Fuzeon Treatment Forum, January 2004

In November of 2003, AIDS Survival Project hosted our final two Treatment Forums of the year. The first, held on November 12, covered the new fusion inhibitor, Enfuvirtide, also known as Fuzeon. The following week, we hosted a forum on smoking cessation. Gerry Hoyt will review this Lunch & Learn in this issue of Survival News. I will report on Fuzeon. I will also take this opportunity to remind our readers that as with all the programs presented by ASP, our Treatment Forums remain free to the public.

Roche sponsored this forum, which was coordinated through the Treatment Education Program. When planning this event with David Nathison, with whom we have coordinated treatment education forums in the past, he was excited to add this additional forum to our roster. He had said that having done similar patient panel discussions in other metropolitan areas, the response was very positive. He wanted to add this additional forum to make sure Atlanta was included in this very casual yet informative exchange of the advantages and disadvantages of this new drug. Fuzeon holds promise for the HIV+ person who has taken (and has had fail) other anti-HIV drugs in the past. Because Fuzeon targets HIV differently than currently available drugs, chances are that most people living with the virus -- regardless of the medications they have taken in the past -- will likely benefit from using Fuzeon.

Depending on whether you count new formulations of existing drugs, there are now between twenty and twenty-four anti-HIV drugs in the U.S., including Fuzeon (T-20). Fuzeon represents a new class of drug known as entry or fusion inhibitors. When it was FDA-approved in March 2003, it came with two major obstacles. T-20 had to be injected subcutaneously twice daily, and it has a retail price of $25,000 a year -- nearly three times that of any existing drug.

The panelists were Steve Hightower, who is currently taking T-20 and a longtime patient at Pride Medical in Atlanta, Georgia; Dr. Jean Robinson, pharmacist and patient educator; and a Roche representative, who introduced the drug with a brief overview and who was there to answer technical questions. The following were the most asked questions.

Why Is Fuzeon so Expensive?

The Roche representative replied, "Fuzeon is the most difficult antiretroviral to make, requiring over 100 steps for each batch, thus requiring us to charge a higher price than other drugs on the market."

Does the AIDS Drug Assistance Program (ADAP) Cover Fuzeon?

No. On the web page www.HIVandHepatitis.com, eleven out of the fifty-six states and territories cover Fuzeon, while eight others plan to in the near future (early 2004). Georgia is discussing adding it to their formulary, but no immediate plans are confirmed at this time to include Fuzeon. For patient support, visit www.fuzeon.com or call (886) 487- 8591. Should this situation change, Survival News will keep you informed.

How Does Fuzeon Work?

Fuzeon binds itself to a protein on HIV’s surface, called gp41. Once it does this, HIV cannot successfully bind with the surface of T-cells, preventing the virus from infecting healthy cells.

Can It Be Taken Alone?

• Fuzeon must be used in combination with other anti-HIV drugs. If taken alone, resistance can develop quickly.
• Monotherapy is not recommended under the current standard of care.
• Fuzeon has not yet been approved by the FDA for HIV+ people who are new to treatment.

Does Fuzeon Come in a Pill Form, and Why Does It Need to Be Injected?

• One of the biggest challenges or obstacles with T-20 is that stomach acid breaks it down, so it can’t be taken in pill form. Because of its fragile structure (it’s a peptide), Fuzeon cannot be taken by mouth.
• It requires two shots (subcutaneous injections) a day, one in the morning and another 12 hours later at night.
• For people in recovery or who have a history of IV drug use, this can be an issue. Using a syringe regularly can possibly trigger their disease of addiction.

How Is Fuzeon Prepared?

• The drug comes as a powder that must be mixed with sterile water. It can take up to 15 to 45 minutes to dissolve correctly. The dose must not be shaken once mixed; however, two doses can be made at once if the second one is refrigerated.
• Mixing and injecting Fuzeon can be a difficult and time-consuming process and must be done correctly in order for the drug to be effective. Steve suggested mixing it in a warm room. He said, "the drug mixes easier and faster at room temperature."

What About Side Effects, and Do the Injections Hurt?

• One of the biggest side effects brought up in the session was injection-site reactions (ISR). Almost all people using Fuzeon get ISR. The reactions usually happen within the first week of treatment; one injection site can be irritated for up to seven days. You can experience pain if the injection is given deeper in the muscle than it should be.
• Fuzeon should be given as a subcutaneous (under the skin) injection and should not be injected repeatedly in the same site. Steve suggested "changing different sides of the body, going left to right on a weekly basis." He went on to explain, "I can’t stress enough the importance of massaging the site after the injection." He then went on to remind us to never inject into moles, scar tissue, bruises or the navel. Other ISRs include itching, swelling, redness, tenderness, hardened skin and bumps (nodules).
• Fuzeon can cause serious allergic reactions, including trouble breathing, blood in your urine, fever with vomiting, skin rash and swelling of the feet.
• Patients are more likely to get bacterial pneumonia while using Fuzeon if they have had a low number of CD4 cells, an increased amount of HIV in the blood, intravenous drug use (IDU), smoking or lung disease in the past. It is unclear if Fuzeon plays a part.

Our thanks to Steve for his willingness to speak plainly about his experience with Fuzeon and to Jean, who also volunteers with THRIVE! Weekend.

The Treatment Resource Center (TRC) at ASP features a complete binder on Fuzeon, which includes information on drug interactions, when and who should consider taking it and injection tips. For Fuzeon’s patient support, visit www.fuzeon.com or call toll-free 1-877-438-9366. I encourage you to give us a call at (404) 874-7926 or come visit us in the TRC for more information on Fuzeon, as well as the latest information on other treatments. Of course, if you can’t visit, we will mail any information you need.

Watch for our upcoming Treatment Forums in Survival News. As I reflect on 2003, a thought comes to mind: The Good, the Bad and the Ugly.

• The Good: Four drugs were FDA-approved in the year 2003.
• The Bad: The challenges of ADAP nationwide.
• The Ugly: It is estimated that ADAP will suffer from possible shortfalls in the fiscal year 2004.

As always, keep safe!