Open AccessA clinical trial to compare the quality of life of HIV+ patients who start monotherapy with LPV/r versus continuing triple therapy with a boosted PI
Author(s) -
Pasquau J,
Hidalgo C,
Vergara A,
Montes M,
Vergas J,
Sanjoaquín I,
HernándezQuero J,
Aguirrebengoa K,
Orihuela F,
RodríguezBaño J,
Imaz A,
GarcíaVallecillos C
Publication year - 2012
Publication title -
journal of the international aids society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.724
H-Index - 62
ISSN - 1758-2652
DOI - 10.7448/ias.15.6.18355
Subject(s) - medicine , lopinavir , tolerability , ritonavir , quality of life (healthcare) , viral load , lopinavir/ritonavir , clinical trial , visual analogue scale , human immunodeficiency virus (hiv) , antiretroviral therapy , adverse effect , physical therapy , immunology , nursing
Purpose of the study Efficacy, 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. Methods A 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 results 225 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.Conclusions The 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.