title: A large prospective study assessing injection site reactions, quality of life and preference in patients using the Biojector vs standard needles for enfuvirtide administration.
abstract: OBJECTIVE
  To determine the severity of injection site reactions (ISRs), patient quality of life (QoL) and preference when enfuvirtide is administered by the Biojector (Bioject, Medical Technologies, Inc., Tualatin, OR, USA) relative to standard needles.
  
  
  METHODS
  A total of 201 HIV-positive patients on stable enfuvirtide-based therapy (n=184) or initiating such therapy (n=17) were evaluated prospectively after switching from standard needles to the Biojector system. Patients used needles for a minimum of 2 weeks prior to switching to the Biojector. Questionnaires to assess the incidence and severity of ISRs (31-item score) and QoL [Medical Outcomes Study HIV Health Survey (MOS-HIV)] were administered at baseline and following a minimum of 14 days of Biojector use.
  
  
  RESULTS
  The median changes in ISR score and number of ISRs following a median of 1.0 month [interquartile range (IQR) 0.9, 1.3] of Biojector use were -3 (IQR -7, 1) and -1 (IQR -3, 1), respectively. The severity of pain (P<0.0001), induration (P<0.0001), pruritus (P<0.0001), nodules (P<0.0001) and erythema (P<0.0001) all decreased with the Biojector. Administration of enfuvirtide with the Biojector was associated with an improved patient QoL (P<0.0001), and was preferred by 72% of patients.
  
  
  CONCLUSIONS
  Compared with needles, the Biojector was associated with a decreased severity of ISRs and improved QoL in patients taking enfuvirtide.
authors.affiliation: Department of Medicine, University of Toronto, Maple Leaf Medical Clinic, and Department of Family and Community Medicine, St Michael's Hospital, Toronto, Ontario, Canada. Mona.Loutfy@wchospital.ca
authors.forename: M R
authors.initials: MR
authors.lastname: Loutfy
authors.forename: M
authors.initials: M
authors.lastname: Harris
authors.forename: J M
authors.initials: JM
authors.lastname: Raboud
authors.forename: T
authors.initials: T
authors.lastname: Antoniou
authors.forename: C
authors.initials: C
authors.lastname: Kovacs
authors.forename: S
authors.initials: S
authors.lastname: Shen
authors.forename: S
authors.initials: S
authors.lastname: Dufresne
authors.forename: F
authors.initials: F
authors.lastname: Smaill
authors.forename: D
authors.initials: D
authors.lastname: Rouleau
authors.forename: A
authors.initials: A
authors.lastname: Rachlis
authors.forename: K
authors.initials: K
authors.lastname: Gough
authors.forename: R
authors.initials: R
authors.lastname: Lalonde
authors.forename: C
authors.initials: C
authors.lastname: Tsoukas
authors.forename: B
authors.initials: B
authors.lastname: Trottier
authors.forename: S L
authors.initials: SL
authors.lastname: Walmsley
authors.forename: J S G
authors.initials: JS
authors.lastname: Montaner
mesh_terms: D000328:Adult; D019540:Area Under Curve; D000077560:Enfuvirtide; D005260:Female; D006678:HIV; D015700:HIV Envelope Protein gp41 / Q000008:administration & dosage* / Q000493:pharmacokinetics; D023581:HIV Fusion Inhibitors / Q000008:administration & dosage* / Q000493:pharmacokinetics; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007267:Injections / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010446:Peptide Fragments / Q000008:administration & dosage* / Q000493:pharmacokinetics; D011446:Prospective Studies; D011788:Quality of Life; D012648:Self Care; D013810:Therapeutic Equivalency
chemical_list: D015700:HIV Envelope Protein gp41; D023581:HIV Fusion Inhibitors; D010446:Peptide Fragments; D000077560:Enfuvirtide