benefits over DTG/3TC.
METHODS: A phase IV, controlled, open-label, multicentre clinical trial in which treatment-naïve PHIV were randomized to DTG + TAF/F or DTG/3TC. The primary endpoint was changes in CD4+ T cells associated with HIV-1-DNA and HIV-1-RNA after 12 and 24 months (Intact Proviral DNA and Intact Viral RNA Assays). Secondary endpoints included immune recovery and changes in T-cell phenotypes and plasma inflammatory markers.
STATISTICS: χ2, Mann-Whitney U test, and general linear model for repeated measures.
RESULTS: Sixty-six participants were randomized, of whom 30 (DTG/3TC) and 29 (DTG + TAF/F) completed follow-up. Overall, the median baseline CD4+/μL count was 401 (293-540), the CD4+/CD8+ ratio 0.47 (0.34-0.76), and the viral load 57 250 copies/mL (16 189-180 500). Results are reported as medians (interquartile ranges) in the DTG + TAF/F and DTG/3TC groups at baseline and month 24, respectively. Intact HIV-1-DNA: 1210 (412-3508) copies/106 CD4+ and 1230 (335-2502), which decreased to 65 (24-236) and 71 (32-110) (F = 0.253; p = 0.691). Total defective HIV-1-DNA: 831 copies/106 CD4+ (315-1636) and 726 (273-1770), decreasing to 143 copies/106 CD4+ (82-368) and 266 (67-353) (F = 1.840, p = 0.201). Similarly, no significant differences were observed between the groups in immune recovery, decrease in activation, proliferation, and exhaustion markers of T cells, as well as in the reduction of plasma levels of interleukin-1β, interleukin-6, tumour necrosis factor-α, interferon-γ, sCD14, and sCD163.
CONCLUSIONS: These data suggest that starting treatment with DTG + TAF/F does not confer benefits over DTG/3TC.
Предметные рубрики MeSH
HumansHIV InfectionsHeterocyclic Compounds, 3-RingPiperazinesPyridonesMaleFemaleOxazinesHIV-1LamivudineAdultEmtricitabineTenofovirAnti-HIV AgentsViral LoadMiddle AgedInflammationAdenineCD4-Positive T-LymphocytesCD4 Lymphocyte CountAlanineRNA, ViralDrug Therapy, CombinationTreatment OutcomeDolutegravir