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PrEP approved by a wide margin. Now, what about those ADAP waiting lists? #HIV #AIDS

PrEP approved by a wide margin.  Now, what about those ADAP waiting lists? #HIV #AIDS

I’ve been a big advocate of PrEP and Gilead’s Truvada as a preventative course of action.  Any solution to me that reduces the number of infections is a good one.  A few days ago, the FDA approved Truvada by a huge margin:

The US Food and Drug Administration (FDA) took a decisive step yesterday towards approving the use of combination pill Truvada (tenofovir/FTC) as a prevention method for HIV-negative people.

The FDA’s Antiviral Drugs Advisory Committee (ADAC) voted by a majority of 19 to 3 in favour of recommending Truvada as PrEP (pre-exposure prophylaxis) for men who have sex with men, and by 19 to 2 with one abstention for an approval for use by the HIV-negative partner in serodiscordant couples.

There was a closer vote, however, when it came to recommending its use generally in individuals for people at risk of HIV infection: 12 to 8, with two abstentions, voted for a general recommendation for any person at risk of HIV.

The ADAC decision was taken after an all-day meeting on 10 May. This meeting discussed the findings of a written report and also heard submissions from a large number of community prevention and treatment advocates. Interest was such that the FDA extended the time for submissions from advocates and community members from one hour to two and had to organise a ballot for access to the hearings.

The written report had concluded that concerns about safety and HIV drug resistance were not sufficient to delay the introduction of PrEP. It also decided that concerns about poor adherence levels seen in some randomised controlled trials, and about whether PrEP would negatively influence behaviour to such a degree that people ended up at greater risk of HIV, were beyond the remit of the FDA.

“I don’t think it’s our charge to judge whether people will take the medicine,” panellist Dr Tom Giordano told the Los Angeles Times. “Our charge is to judge whether it works when taken.”

Considerations of cost are also explicitly ruled out of the FDA’s remit when it comes to approving a new drug or indication.

The bolding above is mine; that’s the money shot.  Despite all the bellyaching from Michael Weinstein of AIDS Health Organization, the final decision is on it’s way toward approval in June.  Furthermore, in comparison to Weinstein’s “it’s not a magic pill mantra” the collection of HIV advocates that are in support of Truvada has been steadily growing. From PR Newswire: (full text of a multi-group letter of support at the bottom of the release)

At the May hearing, an FDA Advisory Committee will consider data from a wide range of safety and efficacy studies, including two pivotal clinical trials of TDF/FTC as PrEP:

  • The Partners PrEP trial, which found that daily TDF/FTC reduced HIV infections by 73 percent among heterosexual couples in Africa in which one partner was HIV infected and the other was not. Efficacy was 90 percent among those who adhered closely to their daily drug regimen.
  • An international study called iPrEx found that daily use of the drugs reduced HIV infections by 42 percent among MSM, and by more than 90 percent among participants who took their medication consistently enough for the drug to be detected in their blood.

These studies demonstrate that PrEP was safe, with minimal side effects and no significant risk of drug resistance. These and other trials also indicate that effectiveness of TDF/FTC as PrEP depends greatly on individuals’ adherence to the PrEP regimen. In each trial, when adherence was low, there was low or no protection, pointing to the central importance of strategies to maximize adherence.

“If FDA approves PrEP, we’ll still have a lot of work to do, just as with any other new drug. We’ll have many questions to answer in order to use PrEP effectively to reduce HIV infections,” said David Munar, President and CEO of the AIDS Foundation ofChicago. “The essential next step will be to launch additional demonstration projects in a wide range of populations and settings. These real-world projects will help us understand how to achieve higher levels of adherence, how to best combine PrEP with other approaches, and which specific populations can benefit the most. While a handful of these real-world studies are now being planned, we need to pick up the pace.”

Now, not to throw ants on anyone’s picnic, but lets level the scale for a moment.  I’m betting that Truvada makes it’s way through approvals and presto! The price falls through the floor.  What’s estimated to about $35 dollars a day per dose (that link is a bit old, but you’ll get the idea) is no doubt going to get cheap.  Real cheap.  What’s the point of Gilead pushing getting a drug approved that no one can afford, and no insurance plan will cover?
None.  It’s business suicide and they know it.  Once the approvals process is over I’m going to wager that Truvada is far more accessible than it is currently.
Now – what about those ADAP waiting lists?  Hmmm?  It’s great that Truvada is on it’s way to becoming a prevention enhancement for people, but what about those who are HIV positive and can’t afford their medications?
ADAP has been a major mess for years now, and while it’s been getting better we are long overdue to eliminate those waiting lists entirely.  More than 2700 people currently are on a waiting list in their state (down from 8000, which is great) but it’s still 2,759 people. I can’t speak for you, but that doesn’t work for me.  Due to budgetary nightmares both at the state and federal level, the lives of these people get to hit the pause button.  Their virus, however keeps progressing.
HIV doesn’t hit a pause button.
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  1. Easily the most delusion of the pro-prep arguements is the bizarre notion that Gilead will somehow find it in its black heart to lower the price of this drug, either because it will find a wider market by doing so, or will finally pay off all that costly R&D we keep hearing about. 

    The company has given no indication that it wants to lower the price of this drug, just as its robust HIV drug pipeline, with plenty of prep-heavy single dose pills gives no indication that it foresees a decrease in the number of new HIV infections. 

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    • Delusional?  Hardly; it’s called good business tactics and sense.  What good is all the work that’s gone into getting Truvada approved and exactly 1% of the population has access to it?

      None.  It’s as worthless as a pitcher of warm spit.

      Now, take that pill after it’s been approved, wait for the dust to settle on the approvals on the “Truvada is badddddddddddd….” hubbub that the AHF has been stomping their feet about and lower it’s price by 60%.  What happens?

      80% of the people who’d want to take it are NOW paying attention, and insurance companies everywhere are having meetings determining their level of coverage for their subscribers.  

      Gilead would capture a huge market share of interested patients, make a buttload of money, and the tide of new HIV infections has something else to push against it.

      Clearly you’ve never played poker or high stakes business.  I’d be far more surprised if Gilead showed their hand this early in the game. 

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