DOI: 10.1097/QAD.0b013e3282364663
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PMID: 17589206
Issn Print: 0269-9370
Publication Date: 2007/07/11
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Excerpt
A 43-year-old caucasian man with haemophilia A, HIV and hepatitis C had used enfuvirtide in 2003, but discontinued it as a result of severe ISR consisting of painful nodules and some intermittent mild bruising; he had no intramuscular bleeding. In July 2005, he re-initiated enfuvirtide using the Biojector 2000 as part of a clinical trial. Concomitant antiretroviral agents included lopinavir/ritonavir, atazanavir and tenofovir. He was not taking any anticoagulants, antiplatelet or chemotherapeutic agents. Clinic staff instructed the patient on the standard use of the Biojector and he self-administered the first dose using the device under nursing supervision on 29 July 2005. Within 8 h, he noticed a significant ecchymosis at the site of injection. By 12 h, the ecchymosis had worsened and significantly increased in diameter. He continued administering enfuvirtide, varying the injection sites and paying close attention to the technique. Before one injection, he administered a standard dose of factor VIII, but noticed no difference in the extent of bruising. He also reported intramuscular bleeding after an injection into the left thigh region. No bleeding or bruising was noted at non-injection sites. He discontinued all antiretroviral medications on 1 August 2005 and returned to the clinic on 5 August 2005, when the marked ecchymosis was photographed (Fig. 1). Two weeks later, the bruises were still evident, although resolving. The patient recovered completely without further intervention and has not resumed any antiretroviral therapy.
The use of the gas-powered system coupled with our patient's underlying blood disorder probably led to his severe ecchymosis. With no previous self-reports of significant bruising at injection sites, it is likely that the Biojector device was the main contributor to this adverse event. Although no injections using no. 2 needle-free syringes penetrated the muscle in a subset of 18 healthy patients [5], our patient had advanced HIV disease and may have had more subcutaneous fat wasting increasing his risk of an intramuscular event. Also potentially increasing his risk may have been the use of two protease inhibitors in his antiretroviral regimen, a class of drugs that has been documented to increase bleeding in patients with haemophilia [6,7]; although he had previously used protease inhibitors without significant increases in bleeding episodes, including his previous needle-administered enfuvirtide-containing regimen, which included amprenavir and lopinavir/ritonavir.
We enrolled three other patients with haemophilia into the Biojector study (total N = 272), two of whom developed ecchymoses (grade 0–1 and grade 3), and discontinued the Biojector but were able to persist with enfuvirtide using the needle-syringe system, and one who had no difficulties and continued with the Biojector System [3]. Harris et al.
