May 18, 2012
With a Food and Drug Administration (FDA) panel's endorsement of the use of the drug Truvada to prevent HIV infection, the 30-year battle against the AIDS epidemic is advancing to a new phase, advocates say.
"With this recommendation, we're nearing a watershed moment in our fight against HIV," said James Loduca, a spokesperson for the San Francisco AIDS Foundation. "We know this isn't a magic bullet, and it's not going to be the right prevention strategy for everyone, but it could save thousands of lives in the United States and potentially millions around the world."
Truvada has been on the US market as an HIV treatment since 2004. It is already being prescribed off-label by some doctors for preventing HIV infection in certain patients who are healthy but at risk. If FDA expands approval to formally sanction this use, insurance companies could likely cover the cost. And widening the market could prompt Truvada's maker, Gilead Sciences Inc., to lower its price -- currently around $11,000 to $14,000 a year.
Truvada is available in poor countries for as little as $9 per month, said a Gilead spokesperson, but generic versions will not be available in the United States until after the US patent expires in 2021.
Truvada can cause kidney and liver problems. But for some people, the risk of kidney problems "10 years down the line may be less than the risk for acquiring HIV, which is significantly more problematic and can be fatal," said Jim Pickett, prevention advocacy director at AIDS Foundation of Chicago.
FDA's decision is expected by June 15.