A needle-free method of administering the anti-HIV drug T-20 (enfuvirtide, Fuzeon) is tolerable and acceptable to patients in the long term, according to a study presented to the Sixteenth International AIDS Conference in Toronto last week. The investigators found that 75% of patients found the Biojector B2000 preferable to the current needle and syringe method of T-20 administration.
T-20 is the only drug currently available in the fusion inhibitor class of antiretrovirals. Its use is almost exclusively reserved for patients with extensive experience of antiretrovirals and limited treatment options. Unlike all other anti-HIV drugs, T-20 can only be administered by injection and although the drug is not associated with side-effects commonly caused by other classes of antiretrovirals, such as diarrohea and nausea, the long-term use of T-20 can lead to the development of injection site reactions and needle fatigue. What’s more, many patients are needle-phobic and fear the initiation of T-20 therapy because of this.
The Biojector B2000 is placed against the skin and delivers T-20 without the need for needles and syringes with T-20 being pushed under the skin using high pressure. The manufacturers of this product designed a prospective, open label, twelve-month study designed to evaluate the Biojector B2000 against insulin syringes and standard syringes currently used for T-20 dosing.
Individuals who required T-20 therapy who had moderate-to-severe injection site reactions, or needle fatigue, or needle-phobia, or a physical disability meaning that they could not use a standard syringe were eligible for recruitment to the study. Individuals were asked about their levels of adherence to T-20 therapy, and how tolerable they found their mode of T-20 delivery. Interim data for the first six months of the study, which was non-randomised, were presented to the conference.
Of the 726 patients who took their T-20 using the Biojector B2000, 15% were starting T-20 treatment for the first time. A total of 60 patients (8%) discontinued treatment with T-20 using the Biojector B2000, the primary reasons being injection site reactions (3%) and loss of virological control (2%).
Insulin syringes were used by 43 patients, and five of these individuals (12%) discontinued T-20 treatment. Only 34 patients took their T-20 using standard needles, but only one of these patients stopped T-20 therapy.
At six months, adherence to T-20 treatment was over 90% of patients taking the drug using standard syringes, and approximately 85% of individuals using both the Biojector B2000 and the insulin syringes. These differences were not statistically significant.
Injection site reactions (p < 0.05) and fear of injections (p < 0.01) improved significantly amongst patients using the Biojector B2000. At baseline, 40% of patients who opted for T-20 therapy said that injections interfered with their daily life, but this had fallen to 17% after six months of T-20 therapy using the Biojector B2000. At six months, 75% of patients said that they preferred the Biojector B2000 to syringes.
“The B2000 demonstrated high levels of persistency, tolerability and patient satisfaction and represents an alternative to standard needle/syringe administration of T-20”, conclude the investigators.