| T-20
may be approved in the European Union later this year. The drug has been
granted priority review by regulatory authorities in Canada so it is
possible that T-20 could be approved in this country as early as
autumn 2003.
How is T-20 different?
Currently licensed anti-HIV drugs work only after a cell has been
infected by HIV. What makes T-20 unique is that it works by
blocking HIV from merging or fusing with a cell before it can
cause infection. Because it stops HIV from merging or fusing with a
cell, T-20 is called a fusion inhibitor. This is a new class of
drugs and T-20 is the first member of this class to be licensed
anywhere in the world.
Not your best friend
T-20 is not an easy drug to take. Unlike other anti-HIV drugs, T-20
must be injected twice daily under the skin (subcutaneously). This drug
can cause local skin reactions at points where it has been injected.
These so-called injection site reactions can be painful. In rare cases, T-20
can cause severe allergic reactions. Signs/symptoms of these include the
following:
- trouble breathing
- fever with vomiting and skin rash
- blood in the urine
- swelling of feet
Another concern with the use of T-20
is the possibility that some users may develop bacterial pneumonia.
Although bacterial pneumonia was uncommon in clinical trials, more users
of T-20 developed this complication than people who did not
receive T-20. Symptoms that suggest bacterial pneumonia include
the following:
- cough with fever
- rapid breathing
- shortness of breath
Issues galore
Another unique characteristic of T-20 is that it is difficult to
manufacture. Consequently, the cost of T-20
is expected to be expensive. A year's supply of the drug may cost the
following:
- $30,000 Canadian
- $20,000 U.S.
- $19,000 Euros
This price will make T-20 the most
expensive anti-HIV drug.
Manufacturing difficulties may also play a role in the supply of the
drug. In 2003, the distributor, Hoffmann-La Roche, is expected to
produce only enough T-20 for 15,000 PHAs; 10,000 of these will be
in the U.S. and the remaining 5,000 elsewhere. Production of T-20
is expected to increase in 2004 to service about 32,000 patients and
40,000 by 2005. However, demand for T-20 may outstrip supply, so
it is possible that for the first few years the drug will have to be
rationed. The high price of T-20 may have an adverse effect on
government-funded programs that subsidize the cost of drugs. This is yet
another factor that may also influence the decision to ration the drug
— denying access to PHAs who need it. Not surprisingly, AIDS activists
held a demonstration earlier this week outside the American headquarters
of Hoffmann-La Roche to make a point about the high cost of T-20.
The FDA based its approval on reviewing six months of data collected
from about 1,000 research subjects. T-20
has only been tested in 35 children. Because of this limited study time,
its long-term side effects are not known. There is also the possibility
that as more people use T-20, new
and unexpected side effects may occur.
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