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The Seattle science that led to FDA approval of HIV-prevention drug


The FDA today approved the first drug, known as Truvada, for preventing HIV in people at high risk of infection due to ‘discordance’ – science lingo for being HIV negative but having a sex partner who is HIV positive.

Seattle scientists, as I reported almost exactly a year ago, played a critical role in demonstrating the drug’s effectiveness in Kenya and Uganda studies.

It’s not a new drug and its use is not without some potential complications. But this still represents big news today:

FDA approves first drug to prevent HIV

FDA approves ‘landmark’ HIV prevention drug

As NPR’s Scott Hensley reports,  one of the ‘complications’ of Truvada will be its expense of anywhere from $11,000 to $14,000 per year.

In addition, the drug needs to be taken daily to be effective, so adherence may become a problem — and lack of adherence could pose a risk for creating drug-resistant HIV. Some studies have indicated Truvada is about 65 percent effective at preventing HIV infection and it does have some side effects.

Connie Celum

Still, in a recent Q&A (see below) with the University of Washington’s Connie Celum, the UW scientist says this drug represents a powerful new tool for preventing HIV among those now at high risk for the infection. Millions of people continue to become infected with HIV every year (some 50,000 in the U.S. alone) so new prevention weapons are needed.

Celum, who has done some of the most critical scientific studies supporting the concept that Treatment is Prevention, notes that drug maker Gilead has agreed to steep discounts for Truvada in poor countries, making it accessible to those most in need.

Here is an excerpt from the UW’s chat with Celum re Truvada:

Q: The drug needs to be taken every day. Won’t that be difficult for some people?

We need to make it clear this isn’t something for everyone. People need to be at sufficient risk to benefit from it. So far, the data from the trials suggests that people either took it or they didn’t take it. There weren’t a lot of intermittent users. The risk of resistance is if people take this drug when they are in the process of becoming infected. The other concern would be if people took it sporadically or they weren’t tested frequently enough for HIV.



About Author

Tom Paulson

Tom Paulson is founder and lead journalist at Humanosphere. Prior to operating this online news site, he reported on science,  medicine, health policy, aid and development for the Seattle Post-Intelligencer. Contact him at tom[at] or follow him on Twitter @tompaulson.