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Chas wrote: I have someone in my life that I love dearly... like a son, who has HIV. I'm trying to keep up to date on all the experimental programs that hospitals and labs might have in progress because he wants to know about them so he can sign up for them. What is new and what is on the horizon?
Dr. Gay writes: Having HIV is one the diseases that nobody wants to get, but unfortunately millions of people around the world have contracted the disease, mostly from childbirth if the latest figures I read on the UN website are correct. There are numerous progresses being made in the anti-viral science and a heavy focus has been on the so called Anti-Viral HIV drugs and HIV vaccination drugs. However, according to the leading scientists in this field it will not become available for some time now.
While browsing on the medical sites about new treatments that are available to all I found one extremely interesting drug called Fuzeon, but however it is also rather expensive and out of reach of most without the proper medical coverage.
What type of drug is Fuzeon?
Fuzeon is the first drug to be approved in a new class of HIV drugs called fusion inhibitors (FIs), also called entry inhibitors.
How does Fuzeon work?
The older drugs fight HIV once it is inside a CD4 cell. But FIs block HIV from entering the cell in the first place. This may slow down the HIV disease.
Who is Fuzeon approved for?
The Food and Drug Administration (FDA) has approved Fuzeon for use in combination with other HIV drugs for the treatment of HIV infection in adults and children over six years old, who have tried other HIV therapies but still have a high viral load and low CD4 cells.
How do I take Fuzeon?
Fuzeon comes in powdered form which must be mixed and injected. The standard adult dose is 90 milligrams (mg) twice a day. Because Fuzeon would be destroyed by stomach acid if taken by mouth, it must be injected under the skin of the upper arm, top of the thigh, or stomach.
Your doctor will teach you how to “reconstitute” (mix) the Fuzeon powder with sterile water and give yourself injections. The mixing and injecting of Fuzeon can be difficult and time consuming, but it must be done correctly to ensure that the drug is effective. Ask your doctor or nurse for help if you have any problems.
Fuzeon in its powdered form should be stored at room temperature. Once the powder has been mixed with water, it may be kept in the refrigerator for up to 24 hours. Check with your child’s doctor for children’s dosing.
Fuzeon must be used with other medications to treat HIV.
Why is it so important to take Fuzeon exactly the way it is prescribed?
As with all HIV drugs, it is important to take Fuzeon as prescribed. Missing or skipping doses can cause the blood levels of the drug to fall too low and resistance can develop. When your virus becomes resistant to an HIV medication, that drug may stop working.
How is Fuzeon used?
Fuzeon has not yet been well studied in HIV+ people who are being treated for the first time, and it is not currently approved for this use. Because Fuzeon targets a different step in the virus lifecycle, it works against HIV that is resistant to the other classes of HIV drugs. Fuzeon is approved as “salvage therapy” for people whose older HIV drugs are no longer working.
What happens if my virus develops resistance to Fuzeon?
Right now, there are no other fusion inhibitors, so you can’t switch to another drug in the same class if you become resistant.
Resistance to Fuzeon does not cause resistance to drugs from other classes.
Does Fuzeon interact with other drugs?
Because Fuzeon is such a new drug, doctors don’t yet know whether it interacts with many other medications. But so far, it does not appear to interact with other HIV drugs. Be sure your doctor knows about all the medications you are taking (including over-the-counter, prescription, street drugs, and herbs), even if you only use them occasionally.
What are the side effects?
So far, Fuzeon side effects seem to be mild. But the drug is still new; it is possible that unexpected long-term side effects could show up later. Most people who use Fuzeon get some irritation from injecting the drug.
If you do experience any side effects from Fuzeon, they are likely to be temporary and go away as your body adjusts to the medication. If you experience any of the side effects listed below, call your doctor for advice. Do not just stop taking your medication.
· Skin irritation, redness, or rash at injection site
· Headaches
· Insomnia (inability to sleep)
More serious side effects:
· More severe injection site irritation, rash, swelling, or hard lumps (nodules) under the skin
· Risk of abscesses (skin infection) at the injection site. Keeping your needles and skin clean can prevent this
· Peripheral neuropathy (nerve damage): this can cause numbness, pain, or tingling, especially in the feet and hands
· Possible rare hypersensitivity (allergic) reaction
· Possible increased risk of bacterial pneumonia
If you are experiencing persistent, unusual, or serious side effects, call your doctor right away.
What specific research has been done on Fuzeon and women?
As one of the newest HIV drugs and the first approved drug in the entry inhibitor class, Fuzeon has been studied in fewer people than other HIV drugs.
Studies of Fuzeon pharmacokinetics (how the drug is processed by the body) showed that clearance (elimination) of the drug is slower in people who weigh less. Clearance is also about 20 percent slower in women, independent of weight. But the drug manufacturer does not recommend any dose adjustments based on weight or gender.
Fuzeon has been studied mostly in people with more advanced HIV disease whose other drugs no longer worked, and trials have included only a small proportion of women. The drug was approved based on two studies, TORO 1 (also known as T20-301) and TORO 2 (also known as T20-302).
TORO 1 included 491 participants and TORO 2 included 504 participants, all of whom either had detectable viral load despite treatment with all three other classes of HIV drugs, or evidence of resistance to drugs in all three classes. Taken together, about 10 percent of the participants in these two studies were women, or about 99 women out of 995 total participants.
In these trials, about one-third of the participants used optimized background regimens (an average of 3-5 drugs). The other two-thirds used the same kind of background regimens plus Fuzeon. After 24 weeks, those taking Fuzeon had lower viral loads and larger CD4 cell increases. People taking Fuzeon were about twice as likely to achieve undetectable viral loads as those taking background regimens without Fuzeon. After one year, people taking Fuzeon still had a better response rate.
In terms of side effects in these studies, women did not seem to experience more or different adverse side effects compared with men.
What about pregnancy?
Studies have shown that pregnant women who use HIV drugs can greatly reduce the risk of passing HIV on to their babies. However, Fuzeon has not been studied in pregnant women. Check with your doctor about the best treatment options for you and your baby if you are thinking of getting pregnant.
Are there any special considerations?
Because Fuzeon is a difficult drug to manufacture, it is very expensive and supplies may be limited. Contact your doctor or AIDS service agency to find out how to get the drug and explore options for covering the cost.
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