PMID- 21999631
OWN - NLM
STAT- MEDLINE
DCOM- 20120110
LR  - 20151119
IS  - 1742-1241 (Electronic)
IS  - 1368-5031 (Linking)
VI  - 65
IP  - 12
DP  - 2011 Dec
TI  - A randomised comparison of safety and efficacy of nevirapine vs. 
      atazanavir/ritonavir combined with tenofovir/emtricitabine in treatment-naive 
      patients.
PG  - 1240-9
LID - 10.1111/j.1742-1241.2011.02807.x [doi]
AB  - BACKGROUND: We report data from NEWART, a randomised phase 4 clinical trial 
      comparing virologic efficacy and safety of nevirapine (NVP) vs. ritonavir-boosted 
      atazanavir (ATV/r) on a background of tenofovir/emtricitabine (TDF/FTC) in 
      HIV-1-infected treatment-naive patients. This study enrolled patients according 
      to CD4-based initiation criteria for NVP (<250 cells/mm(3) for women and <400 
      cells/mm(3) for men), to reduce the likelihood of symptomatic hepatic events. 
      NEWART was designed to support and confirm results from ARTEN, an international 
      trial with similar design and study endpoints. METHODS: A total of 152 patients 
      were randomised 1 : 1 to open-label NVP 200 mg twice daily or ATV/r (300/100 mg) 
      once daily, plus once daily TDF/FTC (300/200 mg). All participants met CD4(+) 
      guidelines at entry. The primary endpoint for non-inferiority was virologic 
      response prior to and at week 48 (confirmed HIV plasma viral load <50 copies/ml, 
      without rebound or change in ARVs). Safety data, including plasma lipids, were 
      recorded throughout the study. RESULTS: The primary endpoint was achieved in 
      46/75 (61.3%) and 50/77 (64.9%) of patients taking NVP and ATV/r, respectively. 
      Frequency of adverse events (AEs) was similar between arms, with 88.0% of 
      NVP-treated patients and 94.8% of ATV/r-treated patients experiencing at least 
      one AE. Nine patients (12%) in each arm experienced an AE that led to 
      discontinuation. At week 48, a significantly greater increase was seen in mean 
      plasma HDL cholesterol (HDL-C) in the NVP arm (9.6 mg/dl) vs. the ATV/r arm (3.5 
      mg/dl); p = 0.016. Also, total cholesterol (TC):HDL-C ratio on-treatment was 
      -0.38 and -0.02 for the NVP and ATV/r arms, respectively (p = 0.038). 
      CONCLUSIONS: Efficacy results were consistent with the ARTEN study demonstrating 
      that NVP was non-inferior to ATV/r when taken in combination with TDF/FTC. Rates 
      of AEs were similar between the two arms, whereas HDL-C increased and TC:HDL-C 
      decreased significantly more in patients taking NVP than ATV/r.
CI  - (c) 2011 Blackwell Publishing Ltd.
FAU - Dejesus, E
AU  - Dejesus E
AD  - Orlando Immunology Center, Orlando, FL 32803, USA. edejesus@oicorlando.com
FAU - Mills, A
AU  - Mills A
FAU - Bhatti, L
AU  - Bhatti L
FAU - Conner, C
AU  - Conner C
FAU - Storfer, S
AU  - Storfer S
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20111014
PL  - India
TA  - Int J Clin Pract
JT  - International journal of clinical practice
JID - 9712381
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination)
RN  - 0 (HIV Protease Inhibitors)
RN  - 0 (Oligopeptides)
RN  - 0 (Organophosphorus Compounds)
RN  - 0 (Pyridines)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 4MT4VIE29P (Atazanavir Sulfate)
RN  - 99DK7FVK1H (Nevirapine)
RN  - O3J8G9O825 (Ritonavir)
SB  - IM
MH  - Adult
MH  - Anti-HIV Agents/*administration & dosage/adverse effects
MH  - Atazanavir Sulfate
MH  - Deoxycytidine/administration & dosage/adverse effects/analogs & derivatives
MH  - Drug Combinations
MH  - Drug Therapy, Combination
MH  - Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
MH  - Female
MH  - HIV Infections/blood/*drug therapy
MH  - HIV Protease Inhibitors/*administration & dosage/adverse effects
MH  - Humans
MH  - Lipid Metabolism/drug effects
MH  - Male
MH  - Middle Aged
MH  - Nevirapine/administration & dosage/adverse effects
MH  - Oligopeptides/administration & dosage/adverse effects
MH  - Organophosphorus Compounds/administration & dosage/adverse effects
MH  - Pyridines/administration & dosage/adverse effects
MH  - Ritonavir/administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Viral Load
MH  - Young Adult
EDAT- 2011/10/18 06:00
MHDA- 2012/01/11 06:00
CRDT- 2011/10/18 06:00
PHST- 2011/10/18 06:00 [entrez]
PHST- 2011/10/18 06:00 [pubmed]
PHST- 2012/01/11 06:00 [medline]
AID - 10.1111/j.1742-1241.2011.02807.x [doi]
PST - ppublish
SO  - Int J Clin Pract. 2011 Dec;65(12):1240-9. doi: 10.1111/j.1742-1241.2011.02807.x. 
      Epub 2011 Oct 14.