Jared Baeten

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

Gilead

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.

 

Seattle scientific meeting on AIDS highlights potential, decries lack of funding | 

Flickr, Benny Sølz

The highly technical Conference on Retroviruses and Opportunistic Infections is meeting in Seattle this week, focused on reviewing the scientific studies being done worldwide to battle the AIDS pandemic.

One of the presenters was Dr. Jared Baeten of the University of Washington, who gave an update on a ground-breaking study known as the Partners PrEP (pre-exposure prophylaxis) study.

The results from this study, which showed the benefit of using anti-HIV drugs to prevent infection, were so dramatic investigators last summer halted it in order to announce the results — and get the therapy into wider use as a powerful new prevention strategy.

A number of studies have shown that common anti-HIV medications can reduce the viral load almost to nothing in infected individuals, likely preventing the spread of HIV. But as Nature reports out of the Seattle meeting, AIDS experts are frustrated at the lack of funding for putting this strategy into use:

Many scientists and advocates agree that there is now an “awesome possibility to prevent the spread of HIV”, says Sharonann Lynch, HIV policy adviser for Médecins Sans Frontières (MSF, also known as Doctors Without Borders) in New York. “If we decrease the money invested in treatment now, we are squandering the best opportunity we’re going to have to get ahead of the wave of new infections.”

WHO says to use a condom if you use injectable contraception | 

Flickr, Jaume d'Urgell

Last fall, Seattle scientists issued some problematic findings indicating higher risk for HIV among women using the contraceptive Depo-Provera, a hormone delivered by injection popular in poor countries for its ease of use and reliability.

Today, experts at the World Health Organization, which contends the evidence for this hormone-HIV risk is equivocal, said women should continue to use the hormonal contraceptive method but also use condoms to prevent against HIV.

As a result of this apparently mixed message, we are getting news stories with equivocal headlines or reports heading in quite different directions:

The Guardian HIV warning to women using injectable contraception

PSI WHO upholds guidance on hormonal contraceptives and HIV

IRIN WHO clarifies guidance on hormonal contraception and HIV

So, is that clear? Not really.

Still, one of the Seattle scientists involved in the original study, Jared Baeten at the University of Washington, told IRIN news that he felt the WHO statement struck the right balance:

“I think the [WHO] statement really reflects what was an extremely thoughtful deliberation and detailed evaluation of the evidence,” Baeten said.

“They made a clear statement by issuing a strong clarification and I think that what’s important in the context of delivering family planning service is that we strongly remind women at high risk of HIV that contraception does not protect against HIV and that condoms are the HIV preventative measure.”