title: Baseline predictors of efavirenz-containing antiretroviral regimen adverse experiences.
abstract: OBJECTIVE
  We aimed to identify modifiable, routinely available patient characteristics associated with adverse experiences potentially attributable to efavirenz-based regimens in patients in Botswana.
  
  
  METHODS
  HIV-infected treatment naïve individuals starting a standard antiretroviral regimen including two nucleoside analog reverse transcriptase inhibitors and efavirenz in Botswana were enrolled in a prospective cohort. Adverse experiences were measured at 1 and 6 months using the efavirenz checklist, a 35-item instrument developed by the AIDS Clinical Trials Group.
  
  
  RESULTS
  We enrolled 232 patients from 11 March 2010 to 17 March 2011. One hundred ninety-six were included in the month 1 analyses. Of the 196 included in the month 1 analyses, 157 (80%) completed the 6-month follow-up. Median efavirenz checklist score was 6 (interquartile range (IQR): 2-15) at month 1 and 1 (IQR: 0-5) at month 6. The median change in efavirenz checklist score from month 1-6 was -4 (IQR: -11 to -1), representing an improvement. Depressive symptoms, low CD4 count and less alcohol use were associated with improvement in adverse experiences over time. Low weight was associated with increased extent of adverse experiences at month 1 and 6. There was no confounding or effect modification.
  
  
  CONCLUSIONS
  Clinicians may want to consider more intensive and tailored adverse experience education and management in patients based on depressive symptoms, CD4 count, and weight. Further assessment of the mechanism of the effect of alcohol use on adverse experiences, including analysis of CYP2B6 genotype and plasma efavirenz concentrations, is warranted.
authors.affiliation: Botswana-University of Pennsylvania Partnership, Gaborone, Botswana; Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA; Center for Pharmacoepidemiology Research and Training, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Sonenthal
authors.forename: Bakgaki
authors.initials: B
authors.lastname: Ratshaa
authors.forename: Gilbert
authors.initials: G
authors.lastname: Chimbengo
authors.forename: Tumelo
authors.initials: T
authors.lastname: Rantleru
authors.forename: Thelma
authors.initials: T
authors.lastname: Ngoni
authors.forename: Sarah
authors.initials: S
authors.lastname: Barenbaum
authors.forename: Rebecca
authors.initials: R
authors.lastname: Platoff
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Steenhoff
authors.forename: Robert
authors.initials: R
authors.lastname: Gross
mesh_terms: D000328:Adult; D000428:Alcohol Drinking / Q000453:epidemiology; D000480:Alkynes; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D048588:Benzoxazines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D001835:Body Weight; D001902:Botswana; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D003521:Cyclopropanes; D003863:Depression / Q000453:epidemiology; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D018894:Reverse Transcriptase Inhibitors; C098320:efavirenz
keywords: HIV; adverse effects; efavirenz; highly active antiretroviral therapy; pharmacoepidemiology