title: Incidence and predictors of adverse drug events in an African cohort of HIV-infected adults treated with efavirenz.
abstract: BACKGROUND
  Adverse drug reactions associated with efavirenz (EFV) therapy are poorly described beyond the first year of treatment. We aimed to describe the incidence and predictors of EFV-related adverse drug reactions (ADRs) in a cohort of adult Nigerian HIV-infected patients on antiretroviral therapy (ART).
  
  
  METHODS
  This retrospective cohort study utilized clinical data of HIV-1 infected adults (aged ≥15 years), commenced on efavirenz containing-regimen between January 2004 and December 2011. The time-dependent occurrence of clinical adverse events as defined by the World Health Organization was analyzed by Cox regression analysis.
  
  
  RESULTS
  A total of 2920 patients with baseline median (IQR) age of 39 (33-46) years, largely made up of men (78%) were included in the study. During 8834 person-years of follow up, 358 adverse drug events were reported; the incidence rate was 40.3 ADRs per 1000 person-years of treatment. Lipodystrophy and neuropsychiatric disorders were the most common ADRs with incidences of 63 and 30 per 1000 patients respectively. About one-third of the neuropsychiatric adverse events were within 12 months of commencement of ART. The risk of neuropsychiatric ADRs was independently predicted for women [adjusted hazard ratio (aHR) 9.05; 95% CI: 5.18-15.82], those aged <40 years (aHR 2.59; 95% CI: 1.50-4.45), advanced HIV disease (WHO stage 3 or 4) [aHR 2.26; 95% CI: 1.37-3.72], and zidovudine [aHR 2.21; 95% CI: 1.27-3.83] or stavudine [aHR 4.22; 95% CI: 1.99-8.92] containing regimen compared to tenofovir.
  
  
  CONCLUSIONS
  Neuropsychiatric adverse drug events associated with efavirenz-based ART had both early and late onset in our clinical cohort of patients on chronic EFV therapy. Continuous neuropsychiatric assessment for improved detection and management of neuropsychiatric ADRs is recommended in resource-limited settings where the use of efavirenz-based regimens has been scaled up.
authors.affiliation: BPharm, MSc, Pharmacy Department, Jos University Teaching Hospital, Jos, Nigeria.
authors.forename: Isaac Okoh
authors.initials: IO
authors.lastname: Abah
authors.affiliation: MBBS, MSCI, Department of Medicine, University of Jos, Jos University Teaching Hospital, Jos, Nigeria.
authors.forename: Maxwell
authors.initials: M
authors.lastname: Akanbi
authors.affiliation: BSc, MSc, Department of Psychology, Faculty of Social Sciences, University of Jos, Jos, Nigeria.
authors.forename: Mercy Enuwa
authors.initials: ME
authors.lastname: Abah
authors.affiliation: BPharm, MSc, Pharmacy Department, Jos University Teaching Hospital, Jos, Nigeria.
authors.forename: Amos Istifanus
authors.initials: AI
authors.lastname: Finangwai
authors.affiliation: BPharm, MSc, Pharmacy Department, Jos University Teaching Hospital, Jos, Nigeria.
authors.forename: Christy W
authors.initials: CW
authors.lastname: Dady
authors.affiliation: BPharm, MSc, Department of Pharmacology, Faculty of Pharmaceutical Sciences, University of Jos, Nigeria.
authors.forename: Kakjing Dadul
authors.initials: KD
authors.lastname: Falang
authors.affiliation: MBBS, MSc, Department of Pediatrics, University of Jos, Jos University Teaching Hospital, Jos, Nigeria.
authors.forename: Augustine Odoh
authors.initials: AO
authors.lastname: Ebonyi
authors.affiliation: BSc, PhD, Department of Microbiology, Faculty of Natural Sciences, University of Jos, Jos, Nigeria.
authors.forename: Joseph Anejo
authors.initials: JA
authors.lastname: Okopi
authors.affiliation: MBBS, Department of Medicine, University of Jos, Jos University Teaching Hospital, Jos, Nigeria.
authors.forename: Oche Ochai
authors.initials: OO
authors.lastname: Agbaji
authors.affiliation: MBBS, Department of Obstetrics and Gynecology, University of Jos, Jos University Teaching Hospital, Jos, Nigeria.
authors.forename: Altiene Solomon
authors.initials: AS
authors.lastname: Sagay
authors.affiliation: MBBS, AIDS Prevention Initiative in Nigeria (APIN) Ltd./Gte., Abuja, Nigeria.
authors.forename: Prosper
authors.initials: P
authors.lastname: Okonkwo
authors.affiliation: MBBS, National Agency for the control of AIDS (NACA), Abuja, Nigeria.
authors.forename: John A
authors.initials: JA
authors.lastname: Idoko
authors.affiliation: DVM, SD, Harvard School of Public Health, Boston, MA, USA.
authors.forename: Phyllis J
authors.initials: PJ
authors.lastname: Kanki
keywords: Africa; Efavirenz; adverse drug reaction; antiretroviral therapy; neuropsychiatric