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Patient Acceptance with Self-Injection of Fuzeon (Enfuvertide) for HIV Over 48 Weeks of Treatment
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Reported by Jules Levin
Cal Cohen and Roche reported at the European AIDS Conference (October 2003) on the results of patient surveys regarding their assessment of taking self-injections. Enfuvirtide (ENF) is the first of a new class of ARVs, the fusion inhibitors. ENF is self-administered twice-daily by subcutaneous injection.
The surveys were of patients receiving ENF in two Phase III multi-national trials over 48 weeks.
Patients were surveyed with the validated Subcutaneous Injection Survey (SIS) at week 48 (n=492). The SIS contains 18 items measuring patients' assessment of injection, ease of use and impact on aspects of daily living.
99.8% of patients completed the survey. Most patients (67%) assessed self-injection as 'easy' or 'very easy' at week 48. Alternative responses were 'neutral' (18%), 'difficult' (13%) and 'very difficult' (3%). The proportion of patients reporting 'little' or 'no impact' of injections at week 48 on work/school (81%), sleep (90%), social life (84%), travel (65%), intimacy (77%), privacy (69%), or appearance (73%) were similar to findings at weeks 8 and 24.
Comparison of patients reporting self-injection as 'neutral', 'easy' or 'very easy' with those finding it 'difficult' or 'very difficult' revealed no significant differences in baseline characteristics for weight, BMI, CD4+ or viral load. 83.3% of patients who found injections 'easy' at week 8 still found them 'easy' at week 48; patients were more likely to go from 'difficult' to 'easy' than vice versa.
The study authors concluded that most patients in a clinical trial setting taking ENF for up to 48 weeks are satisfied with the ease of injection and impact on their activities of daily living. Acceptance of self-injection is not associated with baseline clinical characteristics.
Reference: 9TH EUROPEAN AIDS CONFERENCE (EACS) 1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP. October 25 - 29, 2003 Warsaw, Poland
Abstract 7.1/1 - PATIENT ACCEPTANCE WITH SELF-INJECTION OF ENFUVIRTIDE (ENF) FOR HIV OVER 48 WEEKS OF TREATMENT. Cohen C. (1), * Green J. (2), Wintfeld N. (2), Patel K. (2). (1) CRI, Boston, USA, (2) Roche, Nutley, NJ, USA
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