Background
Steatotic liver disease (SLD) is a common condition in PLWH, linked to overweight and associated metabolic disorders. Both INSTIs and TAF have been associated with weight gain in clinical trials and real-life studies. Likewise, TAF has also been associated with SLD. Controversial results have been reported regarding INSTIs and SLD. In virologically suppressed PLWH, switching to DTG/3TC is non-inferior to BIC/FTC/TAF and leads to less weight gain1. Therefore, switching to 3TC/DTG and to BIC/FTC/TAF could have different impacts on SLD. Our aim was to compare the effect of switching to 3TC/DTG vs. BIC/FTC/TAF on SLD in PLWH.
Methods
Patients from the open-label, randomized clinical trial PASODOBLE1 were analyzed in this sub-study if: 1) were recruited by centers equipped with a vibration-controlled transient elastography (VCTE) device including CAP, and 2) measurements fulfilling quality criteria were obtained. SLD was defined as a CAP≥248 dB/m. Analyses were planned at wks. 48 and 96. Continuous variables are expressed as median (Q1-Q3).
Results
Fifty-nine patients received DTG/3TC and 56 BIC/FTC/TAF. Baseline data of the patients are shown in table. At wk. 48, weight had increased by 0.45 (-1.5-3.1) kg in patients on DTG/3TC and by 1.20 (-1, 4) kg (p=0.356) in those on BIC/FTC/TAF. The corresponding figures for CAP changes were 5 (-17-24) dB/m and 6 (-12-31) dB/m (p=0.544). Among patients on DTG/3TC, 36% and 44% (p=0.225) showed SLD at baseline and at wk. 48, respectively. For those receiving BIC/FTC/TAF the corresponding data were 36% and 43% (p=0.248). Thirty-three (56%) PLWH on DTG/3TC and 32 (57%) on BIC/FTC/TAF (p=0.896) gained weight; in 12 (20%) and 18 (32%) (p=0.150), respectively, the increase was ≥5%. Among patients who gained weight, CAP rose by 5 (-21-25) dB/m in those who were on DTG/3TC and by 24 (-5-39) dB/m (p=0.192) in the BIC/FTC/TAF arm. In this subset, the frequency of SLD increased from 30% at baseline to 36% at week 48 (p=0.564) in patients on DTG/3TC. The corresponding figures for those on BIC/FTC/TAF were 31% and 50% (p=0.034).
Conclusions
Switching to DTG/3TC or BIC/FTC/TAF is associated with a trend towards an increase in the frequency of SLD. Overall, no difference exists between both regimens after 48 wks. of therapy. However, in the subset of patients who gain weight after switching, those treated with BIC/FTC/TAF show a greater increase in the frequency of SLD compared to those receiving DTG/3TC.
1Martínez E, et al. 25th IACS. Munich 2024. Abstr OAB3606LB