Premium
A large prospective study assessing injection site reactions, quality of life and preference in patients using the Biojector ® vs standard needles for enfuvirtide administration *
Author(s) -
Loutfy MR,
Harris M,
Raboud JM,
Antoniou T,
Kovacs C,
Shen S,
Dufresne S,
Smaill F,
Rouleau D,
Rachlis A,
Gough K,
Lalonde R,
Tsoukas C,
Trottier B,
Walmsley SL,
Montaner JSG
Publication year - 2007
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/j.1468-1293.2007.00489.x
Subject(s) - medicine , enfuvirtide , administration (probate law) , preference , radiochemistry , nuclear medicine , statistics , antigen , gp41 , immunology , epitope , chemistry , mathematics , political science , law
Objectives 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.