%0 Generic
%A Podzamczer, Daniel
%A Rozas, Nerea
%A Domingo, Pere
%A Ocampo, Antonio
%A Van den Eynde, Eva
%A Deig, Elisabeth
%A Vergara, Antonio
%A Knobel, Hernando
%A Pasquau, Juan
%A Antela, Antonio
%A Crespo, Manuel
%A Clotet, Bonaventure
%A Muñoz, Jessica
%A Fernandez, Pedro
%A Geijo, Paloma
%A Rodríguez de Castro, Eduardo
%A Diz, Julio
%A Casado, Araceli
%A Torres, Covadonga
%T ACTG-HIV symptoms changes in patients switched to RPV/FTC/TDF due to previous intolerance to CART. Interim analysis of the PRO-STR study.
%D 2014
%U http://hdl.handle.net/10668/2007
%X INTRODUCTIONTolerability and convenience are crucial aspects for the long-term success of combined antiretroviral therapy (cART). The aim of this study was to investigate the impact in routine clinical practice of switching to the single tablet regimen (STR) RPV/FTC/TDF in patients with intolerance to previous cART, in terms of patients' well-being, assessed by several validated measures.METHODSProspective, multicenter study. Adult HIV-infected patients with viral load under 1.000 copies/mL while receiving a stable ART for at least the last three months and switched to RPV/FTC/TDF due to intolerance of previous regimen, were included. Analyses were performed by ITT. Presence/magnitude of symptoms (ACTG-HIV Symptom Index), quality of life (EQ-5D, EUROQoL & MOS-HIV), adherence (SMAQ), preference of treatment and perceived ease of medication (ESTAR) through 48 weeks were performed.RESULTSInterim analysis of 125 patients with 16 weeks of follow up was performed. 100 (80%) were male, mean age 46 years. Mean CD4 at baseline was 629.5±307.29 and 123 (98.4%) had viral load <50 copies/mL; 15% were HCV co-infected. Ninety two (73.6%) patients switched from a NNRTI (84.8% from EFV/FTC/TDF) and 33 (26.4%) from a PI/r. The most frequent reasons for switching were psychiatric disorders (51.2%), CNS adverse events (40.8%), gastrointestinal (19.2%) and metabolic disorders (19.2%). At the time of this analysis (week 16), four patients (3.2%) discontinued treatment: one due to adverse events, two virologic failures and one with no data. A total of 104 patients (83.2%) were virologically suppressed (<50 copies/mL). The average degree of discomfort in the ACTG-HIV Symptom Index significantly decreased from baseline (21±15.55) to week 4 (10.89±12.36) & week 16 (10.81±12.62), p<0.001. In all the patients, quality of life tools showed a significant benefit in well-being of the patients (Table 1). Adherence to therapy significantly and progressively increased (SMAQ) from baseline (54.4%) to week 4 (68%), p<0.001 and to week 16 (72.0%), p<0.001.CONCLUSIONSSwitching to RPV/FTC/TDF from another ARV regimen due to toxicity, significantly improved the quality of life of HIV-infected patients, both in mental and physical components, and improved adherence to therapy while maintaining a good immune and virological response.
%K Coinfección
%K Estudios de seguimiento
%K Infecciones por VIH
%K Humanos
%K Masculino
%K Estudios prospectivos
%K Calidad de vida
%K Inhibidores de transcriptasa inversa
%K Carga viral
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