US OKs HIV-prevention drug
July 17, 2012
The US Food and Drug Administration announced on Monday that it had approved the pill, Truvada, as a preventative drug against HIV.
"Today's approval marks an important milestone in our fight against HIV," FDA Commissioner Margaret Hamburg said.
Truvada, which is manufactured by the California-based company Gilead Science, lowers the risk of contracting HIV when used in combination with a prevention plan. The company will be marketing the drug to people at high risk of becoming infected, for example those who have partners with HIV.
“When you really boil it down that's going to be a relatively focused population, but it's an important population to treat.” Dr. Tom Giordano, a member of the FDA panel, told the Associated Press.
Results from a 2010 study on Truvada showed that regular use of the drug reduced HIV infections by nearly 73 percent. Other studies since 2010 have supported findings of the pill’s effectiveness.
Pill might make people less cautious, critics worry
The FDA’s announcement found criticism, including among foundations that fight the spread of AIDS. The AIDS Healthcare Foundation, for example, feared people will be more likely to engage in “risky behavior” and stop using one of the best preventers: condoms.
The FDA countered concerns with their own research. “What we found was that condom use increased over time,” Dr. Debra Birnkrant, FDA's director of antiviral products, told the AP. “So in essence, we don't have any strong evidence that condoms were not used or there was a decrease in condom use.”
Proponents of Truvada also expressed concern about the correct use of the pill. People already infected with HIV should not use the drug, as it could increase their resistance to other treatments.
Gilead Science began distributing Truvada in 2004 as an HIV treatment drug. The FDA’s approval of Truvada allows the manufacturer to market Truvada officially as HIV-prevention drug. Monday’s news followed the FDA’s announcement earlier this month of the first HIV test available over the counter.
kms/msh (AP, dpa, AFP)