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  • Title: Switching from a ritonavir-boosted PI to dolutegravir as an alternative strategy in virologically suppressed HIV-infected individuals.
    Author: Negredo E, Estrada V, Domingo P, Gutiérrez MD, Mateo GM, Puig J, Bonjoch A, Ornelas A, Echeverría P, Estany C, Toro J, Clotet B.
    Journal: J Antimicrob Chemother; 2017 Mar 01; 72(3):844-849. PubMed ID: 27999056.
    Abstract:
    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.
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