title: Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial.
abstract: BACKGROUND
  Selection of first-line antiretroviral therapy requires consideration of efficacy as well as effects on lipids given the increased concern about cardiovascular risk in HIV-1 patients.
  
  
  METHODS
  ARTEN is a randomized, open-label, non-inferiority trial that compares nevirapine (NVP) 200 mg twice daily or 400 mg once daily to atazanavir/ritonavir (ATZ/r) 300 mg/100 mg once daily, each combined with fixed-dose tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg once daily, in antiretroviral-naive HIV-1 patients with CD4(+) T-cell counts <400 (men) and <250 cells/mm(3) (women). The primary end point was plasma HIV RNA<50 copies/ml at two consecutive visits prior to week 48.
  
  
  RESULTS
  A total of 569 patients were randomized and treated. Overall, 66.8% of NVP and 65.3% of ATZ/r patients achieved the primary end point (difference 1.9%, 95% CI -5.9-9.8%). Similar rates of serious adverse events were observed (9.6% on NVP versus 8.8% on ATZ/r), although discontinuations due to adverse events were more frequent with NVP than ATZ/r (13.6% versus 3.6%, respectively). None of the 28 patients virologically failing ATZ/r selected resistance mutations, while they were selected in 29/44 patients virologically failing NVP. NVP induced a significantly greater increase in high-density lipoprotein cholesterol (HDL-c) and apolipoprotein A1 from baseline than ATZ/r, whereas triglycerides increased significantly more with ATZ/r than NVP. Mean change from baseline in TC:HDL-c ratio was -0.24 for NVP and 0.13 for ATZ/r (P=0.0001).
  
  
  CONCLUSIONS
  NVP demonstrated at week 48 non-inferior antiviral efficacy compared with ATZ/r when given along with TDF/FTC, despite more drug-related discontinuations with NVP than ATZ/r. NVP was associated with a lower atherogenic lipid profile than ATZ/r although resistance mutations were more frequently selected with NVP than ATZ/r.
authors.affiliation: Department of Infectious Diseases, Hospital Carlos III, Madrid, Spain. vsoriano@dragonet.es
authors.forename: Vicente
authors.initials: V
authors.lastname: Soriano
authors.forename: Keikawus
authors.initials: K
authors.lastname: Arastéh
authors.forename: Horacio
authors.initials: H
authors.lastname: Migrone
authors.forename: Thomas
authors.initials: T
authors.lastname: Lutz
authors.forename: Milos
authors.initials: M
authors.lastname: Opravil
authors.forename: Jaime
authors.initials: J
authors.lastname: Andrade-Villanueva
authors.forename: Francisco
authors.initials: F
authors.lastname: Antunes
authors.forename: Giovanni
authors.initials: G
authors.lastname: Di Perri
authors.forename: Daniel
authors.initials: D
authors.lastname: Podzamczer
authors.forename: Steve
authors.initials: S
authors.lastname: Taylor
authors.forename: Pere
authors.initials: P
authors.lastname: Domingo
authors.forename: Holger
authors.initials: H
authors.lastname: Gellermann
authors.forename: Lothar
authors.initials: L
authors.lastname: de Rossi
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use; D000069446:Atazanavir Sulfate; D002318:Cardiovascular Diseases / Q000139:chemically induced / Q000188:drug therapy; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000009:adverse effects / Q000627:therapeutic use; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use; D063065:Organophosphonates / Q000009:adverse effects / Q000627:therapeutic use; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D019438:Ritonavir / Q000009:adverse effects / Q000627:therapeutic use; D000068698:Tenofovir; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D009842:Oligopeptides; D063065:Organophosphonates; D011725:Pyridines; D018894:Reverse Transcriptase Inhibitors; D003841:Deoxycytidine; D000069446:Atazanavir Sulfate; D019829:Nevirapine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine; D019438:Ritonavir