AIDS advocacy groups are dueling over preventive use of Gilead Sciences' ($GILD) Truvada, and the FDA is standing right in the line of fire. The agency is considering the company's application for a new preventive indication based on Gilead-sponsored research showing the drug could stave off infection in people at high risk of contracting HIV.
As The Wall Street Journal reports, the AIDS Healthcare Foundation filed a citizen's petition asking the agency not to approve the new use. The group maintains that the drug would likely be misused by some patients, considering its $14,000-a-year cost, which would increase the risk of treatment resistance. The group also pointed out that Truvada isn't without side effects, including kidney damage, that become more likely with longer use.
But other patient advocates say Truvada would be a valuable new addition to their quiver of AIDS-combating strategies. "It's important to pursue every lead to get ahead of this epidemic," AIDS Foundation of Chicago President David Ernesto Munar told the WSJ. That's the position of Gilead Foundation, the drugmaker's philanthropic arm. President Howard Jaffe told the Journal that AHF's worries should be considered, but Truvada "stands a chance of moving the needle in reducing new infections in the population."
Others say the drug is being prescribed off-label for prevention already, and FDA approval would provide more clarity on how it should best be used. Now, doctors have to study up themselves, and might develop their treatment approaches based on incomplete evidence, said Mitchell Warren of AVAC, an HIV prevention group.