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Metabolic health outcomes at week 96 in the TANGO Study, comparing a switch to DTG/3TC versus maintenance of TAF-based regimens

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BACKGROUND: TANGO is a randomised controlled trial assessing the efficacy/safety of switching to the 2-drug regimen DTG/3TC compared with continuation of a 3/4-drug tenofovir alafenamide (TAF)-based regimen (TBR), for the treatment of HIV-1 infection.
METHODS: Changes in weight; fasting lipids, insulin, and glucose; HbA1c; FIB-4; and insulin resistance and prevalence of metabolic syndrome were assessed and compared between treatment groups at Week 96. Baseline subgroups of interest included duration of prior TAF use, core agent, boosting status, region, and baseline BMI.
RESULTS: Overall change in adjusted mean weight at Week 96 was +1.64 kg with DTG/3TC vs +0.61 kg with TBR (Figure). The proportion of participants who maintained weight ("±5%) was 64% in the DTG/3TC group and 65% in the TBR group. More participants lost '¥5%/'¥10% weight in the TBR (13%/4%) vs DTG/3TC group (7%/3%), partly due to changes after Week 48 in participants who were obese at baseline. Changes at Week 96 in total cholesterol, LDL-C, and triglycerides favoured the DTG/3TC group; changes in HDL-C favoured the TBR group, resulting in similar mean percent changes in TC:HDL-C ratios (DTG/3TC, '0.5%; TBR, +1.7%). Overall, changes in glucose, insulin resistance, and prevalence of metabolic syndrome were similar between groups.


CONCLUSIONS: After 96 weeks of therapy, weight gain in the DTG/3TC group was consistent with that of the general population (0.5-1.0 kg/year); weight gain in the TBR group was lower, partly driven by unexplained weight loss in participants with obese baseline BMI after Week 48. Changes in lipids generally favoured the DTG/3TC group; changes in other metabolic health parameters were generally similar between groups. Long-term follow-up and evaluation of the potential effects of ART and diet/exercise on weight and metabolic outcomes for PLWH remain important.