via bloomberg.com, by Anna Edney
Gilead Sciences Inc. (GILD), the world’s largest maker of AIDS drugs, said U.S. regulators delayed by three months a decision on whether the company can expand use of its HIV treatment Truvada as a therapy to prevent the virus.
The $14,000-a-year treatment would be the first approved to prevent healthy people from getting the virus that causes AIDS. It’s aimed at an estimated 415,000 Americans who are among those at highest risk for contracting HIV from sex, according to the Atlanta-based Centers for Disease Control and Prevention. While some advocates have said Truvada is an important tool to reduce infection, others have argued that users may gain a false sense of security from the pill and engage in riskier behavior.
Truvada, which makes it harder for HIV to multiply, was approved in 2004 to treat people infected with the virus. The drug will eventually get the FDA’s blessing for use as a preventative, said Ira Loss, a health policy analyst at Washington Analysis LLC. The announcement yesterday “just delays the inevitable,” he said in a telephone interview.
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Gilead Sciences Inc. (GILD), the world’s largest maker of AIDS drugs, said U.S. regulators delayed by three months a decision on whether the company can expand use of its HIV treatment Truvada as a therapy to prevent the virus.
The Food and Drug Administration moved the target date to Sept. 14 so it can review a plan by Gilead to ensure people wouldn’t misuse the drug, the Foster City, California-based company said yesterday in an e-mail. Gilead provided the agency a modified risk strategy on June 4, Cara Miller, a spokeswoman for the company, said in the e-mail.
The $14,000-a-year treatment would be the first approved to prevent healthy people from getting the virus that causes AIDS. It’s aimed at an estimated 415,000 Americans who are among those at highest risk for contracting HIV from sex, according to the Atlanta-based Centers for Disease Control and Prevention. While some advocates have said Truvada is an important tool to reduce infection, others have argued that users may gain a false sense of security from the pill and engage in riskier behavior.
Truvada, which makes it harder for HIV to multiply, was approved in 2004 to treat people infected with the virus. The drug will eventually get the FDA’s blessing for use as a preventative, said Ira Loss, a health policy analyst at Washington Analysis LLC. The announcement yesterday “just delays the inevitable,” he said in a telephone interview.
Read the rest.
-------------------
*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.
*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.
*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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