RT Journal Article
T1 High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial.
A1 Pasquau, Juan
A1 Hidalgo-Tenorio, Carmen
A1 Montes, Maria Luisa
A1 Romero-Palacios, Alberto
A1 Vergas, Jorge
A1 Sanjoaquín, Isabel
A1 Hernandez-Quero, Jose
A1 Aguirrebengoa, Koldo
A1 Orihuela, Francisco
A1 Imaz, Arkaitz
A1 Rios-Villegas, Maria Jose
A1 Flores, Juan
A1 Fariñas, Maria Carmen
A1 Vazquez, Pilar
A1 Galindo, Maria Jose
A1 Garcia-Merce, Isabel
A1 Lozano, Fernando
A1 de-Los-Santos, Ignacio
A1 de-Jesus, Samantha Elizabeth
A1 Garcia-Vallecillos, Coral
K1 Área de Gestión Sanitaria Sur de Sevilla
K1 Anti-HIV Agents
K1 CD4 Lymphocyte Count
K1 HIV Infections
K1 HIV Protease Inhibitors
AB The QoLKAMON study evaluated quality of life, efficacy and treatment safety in HIV patients receiving lopinavir/ritonavir in monotherapy (MT) versus continuing combined antiretroviral triple treatment with a boosted protease inhibitor (TT). This was a 24-week, open-label, multicentre study in virologically-suppressed HIV-infected participants (N = 225) with a 2:1 randomization: 146 patients who switched to MT were compared with 79 patients who remained on a TT regimen. The primary endpoint was change in patient-reported outcomes in quality of life as measured by the MOS-HIV and EQ-5D questionnaires. Secondary endpoints included treatment adherence, patient satisfaction, incidence of adverse events and differences in plasma HIV-1 RNA viral load (VL) and CD4 cell counts. Baseline quality of life, measured with the MOS-HIV score, was very good (overall score of 83 ± 10.5 in the MT arm and 82.3 ± 11.3 in the TT arm) and suffered no change during the study in any of the arms (at week 24, 83.5 ± 12.2 in MT arm and 81.9 ± 12.7 in TT arm), without statistically significant differences when compared. In regards to adherence to therapy and patient satisfaction, some aspects (number of doses forgotten in the last week and satisfaction of treatment measured with the CESTA score, dimension 1) improved significantly with MT. There were also no differences in the incidence and severity of adverse events, even though 22.8% of those in the MT arm switched their treatment when they were included in the study. Moreover, there was also no significant difference between the immunological and virological evolution of MT and TT. In the MT arm, the VL was always undetectable in 83% of patients (vs 90.7% in the TT arm) and there were only 6.7% of virological failures with VL > 50 copies/mL (vs 2.3% in the TT arm), without resistance mutations and with resuppression of VL after switching back to TT. In a new clinical trial, monotherapy as a treatment simplification strategy in HIV-1 infected patients with sustained viral suppression has demonstrated quality of life, safety and efficacy profiles comparable to those of conventional triple therapy regimens.
PB Public Library of Science
YR 2018
FD 2018-04-12
LK http://hdl.handle.net/10668/12337
UL http://hdl.handle.net/10668/12337
LA en
NO Pasquau J, Hidalgo-Tenorio C, Montes ML, Romero-Palacios A, Vergas J, Sanjoaquín I, et al. High quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial. PLoS One. 2018 Apr 12;13(4):e0195068
DS RISalud
RD Apr 18, 2025