Evaluating immunological and inflammatory changes of treatment-experienced people living with HIV switching from first-line triple cART regimens to DTG/3TC vs. B/F/TAF: the DEBATE trial

• DOI: 10.3389/fimmu.2023.1279390
• Publication Date: 2023-10-16T05:45:15Z
• Authors: Andrea Cossarizza; Alessandro Cozzi-...; Marco Mattioli; Annamaria Paolini; Anita Neroni; Sara De Biasi; Domenico Lo Tartaro; Rebecca Borella; Lucia Fidanza; Lara Gibellini; Barbara Beghetto; Enrica Roncaglia; Giulia Nardini; Jovana Milic; Marianna Menozzi; Gianluca Cuomo; Margherita Digaetano; Gabriella Orlando; Vanni Borghi; Giovanni Guaraldi; Cristina Mussini
• Keywords: Tenofovir alafenamide; Dolutegravir; Emtricitabine; Regimen; Abacavir

The aim of this randomized clinical trial (RCT) was to compare immunological changes in virally suppressed people living with HIV (PLWH) switching from a three-drug regimen (3DR) two-drug (2DR).An open-label, prospective RCT enrolling PLWH receiving 3DR who switched bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or dolutegravir/lamivudine (DTG/3TC) performed. Blood taken at baseline and months 6 12. primary outcome the change CD4+ CD8+ T-cell counts CD4/CD8 ratio over time points. secondary outcomes were inflammatory parameters. Parametric mixed-linear models random intercepts slopes fitted separately for each marker after controlling potential confounders.Between two arms (33 each), there no difference T cells, ratio, IL-6 trajectories. DTG/3TC had increased levels both transitional memory terminally differentiated cells (arm-time interaction p-value = 0.02) lesser extent corresponding subsets (p 0.09). Significantly lower non-classical monocytes detected B/F/TAF arm T6 (diff -6.7 cells/mm3; 95% CI; -16, +2.6; between 0.03). All differences attenuated T12.No evidence absolute counts, trajectories by study 12 found. on showed higher exhausted lymphocytes T6. Further studies are warranted better understand impact our results.https://clinicaltrials.gov, identifier NCT04054089.