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Avoiding & managing side effects – May 2008
Contents. 
Bilirubin & jaundice. 
T-20 side effects 
Lipodystrophy.
Associated drugs: T-20 (enfuvirtide, Fuzeon)
T-20 is the first drug in a new class of HIV drugs called entry inhibitors.
The main advantages of T-20 are:
The main disadvantages are:
Because the benefits are significant and life saving for people with both resistance to existing drugs, and who have a low CD4 count, and because of the more complicated way that the drug is given, we have taken several pages to cover T-20 in detail.
Comments and suggestions for this section were provided by people who already use T-20 successfully in their combination.
Nearly everyone who uses T-20 gets some level of skin reaction where the T-20 is injected but some people report no problems at all. Less than 5% of people discontinue treatment for this reason.
These reactions can include soreness and redness; nodules, bumps or cysts; and itching or other irritation. ISRs commonly last for a week or less in 75% people.
Often these symptoms are mild and manageable, and they may be minimised by good injection practice described below
The severity of the reactions is difficult to predict, and can vary in the same person. Some people follow all the best advice and are still unlucky and get erratic reactions. Sometimes this may be due to factors that you can’t control.
The information in this guide only provides a limited overview on how to reduce the risk of these reactions.
The manufacturer (Roche) has developed extensive support material that everyone receiving T-20 is given. You will be given this detailed information, together with training before you use T-20.
This pack includes:
T-20 needs to be given twice a day.
Although one study looked at giving both doses at the same time once a day, this was not as effective as twice daily. In some people, drug levels at the end of the 24 hour period were too low, and this increased the risk of the treatment failing, and getting resistance to T-20.
However, each day both doses T-20 can be mixed up at the same time. It is very safe to mix both doses in the morning,for example, and leave the evening dose in the fridge until you come to use it later.
When the T-20 is fully dissolved, the liquid should be clear. There should not be any powder left on the sides of the vial. If there is, you should not use this vial.
There should also not be any air bubbles or foam. If there is, then the vial needs more time to settle.
Once mixed, the reconstituted T-20 should be used straight away, or put into the fridge for use in the evening. Reconstituted T-20 that is kept in the fridge needs to be used within 24 hours.
Detailed information on how to use the syringes is provided in the training pack given to every patient. Different syringes have been used, including fine diabetic needles, and these may change again in the future. This is why we have not included information on specific syringes in this guide.
T-20 is injected under the skin so you need to pick an area that has most tissue or fat. Do not inject into muscle, and never inject into a vein.
The sites recommended for injections are:
Changing where you inject T-20 each day is important.
This person should also receive training, including precautions if they accidentally prick themselves with a needle after giving you an injection.
Because T-20 is injected under the skin, and not into a vein, it is very unlikely to present a risk factor for HIV transmission.
Clean the area to inject with an alcohol swab and allow to air-dry.
Pinch the area of skin that will be injected. Make sure the skin is dry and the cleaning alcohol has evaporated.
Then insert the needle at a 45-degree angle with the flat angled edge facing up, and inject the T-20 very slowly.
Several posts to the FuzeonSupport email discussion group have included varying the angle up to 90 degrees. It may be that you have to experiment to see if one method is better for you.
A half-inch needle should go all the way in to the hub.
The injection needs to be under the skin and not so deep that it reaches muscle. If you have very little body fat then choosing the area with the most fat is recommended.
After injecting, put all the used syringes and needles into the sharps container.
This should be kept away from children and collected by your clinic when it is full.
Never throw needles into general rubbish bins.
Gently massaging the injection site after giving the injection may help reduce the risk of injection site reactions. This can be using your hands, with or without non-irritating oils, or using an electrical massager.
It will also help distribute the drug more quickly and more evenly. The nodules that sometimes occur have T-20 in those tissues, although the inflammatory reaction is unlikely to be related to the local concentration of T-20.
Some people find that an ice pack afterwards can help reduce the swelling. Some people use a warm hot-water bottle. You will have to experiment to see whether or not these options help you.
Creams such as a mild hydrocortisone or benedryl cream may help with more severe reactions.
Most people report that they get used to using needles very quickly. But it may seem strange at first. Try to focus on the benefit you are getting against HIV. For example, contact lenses are very strange when you use them for the first time and T-20 can be a bit like that.
Many people are able to fit using T-20 into a normal and active life. If you travel you can always find a quite space to inject if you need too. One person took their first dose of T-20 in an aeroplane on their way to Moscow.
Take a letter with you from your doctor, that says you need the syringes for medical treatment, and that you are fit and healthy to travel.
The injection process may sound strange when you first have to think about it. Talking to someone already using T-20 may help and your hospital can arrange this.
Over the last few years some patients in the US were able to use a new system to inject T-20.
Instead of needles, the ‘Bioject’ system uses pressurised gas to inject T-20 though the surface of the skin.
Unfortunately this research has not been continued, and this in not going to be an option for European patients,
T-20 studies have reported overall increases in quality of life. This was despite having to inject T-20 twice a day, on top of taking other pills,
T-20 may be a drug that you only need to use for a short time. If a new drug is developed that you are not resistant to, you may be able to switch from T-20 to the new drug.
In 2008 this includes the integrase inhibitor raltegravir, a new PI called darunavir, a new NNRTI called etravirine and a CCR5 inhibitor called maraviroc.
Hypersensitivity reaction
A very small percentage of people get a ‘hypersensitivity reaction’ to T-20, but this is rare.
Symptoms include difficulty breathing, fever, nausea and vomiting, rash, chills, stiffening of muscles, low blood pressure and increased liver enzymes. This can be serious and life-threatening. If you have any such reaction, you should stop taking T-20 and call your doctor immediately.
Bacterial pneumonia
People in the main T-20 studies were at higher risk of bacterial pneumonia if they used T-20 in their combination. The reason for this is not clear.
People with HIV are more susceptible to getting bacterial pneumonia than HIV-negative people.
This risk is higher if your viral load remains high, and your CD4 count is low. If you have trouble breathing, or develop a cough with a fever, then you should once again contact your doctor immediately.
Mood changes - including euphoria
Some people have reported a feeling of euphoria when using T-20. This has often been after using T-20 for many months.
This ‘euphoria’ can last for up to a couple of hours after injecting. It can include a general sense of well-being, contentment, excitement, or feeling ‘buzzy’.
This was not seen in the large T-20 studies but has been reported anecdotally since T-20 was approved. If you already receive T-20, then keep an eye out for this.
Please refer to the patient information leaflet and support material in your pack for full details.
You can join a community-run email support group by sending a blank email to:
Contents. Bilirubin & jaundice. T-20 side effects Lipodystrophy.
This is the
web edition of the i-Base guide Avoiding & managing side effects.
This guide is available in UK clinics. You can order
free printed copies or download
a PDF version (564 Kb). There are also several translations. Decisions relating to your treatment should always be taken in consultation with your doctor. Information in this guide is intended to support those discussions
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