title: Efficacy and safety in clinical practice of a rilpivirine, tenofovir and emtricitabine single-tablet regimen in virologically suppressed HIV-positive patients on stable antiretroviral therapy.
abstract: BACKGROUND
  Switching to a rilpivirine, tenofovir and emtricitabine (RTE) single-tablet regimen (STR) has been evaluated in a limited number of virologically suppressed patients. The aim of this study was to describe clinical outcomes in HIV-positive patients switched from a suppressive antiretroviral regimen to RTE STR in routine clinical practice.
  
  
  METHODS
  In this retrospective study of antiretroviral-treated patients with <50 copies of HIV RNA/mL switched to RTE STR, virological failure (VF) was defined as two consecutive measurements of ≥50 copies/mL or a single measurement of ≥50 copies/mL followed by any change in treatment. Treatment failure (TF) was defined as VF or discontinuation of the STR for any reason. Univariate mixed-linear models were used to identify differences in laboratory parameters over time.
  
  
  CONCLUSIONS
  The analysis involved 307 patients (83% males) with a median age of 45.8 years (interquartile range (IQR 39.3-50.9), who were followed up for a median of 7.4 months (IQR 4.6-10.9). VF occurred in three patients (1%) switched from a protease inhibitor (PI)-based regimen, after a median of 2.6 months (IQR 1.6-3.0), and TF in 34 patients (11%) after a median of three months (IQR 1.4-5.8), 24 of whom (71%) were receiving a PI-based regimen at baseline. Overall, there was a slight but statistically significant improvement in the mean monthly change from baseline in CD4+ cell counts (p=0.027), the CD4+/CD8+ ratio (p=0.0001), and Hb (p=0.024), alanine amino transferase (ALT) (p=0.009), total bilirubin (p<0.0001), indirect bilirubin (p<0.0001), total cholesterol (p<0.0001) and triglyceride (p<0.0001) levels. There was also a slight but statistically significant increase in serum creatinine (p=0.0004), aspartate amino transferase (AST) (p=0.001) and liver fibrosis index (FIB-4) (p=0.002), and a decrease in eGFRcreat (p<0.0001) and high-density lipoprotein (HDL) cholesterol (p<0.0001) values. The study limitations include its retrospective design, the relatively short follow-up, and the absence of data concerning the severity of clinical adverse events; however, it does provide new information concerning the laboratory changes that occur in patients switching from PI-based or PI-sparing regimens to RTE STR.
  
  
  CONCLUSIONS
  The study findings confirm the efficacy and safety in clinical practice of switching to RTE STR in virologically suppressed patients receiving other antiretrovirals.
authors.affiliation: Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy; nicola.gianotti@hsr.it.
authors.forename: Nicola
authors.initials: N
authors.lastname: Gianotti
authors.affiliation: Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Poli
authors.affiliation: Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Nozza
authors.affiliation: Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy.|School of Infectious Diseases, Università Vita-Salute San Raffaele, Milan, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Spagnuolo
authors.affiliation: Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tambussi
authors.affiliation: Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Bossolasco
authors.affiliation: Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Cinque
authors.affiliation: Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Myriam
authors.initials: M
authors.lastname: Maillard
authors.affiliation: Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Cernuschi
authors.affiliation: Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Galli
authors.affiliation: Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy.|School of Infectious Diseases, Università Vita-Salute San Raffaele, Milan, Italy.
authors.forename: Adriano
authors.initials: A
authors.lastname: Lazzarin
authors.affiliation: Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Castagna
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D000068679:Emtricitabine / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000068696:Rilpivirine / Q000627:therapeutic use*; D000068698:Tenofovir / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D000068698:Tenofovir; D000068696:Rilpivirine; D000068679:Emtricitabine
keywords: efavirenz; emtricitabine; nevirapine; protease inhibitors; rilpivirine; simplification regimen; single-tablet regimen; tenofovir