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)

HIV Med. 2011 Jul;12(6):374-82. doi: 10.1111/j.1468-1293.2011.00917.x. Epub 2011 Apr 24.

Abstract

Objectives: 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenine / administration & dosage
  • Adenine / adverse effects
  • Adenine / analogs & derivatives*
  • Anti-HIV Agents / adverse effects*
  • Atazanavir Sulfate
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives*
  • Drug Therapy, Combination
  • Dyslipidemias / chemically induced*
  • Dyslipidemias / complications
  • Emtricitabine
  • Female
  • HIV Infections / complications
  • HIV Infections / drug therapy*
  • HIV-1 / drug effects*
  • Humans
  • Lipids
  • Male
  • Nevirapine / administration & dosage
  • Nevirapine / adverse effects*
  • Oligopeptides / administration & dosage
  • Oligopeptides / adverse effects*
  • Organophosphonates / administration & dosage
  • Organophosphonates / adverse effects*
  • Pyridines / administration & dosage
  • Pyridines / adverse effects*
  • Ritonavir / administration & dosage
  • Ritonavir / adverse effects*
  • Tenofovir
  • Viral Load

Substances

  • Anti-HIV Agents
  • Lipids
  • Oligopeptides
  • Organophosphonates
  • Pyridines
  • Deoxycytidine
  • Atazanavir Sulfate
  • Nevirapine
  • Tenofovir
  • Emtricitabine
  • Adenine
  • Ritonavir