Patient acceptance of self-injected enfuvirtide at 8 and 24 weeks.
OBJECTIVE
Enfuvirtide is the first of a new class of antiretrovirals called the fusion inhibitors. It is administered twice daily by self-injection. This study assessed patient acceptance of enfuvirtide self-injection.


METHODS
Patients (n = 661, intent-to-treat [ITT]) in two ongoing phase 3 trials were surveyed at treatment Weeks 8 and 24 using the Subcutaneous Injection Survey. This validated instrument contains 18 items measuring patients' assessment of ease of injection, impact on daily functioning, and activities of daily living.


RESULTS
The majority (65%-92%) of patients assessed all items relating to ease of injection as "very easy" or "easy" at both 8 and 24 weeks. Similarly, at both visits, the majority (69%-90%) of patients assessed their daily functioning as "not at all" or "a little" limited by enfuvirtide self-injection, and 96%-98% gave these assessments for impact on activities of daily living.


CONCLUSIONS
These findings indicate that most patients taking enfuvirtide in clinical trials learn to integrate enfuvirtide dosing in their daily routines; with appropriate education and training, enfuvirtide self-injection becomes routine with relatively little subjective impact on daily functioning and activities of daily living. Patient acceptance of self-injected enfuvirtide is high and does not decline over 24 weeks of therapy.
Community Research Initiative of New England, Boston, Massachusetts 02215, USA. ccohen@crine.org
Calvin
C
Cohen
James
J
Hellinger
Margaret
M
Johnson
Schlomo
S
Staszewski
Neil
N
Wintfeld
Kavita
K
Patel
Jesse
J
Green
D000203:Activities of Daily Living; D000328:Adult; D001315:Australia; D001938:Brazil; D002170:Canada; D000077560:Enfuvirtide; D005060:Europe; D005260:Female; D015700:HIV Envelope Protein gp41 / Q000008:administration & dosage*; D023581:HIV Fusion Inhibitors / Q000008:administration & dosage*; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007267:Injections; D008297:Male; D008800:Mexico; D017060:Patient Satisfaction; D010446:Peptide Fragments / Q000008:administration & dosage*; D012651:Self Medication / Q000379:methods* / Q000523:psychology; D011795:Surveys and Questionnaires; D014481:United States
D015700:HIV Envelope Protein gp41; D023581:HIV Fusion Inhibitors; D010446:Peptide Fragments; D000077560:Enfuvirtide