title: Short Communication: Efficacy and Safety of Treatment Simplification to Lopinavir/Ritonavir or Darunavir/Ritonavir Monotherapy: A Randomized Clinical Trial.
abstract: Antiretroviral treatment simplification strategies based on monotherapy with darunavir/ritonavir (DRV/r) or lopinavir/ritonavir (LPV/r) have not been directly compared in clinical trials. We evaluated the 48-week efficacy and safety of DRV/r versus LPV/r monotherapy as a treatment simplification strategy in a multicenter, randomized open-label study. Maintenance of viral suppression in cerebrospinal fluid (CSF) and semen was also explored. An intention to treat efficacy analysis was performed considering missing equals to failure (ITT:M = F). Virological failure (VF) was defined as a confirmed increase in plasma HIV-1 RNA >50 copies/mL. A total of 75 patients were enrolled: 40 were allocated to DRVr and 33 to LPVr. In the ITT: M = F analysis, 77.5% of patients on DRV/r and 66.6% of patients on LPV/r maintained HIV-1 RNA <50 copies/mL at week 48 (p = .302, treatment difference 10.8% [95% CI,-12.6 to 34.2]). In the DRV/r arm, no patients developed VF and 15.0% discontinued treatment due to adverse events. In the LPV/r arm, 2 (6.1%) patients developed VF and 18.2% discontinued monotherapy due to adverse events. Gastrointestinal disturbances were experienced by 18.2% and 2.5% of patients in the LPV/r and DRV/r arms, respectively (p = .019). Two patients had detectable HIV-1 RNA ≥50 copies/mL in CSF or semen. Monotherapy with LPV/r or DRV/r seems to be virologically effective in selected HIV-1-infected patients with sustained viral suppression. Differences between both regimens seem driven mainly by the better tolerability profile of DRV/r.
authors.affiliation: 1 Lluita contra la SIDA Foundation, Hospital Universitari Germans Trias i Pujol , Badalona, Spain .|2 Universitat Autònoma de Barcelona , Barcelona, Spain .
authors.forename: José R
authors.initials: JR
authors.lastname: Santos
authors.affiliation: 1 Lluita contra la SIDA Foundation, Hospital Universitari Germans Trias i Pujol , Badalona, Spain .|2 Universitat Autònoma de Barcelona , Barcelona, Spain .
authors.forename: Josep M
authors.initials: JM
authors.lastname: Llibre
authors.affiliation: 1 Lluita contra la SIDA Foundation, Hospital Universitari Germans Trias i Pujol , Badalona, Spain .
authors.forename: Isabel
authors.initials: I
authors.lastname: Bravo
authors.affiliation: 3 Hospital Universitario de Canarias , San Cristóbal de la Laguna, Tenerife, Spain .
authors.forename: Dácil
authors.initials: D
authors.lastname: García-Rosado
authors.affiliation: 4 Labco.GeneralLab , Barcelona, Spain .
authors.forename: Mari Paz
authors.initials: MP
authors.lastname: Cañadas
authors.affiliation: 1 Lluita contra la SIDA Foundation, Hospital Universitari Germans Trias i Pujol , Badalona, Spain .|5 Universitat Politécnica de Catalunya , Barcelona, Spain .
authors.forename: Nuria
authors.initials: N
authors.lastname: Pérez-Álvarez
authors.affiliation: 1 Lluita contra la SIDA Foundation, Hospital Universitari Germans Trias i Pujol , Badalona, Spain .|6 IrsiCaixa Foundation , Barcelona, Spain .|7 Universitat de Vic-Universitat Central de Catalunya , Vic, Spain .
authors.forename: Roger
authors.initials: R
authors.lastname: Paredes
authors.affiliation: 1 Lluita contra la SIDA Foundation, Hospital Universitari Germans Trias i Pujol , Badalona, Spain .|2 Universitat Autònoma de Barcelona , Barcelona, Spain .|6 IrsiCaixa Foundation , Barcelona, Spain .|7 Universitat de Vic-Universitat Central de Catalunya , Vic, Spain .
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
authors.affiliation: 1 Lluita contra la SIDA Foundation, Hospital Universitari Germans Trias i Pujol , Badalona, Spain .|2 Universitat Autònoma de Barcelona , Barcelona, Spain .
authors.forename: José
authors.initials: J
authors.lastname: Moltó
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D002555:Cerebrospinal Fluid / Q000821:virology; D000069454:Darunavir / Q000009:adverse effects / Q000627:therapeutic use*; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D061466:Lopinavir / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D019438:Ritonavir / Q000009:adverse effects / Q000627:therapeutic use*; D012661:Semen / Q000821:virology; D019562:Viral Load / Q000187:drug effects; D055815:Young Adult
chemical_list: D017320:HIV Protease Inhibitors; D061466:Lopinavir; D019438:Ritonavir; D000069454:Darunavir