Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial

Fätkenheuer, Gerd; Duvivier, Claudine; Rieger, Armin; Durant, J.; Rey, David; Schmidt, Warren N.; Hill, A.D.; Delft, Yvon van; Marks, Stephan; Vetter, N; Greil, Richard; Pedersen, Court; Storgaard, Merete; Morlat, Philippe; Katlama, Christine; Cotte, Laurent; Duvvier, C.; Esser, Stephan; Stellbrink, C.; Stoll, Matthias; Stephan, C.; Stoehr, Albrecht; Rockstroh, Juergen; Bánhegyi, Dénes; Itzchak, L.; Shahar, Eduardo; Maayan, Shlomo; Turner, Dan; Lazzarin, Adriano; Antinori, Andrea; Carosi, G.; Minoli, L.; Perri, Giovanni Di; Filice, G.; Andreoni, Massimo; Duiculescu, Dan; Rugină, Sorin; Erscoiu, Simona; Streinu, A.; Пронин, А В; Pokrovsky, Vadim; Gruzdev, B M; Yakovlev, Alexey N.; Voronin, Evgeny; Clotet, Bonaventura; Gatell, Josep M.; Arribas, José Ramón; Podzamczer, Daniel; Domingo, Peré; Álvarez, Cristina; Quero, José Hernández; Furrer, Hansjakob; Feher, J.; Johnson, Marc A.; Fox, Jacob H.; Nelson, Mark; Fisher, Martin; Orkin, Chloe

doi:10.1093/jac/dkr533

Cited by 27 publications

(20 citation statements)

References 20 publications

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“…As expected, and consistent with previous data for the effect of etravirine on lipid profile [4], [5], [23]–[25], the switch from a PI to etravirine led to an improvement in metabolic parameters. After 48 weeks, a significantly more favorable metabolic profile (decreased levels of total cholesterol, triglycerides, glycemia and no patients with grade 3–4 dyslipidemia at week 48) was observed in patients who switched to etravirine than in those who continued with a ritonavir-boosted PI.…”

Section: Discussionsupporting

confidence: 92%

See 1 more Smart Citation

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

et al. 2014

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BackgroundEtravirine (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.MethodsHIV-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.ResultsWe 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.ConclusionSwitch 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.Trial RegistrationClinicalTrials.gov NCT01034917

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Section: Discussionsupporting

confidence: 92%

“…Published evidence also shows that etravirine works well as first-line HIV therapy, as part of a once daily regimen, compared with efavirenz [23], [24]. This new-generation NNRTI induces few neuropsychiatric side effects and has a friendly lipid profile [23]–[25].…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2014

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“…In the Switch-EE study [13], patients switched to ETR had lower lipid plasma levels than when on EFV. In the SENSE study [25] both total cholesterol and LDL-c were lower in patients on ETR as compared with patients on EFV (number of patients with grade 3 or 4 elevation of total cholesterol was 1% vs. 8%). In the C227 trial [26], exploring two treatment regimens (ETR+2NRTI or boosted PI+2NRTI) after an NNRTI-first line failure, lipid and bilirubin elevations were less frequent in the ETR arm.…”

Section: Discussionmentioning

confidence: 89%

Switch to etravirine for HIV‐positive patients receiving statin treatment: a prospective study

Ciaffi

Cavassini

Genné

et al. 2015

Eur J Clin Investigation

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“…71 With regard to other agents, the newer NNRTIs, rilpivirine and etravirine, have more favorable lipid profiles than efavirenz. 72 …”

Section: Dyslipidemia and Cvd In Hiv Infectionmentioning

confidence: 99%

Dyslipidemia and Cardiovascular Risk in Human Immunodeficiency Virus Infection

Kelesidis

Currier²

2014

Endocrinology and Metabolism Clinics of North America

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Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial

Abstract: In the SENSE trial, first-line treatment with 400 mg of etravirine once daily plus two nucleoside analogues led to fewer grade 3 or 4 lipid elevations compared with efavirenz plus two nucleoside analogues.

Cited by 27 publications

References 20 publications

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

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

Switch to etravirine for HIV‐positive patients receiving statin treatment: a prospective study

Dyslipidemia and Cardiovascular Risk in Human Immunodeficiency Virus Infection

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