Real World Patient-reported Outcomes in HIV-infected Adults Switching to EVIPLERA (R), Because of a Previous Intolerance to cART. PRO-STR Study
Por:
Podzamczer, D, Rozas, N, Domingo, P, Miralles, C, van den Eynde, E, Romero, A, Deig, E, Knobel, H, Pasquau, J, Antela, A, Clotet, B, Geijo, P, de Castro, ER, Casado, MA, Munoz, A, Casado, A, Palter, DP, Gonzalez, JS, Palacios, AR, Mayorga, MI, Liano, JP, Alfaro, EM, Sepulveda, MA, Yzusqui, M, Farre, JRB, Martinez, PG, Zapata, MR, Luque, PB, Carrasco, AB, Lorenzo, JF, Knobel, H, Comerma, ED, Torrella, A, Domingo, P, Clotet, B, Serrano, XS, Lopez, AA, Alvarez, CM, Aren, JD, Fernandez, P and Hurtado, ERD
Publicada:
1 ene 2018
Resumen:
Background: To investigate the impact of switching from stable Combined Antiretroviml Therapy (cART) to single-tablet regimen (RPV/FTC/TDF=EVIPLERA (R) /COMPLERA (R)) on patient-reported outcomes in HIV-infected adults who cannot tolerate previous cART, in a real-world setting.
Methods: 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.
Results: Three hundred patients with 48-week follow-up, who switched to EVIPLERA (R) (mean age: 46.6 years; male: 74.0%; 74.7% switched from a non-nucleoside reverse-transcriptase-inhibitor, ARTICLE HISTORY 25.3% from a protease inhibitor + ritonavir) were included. There was no statistical difference in median CD4+ cell count (baseline: 678.5 cells/mm(3) ; 48-week: 683.0 cells/mm 3 ) 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 (R) 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 (R) was higher in the three groups.
Conclusion: Switching to EVIPLERA (R) 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 (R) maintained a virological response, CD4+ cell count and maintained or improved adherence.
Filiaciones:
Podzamczer, D:
Hosp Univ Bellvitge, Barcelona, Spain
Rozas, N:
Hosp Univ Bellvitge, Barcelona, Spain
Domingo, P:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Hosp Santa Creu & Sant Pau, Cataluna, Spain
Miralles, C:
Hosp Xeral Vigo, Pontevedra, Spain
van den Eynde, E:
Hosp Univ Bellvitge, Barcelona, Spain
Romero, A:
Hosp Especialidades Puerto Real, Cadiz, Spain
Deig, E:
Hosp Gen Granollers, Barcelona, Spain
Knobel, H:
Hosp del Mar, Barcelona, Spain
Hosp del Mar, Cataluna, Spain
Pasquau, J:
Hosp Univ Virgen Nieves, Granada, Spain
Antela, A:
Complejo Hosp Univ Santiago, La Coruna, Spain
:
Hosp Badalona Germans Trias & Pujol, Barcelona, Spain
Hosp Badalona Germans Trias & Pujol, Cataluna, Spain
Geijo, P:
Hosp Virgen Luz, Cuenca, Spain
de Castro, ER:
Hosp Mateu Orfila, Mahon, Spain
Casado, MA:
Pharmacoecon & Outcomes Res Iberia, Madrid, Spain
Munoz, A:
Pharmacoecon & Outcomes Res Iberia, Madrid, Spain
Casado, A:
Pharmacoecon & Outcomes Res Iberia, Madrid, Spain
Palter, DP:
Hosp Univ Bellvitge, Cataluna, Spain
Gonzalez, JS:
Hosp Virgen Victoria, Andalucia, Spain
Palacios, AR:
Hosp Especialidades Puerto Real, Andalucia, Spain
Mayorga, MI:
Hosp Carlos Haya, Andalucia, Spain
Liano, JP:
Hosp Univ Virgen Nieves, Andalucia, Spain
Alfaro, EM:
Complejo Hosp Univ Albacete, Castilla La Mancha, Spain
Sepulveda, MA:
Hosp Virgen Salud, Castilla La Mancha, Spain
Yzusqui, M:
Hosp Nuestra Sra Prado, Castilla La Mancha, Spain
Farre, JRB:
Complejo Hosp La Mancha Ctr, Castilla La Mancha, Spain
Martinez, PG:
Hosp Gen Virgen Luz, Castilla La Mancha, Spain
Zapata, MR:
Hosp Univ Guadalajara, Castilla La Mancha, Spain
Luque, PB:
Hosp Univ Rio Hortega, Castilla Y Leon, Spain
Carrasco, AB:
Hosp Bierzo, Castilla Y Leon, Spain
Lorenzo, JF:
Hosp Gen Burgos, Castilla Y Leon, Spain
Knobel, H:
Hosp del Mar, Barcelona, Spain
Hosp del Mar, Cataluna, Spain
Comerma, ED:
Hosp Gen Granollers, Cataluna, Spain
Torrella, A:
Hosp Valle De Hebron, Cataluna, Spain
Domingo, P:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Hosp Santa Creu & Sant Pau, Cataluna, Spain
Clotet, B:
Hosp Badalona Germans Trias & Pujol, Barcelona, Spain
Hosp Badalona Germans Trias & Pujol, Cataluna, Spain
Serrano, XS:
Hosp Dr Josep Trueta Girona, Cataluna, Spain
Lopez, AA:
Complejo Hosp Univ Santiago, Galicia, Spain
Alvarez, CM:
Hosp Xeral Vigo, Galicia, Spain
Aren, JD:
Hosp Montecelo, Galicia, Spain
Fernandez, P:
Hosp Can Misses Ibiza, Islas Baleares, Spain
Hurtado, ERD:
Hosp Mateu Orfila, Islas Baleares, Spain
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