PMID- 12187501
OWN - NLM
STAT- MEDLINE
DCOM- 20021226
LR  - 20220311
IS  - 1528-4336 (Print)
IS  - 1528-4336 (Linking)
VI  - 3
IP  - 4
DP  - 2002 Jul-Aug
TI  - Safety and tolerance of efavirenz in different antiretroviral regimens: results 
      from a national multicenter prospective study in 1,033 HIV-infected patients.
PG  - 279-86
AB  - PURPOSE: To evaluate the incidence and severity of adverse events (AEs) and 
      treatment interruption (TI) with efavirenz in a population with a high rate of 
      intravenous drug use (IVDU). METHOD: This was a national, multicenter, and 
      observational study of HIV-infected adult patients who were starting an 
      efavirenz-containing regimen. Evaluations of AEs were made in routine clinical 
      practice at baseline and at least 3 months later. A total of 1,033 patients were 
      included from 60 participating hospitals; 20% were antiretroviral naive. The risk 
      factor for HIV infection was IVDU in 62.3%, and 6.6% of participants were on 
      methadone. RESULTS: AEs affected 29.3% of participants, and treatment was 
      interrupted in 8.23%. The most frequent AEs were CNS disturbances that affected 
      24.1% participants; these AEs were considered related to efavirenz in 18.5% 
      patients. AEs were not severe, and treatment had to be interrupted in 6% of 
      patients. Other AEs were cutaneous rash (incidence of 5.9%; 2.4% of TI), 
      gastrointestinal disturbances (1.45%; no TI), and elevation of liver function 
      test (0.68%; no TI). Patients taking methadone had more AEs (39.7%), mainly CNS 
      disturbances, and TI (19.1%). Cutaneous rash was more frequent among women. 
      Psychoactive drug consumption, previous history of psychiatric disorders, 
      antiretroviral experience, or previous nevirapine intolerance were not associated 
      with higher incidence of AEs. CONCLUSION: Safety and tolerance of efavirenz is 
      good in most patients, even in a population with a high rate of IVDU. The most 
      common AEs are CNS disturbances; they are not severe and rarely lead to TI.
FAU - Perez-Molina, Jose A
AU  - Perez-Molina JA
AD  - Clinical Microbiology and Infectious Diseases Department, Hospital General 
      Universitario Gregorio Maranon, Madrid, Spain. jperezmol@efd.net
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - England
TA  - HIV Clin Trials
JT  - HIV clinical trials
JID - 100936377
RN  - 0 (Alkynes)
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Benzoxazines)
RN  - 0 (Cyclopropanes)
RN  - 0 (Oxazines)
RN  - JE6H2O27P8 (efavirenz)
SB  - IM
MH  - Adult
MH  - Alkynes
MH  - Anti-HIV Agents/*adverse effects/*therapeutic use
MH  - Benzoxazines
MH  - Central Nervous System Diseases/chemically induced
MH  - Cyclopropanes
MH  - Drug Therapy, Combination
MH  - Exanthema/chemically induced
MH  - Female
MH  - Gastrointestinal Diseases/chemically induced
MH  - HIV/physiology
MH  - HIV Infections/*drug therapy
MH  - Humans
MH  - Male
MH  - Oxazines/*adverse effects/*therapeutic use
MH  - Spain
MH  - Substance Abuse, Intravenous
MH  - Viral Load
EDAT- 2002/08/21 10:00
MHDA- 2002/12/27 04:00
CRDT- 2002/08/21 10:00
PHST- 2002/08/21 10:00 [pubmed]
PHST- 2002/12/27 04:00 [medline]
PHST- 2002/08/21 10:00 [entrez]
AID - 10.1310/3q91-yt2d-but4-8hn6 [doi]
PST - ppublish
SO  - HIV Clin Trials. 2002 Jul-Aug;3(4):279-86. doi: 10.1310/3q91-yt2d-but4-8hn6.