FDA panel backs drug to prevent HIV infection risk
(CBS/AP) History was made Thursday evening as an FDA panel recommended approval of a drug that could prevent the spread of HIV, the virus that causes AIDS -- a disease that has killed 30 million people around the world. CBS News medical correspondent Dr. Jon LaPook looks into this latest development.
The drug is called Truvada and is currently used as part of a cocktail of drugs to treat patients with HIV. The FDA recommendation could dramatically expand its use to include healthy people who are at risk for contracting HIV. The Associated Press reported that the FDA is not required equired to follow the panel's advice, though it usually does. A final decision is expected by June 15.
Dr. Robert Grant, of the University of California, San Francisco, led the research. "I think this is a huge milestone," he said. "I think we are in an era for the first time when we can see the end of the AIDS epidemic."
In Dr. Grant's study, more than 1,200 healthy gay men took Truvada. The drug reduced their risk of HIV infection by 44 percent. However, many participants failed to take the pill every day. For those who took it faithfully, protection from HIV was much greater.
"Among those who actually used the drug on a regular basis, the protection was much higher," said Grant, "over 90 percent reduction in the rate of HIV infection."
Scott Owens was part of the study and has been taking the drug for four years.
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"It's not a death sentence anymore like it was 20 years ago," Owen said, "and I'm hoping if this drug comes out, that it would just add one more protection in their lives."
Dr. Rodney Wright of the AIDS Healthcare Foundation is critical of the FDA recommendation. He believes Truvada may hurt other HIV prevention efforts.
"If someone thinks that they're protected from something," said Wright, "they're more likely to behave riskily, so someone would not be likely to use condoms and take Truvada at the same time."
But Dr. Grant said in his study, condom use and safe sex increased after men started taking the medication.
"We are hopeful that the prevention pill plus early treatment can decrease the rate of new infection to very low levels. Our goal is to get to the point where there is no new infections," he said.
Big questions remain. For example, in the real world, will people take the medication faithfully? Will they continue to practice safe sex? And will insurance pay for this at a cost of up to $14,000 a year?
As for why that news is so important: AIDS has taken a terrible toll. CBS News' research department said that since 1981, when the epidemic began, 600,000 people have died of AIDS in the U.S. and, as earlier mentioned, 30 million have died worldwide.