title: Early warning indicators for HIV drug resistance in adults in South Africa at 2 pilot sites, 2008-2010.
abstract: BACKGROUND
  Approximately 5.2 million people in South Africa were infected with human immunodeficiency virus (HIV) by the year 2010, with just over 30% initiated on highly active antiretroviral therapy by 2011. With such numbers involved, the potential for the emergence of HIV drug resistance (HIVDR) is high. This study piloted early warning indicators (EWIs) for HIVDR at 2 clinics in South Africa.
  
  
  METHODS
  HIV-infected individuals aged ≥15 years and receiving antiretroviral drugs were enrolled into this cohort study between March 2008 and February 2010. All analyses were performed using the 2012 World Health Organization EWI score card.
  
  
  RESULTS
  A total of 1144 subjects were enrolled. Clinic A reached the target for 2 of the 5 EWIs but missed the desired target for on-time pill pickup, pharmacy stockouts, and virological suppression. Clinic B reached the target for 1 of 4 EWIs, namely, dispensing practices. Targets were missed for on-time pill pickup, retention in care, and virological suppression. Pharmacy stockouts could not be calculated at this site.
  
  
  CONCLUSIONS
  Actual performance against the levels that the pilot sites should reach to minimize HIVDR was low. Improvements in follow-up procedures, internal adherence support, monitoring for drug stockouts, and adherence are all aspects that need support to ensure that all records are complete. This pilot study may help to inform the South African government as EWI monitoring is implemented.
authors.affiliation: Medunsa National Pharmacovigilance Centre, Medunsa Campus, University of Limpopo, Pretoria.
authors.forename: Nomathemba M
authors.initials: NM
authors.lastname: Dube
authors.forename: Khin S
authors.initials: KS
authors.lastname: Tint
authors.forename: Robert S
authors.initials: RS
authors.lastname: Summers
mesh_terms: D000293:Adolescent; D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D024882:Drug Resistance, Viral; D004363:Drug Utilization / Q000706:statistics & numerical data; D005260:Female; D006678:HIV / Q000187:drug effects* / Q000302:isolation & purification; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013019:South Africa; D055815:Young Adult; D016903:Drug Monitoring
chemical_list: D044966:Anti-Retroviral Agents
keywords: HIV; antiretroviral medicines; drug resistance; early warning indicators; pharmacovigilance