Background: Switching from PIs to dolutegravir in virologically suppressed HIV-infected individuals has not been assessed.
Objectives: The principal aim was to assess the evolution of bone mineral density (BMD) when switching from a ritonavir-boosted PI to dolutegravir in HIV-infected patients with osteopenia or osteoporosis. The secondary objective was to assess the antiviral efficacy and safety of the switch therapy.
Methods: This randomized, multicentre study assessed changes in BMD, bone turnover markers, and antiviral efficacy and safety in 73 virologically suppressed patients with osteopenia/osteoporosis taking a ritonavir-boosted PI plus abacavir/lamivudine who were randomized to switch from PI to dolutegravir (DOLU group, n = 37) or continue with a PI (PI group, n = 36). Clinical Trials: NCT02577042.
Results: One and three patients from the DOLU and PI groups, respectively, withdrew prematurely (unrelated to treatment). At 48 weeks, 97.3% versus 91.7%, respectively, maintained viral suppression (snapshot analysis, ITT, M = F). No significant differences were seen between the groups in percentage change from baseline to week 48 in femoral (P = 0.56) and lumbar spine (P = 0.29) BMD, although lumbar spine BMD improved by 1.43% (–1.36; 2.92) in the DOLU group [0.12% (–2.83; 2.89) in the PI group]. Bone marker values did not vary significantly. At week 48, triglycerides were lower (P < 0.001) and HDL cholesterol higher (P = 0.027) in the DOLU group.
Conclusions: Dolutegravir + Kivexa® was safe and well-tolerated in virologically suppressed patients receiving a PI-based regimen. The lipid profile was better, albeit without significant changes in BMD, probably because of the short follow-up.