HIV Activists Launch #BreakThePatent Campaign and National Plan for Generics and Lower-Cost Truvada for HIV Prevention in the U.S.

Jason Walker and Emily Sanderson at AIDS 2018 in Amsterdam, the Netherlands
Terri Wilder

NYC-based HIV activists Jason Walker and Emily Sanderson think that, just like the cost of rent, pre-exposure prophylaxis PrEP is too damn expensive. To address the cost of accessing PrEP, they are among a group of activists who launched #BreakThePatent, a campaign advocating to make the generic form of Truvada (FTC/tenofovir disoproxil fumarate) available in the U.S. or to greatly reduce the price of the Gilead drug so that communities most in need can have access to it. They sat down with TheBody at the International AIDS Conference in Amsterdam to discuss the white paper they recently launched, detailing their national plan of action for universal PrEP access in the U.S.

Terri Wilder, M.S.W.: So, this is an exciting week. You have just released a National Action Plan for universal access to PrEP in the United States. Start out by just telling me a little bit about what is PrEP4All, and then, we'll dive right in, talk about the National Action Plan and what's in that.

Emily Sanderson: So, PrEP4All is a group that started when we realized that Gilead Sciences was withholding PrEP due to pricing from people who needed it most to prevent HIV. And we realized that most of the research that was done to develop PrEP was done with American taxpayer money, and then Gilead came in and bought the patent.

We formed this group so that we could inform people and change the policy and change the access to Truvada as PrEP.

TW: In the United States, the pricing is very different from maybe other parts of the world.

ES: Yes. In the U.S., it costs on average $1,600 a month to fill a one-month prescription of PrEP. But, in other countries, it is cheaper to access because drug companies know that they can make a lot of money off people in the United States, because we're a high-income country.

TW: Great. So, yesterday at the conference, you guys had a press conference. You released your National Action Plan for universal access. Talk to me a little bit about this National Action Plan.

Jason Walker: Our National Action Plan is really a call to get different folks who are impacted, communities who are impacted by the HIV/AIDS crisis, to come together to put public pressure on Gilead and the [National Institutes of Health](NIH) to ensure that we have generic drugs that come onto the market so that we can provide options for folks who want to take preventative HIV medication.

Our whitepaper is really just outlining how we got here, how we got to a place where folks cannot access Truvada. It's essentially a call to action to get communities together so that we can organize, so that we can strategize, so that we can build our collective power to put public pressure on Big Pharma, so that we can make sure that we have an accessible biomedical prevention strategy for high-impact communities.

TW: It sounds like, at the foundation, [in the U.S.], the prices are higher, and Gilead's application to the [U.S. Food and Drug Administration] (FDA) for PrEP indication for Truvada was not funded by Gilead but, rather, by U.S. taxpayers.

ES: Right. Exactly.

JW: We paid, U.S. taxpayers paid, for the research, we paid for this drug, essentially, to be utilized to help keep communities safe, to keep people safe, and to keep key populations safe. However, those communities are not receiving or reaping the full benefits of this new strategy, this new approach that we have to combating the virus.

TW: And so, specifically, when you look at the cost difference -- you mentioned the $1,600 in the United States, and then maybe $6 for a monthly supply from other parts of the world -- the $6 is because people in other countries have access to a generic.

ES: The $6 a month is what it costs Gilead to produce this drug in their factories. So, if we bought it at price, it would be $6 a month, and if people are accessing it in other countries, it is either low-cost or free, depending on where they're accessing it from.

TW: So why is Truvada so expensive in the United States?

ES: Truvada is so expensive in the United States because drug companies and pharmaceutical companies have too much power, and there are no regulations around how much they can charge people for drugs. Especially, there's no heed paid to whether a medicine is on the essential medicines list; they still get to charge whatever they want for drugs because there's no check on them.

