title: Safety and Tolerability of Stribild in the Southeast United States.
abstract: The purpose of this study is to assess postmarketing safety and tolerability of Stribild (elvitegravir [EVG]/cobicistat [COBI]/tenofovir disoproxil fumarate [TDF]/emtricitabine [FTC]).
  
  
  
  A retrospective, pharmacoepidemiologic study in 2 outpatient HIV clinics in the Southeast United States was conducted among adults receiving EVG/COBI/TDF/FTC. We evaluated incidence and treatment-related adverse events, including change in serum creatinine (SCr).
  
  
  
  Patients were primarily treatment experienced (n = 173, 60%), African American (n = 210, 73%), and males (n = 187, 65%). One hundred ninety-five (68%) patients had any increase in SCr, and 65 (23%) had an increase of ≥0.3 mg/dL. Mean SCr change from baseline to peak was 0.2 mg/dL. Being treatment experienced (odds ratio [OR] = 2.21, 95% confidence interval [CI]: 1.12-4.38) was associated with SCr ≥0.3 mg/dL, while body mass index ≥30 kg/m(2) (OR = 0.41, 95% CI: 0.18-0.93) was protective. Twenty (7%) patients discontinued therapy, 3 due to acute kidney injury.
  
  
  
  Our results demonstrate limited adverse events and low discontinuation rates associated with EVG/COBI/TDF/FTC.
authors.affiliation: University of South Carolina School of Medicine, Columbia, SC, USA.
authors.forename: Caroline Boyd
authors.initials: CB
authors.lastname: Derrick
authors.affiliation: Department of Clinical Pharmacy and Outcomes Sciences, SC College of Pharmacy, University of South Carolina, Columbia, SC, USA.
authors.forename: Zhiqiang Kevin
authors.initials: ZK
authors.lastname: Lu
authors.affiliation: Department of Clinical Pharmacy and Outcomes Sciences, SC College of Pharmacy, University of South Carolina, Columbia, SC, USA.
authors.forename: Celeste Rudisill
authors.initials: CR
authors.lastname: Caulder
authors.affiliation: Department of Pharmacy Practice, Harrison School of Pharmacy, Auburn University, AL, USA.
authors.forename: Elizabeth Kelly
authors.initials: EK
authors.lastname: Hester
authors.affiliation: SC College of Pharmacy, University of South Carolina, Columbia, SC, USA.
authors.forename: Tyler David
authors.initials: TD
authors.lastname: Wagner
authors.affiliation: Department of Clinical Pharmacy and Outcomes Sciences, SC College of Pharmacy, University of South Carolina, Columbia, SC, USA bookstaver@sccp.sc.edu.
authors.forename: Paul Brandon
authors.initials: PB
authors.lastname: Bookstaver
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003404:Creatinine / Q000097:blood; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D000069545:Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology*; D006801:Humans; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D015144:Southeastern United States / Q000453:epidemiology
chemical_list: D019380:Anti-HIV Agents; D000069545:Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D003404:Creatinine
keywords: adverse effects; cobicistat; elvitegravir; inhibitor; integrase; serum creatinine