By Advocate.com Editors
Originally published on Advocate.com May 30 2003 12:00 AM ET
Two new studies in the May 29 issue of The New England Journal of Medicine add to the growing evidence that Fuzeon is effective in treating HIV in patients resistant to other antiretroviral drugs, with new data showing the drug doubles the chances for someone with drug resistance to achieve an undetectable viral load. In one of the studies, researchers studied 1,000 patients from 48 cities in the United States, Canada, Mexico, and Brazil who had at least six months of treatment with other anti-HIV drugs and had developed resistance to one or more of the medications. The study concluded that adding Fuzeon to an existing drug cocktail "provided significant antiretroviral and immunologic benefit " for the study participants. A second study, conducted in the United States, Australia, and Europe, also showed Fuzeon to significantly boost the effectiveness of antiretroviral therapy for those already treated with other anti-HIV medications.
In an accompanying editorial, Karen Tashima and Charles Carpenter of Miriam Hospital in Providence, R.I., write that the studies offer "heartening news of the success" of Fuzeon because the two research projects provided nearly identical results. But they add that additional issues still need to be worked out, including the high pricing of the medication--Fuzeon is priced at nearly $20,000 for a one-year regimen--and concerns about adverse side effects of the drug.
The European Union on Tuesday gave marketing approval to drugmakers Roche and Trimeris to sell Fuzeon in all 15 member nations. The U.S. Food and Drug Administration approved Fuzeon for sale on March 13. Fuzeon, previously known as T-20, is the world's first HIV fusion inhibitor that works outside immune system cells to prevent HIV from attaching to and infecting the cells. All other available anti-HIV medications work to slow HIV replication inside cells already infected with the virus.