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 T-20 will be Fuzeon, and its 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.

The Early Access Program began in August of 2002, and physicians can now register to participate in the Expanded Access Program at the following web site: www.T20EAP.com. It is anticipated that the drug for this program will be available in October of 2002. Healthcare providers at major hospitals and universities may have to get approval from their local institutional review board (IRB), a process that can take up to several months.

The criteria or eligibility for this program are 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 highly active antiretroviral treatment (HAART) regimen. Individuals must also have limited treatment options in the judgment of their healthcare provider. Initially, each registered healthcare provider will be allowed to enroll a maximum of five people. As drug supply increases, it is hoped that this limit will be increased.

Reports of 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 is an entry inhibitor development, 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.