title: Rate of initial highly active anti-retroviral therapy regimen change and its predictors among adult HIV patients at University of Gondar Referral Hospital, Northwest Ethiopia: a retrospective follow up study.
abstract: BACKGROUND
  Regimen change is a major challenge for the sustainability of human immunodeficiency virus (HIV) treatment program. In a resource limited setting where treatment options are limited, designing strategies to increase the durability of original regimen are essential. However, information's on rate of initial regimen change and its predictors is scarce in Ethiopia. Therefore, the purpose of this study was to assess the rate of initial highly active anti retroviral therapy (HAART) regimen change and its predictors among adult HIV patients at the University of Gondar Referral Hospital, Northwest Ethiopia.
  
  
  METHODS
  An institutional based retrospective follow up study was conducted among 410 adult HIV patients started HAART from January 2010 to December 2014. Simple random sampling technique was used to select patient records using computer generated random number. Data were collected from patient chart using data extraction tool. The Kaplan-Meier curve was used to estimate the median duration of regimen change. Life table was used to estimate the cumulative survival for initial regimen change and log rank test to compare regimen change survival curves between the different categories of explanatory variables. Bivariate and multivariate Cox proportional hazard model were used to identify predictors of initial regimen change.
  
  
  RESULTS
  The overall incidence rate of initial regimen change was 10.11 (95 % CI 8.29, 12.6) per 100 person years (PY). Baseline WHO clinical stage III (AHR = 1.92, 95 % CI 1.12-3.35), occurrence of tuberculosis (TB) on the initial regimen (AHR = 8.33, 95 % CI 4.47-15.53), side effect on the initial regimen (AHR = 25.27, 95 % CI 15.12-42.00) and co-medication with ART (AHR = 2.5, 95 % CI 1.46-4.34) were significant predictors of initial regimen change.
  
  
  CONCLUSIONS
  The rate of initial HAART regimen change was found to be high. Having WHO clinical stage III, co-medication with ART, occurrence of tuberculosis and side effect on initial regimen were independent predictors of regimen change. Hence, close follow-up and screening of patient for side effect and tuberculosis is important.
authors.affiliation: Department of Nursing, College of Medicine and Health Science, University of Gondar, Gondar, Ethiopia.
authors.forename: Degefaye Zelalem
authors.initials: DZ
authors.lastname: Anlay
authors.affiliation: Department of Internal Medicine, College of Medicine and Health Science, School of Medicine, University of Gondar, Gondar, Ethiopia.
authors.forename: Zinahbizu Abay
authors.initials: ZA
authors.lastname: Alemayehu
authors.affiliation: Department of Epidemiology and Biostatistics, College of Medicine and Health Science, Institute of Public Health, University of Gondar, Gondar, Ethiopia.
authors.forename: Berihun Assefa
authors.initials: BA
authors.lastname: Dachew
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods* / Q000706:statistics & numerical data; D057915:Drug Substitution / Q000706:statistics & numerical data*; D005002:Ethiopia; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents
keywords: Gondar; HIV infection; Rate; Regimen change; Survival analysis