The aim of this study was to assess HIV cellular reservoir size, plasma residual viremia and drug plasma concentrations in virologically-suppressed patients receiving a dual-class therapy: DTG+3TC.
Patients were those included in the ANRS 167 LAMIDOL, a non comparative open-label, single arm, multicenter trial. HIV total DNA was measured at D0 and W48 of DTG+3TC using real-time PCR (Biocentric®; limit of quantification [LOQ]=10 c/PCR). Ultra-sensitive plasma viral load (USpVL) was measured to assess plasma residual viremia at D0, W24 and W48. The maximum volume of available plasma was centrifuged, the pellet was resuspended, and USpVL was determined using COBAS® HIV-1, v2.0. The LOQ depended on the available volume of plasma (3 c/mL in 90% of cases). USpVL was considered to be below the limit of detection (LOD) when no PCR signal was detected. The evolution of the USpVL over time was analyzed using a linear mixed effects model. The relationship between HIV DNA and USpVL was studied using linear regression. Total and unbound plasma DTG concentrations (Cmin) were measured using UPLC-MS/MS.
Paired D0 and W48 HIV total DNA results were obtained in 100 patients. Two and four patients showed HIV DNA below the LOQ at D0 and W48, respectively. Median (IQR) HIV DNA was 2.49 log10 c/106 PBMC (2.17-2.95) at D0 and 2.52 (2.09-2.89) at W48 (p=0.28). Plasma residual viremia was measured in 101, 101 and 99 patients at D0, W24 and W48 of DTG+3TC, respectively. The proportion of patients with USpVL
No change was observed, during the first year of DTG+3TC maintenance dual therapy, in plasma residual viremia level or in HIV cellular reservoir size with stable plasma DTG Cmin. As described under triple-class therapy, we observed a positive relationship between plasma residual viremia and HIV cellular reservoir size under the maintenance DTG+3TC dual therapy.