Fuzeon (T-20), the First HIV Entry Inhibitor, Is Now FDA-Approved

The FDA approved licensing of Fuzeon on March 20, 2003. There remain, however, two major unanswered questions about this drug. The first is when Fuzeon should be used. The second is whether there are adequate supplies to meet the anticipated need for this drug. The drug comes in a powder form that must be dissolved prior to each use, a process that takes about 15-20 minutes. It is administered twice a day, by injection under the skin (subcutaneously). One other not so minor issue is that Fuzeon is priced at about $20,000 per year!

Fuzeon is truly a new class of HIV drugs. It works by blocking the entry of HIV into cells. It has been shown to decrease HIV viral load by about ten-fold (1 log decrease) in people with multi-drug-resistant (MDR) HIV infection. However, only about 30 percent of people will get to levels of HIV RNA below 400 copies/mL. Ideally, Fuzeon would be added with another new drug that would work in people with MDR HIV. Probably the most promising drug in development at this time is the PI tipranavir, but there are only limited trials ongoing with tipranavir, and no expanded access program is available. At the 10th CROI, data was presented showing that the next entry inhibitor in development at Roche, T-1249, has some efficacy in people who developed resistance to T-20. So, a major question is whether to add Fuzeon now or wait until another new drug becomes available to add with it. For people with MDR-HIV who are not too sick and have T-cell counts above 100, it may be better to wait. For people who are clinically sick, with the complications that result from a very weak immune system, it may be better to begin Fuzeon now. This will be a difficult decision for many people.

Due to the anticipated limited supply relative to demand, Roche has set up a "progressive distribution system." Roche estimates that there will be supplies for about 1,500 people in the first month after approval. This is really a first-fax, first-served plan, if you can show you have insurance coverage for the drug. Details about the distribution plan can be found at www.Fuzeon.com. Medicaid is covering the cost of Fuzeon in Washington State, but the Early Intervention Program (EIP) has not yet determined whether it will be covered under the state's AIDS Prescription Drug Plan (APDP). This is in part due to the lack of passage of a state budget at the last EIP meeting. The expected funding for APDP does not include any new funds to pay for Fuzeon. It is also important to note that Fuzeon would be added onto an optimized three- or four-drug HIV regimen and not used in place of another drug. Thus, it would essentially double the cost of treatment for people.

Dr. Jeffrey T. Schouten is a former general surgeon who has been living with HIV for over 16 years. He is chair of STEP's Publications Advisory Committee and a primary care provider at Harborview's HIV Clinic in Seattle, Washington.