New Expanded Access Program for T-20

The Expanded Access Program for the first entry inhibitor T-20 (aka Fuzeon) has begun.

The brand name for this product will be Fuzeon, and the generic name enfuvirtide. The manufacturer, Trimeris, has had problems in making large volumes of this compound for distribution. Slowly, however the supply of this first entry inhibitor has started to increase. T-20 is a protein chain of 36 amino acids. It is not absorbed in the stomach and must be injected under the skin twice a day. In August, 2002, an "Early Access Program" began for Fuzeon. Physicians can register to participate in the program at the following Web site: www.T20EAP.com. It is anticipated that the drug for this program will be available in October. Health care providers at major hospitals and universities may also have to get approval from their local institutional review board (IRB) a process which can take up to several months.

The criteria or eligibility for this program is as follows: age 16 or older; HIV RNA viral load above 10,000 copies/ml; and CD4 T cell count under 100 cells/mm while on a HAART regimen. Individuals must also have limited treatment options in the judgment of their health care provider. Initially, each registered health care provider will be allowed to enroll a maximum of 5 people. Hopefully, as drug supply increases, this limit will be increased.

Reported trials of Fuzeon have shown that it can add additional viral suppression when added to a current "failing" regimen. Difficulties can arise with the issue of twice a day injections (like insulin) and tender nodules can become present at the injection sites. However, in early trials the discontinuation rates were very low. Also, resistance to Fuzeon develops in some people over time. The next entry inhibitor in development by Trimeris is T-1249. This inhibitor will need only a once a day injection, and appears to be effective even if resistance to T-20 develops. Schering also has a compound in development which is an entry inhibitor, Schering-C, which can be taken by mouth. Both T-1249 and Schering C are still fairly early in development. It is not known when, or if, there will be an expanded access program available for these compounds.