title: Efficacy and safety of darunavir/ritonavir plus etravirine dual regimen in antiretroviral therapy-experienced patients: a multicenter clinical experience.
abstract: OBJECTIVE
  To assess the outcome of a dual regimen combining darunavir/ritonavir plus etravirine in a cohort of antiretroviral therapy (ART)-experienced patients.
  
  
  METHODS
  A retrospective analysis was performed on all ART-experienced patients starting a darunavir/ritonavir plus etravirine regimen at the 3 clinics. Patients were stratified according to HIV RNA detectability (≥ 40 copies/mL) at baseline. Two efficacy endpoints were evaluated by Kaplan-Meier and Cox multivariable models: virological failure (confirmed HIV RNA ≥ 40 copies/mL after 6 months) and therapeutic failure (including virological failure and treatment discontinuation for any reason).
  
  
  RESULTS
  Sixty-eight patients were included in the study. They had a median of 10.8 years on ART and 5 previous ART regimens; 61.3% showed primary protease inhibitor (PI) mutations and 70% showed previous non-nucleoside reverse transcriptase inhibitor (NNRTI) exposure. HIV RNA was detectable in 34 (50%) patients. The median observation period was 21 (interquartile range [IQR], 11.9-25.1) months. After 24 months, 75.1% of the patients were still on the study regimen and 88.8% remained free from virological failure. Although a higher therapeutic failure rate was reported in patients with detectable viremia at baseline, only the immunological status revealed an independent predictive role. No differences in virological failure were observed according to HIV RNA detectability at baseline; a higher number of previous ART regimens was the only predictor. Discontinuation due to adverse events occurred in 5.9%.
  
  
  CONCLUSIONS
  Darunavir/ritonavir plus etravirine regimen proved virological efficacy and safety in heavily pretreated patients with a high rate of virological success, even in patients who switched during virological failure.
authors.affiliation: Department of Health Sciences, Clinic of Infectious Diseases, "San Paolo" Hospital, University of Milan, Milan, Italy.
authors.forename: Lidia
authors.initials: L
authors.lastname: Gazzola
authors.affiliation: Department of Health Sciences, Clinic of Infectious Diseases, "San Paolo" Hospital, University of Milan, Milan, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Cicconi
authors.affiliation: Unit of Infectious Diseases, Ospedale Papa Giovanni XXIII, Bergamo, Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Ripamonti
authors.affiliation: Unit of Infectious Diseases, Ospedale Papa Giovanni XXIII, Bergamo, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Di Filippo
authors.affiliation: Clinic of Infectious Diseases, "San Martino" Hospital, University of Genova, Genova, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Gustinetti
authors.affiliation: Clinic of Infectious Diseases, "San Martino" Hospital, University of Genova, Genova, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Di Biagio
authors.affiliation: Department of Health Sciences, Clinic of Infectious Diseases, "San Paolo" Hospital, University of Milan, Milan, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Marchetti
authors.affiliation: Department of Health Sciences, Clinic of Infectious Diseases, "San Paolo" Hospital, University of Milan, Milan, Italy.
authors.forename: Teresa
authors.initials: T
authors.lastname: Bini
authors.affiliation: Department of Health Sciences, Clinic of Infectious Diseases, "San Paolo" Hospital, University of Milan, Milan, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: d'Arminio Monforte
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D015331:Cohort Studies; D000069454:Darunavir; D004338:Drug Combinations; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D005260:Female; D006678:HIV / Q000235:genetics; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009570:Nitriles; D011724:Pyridazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011743:Pyrimidines; D012367:RNA, Viral; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D004338:Drug Combinations; D009570:Nitriles; D011724:Pyridazines; D011743:Pyrimidines; D012367:RNA, Viral; D013449:Sulfonamides; C451734:etravirine; D019438:Ritonavir; D000069454:Darunavir
keywords: NRTI sparing; darunavir; dual therapy; etravirine; virological efficacy