FRIDAY, March 14, 2003 (HealthDayNews) -- The first in a new class of drugs to fight the AIDS virus has won accelerated approval from the U.S. Food and Drug Administration.
Fuzeon, a "fusion inhibitor," works by blocking HIV from getting inside the body's immune system cells and destroying them. Today's AIDS drugs work to block the virus from doing damage after it has already entered those cells, known as CD4.
Combinations of drugs -- dubbed cocktails -- for years have prolonged AIDS patients' lives. But since the HIV virus constantly mutates, it has become resistant to some of the drugs.
Approved for people ages 6 and older, Fuzeon must be taken by injection twice daily. In 6-month clinical studies of 1,000 participants, people who took the drug in combination with other AIDS medications were much more likely to reduce their viral blood levels than those who didn't take the drug.
Fuzeon patients may be more likely to develop pneumonia, so the FDA is warning users to be on the lookout for symptoms including cough, fever, rapid breathing and shortness of breath. Other side effects may include serious allergic reactions and local skin reactions.
Here is the FDA Talk Paper announcing the approval. For more information about HIV and AIDS, visit the U.S. Centers for Disease Control and Prevention.
