López-Cortés, Luis FViciana, PompeyoGirón-González, José ARomero-Palacios, AlbertoMárquez-Solero, ManuelMartinez-Perez, Maria ALópez-Ruz, Miguel ATorre-Lima, Javier de laTéllez-Pérez, FranciscoDelgado-Fernández, MarcialGarcia-Lázaro, MilagrosLozano, FernandoMohamed-Balghata, Mohamed O2014-06-092014-06-092014-05-16López-Cortés LF, Viciana P, Girón-González JA, Romero-Palacios A, Márquez-Solero M, Martinez-Perez MA, et al. Clinical and Virological Efficacy of Etravirine Plus Two Active Nucleos(t)ide Analogs in an Heterogeneous HIV-Infected Population. PLoS ONE. 2014; 9(5):e97262http://hdl.handle.net/10668/1629Journal Article; ClinicalTrials.gov NCT01437241.Etravirine (ETV) is recommended in combination with a boosted protease inhibitor plus an optimized background regimen for salvage therapy, but there is limited experience with its use in combination with two nucleos(t)ide reverse-transcriptase inhibitors (NRTIs). This multicenter study aimed to assess the efficacy of this combination in two scenarios: group A) subjects without virologic failure on or no experience with non-nucleoside reverse-transcriptase inhibitors (NNRTIs) switched due to adverse events and group B) subjects switched after a virologic failure on an efavirenz- or nevirapine-based regimen. The primary endpoint was efficacy at 52 weeks analysed by intention-to-treat. Virologic failure was defined as the inability to suppress plasma HIV-RNA to <50 copies/mL after 24 weeks on treatment, or a confirmed viral load >200 copies/mL in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion. Two hundred eighty seven patients were included. Treatment efficacy rates in group A and B were 88.0% (CI95, 83.9-92.1%) and 77.4% (CI95, 65.0-89.7%), respectively; the rates reached 97.2% (CI95, 95.1-99.3%) and 90.5% (CI95, 81.7-99.3), by on-treatment analysis. The once-a-day ETV treatment was as effective as the twice daily dosing regimen. Grade 1-2 adverse events were observed motivating a treatment switch in 4.2% of the subjects. In conclusion, ETV (once- or twice daily) plus two analogs is a suitable, well-tolerated combination both as a switching strategy and after failure with first generation NNRTIs, ensuring full drug activity. TRIAL REGISTRATION ClinicalTrials.gov NCT01437241.enEtravirinaPiridazinasInhibidores de ProteasasEstudios Multicéntricos como AsuntoSeropositividad para VIHFármacos Anti-VIHHumanosInhibidores de la Proteasa VIHInhibidores de Transcriptasa InversaMedical Subject Headings::Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::PyridazinesMedical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protease InhibitorsMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Multicenter Studies as TopicMedical Subject Headings::Diseases::Immune System Diseases::Immunologic Deficiency Syndromes::HIV Infections::HIV SeropositivityMedical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents::Anti-Retroviral Agents::Anti-HIV AgentsMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protease Inhibitors::HIV Protease InhibitorsMedical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Nucleic Acid Synthesis Inhibitors::Reverse Transcriptase Inhibitorsresearch article24836963open access10.1371/journal.pone.00972621932-6203PMC4023987