TW: So, [Truvada] is the only evidence-based, highly effective prevention sold for HIV. And, when we're looking at moving forward, people are constantly talking about ending epidemics. So, where I'm from, the New York State Department of Health, as you know, has this Ending the Epidemic plan; we have 90-90-90 globally. Where do you think that lowering the price of PrEP, particularly in the United States, plays into these ambitious goals of ending epidemics, particularly in the United States?

JW: I think PrEP is essential to these goals, right? I think we wouldn't have a clear vision of ending the epidemic without tools like PrEP. They're essential. They're crucial to making sure that we can drive down the rates of infection and protect vulnerable communities.

But I think, like Emily was stating, it is Pharma, I think, that is not equally as invested as the people are. So, [by] ensuring that drugs like Truvada are inaccessible to, particularly, communities in the South, particularly low-income people of color, particularly trans folks, it does seem to me that they are not in line with our values, and they don't share the same vision that we have, at the same level of commitment.

ES: And the story of the AIDS crisis currently is that people are still dying because there are tools that are not being utilized. People are dying from coinfections. And it's not because we don't have the science to fix the problem; it's because -- the resources that we have, and the tools that we have, to fight the epidemic and to stop people from dying and becoming newly infected -- people can't access those tools, such as PrEP.

TW: Pharmaceutical companies often have these patient-assistance programs. One of the things that's in this whitepaper is a heading that says, "Gilead's Financial Assistance Programs Are Inadequate." And so, that's stated pretty strongly in this document.

How are these programs inadequate, in terms of helping people, particularly in the United States, when the costs of these drugs are so high? Why does this group think that these programs are inadequate?

ES: Well, for starters, there are people without health insurance. Part of the copay assistance program, from my understanding, is that there is a limit to how it is used. In some cases, it's that you have to pay a certain amount of money before that program kicks in.

TW: The document says that [Gilead's] advancing access copay program is insufficient, given the high cost of Truvada, because it only covers $4,800 of the out-of-pocket costs and, until recently, it was only $3,600. Only because of pressure from advocates was that even increased.

ES: It's also that, when the drug costs $1,600 a month, then that copay assistance program can only cover, what? Like, six months' worth of PrEP -- or less -- which is a problem, as well.

TW: At the very end of the document, you guys talk about this case for government action and a National PrEP Access Program. And so, talking about the need for a national PrEP program -- what does that look like to you?

JW: I think the national program would be like a PrEP drug assistance program. So like what we started in New York, like the PrEP-AP: a national program in which not only do we ensure that folks who really need and desire and want PrEP can have access to it, but also, the national program would ensure that they also have access to the doctors, right?

Because, you know, that care and being engaged with your doctor is also a critical component. So, to answer the previous question, the reason why the Gilead copayment assistance program isn't sufficient is because folks can't afford to go to the doctors to maintain their care, right? So, it just pays for the drugs, but not any of the other services that are needed and that are required to be on PrEP. That's one of the reasons why the Gilead program is insufficient. So, a national program would help to support and supplement that, to ensure that folks not only have access to the drug but also can have continual access to the doctors and providers that are needed to ensure that they remain safe on PrEP.

TW: Including nurse practitioners, physician assistants, etc.

JW: Yes, all that. Right.

ES: And even things like getting an Uber, or a car, or a ride to your appointment, or to your doctor's office. Because that's a barrier for a lot of people, too.

JW: Particularly in the South.

ES: Right, exactly. Particularly in the South and in rural areas. That's also one of the things that the whitepaper talks about.

TW: Yeah. We also have a problem with medical providers, in general, being aware of PrEP. Since Truvada was approved for PrEP in July 2012, having health care providers aware of it, but then, after they're aware of it, being willing to prescribe PrEP. Because some providers think, "Oh, that's an HIV specialist issue," when most of the activists that I've interacted with have said, "No, PrEP is a primary care issue; it should be part of primary care." So anyone should be able to prescribe PrEP. We have [Centers for Disease Control and Prevention] (CDC) guidelines on it and, in New York state, New York state has their own PrEP guidelines.

It's about, in some ways, getting the pen to hit the pad -- as in, the prescription pad. It sounds like PrEP is complicated and takes a lot of choreography.

