title: Patient-Reported Outcomes After a Switch to a Single-Tablet Regimen of Rilpivirine, Emtricitabine, and Tenofovir DF in HIV-1-Positive, Virologically Suppressed Individuals: Additional Findings From a Randomized, Open-Label, 48-Week Trial.
abstract: BACKGROUND
  Patient-reported outcomes (PROs) can provide important information about treatment tolerability in HIV-1-infected patients.
  
  
  OBJECTIVE
  The aim of this study was to evaluate PROs following switching from a boosted protease inhibitor-based regimen to the single-tablet regimen (STR) of rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF) in the 48-week open-label Switching Boosted PI to Rilpivirine in Combination with Truvada as a Single-Tablet Regimen (SPIRIT) trial.
  
  
  METHODS
  In the open-label SPIRIT trial, patients were randomized to receive an STR of RPV/FTC/TDF (n = 317) for 48 weeks or stay on their baseline regimen of a ritonavir-boosted protease inhibitor and two nucleoside/nucleotide analog reverse transcriptase inhibitors (PI + RTV + 2NRTIs, n = 159) for 24 weeks before switching to RPV/FTC/TDF for another 24 weeks. PRO assessments included the HIV Treatment Satisfaction Questionnaire (TSQ) and the HIV Symptom Index Questionnaire (SIQ).
  
  
  RESULTS
  At week 24, the mean HIV TSQ improvement from baseline was significantly greater in the RPV/FTC/TDF group than the PI + RTV + 2NRTIs group (p < 0.001). On the HIV SIQ, the percentage of patients reporting a shift from 'symptom' to 'no symptom' was significantly greater with RPV/FTC/TDF treatment compared with PI + RTV + 2NRTIs for all items (all p ≤ 0.01), with total within-group occurrence of 13/20 symptoms significantly decreasing from baseline for RPV/FTC/TDF patients. In the delayed switch group, significantly fewer patients reported diarrhea and sleep problems at week 48 vs. week 24.
  
  
  CONCLUSIONS
  These data suggest that switching to the STR RPV/FTC/TDF from a PI-based multi-pill regimen is associated with greater patient-reported treatment satisfaction and improved tolerability in HIV-1-infected, virologically suppressed individuals.
authors: Faculty of Medicine, University of Toronto, Toronto, ON, Canada, jbrunetta@mlmedical.com.
authors: Jason
authors: J
authors: Brunetta
authors: Santiago
authors: S
authors: Moreno Guillén
authors: Andrea
authors: A
authors: Antinori
authors: Patrick
authors: P
authors: Yeni
authors: Barbara
authors: B
authors: Wade
authors: Margaret
authors: M
authors: Johnson
authors: Peter
authors: P
authors: Shalit
authors: Ramin
authors: R
authors: Ebrahimi
authors: Bethsheba
authors: B
authors: Johnson
authors: Ivan
authors: I
authors: Walker
authors: Shampa
authors: S
authors: De-Oertel
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / 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; D055118:Medication Adherence; D008875:Middle Aged; D063868:Patient Outcome Assessment; D017060:Patient Satisfaction; D000068696:Rilpivirine / 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; D000068698:Tenofovir; D000068696:Rilpivirine; D000068679:Emtricitabine