United Press International - July 28, 2005
Ed Susman

"Our patients love this device," Dr. Julio Montaner, professor of medicine at the University of British Columbia in Vancouver, told United Press International. "It is so easy to use that one of our patients who is blind is able to operate it successfully."

The new device, called the Biojector B2000, is manufactured by Bioject Medical Technologies Inc. in Bedminster, N.J. It is designed to deliver a precise amount of the drug enfuvirtide (Fuzeon), also known by its developmental name, T-20. The drug is the only one of more than two dozen medications designed to fight the human immunodeficiency virus that has to be injected into the skin. The other drugs are taken orally.

Fuzeon is most often used as a salvage treatment for patients infected with an HIV strain that is resistant to other classes of drugs, but many patients find it difficult to use the Fuzeon due to a number of problems:

--They suffer from injection-site reactions that can occur early in the treatment or later as they development bumps under the skin from constantly injecting themselves twice a day.

--They may have needle phobia and for that reason do not even consider use of the potentially life-saving drug.

--They may have been an injecting drug abuser, and needles might trigger a return to past unsafe habits. In the Western world, injecting drug use is one of the main ways in which people become infected with HIV.

Montaner said the Biojector allows one-handed use and gives patients the opportunity to expand areas of injection. More important, the device is just as efficient as getting Fuzeon into the bloodstream, where it can fight HIV, as needle injections, said Dr. Marianne Harris, clinical research adviser at the British Columbia Center for Excellence in HIV/AIDS, in Vancouver.

"The T-20 blood levels in patients receiving the drug through the Biojector appear to be exactly the same as with needle injection," Harris said at a presentation Wednesday at the 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment.

She also said patients using the Biojector were able to maintain control of their virus as well as they had using needles.

Harris later told UPI the device will make it easier for patients to deliver the drug twice a day, which is particularly helpful in giving more individuals who have few other options in treating their HIV infection access to the newest class of anti-retroviral medication.

Dr. Celso Ramos, professor of medicine at the Federal University of Rio de Janeiro, said the Biojector also eliminates the need of having to dispose of used syringes.

"While there is little chance that these safe syringes could transmit disease, they nevertheless represent a health risk that has to be considered as well as these other factors," Ramos told UPI. "I think the Biojector will make a great difference in getting people to use T-20."

In the study, Harris recruited 33 HIV-infected individuals and taught them how to use both the gas-powered instruments and needles. Eventually, 23 of the patients switched to the Biojector.

Researchers asked the patients to rate their injection-site reactions on a scale that ranged from 0 to 31. The needle users scored 11, while the Biojector users scored 5.5. That difference was statistically significant, Harris said.

In a few cases, patients used the Biojector close to joints, causing pain and numbness in limbs and taking weeks or months to resolve.

"We now tell patients to make sure they don't inject near their joints in arms and legs," Harris said. Only two individuals stopped use of the device due to those reactions.

Bioject filed for approval of the device with the Food and Drug Administration for delivering Fuzeon to patients.

The study was funded by Bioject, and Trimeris and Roche, the companies that developed the drug. A Roche representative said patients interested in receiving information on expanded access for the Biojector should contact the specialty pharmacy house, Bio Scrip, at bioscrip.com.

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Edward Susman covers medical research and health matters for UPI Science News. E-mail: sciencemail@upi.com
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