PMID- 22413938
OWN - NLM
STAT- MEDLINE
DCOM- 20120928
LR  - 20201209
IS  - 1468-1293 (Electronic)
IS  - 1464-2662 (Linking)
VI  - 13
IP  - 7
DP  - 2012 Aug
TI  - Pooled week 96 results of the phase III DUET-1 and DUET-2 trials of etravirine: 
      further analysis of adverse events and laboratory abnormalities of special 
      interest.
PG  - 427-35
LID - 10.1111/j.1468-1293.2012.00994.x [doi]
AB  - OBJECTIVES: The aim of the study was to investigate the frequency and severity of 
      adverse events (AEs) and laboratory abnormalities of interest over 96 weeks of 
      treatment with etravirine or placebo in the pooled TMC125 DUET (Demonstrate 
      Undetectable viral load in patients Experienced with ARV Therapy) trials. 
      METHODS: Treatment-experienced, HIV-1-infected patients randomly received 
      etravirine 200 mg twice a day (bid) or placebo, plus a background regimen. The 
      frequency and severity of neuropsychiatric, rash, hepatic and lipid AEs were 
      analysed; frequencies were also adjusted for total patient-years of exposure 
      (PYE). RESULTS: A total of 599 and 604 patients received etravirine and placebo, 
      respectively (median treatment duration 96.0 and 69.6 weeks, respectively). There 
      was no significant difference between the treatment groups in the frequency of 
      neuropsychiatric AEs. However, a significant difference in the frequency of rash 
      was observed (20.5% vs. 11.8%, respectively; P < 0.0001); rash was generally mild 
      to moderate in severity; the rate of discontinuation because of rash was low 
      (2.2% vs. 0% in the etravirine and placebo groups, respectively). The frequency 
      of hepatic AEs was low and similar between the treatment groups (8.7% vs. 7.1%, 
      respectively; P = 0.3370); hepatic enzyme levels did not increase over time. 
      Lipid-related laboratory abnormalities and changes over time in lipid levels were 
      generally comparable between treatment groups. Adjusting for treatment exposure, 
      the frequency of AEs remained similar between treatment groups, with the 
      exception of rash [13.7 vs. 9.3 per 100 PYE; relative risk (95% confidence 
      interval) 1.48 (1.02-1.95)]. CONCLUSIONS: The frequency of AEs of interest was 
      generally similar between the treatment groups, both overall and when adjusted 
      for treatment exposure, with the exception of rash which was more frequent in the 
      etravirine group.
CI  - (c) 2012 British HIV Association.
FAU - Girard, P-M
AU  - Girard PM
AD  - Hopital Saint-Antoine, Paris; INSERM U707, Universite Pierre et Marie Curie, 
      Paris, France. pierre-marie.girard@sat.aphp.fr
FAU - Campbell, T B
AU  - Campbell TB
FAU - Grinsztejn, B
AU  - Grinsztejn B
FAU - Hartikainen, J
AU  - Hartikainen J
FAU - Rachline, A
AU  - Rachline A
FAU - Nijs, S
AU  - Nijs S
FAU - Witek, J
AU  - Witek J
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120314
PL  - England
TA  - HIV Med
JT  - HIV medicine
JID - 100897392
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
MH  - Adult
MH  - Anti-HIV Agents/administration & dosage/*adverse effects
MH  - Dizziness/chemically induced
MH  - Double-Blind Method
MH  - Exanthema/*chemically induced
MH  - Female
MH  - Headache/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mood Disorders/chemically induced
MH  - Nitriles
MH  - Pyridazines/administration & dosage/*adverse effects
MH  - Pyrimidines
MH  - Sleep Wake Disorders/chemically induced
MH  - Viral Load
EDAT- 2012/03/15 06:00
MHDA- 2012/09/29 06:00
CRDT- 2012/03/15 06:00
PHST- 2011/12/20 00:00 [accepted]
PHST- 2012/03/15 06:00 [entrez]
PHST- 2012/03/15 06:00 [pubmed]
PHST- 2012/09/29 06:00 [medline]
AID - 10.1111/j.1468-1293.2012.00994.x [doi]
PST - ppublish
SO  - HIV Med. 2012 Aug;13(7):427-35. doi: 10.1111/j.1468-1293.2012.00994.x. Epub 2012 
      Mar 14.