title: Lipid profiles for nevirapine vs. atazanavir/ritonavir, both combined with tenofovir disoproxil fumarate and emtricitabine over 48 weeks, in treatment-naïve HIV-1-infected patients (the ARTEN study).
abstract: OBJECTIVE
  Dyslipidaemic effects of antiretrovirals (ARVs) may contribute to increased cardiovascular risk (CR) in HIV-1-infected patients. The ARTEN (atazanavir/ritonavir on a background of tenofovir and emtricitabine vs. nevirapine on the same background, in naïve HIV-1-infected patients) study compared prospectively ritonavir-boosted atazanavir (ATZ/r) 300 mg/100 mg once daily (qd) with immediate release nevirapine (NVP) 200 mg twice daily or 400 mg qd, each combined with fixed-dose tenofovir 300 mg/emtricitabine 200 mg qd in 569 ARV-naïve HIV-1-infected patients. Lipid profiles and CR from baseline to week 48 are reported.
  
  
  METHODS
  Changes from baseline to week 48 in fasting plasma levels of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-c), low-density lipoprotein cholesterol (LDL-c), TC:HDL-c ratio, apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB) and total triglycerides (TG) were determined. The Framingham algorithm was used to estimate CR. Analysis was by intention-to-treat (ITT) with last observation carried forward (LOCF) for missing data.
  
  
  RESULTS
  At week 48, NVP treatment resulted in significantly greater mean increases from baseline in TC (24.4 vs. 19.6 mg/dL; P=0.038), HDL-c (9.7 vs. 3.9 mg/dL; P<0.0001), LDL-c (15.0 vs. 10.4 mg/dL; P=0.011) and ApoA1 (0.18 vs. 0.08 g/L; P<0.0001) but not ApoB (0.02 vs. 0.02 g/L) compared with ATZ/r treatment. ATZ/r use was associated with higher mean TG increases (27.80 vs. 0.02 mg/dL; P=0.0001). Significantly greater mean decreases in TC:HDL-c and ApoB/ApoA ratios were observed with NVP vs. ATZ/r (P=0.0001 and P=0.008, respectively). Framingham CR scores were low and comparable between the arms, with only a slight mean increase from baseline to week 48 of 0.70 for NVP and 0.80 for ATZ/r [difference -0.069; 95% confidence interval (CI) -0.61 to 0.46; P=0.80].
  
  
  CONCLUSIONS
  In ARV-naïve patients with low CR at the outset, NVP showed a potentially less atherogenic lipid profile compared with ATZ/r.
authors.affiliation: Infectious Disease Service, Hospital Universitario de Bellvitge, Barcelona, Spain. dpodzamczer@bellvitgehospital.cat
authors.forename: Daniel
authors.initials: D
authors.lastname: Podzamczer
authors.forename: J
authors.initials: J
authors.lastname: Andrade-Villanueva
authors.forename: B
authors.initials: B
authors.lastname: Clotet
authors.forename: S
authors.initials: S
authors.lastname: Taylor
authors.forename: J K
authors.initials: JK
authors.lastname: Rockstroh
authors.forename: P
authors.initials: P
authors.lastname: Reiss
authors.forename: P
authors.initials: P
authors.lastname: Domingo
authors.forename: H J
authors.initials: HJ
authors.lastname: Gellermann
authors.forename: L
authors.initials: L
authors.lastname: de Rossi
authors.forename: V
authors.initials: V
authors.lastname: Cairns
authors.forename: V
authors.initials: V
authors.lastname: Soriano
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D019380:Anti-HIV Agents / Q000009:adverse effects*; D000069446:Atazanavir Sulfate; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000139:chemically induced* / Q000150:complications; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D008055:Lipids; D008297:Male; D019829:Nevirapine / Q000008:administration & dosage / Q000009:adverse effects*; D009842:Oligopeptides / Q000008:administration & dosage / Q000009:adverse effects*; D063065:Organophosphonates / Q000008:administration & dosage / Q000009:adverse effects*; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects*; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects*; D000068698:Tenofovir; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D008055:Lipids; D009842:Oligopeptides; D063065:Organophosphonates; D011725:Pyridines; D003841:Deoxycytidine; D000069446:Atazanavir Sulfate; D019829:Nevirapine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine; D019438:Ritonavir