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
Echeverría, Patricia (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Bonjoch, Anna (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Puig, Jordi (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Moltó, José (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Paredes, Roger (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Sirera, Guillem (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Ornelas, Arelly (Universitat de Barcelona. Departament d'Econometria, Estadística i Economia Espanyola)
Pérez-Álvarez, Núria (Universitat Politècnica de Catalunya. Departament d'Estadística i Investigació Operativa)
Clotet Sala, Bonaventura (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Negredo Puigmal, Eugènia (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Universitat Autònoma de Barcelona

Date:	2014
Abstract:	Etravirine (ETR) was approved for patients with virological failure and antiretroviral resistance mutations. It has also shown antiviral efficacy in antiretroviral-naïve patients. However, data on the switching from protease inhibitors (PI) to ETR are lacking. 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. 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/µL in the ETR group (p = 0. 25) and −4 cells/µL 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. 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.
Grants:	Ministerio de Sanidad y Consumo RD06/0006
Rights:	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, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	PloS one, Vol. 9 (february 2014) , ISSN 1932-6203

DOI: 10.1371/journal.pone.0084676
PMID: 24503952

6 p, 99.3 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles