Shall we dance? Extending tango's results to clinical practice

After previous evidence from the ASPIRE trial [1], results from TANGO study [2] definitively proved the efficacy of lamivudine (3TC) plus dolutegravir (DTG) as a maintenance strategy. As trials’ populations often differ from real-practice settings, we aimed to assess whether these results are reproducible in an unselected HIV-population. An observational longitudinal multicenter research study was conducted. HIV-positive patients with viral suppression (at least one HIV-RNA<50 copies/mL) were followed-up from the start of 3TC+DTG. The cohort was divided into two groups based on compliance or not with the inclusion criteria of TANGO study (absence of HBV-coinfection, of previous virological failure (VF), of a M184V-harboring virus and of previous AIDS-event other than cutaneous Kaposi’s sarcoma and nadir CD4 count≤200 mm3). Time to VF (i.e. 2 consecutive HIV-RNA determinations ≥50 cps/mL or a single HIV-RNA≥1000 cps/mL) and to treatment discontinuation (TD, i.e. the interruption of any of the study drugs) in the 2 groups were compared through Kaplan-Meier with log-rank test and Cox-regression model after adjusting for the main clinical and demographic between-groups differences. Changes in immunological parameters were assessed by linear mixed model for repeated measures. We analyzed 557 patients with a median follow-up time of 22 months: 145 (26.0%) met the TANGO inclusion criteria (TANGO group, TG).