September 17, 2007
Welcome. This is Bonnie Goldman, Editorial Director of The Body PRO. I'm in Chicago at ICAAC 2007, one of the year's HIV conferences. Right now, I'm in the poster session where researchers are standing in front of their posters. There's nothing like hearing the results of research directly from those who actually conducted the research. It is these women and men who are transforming HIV treatment and care. In this podcast, the researchers will introduce themselves and then summarize their study. After their summary, I'll ask a few questions.
It's Dr. Jay Lalezari of Quest Research, talking about the BOSS study1 [on the use of the] Biojector, a needle-free device, injection device, for the administration of T-20 [generic name: enfuvirtide; brand name: Fuzeon]. At the start of the study, I didn't really think this was going to work. We had seen previous work that showed that the pharmacokinetics -- the amount of drug delivered -- were equivalent between this needle-free injection device and the needle, itself. But it wasn't clear to me that the subset of patients who have bad injection site reactions, people with bad nodules, and so on, would really benefit from a different way of delivering the drug. The needle-free injection device is needle-free -- it's just a high-powered jet that delivers the drug into the sub-Q [subcutaneous] space without using a needle.
To my surprise, in fact, the study did work. At the end of the day, patients did prefer the needle-free injection device. We used a composite endpoint to objectively measure the injection site reactions. That included three things, including pain, induration, and nodules and cysts. Patients were randomized to the eight-week study to either begin use of the NFID -- the needle-free injection device -- or continue four weeks with a needle and then switch to the NFID. So the primary analysis was at week 4. There was a dropout of about 10% of patients, both arms, to start, which reflected both disappointment from not being randomized to the new device, as well as, some patients who began the device and felt like it wasn't going to be able to help them tolerate their injection site reactions.
At the end of the day what we saw is that, at week 4, there was a substantial decrease in the number of patients who had reached the composite endpoint from 40% at baseline to 25% at week 4 and 20% at week 8 using this device -- that's the percentage of patients who continue to have pain, induration and nodules, that met prespecified criteria.
In contrast, folks who stayed with the needle for four weeks actually saw an increase in the percentage achieving that composite endpoint, from about 35% to 45%, which we thought reflected patients switching from their 31-gauge needle down to the 27-gauge needle that the FDA [U.S. Food and Drug Administration] mandated for this study. Those folks then switched to the needle-free injection device, and they, too, saw a decrease in their composite endpoint, down to 26%. So even the folks who had delayed use of the device benefited by week 8.
The important thing, then, is of the folks who completed the study, 87.2 -- almost 90 -- percent expressed a preference for the needle-free injection device over the standard needle. That's been our experience -- this isn't for everybody. There is a certain number of patients who, when they first use the device, are put off. But we have been very pleasantly surprised by the number of patients, particularly those who are having significant nodules and other injection site reactions, who, at the end of the day, do prefer the Biojector to the standard needle.
That said, we are not in a position to offer our patients the Biojector, because it won't be available, because of regulatory issues, for at least six to 12 months.
Could you talk a little bit about the patient characteristics? What were the numbers?
They were mostly male. What would you particularly be interested in?
You said there were 317 participants.
Yes. What would you be interested in, in all of this?
Well, body mass, because there was a study2 that showed that people who had less fat were more likely to experience injection site reactions.
I'm aware of that study, although that is not any part of this analysis. Patients who have less subcutaneous tissue are more likely to inadvertently deposit the drug into intramuscle. In our experience, intramuscular deposition is a nightmare. That's why a lot of the patients who do their T-20 injections in the thigh run into problems. Because there isn't enough sub-Q space there to take the drug. When they nick the muscle, they end up with these horrific injection site reactions. I always tell patients to avoid the legs at all costs because that's where the most muscle and the least amount of sub-Q tissue is. The abdomen, the sides of the abdomen, and the buttocks are good. In the upper arm, in the triceps area, there's a fold there of tissue that one can often use, and actually have the least severe injection site reactions.
So, you're quite right that the amount of sub-Q tissue available is key to tolerating the drug.
One more question. Wasn't there another study recently looking at this needle-free device that was disappointing? It had a disappointing reaction. The patients did not prefer it, and it did not make the injections easier.
This is the only randomized study of patients who, with injection site reactions, were then randomized to needle or device. And I think the outcome was fairly positive. There are other studies going on: the WAND study, in patients who are newly starting T-20. I'm not sure if those results have been published yet.
How soon will the regulatory issues be resolved?
I'm told that it's six to 12 months before this will be something that we can really offer our patients.
Are there ongoing studies? So if patients want to use an injection-free device, can they join a study?
They can join a study. The only study that's accruing is through the ACTG [AIDS Clinical Trials Group] right now.
Okay. Well, thank you very much, Dr. Lalezari.