Autor/a:
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Podzamczer Palter, Daniel; Rozas, Nerea; Domingo, Pere; Ocampo, Antonio; van den Eynde, Eva; Deig, Elisabeth; Vergara, Antonio; Knobel, Hernando; Pasquau, Juan; Antela, Antonio; Crespo, Manuel; Clotet i Sala, Bonaventura; Muñoz, Jessica; Fernandez, Pedro; Geijo, Paloma; Rodríguez de Castro, Eduardo; Diz, Julio; Casado, Araceli; Torres, Covadonga
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Abstract:
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Introduction: Tolerability 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.
Methods: Prospective, 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.
Results: Interim 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 629.59307.29 and 123 (98.4%) had viral load B50 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 (B50 copies/mL). The
average degree of discomfort in the ACTG-HIV Symptom Index significantly decreased from baseline (21915.55) to week 4
(10.89912.36) & week 16 (10.81912.62), pB0.001. In all the patients, quality of life tools showed a significant benefit in wellbeing
of the patients (Table 1). Adherence to therapy significantly and progressively increased (SMAQ) from baseline (54.4%) to
week 4 (68%), pB0.001 and to week 16 (72.0%), pB0.001.
Conclusions: Switching 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. |