ES: Yes. But if we can do it with treatment, why can't we do it with PrEP? It's definitely possible, and it's necessary. But we just need to organize to get there.

TW: Right. At the end of this document, you do an analysis of the clinical and drug cost of a national PrEP program and really break it down in terms of an estimated cost of Truvada and clinical care per person, looking at the Medicare fee schedules and the CDC PrEP clinical guidelines to come up with this estimate. That is amazing that this is in here. So, a 30-day supply of Truvada is like $9.70; 12 units per year, so the annual cost is $116.40.

Then, you add in a fourth generation test, four times a year; renal function, two times a year; sexually transmitted infection test, which is part of guidelines, two times a year; a pregnancy test if you're a person who could get pregnant, four times a year; and then a physician visit cost, which is four times a year. So, a total cost of $1,227.61 -- which, if the drug, as it currently stands, is $1,600, that doesn't even include all these other costs that go into having PrEP being part of your clinical care.

Because it's not just the prescription: You have to go see the prescriber. You have to get an HIV test, because this is for people who are HIV negative. If they test positive, obviously, they would start hopefully on antiretroviral therapy immediately.

That's a great document for people to look at. And you can literally see the savings in writing.

ES: Yeah, exactly.

TW: The other thing that was interesting about this document was that you talked about what could you do with the savings. So, if the $1,600 got down to what you are advocating for, there would be potentially $50 million that could potentially help raise awareness about PrEP to priority populations.

Right now, it doesn't feel like we have a coordinated way in the United States to raise awareness about it. The CDC obviously does some, but a lot of community-based organizations are trying to find smaller grants from the Department of Health, or a foundation or whatever, to put together a campaign. And you usually only have enough money to target one population.

In terms of money to raise awareness, what would that look like to you?

JW: Great question, you know? Great question. Because I was just watching a video last night of three guys from a ballroom scene, talking about PrEP. And you could see how much information was misinformed, how much information that they did not know, and how much inaccurate information they had about it. I think having money for campaigns and for public education is critical and crucial and is definitely needed, and definitely making sure that it reaches a diverse audience.

I think even what we saw in New York is that HIV infection among women went up. Because women directly said what they saw in the messaging was that PrEP was not for them.

So, making sure that we have messaging, diverse messaging, that reaches all populations in a way that is not stigmatizing at all is very crucial to ensuring that folks get accurate information about PrEP and feel like it's for them.

So, with that, what would a campaign look like on a national level? I'm not too sure yet. But I know that it definitely should be accessible to all communities, that it should be destigmatizing and help and encourage community conversation at a very local level. That's what I would see from a national campaign.

TW: Yeah. I'm glad you brought up that point about women, because so often women are not included in the conversation about PrEP at all. And, yeah, those messages? You see them up, like you said, in New York City; there's a lot of stuff happening; [you] see posters in clinics. Maybe, if you're lucky enough to live in a city that has a campaign that's more public, on a subway or a bus stop, or whatever. [But] they're overwhelmingly not targeting certain populations and, particularly, women.

ES: That's especially important, too, when we're talking about sex workers. Sex workers are a key population here that needs to have access to PrEP and so, seeing them represented, and seeing more women represented, as well.

TW: Have you met with Gilead about your concerns? I mean, do they have a copy of the paper?

JW: We haven't met with Gilead, but I'm sure they know of our presence. I think they're probably going to pick up our whitepaper. I'm sure they'll see it.

TW: I guess the overall thing driving this is that there are very high prices for this in the [United] States. And then, we have current low rates of PrEP utilization, which is problematic.

Where does the U.S. government play in enforcing the people's right to health and making sure that PrEP is widely available to all Americans?

ES: The U.S. government tomorrow could step in and say that they could break the patent, using the march-in provision of the Bayh-Dole Act. So they could march in and say, "We did the research and development of this drug, and we want it to be available at this price."

We're asking them to do that. We're waiting for them to do that.

This transcript has been edited for clarity and brevity.