PMID- 22497697
OWN - NLM
STAT- MEDLINE
DCOM- 20120910
LR  - 20201209
IS  - 1873-4251 (Electronic)
IS  - 1570-162X (Linking)
VI  - 10
IP  - 3
DP  - 2012 Apr
TI  - Week 96 outcomes of patients with less treatment experience versus more treatment 
      experience receiving etravirine in the DUET trials.
PG  - 256-61
AB  - BACKGROUND: The disease profile of treatment-experienced HIV-1 patients (TEPs) 
      looks different today compared with that of 5 years ago. Because less highly 
      treated DUET patients may more closely resemble today's TEPs, we conducted a post 
      hoc efficacy and safety analysis of the pooled 96-week DUET data stratified by 
      level of treatment experience. METHODS: TEPs with HIV-1 were randomised to 
      etravirine (ETR) 200mg twice daily (bid) or placebo bid with a background regimen 
      for 48 weeks (plus optional 48-week extension). TEPs were categorized using 10 
      demographic and disease characteristics that in prior studies of 
      treatment-experienced subjects had been associated with virologic response; 
      patients meeting >/=5 criteria were categorized as less TEP. RESULTS: 183 patients 
      (men, 87.4%) who received ETR were less TEP and 413 patients (men, 91.0%) were 
      more TEP. At baseline, more TEPs had more advanced disease, more previous 
      antiretroviral (ARV) exposures and fewer options for active ARVs. At Week 96, for 
      patients receiving ETR, response rates for the less TEP group and more TEP group 
      were 68.3% and 52.8%, respectively. Incidence of adverse events (AEs) was similar 
      between groups. A greater proportion of nonresponders in the more TEP group 
      discontinued due to AEs (9.0% vs 5.5%) and virologic failure (18.9% vs 5.5%) 
      compared with the less TEP group. CONCLUSION: Less TEPs had higher virologic 
      response rates with ETR compared with more TEPs. Because the less TEP population 
      from DUET more closely resembles TEPs with HIV-1 today, data from this subgroup 
      may provide valuable information for real-life treatment decisions.
FAU - Anderson, David
AU  - Anderson D
AD  - Janssen Services, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA. 
      DAnder20@its.jnj.com
FAU - DeMasi, Ralph
AU  - DeMasi R
FAU - DeLaitsch, Lori
AU  - DeLaitsch L
FAU - Surles, Tiffany
AU  - Surles T
FAU - Coate, Bruce
AU  - Coate B
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - Curr HIV Res
JT  - Current HIV research
JID - 101156990
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Nitriles)
RN  - 0 (Pyridazines)
RN  - 0 (Pyrimidines)
RN  - 0C50HW4FO1 (etravirine)
SB  - IM
MH  - Acquired Immunodeficiency Syndrome/*drug therapy/epidemiology/immunology
MH  - Adult
MH  - Anti-HIV Agents/*administration & dosage
MH  - CD4 Lymphocyte Count
MH  - Double-Blind Method
MH  - Female
MH  - HIV-1/*drug effects/immunology
MH  - Humans
MH  - Male
MH  - Medication Adherence
MH  - Middle Aged
MH  - Nitriles
MH  - Pyridazines/*administration & dosage
MH  - Pyrimidines
MH  - Treatment Outcome
MH  - Viral Load/drug effects
EDAT- 2012/04/14 06:00
MHDA- 2012/09/11 06:00
CRDT- 2012/04/14 06:00
PHST- 2011/10/21 00:00 [received]
PHST- 2012/03/15 00:00 [revised]
PHST- 2012/03/22 00:00 [accepted]
PHST- 2012/04/14 06:00 [entrez]
PHST- 2012/04/14 06:00 [pubmed]
PHST- 2012/09/11 06:00 [medline]
AID - CHIVR-EPUB-20120411-003 [pii]
AID - 10.2174/157016212800618110 [doi]
PST - ppublish
SO  - Curr HIV Res. 2012 Apr;10(3):256-61. doi: 10.2174/157016212800618110.