Background
DTG/3TC and BIC/FTC/TAF are recommended ART regimens in major HIV guidelines. However, data on the metabolic and inflammatory effects of switching from DTG/3TC to BIC/FTC/TAF are scarce. We investigated the impact of this switch on metabolic parameters and systemic inflammation in virologically suppressed individuals.
Methods
This randomized, open-label, multicenter INSTINCT study (GESIDA10918) assessed the impact of switching from DTG/3TC to BIC/FTC/TAF vs. continuing DTG/3TC on weight, cholesterol and systemic inflammation up to 96 weeks. Adults with virologically suppressed HIV, stable on DTG/3TC for at least 48 weeks were enrolled. Exclusions included previous virological failure, drug resistance, and autoimmune conditions. For inflammation, we focused on IL-6 changes from baseline to week 96 using high-sensitivity ELISA. We estimated treatment effects using linear mixed models in Stata v.18.
Results
We included 141 participants, with 135 completing follow-up; 14% women, mean age 45 ± 11 years; 78% were white; 58% MSM; 11% had a previous AIDS diagnosis, and the median nadir CD4 was 368 cells/uL. Baseline CD4 count was 789/uL, the mean duration of HIV suppression 6.5 years, mean weight at baseline 77 kg, and mean IL6 levels within normal range (1.72 pg/mL 95% CI [1.46-1.99]). No differences were observed in baseline characteristics between groups. At 96-week, there were no differences in the rates of virological efficacy between DTG/3TC and BIC/FTC/TAF (risk difference 0.01%, 95% CI -0.07 to 0.04). The overall mean weight gain of 1.22 kg, (95% CI 0.31-2.13), with no significant differences between regimens (Fig. A). Changes in total cholesterol (-4.7 mg/dL), HDL cholesterol (0.9 mg/dL), and LDL cholesterol (-2.3 mg/dL) were similar in both groups. Adjusted IL-6 changes were not significantly different (median fold change: DTG/3TC 2.0 [1.3-2.7]; BIC/FTC/TAF 1.2 [1.0-1.4], P = 0.106)(Fig. B).
Conclusions
Switching from DTG/3TC to BIC/FTC/TAF in virologically suppressed individuals showed comparable effects on weight, cholesterol levels, and systemic inflammation (IL-6) compared to continuing DTG/3TC. Ongoing analyses of additional inflammatory markers are needed to determine if either regimen may lead to differential effects on systemic inflammation.
Table or Figure
