Background: Switching from a PI/r to dolutegravir (DTG) may improve convenience and lipid profile.
Methods: NEAT022-NCT02098837 is a European, open label, randomized, non-inferiority trial. HIV-infected adults ≥ 50 years or with a Framingham score ≥10% were eligible if HIV RNA < 50 copies/mL for at least 24 weeks while on a PI/r regimen. Patients were randomized (1:1) to switch to DTG or to remain on PI/r. Primary end-points were: proportion of patients with HIV RNA < 50 copies/ml at week 48 and a non-inferiority margin of -10% and percentage change of total plasma cholesterol. Secondary end-points included changes in other plasma lipid fractions, and adverse events.
Results: 415 patients were randomized: 205 to DTG and 210 to continue PI/r. 89% were men, 87 % were ≥50 years, 74 % had a Framingham score >10%, and suppressed viremia for a median of 5 years. At week 48, in the ITT analysis, treatment success rate was 93% in DTG arm and 95% in PI/r arm (difference -2.0%, 95%CI -6.5 to 2.6, non-inferiority demonstrated). There were 4 virological failures with DTG (from 58 to 130 copies) and 1 with PI/r (3,373 copies) without selection of resistance. There was no significant difference in terms of grade 3 or 4 AE´s or treatment modifying AE´s (7 in DTG arm -of whom 6 due to mood disturbances or insomnia- and 3 PI/r arm). Total cholesterol and other lipid fractions (except HDL) significantly (p< 0.001) improved in the DTG arm overall

Fig 1. Changes in lipid fractions at 48 weeks
[Fig 1. Changes in lipid fractions at 48 weeks]

and in all baseline PI/r strata. About 30 % were on lipid lowering agents at weeks 0 and 48 in each arm.
Conclusions: Switching from a PI/r based regimen to a DTG regimen in virologically suppressed HIV patients ≥ 50 years old or with a Framingham score ≥10% was non-inferior, well tolerated and improved the lipid profile.