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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
dc.contributor.author | Echeverria, Patricia |
dc.contributor.author | Bonjoch, Anna |
dc.contributor.author | Puig Batalla, Jorge |
dc.contributor.author | Molto, Jose |
dc.contributor.author | Paredes, Roger |
dc.contributor.author | Sirera, Guillem |
dc.contributor.author | Ornelas, Arelly |
dc.contributor.author | Pérez Álvarez, Nuria |
dc.contributor.author | Clotet, Bonaventura |
dc.contributor.author | Negredo, Eugènia |
dc.contributor.other | Universitat Politècnica de Catalunya. Departament d'Organització d'Empreses |
dc.contributor.other | Universitat Politècnica de Catalunya. Departament d'Estadística i Investigació Operativa |
dc.date.accessioned | 2014-04-23T10:44:16Z |
dc.date.available | 2014-04-23T10:44:16Z |
dc.date.created | 2014-02-04 |
dc.date.issued | 2014-02-04 |
dc.identifier.citation | Echeverria, P. [et al.]. 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. "PLoS One", 04 Febrer 2014, vol. 9, núm. 2. |
dc.identifier.issn | 1932-6203 |
dc.identifier.uri | http://hdl.handle.net/2117/22665 |
dc.description.abstract | 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. |
dc.language.iso | eng |
dc.rights | Attribution 3.0 Spain |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es/ |
dc.subject | Àrees temàtiques de la UPC::Ciències de la salut |
dc.subject.lcsh | Virus-induced immunosuppression |
dc.subject.lcsh | HIV (Viruses)--Research |
dc.subject.other | Reverse-transcriptase inhibitor |
dc.subject.other | Placebo-controlled trial |
dc.subject.other | Experienced HIV-1-infected patients |
dc.subject.other | Immunodeficiency-virus-infection |
dc.subject.other | Treatment-naive patients |
dc.subject.other | Double-blind |
dc.subject.other | TMC125 etravirine |
dc.subject.other | Antiretroviral treatment |
dc.subject.other | HDL-cholesterol |
dc.subject.other | Lipid profiles |
dc.title | 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 |
dc.type | Article |
dc.subject.lemac | VIH (Virus) -- Tractament |
dc.contributor.group | Universitat Politècnica de Catalunya. GREMA - Grup de Recerca en Estadística Matemàtica i les seves Aplicacions |
dc.identifier.doi | 10.1371/journal.pone.0084676 |
dc.description.peerreviewed | Peer Reviewed |
dc.rights.access | Open Access |
local.identifier.drac | 13616895 |
dc.description.version | Postprint (published version) |
local.citation.author | Echeverria, P.; Bonjoch, A.; Puig, J.; Molto, J.; Paredes, R.; Sirera, G.; Ornelas, A.; Perez, N.; Clotet, B.; Negredo, E. |
local.citation.publicationName | PLoS One |
local.citation.volume | 9 |
local.citation.number | 2 |
dc.identifier.pmid | 24503952 |
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