title: Patient-Reported Symptoms Over 48 Weeks in a Randomized, Open-Label, Phase IIIb Non-Inferiority Trial of Adults with HIV Switching to Co-Formulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir DF versus Continuation of Non-Nucleoside Reverse Transcriptase Inhibitor with Emtricitabine and Tenofovir DF.
abstract: BACKGROUND
  Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF; Stribild(®)) is a guideline-recommended regimen for HIV treatment-naïve patients and a switch option for virologically suppressed patients.
  
  
  OBJECTIVE
  The purpose of this analysis was to understand how HIV patients' symptoms change after switching to Stribild(®) versus continuing a regimen consisting of a non-nucleoside reverse transcriptase inhibitor (NNRTI) with emtricitabine and tenofovir disoproxil fumarate.
  
  
  METHODS
  A secondary analysis was conducted of the STRATEGY-NNRTI study (GS-US-236-0121), a randomized, open-label, phase IIIb trial of HIV-infected adults who were taking an NNRTI plus FTC/TDF and were randomly assigned (2:1) either to Stribild(®) ('switch') or to continue on their existing regimen ('no-switch'). Logistic regressions and longitudinal modeling were conducted to evaluate the relationship of treatment with bothersome symptoms. These models adjusted for age, sex, race, number of bothersome symptoms at baseline, Veterans Aging Cohort Study Risk (VACS) Index score, years since HIV diagnosis, and first antiretroviral therapy use, NNRTI type, serious mental illness, and baseline depression and health-related quality of life (HRQL) scores.
  
  
  RESULTS
  At baseline, the prevalence of nightmares, vivid dreams, weird/intense dreams, muscle aches/joint pain, and fevers/chills/sweats was greater in the switch group. The prevalence of nightmare, vivid dreams, weird/intense dreams, dizzy/lightheadedness, fatigue/loss of energy, and pain/numbness/tingling in hands/feet deceased in the switch group at week 4, and these benefits were maintained over time. Nervous/anxious, drowsiness, trouble remembering, off balance, and body changes decreased in the switch group at week 4 but were not maintained over time. Difficulty sleeping, diarrhea/loose bowels, and bloating did not differ in prevalence at week 4 or 48, but longitudinal models suggested differences between groups over time. HRQL did not differ between groups and was unchanged over time.
  
  
  CONCLUSIONS
  In this study sample, a switch to co-formulated EVG/COBI/FTC/TDF was associated with significant persistent improvements in six patient-reported HIV symptoms.
authors.affiliation: Southern California's Men's Medical Group/Men's Health Foundation, Los Angeles, CA, USA.
authors.forename: Anthony
authors.initials: A
authors.lastname: Mills
authors.forename: Will
authors.initials: W
authors.lastname: Garner
authors.forename: Anton
authors.initials: A
authors.lastname: Pozniak
authors.forename: Juan
authors.initials: J
authors.lastname: Berenguer
authors.forename: Rebecca M
authors.initials: RM
authors.lastname: Speck
authors.forename: Randall
authors.initials: R
authors.lastname: Bender
authors.forename: Thai
authors.initials: T
authors.lastname: Nguyen
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069547:Cobicistat / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D000068679:Emtricitabine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D011788:Quality of Life; D015363:Quinolones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068698:Tenofovir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D004338:Drug Combinations; D015363:Quinolones; C509700:elvitegravir; D000068698:Tenofovir; D000068679:Emtricitabine; D000069547:Cobicistat