AEGiS-ATDN: A Brand New Heavy T-20 on center stage

Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.

A Brand New Heavy T-20 on center stage

Informatin Bulletin #16 - August 2002

The big HIV treatment news this year is the drug T-20. This drug is in a brand new class of drugs called fusion inhibitors. The drug stops HIV from fusing with a cell and infecting it, preventing the virus from taking over the cell and setting up an HIV factory. This drug blocks HIV at a different point of infection than every other existing drug. This is a critical development for people who have HIV that is resistant to existing HIV drugs, and for people who just can't tolerate those drugs. T-20 is administered by injection twice a day. FDA approval of the drug is expected to come soon, and another round of the Expanded Access program described below is expected to start within a few months. The positive results described in this article offer much needed hope for people who have run out of treatment options, as well as people who are getting to that point.

Two Phase III trial results were presented at the Conference. Both had 500 or so people who had previously tried most other HIV treatments. On average, the study participants had taken 12 drugs, for an average of seven years. The average CD4 count of the people in these studies was 80. Eighty-seven percent (87%) of the participants had an AIDS defining illness. The median viral load was 5.2 log or about 150,000. People in the study were given T-20 in addition to 3 to 5 other HIV drugs that were chosen based on their treatment history and levels of resistance to those drugs. Although some people may be resistant to a specific HIV drug, the level of resistance may not be so high that the drug is worthless against HIV.

Although ninety-eight (98%) of participants in these study had an injection site reaction, no other major side effects were reported. Minor side effects such as headaches were reported in a small percentage of the participants. In all 11% to 17% of the people who joined the study discontinued for various reasons. After 24 weeks, a drop of -1.7 and -1.4 log in viral load were seen in the two studies. Fifty-two (52%) and forty-three percent (43%) of participants in the two studies had more than 1 log viral load decrease. In one study thirty-seven (37%) of participants, and in the other study twenty-four percent (24%) reduced the level of HIV in their blood to an undetectable amount (under 400).

According to the drug companies Trimeris and Roche, there is a large batch of the drug undergoing safety, stability and shelf life testing in their Colorado plant. The earliest possible available date for another round of the T-20 Expanded Access Program is most likely October of 2002. If you are in need of a salvage therapy such as T-20, you should start talking about it with your doctor now. Expanded access programs can be a very involved process, and your doctor must participate in the program in order for you to get such drugs. If you need further help you could enroll in The Network's Case Management program.
020810
TR020802

AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, iMetrikus, Inc., John M. Lloyd Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2002. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2002. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .