Para acceder a los documentos con el texto completo, por favor, siga el siguiente enlace:

Randomised study to assess the efficacy and safety of once-daily etravirine-based regimen as a switching strategy in HIV-infected patients receiving a protease inhibitor-containing regimen. Etraswitch study
Echeverria, Patricia; Bonjoch, Anna; Puig Batalla, Jorge; Molto, Jose; Paredes, Roger; Sirera, Guillem; Ornelas, Arelly; Pérez Álvarez, Nuria; Clotet, Bonaventura; Negredo, Eugènia
Universitat Politècnica de Catalunya. Departament d'Organització d'Empreses; Universitat Politècnica de Catalunya. Departament d'Estadística i Investigació Operativa; Universitat Politècnica de Catalunya. GREMA - Grup de Recerca en Estadística Matemàtica i les seves Aplicacions
Background: Etravirine (ETR) was approved for patients with virological failure and antiretroviral resistance mutations. It has also shown antiviral efficacy in antiretroviral-naive patients. However, data on the switching from protease inhibitors (PI) to ETR are lacking.; Methods: HIV-1-infected patients with suppressed viral load (VL) during a PI-containing regimen (>12 months) and no previous virological failure were randomized to switch from the PI to ETR (400 mg/day, dissolved in water) (ETR group, n = 22) or to continue with the same regimen (control group, n = 21). Percentage of patients with VL <= 50 copies/mL were assessed at week 48, as well as changes in CD4 T-cell counts and metabolic profile.; Results: We included 43 patients [72.9% male, 46.3 (42.2; 50.6) years]. Two patients receiving ETR (grade-1 diarrhea and voluntary discontinuation) and another in the control group (simplification) discontinued therapy early. No patients presented virological failure (two consecutive VL>50 copies/mL); treatment was successful in 95.2% of the control group and 90.9% of the ETR group (intention-to-treat analysis, missing = failure) (p = 0.58). CD4+ T-cell counts did not significantly vary [+49 cells/mu L in the ETR group (p = 0.25) and -4 cells/mu L in the control group (p = 0.71)]. The ETR group showed significant reductions in cholesterol (p<0.001), triglycerides (p=<0.001), and glycemia (p = 0.03) and higher satisfaction (0-10 scale) (p = 0.04). Trough plasma concentrations of ETR were similar to observed in studies using ETR twice daily.; Conclusion: Switch from a PI-based regimen to a once-daily combination based on ETR maintained undetectable VL during 48 weeks in virologically suppressed HIV-infected patients while lipid profile and patient satisfaction improved significantly.
Peer Reviewed
Àrees temàtiques de la UPC::Ciències de la salut
Virus-induced immunosuppression
HIV (Viruses)--Research
Reverse-transcriptase inhibitor
Placebo-controlled trial
Experienced HIV-1-infected patients
Treatment-naive patients
TMC125 etravirine
Antiretroviral treatment
Lipid profiles
VIH (Virus) -- Tractament
Attribution 3.0 Spain

Mostrar el registro completo del ítem

Documentos relacionados

Otros documentos del mismo autor/a

Echeverria, Patricia; Domingo, Pere; Llibre, Josep M.; Gutierrez, Mar; Mateo, Gracia; Puig, Jordi; Bonjoch, Anna; Pérez Alvarez, Núria; Sirera, Guillem; Clotet, Bonaventura; Negredo, Eugenia
Santos, Julia; Clotet, Bonaventura; Ramón Santos, José; Negredo, Eugènia; Massanella, Marta; Puig, Jordi; Pérez Álvarez, Nuria; Gallego-Escuredo, Jose Miguel; Villarroya, Joan; Villarroya, Francesc; Molto, Jose
Clotet, Bonaventura; Garolera, Maite; Muñoz Moreno, Jose A.; Fumaz, Carmina R.; Prats, Anna; Ferrer, Maria J.; Negredo, Eugènia; Pérez Álvarez, Nuria; Molto, Jose; Gómez Melis, Guadalupe
Negredo, Eugènia; Bonjoch, Anna; Gómez Mateu, Moisés; Estany, Carla; Puig, Jordi; Pérez Álvarez, Nuria; Rosales, Joaquim; di Gregorio, Silvana; del Rio, Luis; Gómez Melis, Guadalupe; Clotet, Bonaventura
Llibre, Josep M.; Bravo, Isabel; Ornelas, Arelly; Santos, José R.; Puig, Jordi; Martín Iguacel, Raquel; Paredes, Roger; Clotet, Bonaventura