Real world patient-reported outcomes in HIV-infected adults switching to EVIPLERA®, because of a previous intolerance to cART. PRO-STR study
Podzamczer, D. (Hospital Universitari de Bellvitge)
Rozas, N. (Hospital Universitari de Bellvitge)
Domingo, Pere (Institut d'Investigació Biomèdica Sant Pau)
Miralles, C. (Hospital Xeral de Vigo)
Van den Eynde, E. (Hospital Universitari de Bellvitge)
Romero, A. (Hospital de Especialidades de Puerto Real)
Deig, E. (Hospital General de Granollers)
Knobel Freud, Hernando (Hospital del Mar (Barcelona, Catalunya))
Pasquau, J. (Hospital Universitario Virgen de las Nieves (Granada))
Antela, A. (Complejo Hospitalario Universitario de Santiago de Compostela)
Clotet Sala, Bonaventura (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Geijo, P. (Hospital Virgen de La Luz (Cuenca))
Rodríguez de Castro, E. (Hospital Mateu Orfila)
Casado, M.A. (Pharmacoeconomics & Outcomes Research Iberia)
Muñoz, A. (Pharmacoeconomics & Outcomes Research Iberia)
Casado, A. (Pharmacoeconomics & Outcomes Research Iberia)
Universitat Autònoma de Barcelona

Fecha:	2018
Resumen:	To investigate the impact of switching from stable Combined Antiretroviral Therapy (cART) to single-tablet regimen (RPV/FTC/TDF=EVIPLERA®/COMPLERA®) on patient-reported outcomes in HIV-infected adults who cannot tolerate previous cART, in a real-world setting. PRO-STR is a 48-week observational, prospective, multicenter study. Presence and magnitude of symptoms (main endpoint), health-related quality-of-life (HRQoL), adherence, satisfaction with treatment and patient preferences were assessed. Three hundred patients with 48-week follow-up, who switched to EVIPLERA® (mean age: 46. 6 years; male: 74. 0%; 74. 7% switched from a non-nucleoside reverse-transcriptase-inhibitor, 25. 3% from a protease inhibitor + ritonavir) were included. There was no statistical difference in median CD4+ cell count (baseline: 678. 5 cells/mm; 48-week: 683. 0 cells/mm) neither in virological suppression (≤50 copies/mL) (baseline: 98. 3%; 48-week: 95. 3%). The most frequent reasons for switching were neuropsychiatric (62. 3%), gastrointestinal (19. 3%) and biochemical/metabolic (19. 3%) events. Only 7. 7% of patients permanently discontinued therapy. At 48-week, all outcomes showed an improvement compared to baseline. Overall, there was a significant decrease (p-value≤0. 05) in number and magnitude of symptoms, while HRQoL, satisfaction and adherence improved significantly. Most patients prefered EVIPLERA® than previous cART. According to the type of intolerance, HRQoL was improved, but only significantly in patients with neuropsychiatric and gastrointestinal symptoms. Adherence improved significantly in patients with metabolic disturbances and satisfaction with EVIPLERA® was higher in the three groups. Switching to EVIPLERA® from non-nucleoside reverse-transcriptase-inhibitor or protease inhibitor-based regimens due to toxicity, improved the presence/magnitude of symptoms, HRQoL, and preference with treatment. EVIPLERA® maintained a virological response, CD4+ cell count and maintained or improved adherence.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Eviplera® ; HIV ; Health-related quality-of-life ; Patient-reported outcomes ; Real-world evidence ; Single treatment regimen
Publicado en:	Current HIV Research, Vol. 16 Núm. 6 (2018) , p. 425-435, ISSN 1873-4251

DOI: 10.2174/1570162X17666190212163518
PMID: 30760189

11 p, 1.8 MB

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Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Institut de Recerca Sant Pau
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