Connie Celum

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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.

 

Studies provide proof of powerful new HIV/AIDS prevention strategy | 

Gilead

Two clinical studies done in Africa, the largest done by Seattle scientists involving nearly 10,000 people in Uganda and Kenya, have shown that the same drugs used to treat HIV infection can be used to prevent the infection.

“This is huge news because of the impact it could have on prevention worldwide,” said Jared Baeton, one of the leading researchers at the University of Washington on the study, which was funded by the Bill & Melinda Gates Foundation.

“These results are tremendously exciting and confirm we are at a pivotal period in the AIDS epidemic,” said Mitchell Warren, a leading voice on HIV-AIDS prevention matters and director of the AIDS Vaccine Advocacy Coalition.

A number of earlier studies have shown that getting people who are HIV infected on anti-HIV drugs significantly reduces the risk of spreading the virus. Now, Warren said, it seems clear that people who are at high risk for HIV can also be protected if they take the drugs prior to being exposed to the virus.

The approach is known as pre-exposure prophylaxis, or PrEP. The other study cited today as demonstrating PrEP’s potential was done by the U.S. Centers for Disease Control and Prevention in Botswana involving more than 1,200 volunteers.

Connie Celum

“This study demonstrates that anti-retrovirals (anti-HIV drugs) are a highly potent and fundamental cornerstone for HIV prevention and should become an integral part of global efforts for HIV prevention,’ said Celum, who was among the first to show the power of these drugs to prevent infection.

The UW study in Uganda and Kenya was of 4,758 “discordant” couples (in which one partner has HIV and the other does not) was called Partners PrEP and led by Celum and Baeten. On Sunday, scientific advisers monitoring the UW study ordered the placebo arm halted and the results released early.

Earlier studies of PrEP strategies had shown conflicting results, some effective and some not, but many experts say these new studies will resolve the uncertainty.

The UW study, which compared a single anti-HIV drug regimen vs a combo drug regimen, found that giving non-infected partners these drugs reduced the risk of infection by 62-73 percent (depending on if it was the single or combo drug).

But, as AIDS prevention advocate Warren noted in his statement heralding these results, science is one thing and implementing treatment or prevention programs in the real world is another.

Many millions of HIV-infected people living in poor countries and who right now need access to these drugs to save their lives are not getting them. Programs such as the Global Fund to Fight AIDS, TB and Malaria have not been fully funded by donors and governments.

 

Scientists discover (again): AIDS treatment prevents infection | 

Flickr, Benny Sølz

As MSNBC, the Wall Street Journal, New York Times and many other media report today:

People infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate, scientists report.

The study, begun in 2005, was done by the National Institutes of Health and had such dramatically positive results it was ended five years early. As the Wall Street Journal’s Mark Schoofs writes:

The results were so overwhelming that an independent panel monitoring the research recommended the results be released four years before the large, multi-country study had been scheduled to end.

Connie Celum

What may be even more surprising is that a Seattle-based AIDS expert, Connie Celum, as well as some Swiss scientists had already discovered this!

Here’s my post on Celum’s findings last July, UW Study shows AIDS Treatment IS Prevention. As Celum and her team reported back then in The Lancet:

“We found a 92 percent reduction in transmission among those who went on (anti-HIV drug therapy),” said Celum.

The New York Times said the NIH study was convincing because it is the first time this was shown in a major randomized clinical trial and earlier studies had only “implied” this. That’s a little misleading and certainly ignores the power of what Celum and her colleagues showed. Continue reading