On March 20, 2003, Health Canada
granted approval for sale of the drug Viread (tenofovir). This
drug is to be used as part of combination therapy for the
treatment of people with HIV/AIDS.
Cost issues
Because health care is administered by Canada's provinces and
territories, it will be months before tenofovir appears on their
subsidized drug lists or formularies. One factor that may affect
the speed at which tenofovir appears on formularies will be its
cost. Currently, no Canadian price has been selected by the
company. In the United States, one month's supply of tenofovir
costs $433 U.S. ($640 CDN).
Expanded access program
The manufacturer of tenofovir, Gilead Sciences, hopes to
re-activate its Canadian expanded access program in the coming
months. However, the new program will make tenofovir available
only to a limited number of people. To gain access to tenofovir,
Canadian physicians must have patients with the following
profile:
- viral load greater than
10,000 copies
- fewer than 100 CD4+ cells
Doctors will also have to supply
evidence that their patients are resistant to many other
available drugs, indicating that tenofovir is a last option.
Therefore, results of genotypic or phenotypic drug resistance
testing will be needed.
For further information, physicians may contact Gilead directly
at 1.800.GILEAD-5 and follow the voice prompts.
What About Side Effects?
Tenofovir can cause nausea, vomiting, diarrhea, and flatulence
(intestinal gas). Individuals must be careful if they use
Viread in combination with ddI because this combination can
increase ddI levels in the blood by as much as 60%. This
increase in ddI levels may, in turn, increase the risk of side
effects that can be caused by ddI, such as life-threatening
pancreatitis and peripheral neuropathy.
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