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BackgroundUntil the past decade, immune/viral failure was the main reason for antiretroviral treatment changes. After HAART generalization the management of antiretroviral treatment toxicities was the most prevalent reason for treatment modification. Today, with the advent of new more potent and less toxic drugs as well as more convenient combinations may have changed the situation. We aim to describe the main reasons that today leads to ART changes in HIV+ patients in Spain in the current clinical practice.MethodsMulticentre, national, cross‐sectional epidemiological study. Eligible patients had to be HIV+, >18 years old and under current ART that was going to be changed by any reason. Patients did sign inform consent. The study consisted in a single visit (change of treatment) in which data on social and demographic characteristics, HIV disease and ARV treatment were collected.Results349 patients were included; mean age: 43.7±8.9 y, 70.5% male and 89.1% Caucasian. Main transmission categories were IVDU (36.4%) and heterosexual (36.4%). Mean time from HIV diagnosis was 11.3±7.6 y. 59.5% were CDC C category. Median CD4 nadir was: 155 cells/mm3 and median CD4 at the time of switching was 467 cells/mm3. 64.1% had undetectable viral load (<50 copies/ml); 40.1% had HCV or HBV co‐infection. Main reasons for treatment change were simplification (40.2%), treatment toxicities (29.2%) and immune/viral failure (20.1%). No significant correlations were found between reason for changing treatment and age, gender, race, nationality and level of education. Simplification was significantly the main reason both in employed and unemployed patients (p<0.01).ConclusionsCurrently, treatment simplification was the most prevalent reason for a change of treatment even in advanced lines of treatment. This is so probably because of the advent of ARV drugs that are more potent and effective, with less toxicity and more convenient. Treatment simplification was significantly the first cause of treatment change in those patients who are currently working or seeking for a job. This highlights the need for simpler regimens that can adapt to an active life.

Purpose of the studyEfficacy, toxicity and complexity of antiretroviral (ARV) regimens may impact the quality of life (QoL). Since over the past years the simplification approach of lopinavir/ritonavir (LPV/r) as monotherapy (MT) has been shown to be non‐inferior to triple therapy (TT) in virological and immunological efficacy, the objective of this study was to compare several health‐ and treatment‐related outcomes between both ARV strategies with LPV/r.MethodsA phase IV national, multicenter, controlled, randomized (2:1), open label, parallel‐group clinical trial to compare the QoL in patients on ARV TT containing any boosted protease inhibitor (PI), undetectable viral load (VL< 50 cop/mL) in the past 6 months and a CD4 nadir > 100 cells/µL, versus those who were simplified to LPV/r MT, for 24 weeks. QoL and health outcomes were evaluated by the Medical Outcomes Study HIV Health Survey (MOS‐HIV) and the five‐dimensional EuroQol questionnaire (EQ‐5D). Treatment satisfaction was assessed by the Spanish Questionnaire of Satisfaction with ARV Treatment (CESTA). Treatment adherence was assessed by the Spanish Multifactorial Adherence questionnaire (GEEMA) and a visual analog scale (VAS). Tolerability, safety and virological and immunological efficacy at week 24 were also analyzed.Summary of results225 patients from 29 sites were enrolled (MT: 146, 64.5%; TT: 79, 35.1%). Mean age (years) was 44.5 in MT and 45.2 in TT (p=0.745); mean duration (years) from HIV infection was 13.4 in MT and 12.8 in TT (p=0.587) and 71% were male in both arms. 87.6% of patients completed correctly the study (MT: 88.4%; TT: 86.1%; p=0.674). Health and treatment outcomes evaluated at final study visit are shown in figure 1 1. At study end, 84.1% in MT and 89.6% in TT had undetectable VL (p=0.313) and mean CD4 count were 742.8 cells/µL in MT and 646.5 cells/µL in TT (p=0.060). There were no significant differences in the percentage of patients with virological failure at week 24 as VL >50 cop/mL (MT: 8.2%; TT: 3.9%; p=0.271) and as VL >200 cop/mL (MT: 3.4%; TT: 0%; p=0.167).'Quality of life' impact: monotherapy vs triple therapy.imageConclusionsThe MT simplification strategy with LPV/r maintains comparable virological and immunological efficacy, as well as the tolerability profile, than the TT. The saving resulting from NRTIs withdrawal from the ARV regimen and the good results on QoL and patients treatment satisfaction make MT strategy with LPV/r be taken into account in clinical practice.