title: Switching from a ritonavir-boosted PI to dolutegravir as an alternative strategy in virologically suppressed HIV-infected individuals.
abstract: Switching from PIs to dolutegravir in virologically suppressed HIV-infected individuals has not been assessed.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Fundació de la Lluita contra la Sida, Hospital Universitari Germans Trias i Pujol, Badalona, Spain/Universitat Autònoma de Barcelona, Barcelona, Spain.|Universitat de Vic-Universitat Central de Catalunya, Vic, Barcelona, Spain.
authors.forename: Eugènia
authors.initials: E
authors.lastname: Negredo
authors.affiliation: Hospital Clínico San Carlos, IDISSC, Universidad Complutense, Madrid, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Estrada
authors.affiliation: Hospital Santa Creu i Sant Pau, Institut de Recerca Biomédica Sant Pau (IIB Sant Pau), Universitat Autònoma de Barcelona, Barcelona, Spain.|Hospitals Universitaris Arnau de Vilanova & Santa Maria, Universitat de Lleida, Institut de Recerca Biomédica (IRB) de Lleida, Lleida, Spain.
authors.forename: Pere
authors.initials: P
authors.lastname: Domingo
authors.affiliation: Hospital Santa Creu i Sant Pau, Institut de Recerca Biomédica Sant Pau (IIB Sant Pau), Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Maria Del Mar
authors.initials: MD
authors.lastname: Gutiérrez
authors.affiliation: Hospital Santa Creu i Sant Pau, Institut de Recerca Biomédica Sant Pau (IIB Sant Pau), Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Gracia M
authors.initials: GM
authors.lastname: Mateo
authors.affiliation: Fundació de la Lluita contra la Sida, Hospital Universitari Germans Trias i Pujol, Badalona, Spain/Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Puig
authors.affiliation: Fundació de la Lluita contra la Sida, Hospital Universitari Germans Trias i Pujol, Badalona, Spain/Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Anna
authors.initials: A
authors.lastname: Bonjoch
authors.affiliation: Fundació de la Lluita contra la Sida, Hospital Universitari Germans Trias i Pujol, Badalona, Spain/Universitat Autònoma de Barcelona, Barcelona, Spain.|Departament d'econometria, estadística i economia espanyola, Universitat de Barcelona, Barcelona, Spain.
authors.forename: Arelly
authors.initials: A
authors.lastname: Ornelas
authors.affiliation: Fundació de la Lluita contra la Sida, Hospital Universitari Germans Trias i Pujol, Badalona, Spain/Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Patricia
authors.initials: P
authors.lastname: Echeverría
authors.affiliation: Fundació de la Lluita contra la Sida, Hospital Universitari Germans Trias i Pujol, Badalona, Spain/Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Carla
authors.initials: C
authors.lastname: Estany
authors.affiliation: Fundació de la Lluita contra la Sida, Hospital Universitari Germans Trias i Pujol, Badalona, Spain/Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Jessica
authors.initials: J
authors.lastname: Toro
authors.affiliation: Fundació de la Lluita contra la Sida, Hospital Universitari Germans Trias i Pujol, Badalona, Spain/Universitat Autònoma de Barcelona, Barcelona, Spain.|Universitat de Vic-Universitat Central de Catalunya, Vic, Barcelona, Spain.|Fundació Irsicaixa, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D015519:Bone Density / Q000187:drug effects; D015224:Dideoxynucleosides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006575:Heterocyclic Compounds, 3-Ring / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019562:Viral Load / Q000187:drug effects; D000099226:Dolutegravir; D000099227:Abacavir
chemical_list: D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D004338:Drug Combinations; D017320:HIV Protease Inhibitors; D006575:Heterocyclic Compounds, 3-Ring; D019259:Lamivudine; D008055:Lipids; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D019438:Ritonavir; D000099226:Dolutegravir; C492871:abacavir, lamivudine drug combination; D000099227:Abacavir