000070300 001__ 70300 000070300 005__ 20210902121600.0 000070300 0247_ $$2doi$$a10.1371/journal.pone.0195068 000070300 0248_ $$2sideral$$a105776 000070300 037__ $$aART-2018-105776 000070300 041__ $$aeng 000070300 100__ $$aPasquau, J. 000070300 245__ $$aHigh quality of life, treatment tolerability, safety and efficacy in HIV patients switching from triple therapy to lopinavir/ritonavir monotherapy: A randomized clinical trial 000070300 260__ $$c2018 000070300 5060_ $$aAccess copy available to the general public$$fUnrestricted 000070300 5203_ $$aTrial design 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). Methods 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. Results 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. Conclusions 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. 000070300 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/ 000070300 590__ $$a2.776$$b2018 000070300 591__ $$aMULTIDISCIPLINARY SCIENCES$$b23 / 69 = 0.333$$c2018$$dQ2$$eT2 000070300 592__ $$a1.1$$b2018 000070300 593__ $$aAgricultural and Biological Sciences (miscellaneous)$$c2018$$dQ1 000070300 593__ $$aMedicine (miscellaneous)$$c2018$$dQ1 000070300 593__ $$aBiochemistry, Genetics and Molecular Biology (miscellaneous)$$c2018$$dQ1 000070300 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000070300 700__ $$aHidalgo-Tenorio, C. 000070300 700__ $$aMontes, M.L. 000070300 700__ $$aRomero-Palacios, A. 000070300 700__ $$aVergas, J. 000070300 700__ $$0(orcid)0000-0003-1436-4334$$aSanjoaquín, I.$$uUniversidad de Zaragoza 000070300 700__ $$aHernández-Quero, J. 000070300 700__ $$aAguirrebengoa, K. 000070300 700__ $$aOrihuela, F. 000070300 700__ $$aImaz, A. 000070300 700__ $$aRíos-Villegas, M.J. 000070300 700__ $$aFlores, J. 000070300 700__ $$aFariñas, M.C. 000070300 700__ $$aVázquez, P. 000070300 700__ $$aGalindo, M.J. 000070300 700__ $$aGarcía-Mercé, I. 000070300 700__ $$aLozano, F. 000070300 700__ $$ade los Santos, I. 000070300 700__ $$ade Jesus, S.E. 000070300 700__ $$aGarcía-Vallecillos, C. 000070300 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000070300 773__ $$g13, 4 (2018), e0195068[15 pp]$$pPLoS One$$tPloS one$$x1932-6203 000070300 8564_ $$s427566$$uhttps://zaguan.unizar.es/record/70300/files/texto_completo.pdf$$yVersión publicada 000070300 8564_ $$s102556$$uhttps://zaguan.unizar.es/record/70300/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000070300 909CO $$ooai:zaguan.unizar.es:70300$$particulos$$pdriver 000070300 951__ $$a2021-09-02-08:34:46 000070300 980__ $$aARTICLE