TY - JOUR
T1 - Real world patient-reported outcomes in HIV-infected adults switching to EVIPLERA®, because of a previous intolerance to cART. PRO-STR study
AU - Podzamczer, D.
AU - Rozas, N.
AU - Domingo, P.
AU - Miralles, C.
AU - Van den Eynde, E.
AU - Romero, A.
AU - Deig, E.
AU - Knobel, H.
AU - Pasquau, J.
AU - Antela, A.
AU - Clotet, B.
AU - Geijo, P.
AU - Rodríguez de Castro, E.
AU - Casado, M. A.
AU - Muñoz, A.
AU - Casado, A.
PY - 2018
Y1 - 2018
N2 - Background: 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. 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® (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/mm3; 48-week: 683.0 cells/mm3) 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. Conclusion: 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.
AB - Background: 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. 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® (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/mm3; 48-week: 683.0 cells/mm3) 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. Conclusion: 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.
KW - Eviplera®
KW - Health-related quality-of-life
KW - HIV
KW - Patient-reported outcomes
KW - Real-world evidence
KW - Single treatment regimen
UR - http://www.scopus.com/inward/record.url?scp=85064205559&partnerID=8YFLogxK
U2 - 10.2174/1570162X17666190212163518
DO - 10.2174/1570162X17666190212163518
M3 - Artículo
C2 - 30760189
AN - SCOPUS:85064205559
SN - 1570-162X
VL - 16
SP - 425
EP - 435
JO - Current HIV Research
JF - Current HIV Research
IS - 6
ER -
