OBJECTIVES: The efficacy and safety of lopinavir/ritonavir monotherapy has been explored with promising results in well-controlled, randomized clinical trials. However, less information about its clinical usefulness in routine clinical practice is currently available. The objective of this study was to assess the effectiveness and safety of monotherapy with lopinavir/ritonavir as a treatment simplification strategy in HIV-infected patients with viral suppression outside a clinical trial setting. METHODS: Fifty-one subjects who were switched to lopinavir/ritonavir monotherapy and whose HIV-1 RNA was <50 copies/mL were included in this retrospective study. Data were obtained from a prospectively compiled database. The primary endpoint was the percentage of subjects who maintained viral suppression after 48 weeks of follow-up. Secondary endpoints included the incidence of adverse events and changes in CD4+ T cell count and in lipid profile. RESULTS: Two patients lost viral suppression, seven patients interrupted lopinavir/ritonavir monotherapy because of adverse events and four patients were lost before completing 48 weeks of follow-up. Thus, 38/40 (95.0%) patients maintained viral suppression when only subjects whose outcomes were available up to week 48 were considered and 38/51 (74.5%) patients maintained viral suppression when subjects who discontinued therapy or who were lost to follow-up were considered as treatment failures. The mean CD4+ T cell count significantly increased, from 541 (280) cells/mm3 at baseline to 609 (212) cells/mm3 at week 48 of follow-up (P=0.034). This increase was similar to that observed in the 48 weeks prior to lopinavir/ritonavir monotherapy (P=0.792). Although total cholesterol remained unchanged, there was a significant decrease in triglyceride levels during follow-up (P=0.029). CONCLUSIONS: Monotherapy with lopinavir/ritonavir is safe and effective as a treatment simplification approach in HIV-1-infected patients with sustained viral suppression in routine clinical practice, particularly in those patients already receiving a lopinavir/ritonavir-based antiretroviral regimen.
OBJECTIVES: The efficacy and safety of lopinavir/ritonavir monotherapy has been explored with promising results in well-controlled, randomized clinical trials. However, less information about its clinical usefulness in routine clinical practice is currently available. The objective of this study was to assess the effectiveness and safety of monotherapy with lopinavir/ritonavir as a treatment simplification strategy in HIV-infectedpatients with viral suppression outside a clinical trial setting. METHODS: Fifty-one subjects who were switched to lopinavir/ritonavir monotherapy and whose HIV-1 RNA was <50 copies/mL were included in this retrospective study. Data were obtained from a prospectively compiled database. The primary endpoint was the percentage of subjects who maintained viral suppression after 48 weeks of follow-up. Secondary endpoints included the incidence of adverse events and changes in CD4+ T cell count and in lipid profile. RESULTS: Two patients lost viral suppression, seven patients interrupted lopinavir/ritonavir monotherapy because of adverse events and four patients were lost before completing 48 weeks of follow-up. Thus, 38/40 (95.0%) patients maintained viral suppression when only subjects whose outcomes were available up to week 48 were considered and 38/51 (74.5%) patients maintained viral suppression when subjects who discontinued therapy or who were lost to follow-up were considered as treatment failures. The mean CD4+ T cell count significantly increased, from 541 (280) cells/mm3 at baseline to 609 (212) cells/mm3 at week 48 of follow-up (P=0.034). This increase was similar to that observed in the 48 weeks prior to lopinavir/ritonavir monotherapy (P=0.792). Although total cholesterol remained unchanged, there was a significant decrease in triglyceride levels during follow-up (P=0.029). CONCLUSIONS: Monotherapy with lopinavir/ritonavir is safe and effective as a treatment simplification approach in HIV-1-infectedpatients with sustained viral suppression in routine clinical practice, particularly in those patients already receiving a lopinavir/ritonavir-based antiretroviral regimen.
Authors: Kate El Bouzidi; Dami Collier; Eleni Nastouli; Andrew J Copas; Robert F Miller; Ravindra K Gupta Journal: J Antimicrob Chemother Date: 2016-07-07 Impact factor: 5.790
Authors: José R Santos; José A Muñoz-Moreno; José Moltó; Anna Prats; Adrià Curran; Pere Domingo; Josep M Llibre; Daniel R McClernon; Isabel Bravo; Jaume Canet; Victoria Watson; David Back; Bonaventura Clotet Journal: PLoS One Date: 2013-07-26 Impact factor: 3.240
Authors: Juan Pasquau; Carmen Hidalgo-Tenorio; María Luisa Montes; Alberto Romero-Palacios; Jorge Vergas; Isabel Sanjoaquín; José Hernández-Quero; Koldo Aguirrebengoa; Francisco Orihuela; Arkaitz Imaz; María José Ríos-Villegas; Juan Flores; María Carmen Fariñas; Pilar Vázquez; María José Galindo; Isabel García-Mercé; Fernando Lozano; Ignacio de Los Santos; Samantha Elizabeth de Jesus; Coral García-Vallecillos Journal: PLoS One Date: 2018-04-12 Impact factor: 3.240