title: Optimizing the virological success of tenofovir DF/FTC/rilpivirine in HIV-infected naive and virologically suppressed patients through strict clinical and virological selection.
abstract: BACKGROUND
  Tenofovir DF/FTC/rilpivirine (TDF/FTC/RPV) is a single tablet regimen considered as safe and efficacious in HIV population as long as food requirements, concomitant PPI administration, and compromised antiviral activity have been carefully reviewed. We evaluated TDF/FTC/RPV in a real-life setting with focus on clinical and virological outcomes.
  
  
  METHODS
  OCEAN II is a prospective, two-centre observational study. From September 2012 to December 2013, antiretroviral-naive patients with HIV RNA <100,000 copies/mL or wishing to switch for simplification were considered for TDF/FTC/RPV. A systematic review of potential obstacles to TDF/FTC/RPV administration was undertaken during a multidisciplinary meeting, including DNA genotyping to detect archived RPV and/or NRTI-associated resistance mutations if historical RNA resistance testing was lacking.
  
  
  RESULTS
  TDF/FTC/RPV was considered for 480 patients, however was not offered to 194 patients (40%), mainly because of risk of insufficient virological efficacy, issues on adherence, patient refusal, meal constraint, or PPI therapy. A total of 286 patients (269 in maintenance; 17 ART-naive) received TDF/FTC/RPV. After a median follow-up of 30 months, virological failure occurred in five patients (1.7%) without the emergence of resistance mutations. Discontinuation of TDF/FTC/RPV occurred in 98 patients, due to adverse events in 43 patients (44%) and non-safety reasons in 55 patients (56%). No grade three-fourth adverse events occurred.
  
  
  CONCLUSIONS
  In this real-life experience, cohort consisting primarily of virologically suppressed patients, TDF/FTC/RPV usually maintained virologic suppression. Discontinuation of therapy because of intolerability was due to mild adverse events. Strict clinical and virological screening probably explained the low rate of virological failure.
authors.affiliation: a CHU Hôtel-Dieu, Infectious Diseases Department , Nantes University Hospital , Nantes , France ;
authors.forename: Camille
authors.initials: C
authors.lastname: Bernaud
authors.affiliation: a CHU Hôtel-Dieu, Infectious Diseases Department , Nantes University Hospital , Nantes , France ;
authors.forename: Lydie
authors.initials: L
authors.lastname: Khatchatourian
authors.affiliation: b CHU Hôtel-Dieu, Virology Department , Nantes University Hospital , Nantes , France ;
authors.forename: Audrey
authors.initials: A
authors.lastname: Rodallec
authors.affiliation: a CHU Hôtel-Dieu, Infectious Diseases Department , Nantes University Hospital , Nantes , France ;
authors.forename: Nolwenn
authors.initials: N
authors.lastname: Hall
authors.affiliation: c CHD Vendée, Internal Medicine Department , La Roche sur Yon , France ;
authors.forename: Philippe
authors.initials: P
authors.lastname: Perre
authors.affiliation: c CHD Vendée, Internal Medicine Department , La Roche sur Yon , France ;
authors.forename: Marine
authors.initials: M
authors.lastname: Morrier
authors.affiliation: a CHU Hôtel-Dieu, Infectious Diseases Department , Nantes University Hospital , Nantes , France ;|d COREVIH Pays de la Loire , Nantes University Hospital , Nantes , France.
authors.forename: Solène
authors.initials: S
authors.lastname: Pineau
authors.affiliation: a CHU Hôtel-Dieu, Infectious Diseases Department , Nantes University Hospital , Nantes , France ;|d COREVIH Pays de la Loire , Nantes University Hospital , Nantes , France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Jovelin
authors.affiliation: b CHU Hôtel-Dieu, Virology Department , Nantes University Hospital , Nantes , France ;
authors.forename: Elisabeth
authors.initials: E
authors.lastname: André-Garnier
authors.affiliation: a CHU Hôtel-Dieu, Infectious Diseases Department , Nantes University Hospital , Nantes , France ;
authors.forename: François
authors.initials: F
authors.lastname: Raffi
authors.affiliation: a CHU Hôtel-Dieu, Infectious Diseases Department , Nantes University Hospital , Nantes , France ;
authors.forename: Clotilde
authors.initials: C
authors.lastname: Allavena
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood; D000072230:Sustained Virologic Response; D013607:Tablets / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D004338:Drug Combinations; D054328:Proton Pump Inhibitors; D012367:RNA, Viral; D013607:Tablets
keywords: HIV; NNRTI; STR; rilpivirine; switch; tolerability; virological response