Food and Drug Administration Approves First in Class of AIDS Drugs
March 14, 2003
The Food and Drug Administration yesterday approved the first of a new class of HIV drugs, providing, for the first time in seven years, an entirely different mode of attacking the virus. Enfuvirtide, sold under the trade name Fuzeon but known by its development name T-20, belongs to a class of drugs called "fusion inhibitors" that block the first step in the complicated process of infection: the virus's attachment to the cell.Adapted from:
Fusion inhibitors join three other classes of AIDS drugs. Protease inhibitors, the most recent up until now, arrived in 1995 and led to a significant drop in AIDS mortality. Although T-20 is not expected to have such dramatic results, it may add years to the lives of some late-stage patients. About one-third of people who began AIDS treatment before 1995 carry virus resistant to at least one drug in all three drug classes. These patients are likely to benefit the most from T-20, which will usually be added to combination antiviral therapy. "Anytime you have a new class of HIV drugs, it's a big deal," said Anthony S. Fauci, head of the National Institute of Allergy and Infectious Diseases.
Extremely expensive, in short supply and uncomfortable to take, T-20 will be distributed from a central pharmacy, not yet named, on a first-come, first-served basis. Doctors prescribing T-20 to more than one patient will be asked to rank them in order of need. At least 20,000 Americans -- and up to as many as 100,000 -- are candidates for the drug. Developed by Roche AG and Trimeris Inc., Fuzeon supplies will treat about 15,000 patients this year. About 10,000 Americans will receive T-20, and the rest of production is allocated to other countries. The companies expect production to be sufficient to treat about 32,000 patients next year and 40,000 in 2005.
The arrival of Fuzeon may mark a new wave of HIV treatment. There are currently five other new classes of drugs in development. If just one drug from each class makes it to market, doctors will have more choices in treating HIV infection than they have for treating all other viral infections and most bacterial ones, as well.
03.14.03; David Brown
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.