Stopping HIV Without a Vaccine
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AARP has a bevy of free skill-building courses for you to choose from, because the steps you choose to take today will help you love what you do in the future. That's why the younger you are, the more you need AARP. Learn more at aarp.org slash skills. So I'm curious, in your own life, when you first became aware of HIV and AIDS,

Oh, gosh, this was a great question to start the interview. I am 50. I'm 51. So I do remember. I remember the first news story as a child. It's also been a driver of everything I've worked on and wanted to work on. I am also 51, coincidentally, and I...

You know, I vaguely remember the world before HIV and AIDS. I also remember, and I'm sure you remember this too, like coming of age at a time when if you got AIDS, you died and you could get it from having sex. To me, that's the...

That's the big imprint it left on my own, you know, narrowly, narcissistically on my own life. Yes. So much fear, right? So much, so much death, so much destruction, destruction of potential and so much fear. And certainly for a generation to have fear and sex so coupled with each other, so intertwined. Yeah.

I'm Jacob Goldstein, and this is What's Your Problem, the show where I talk to people who are trying to make technological progress. My guest today is Jared Baton. He's Senior Vice President in Virology at Gilead Sciences.

Jared's problem is this. In a world without a vaccine, how do you prevent people from getting HIV? It's been clear for years that taking a daily pill dramatically reduces the risk of getting HIV. But as you'll hear, the vast majority of people who are at high risk for getting HIV just don't take a pill every day. Now, Jared and his colleagues are working on a new option, a drug called lenacapavir that you get as a shot once every six months.

The drug has not yet been approved to prevent HIV, but there have been some really compelling results from a couple big clinical trials. There's a lot that's interesting in the show today. How medicine only works if it meets people where they are, and how what seemed like a big problem for lenacapavir may turn out to be the key to its success.

But we started with Jared's own career, which tracks a lot of the history of HIV and AIDS and the emergence of drugs that can prevent people from becoming infected. So when do you decide to make fighting HIV your career? When I went to graduate school and medical school, I was when I decided to work on HIV, that I wanted to do health work that was meaningful to the world, that was that it was and it was immediately actionable.

As a graduate student during medical school, I lived and worked on HIV prevention in Kenya, obviously before there was medicine for prevention. And

I remember very well even before there was very good testing. It was a strain of thought at the time that testing was too scary to do because there was nothing to be done. I certainly had other doctors say that to me. The hospital that I worked in in Kenya,

The only testing that was done was so people could stop spending money on their family members. Oh, my God. So meaning, oh, don't spend any money on them. They have HIV. They're going to die. That's why they were doing the tests. Yeah. Someone in the hospital extraordinarily sick. Let's do an HIV test. OK, you can stop spending money. Jesus. And then really importantly, I remember when medicines came. I remember when medicines came. I remember when

I remember very well when the coffin makers who would work in the street outside the hospital started going out of business. The coffin makers? The coffin makers, yep. Holy cow. Holy cow, yeah. In a place like Kenya, which, gosh, Kenya's prevalence peaked maybe at 15% or something like that at some point, and is now much lower, to be able to...

to see in that country and other countries what medicines can do. And that's actually, that's what drove a lot of the science I've always done is HIV prevention and then HIV treatment, but making medicines that make a difference in people's lives and like what good medicines did for HIV care here in the US where I live, where I'm from and many parts of Africa where I've worked and how fundamentally transformative, how socially transformative, how something risked

really destroying huge fraction societies and how good science was able to arrest that and avert that. So, okay, so that's what's happening, you know, around the turn of this century. And then there's this new idea that comes along after that, right? And that is, what if we can use these drugs to prevent people at high risk from getting HIV in the first place, right? This idea called PrEP. Where does that come from?

So this idea of PrEP, pre-exposure prophylaxis, you take a medicine by having that medicine in your bloodstreams, your tissues, or whatever. If you're exposed to the virus, it doesn't take hold. And

The idea of prophylaxis is not totally novel in infectious diseases. If you've ever traveled to a place with malaria, you've probably taken a malaria prophylaxis, that kind of idea. But the idea of PrEP for HIV was super surprising at the time. You have to have a medicine...

that would work to prevent HIV, and HIV is very transmissible. So to avert infection would be a high bar. And then it has to be medicine itself that's very well-tolerated, very safe, because it would be given to healthy individuals, individuals who don't have infection. And the societal medical tolerance for side effects for treating HIV, just like treating any really serious deadly disease, is different than...

for preventing it. Sure. It has to be lower risk, right? If you already have HIV and you're going to die, you're willing to take a medicine that has pretty severe side effects. Whereas if you're healthy, you're not going to take some really harsh, risky drug just

Exactly. Exactly right. And unfortunately for treating HIV, just for your listeners, the complexity and the side effects of the medicines from the late 90s and 2000s have changed dramatically in the last couple of decades. And so most people these days actually take a single pill once a day, extremely well tolerated, and live longer.

what's expected to be a full lifespan, live as long as someone who doesn't have HIV and are uninfected. So just so people know what's changed. But in the early 2000s,

Medicine still had side effects. Were you working on PrEP at this time? I worked on one of the two trials that formed the registrational package of PrEP. One in mostly gay men and some transgender individuals, and then one in heterosexual individuals, women and men. And that was the second one was the study that I worked on with collaborators from all over the world and based in Kenya and Uganda. It was...

Almost 5,000 couples where one person didn't have HIV and the other one did. So that's a very high-risk setting. Very high-risk setting, and also a setting where there was tremendous motivation to have a different life experience for the couple. It was a really remarkable time because there was lots of questions whether the prep would work at all. There was lots of questions whether it could be safe enough. And both of the trials demonstrated both safety and HIV protection. Protection that was dependent on people taking it.

Like all medicines, medicines only work if you take them. And there are all kinds of different motivations to take something, produce something that's every day. And some people really succeed and some people really struggle, as you can imagine. So you are there setting up the next turn in our story, which is the new drug we are here to talk about. Right. But let's let's just.

Do that for a minute more because, as you said, the drugs people can take to prevent getting HIV have gotten easier to take and better tolerated. And, you know, if you can take one pill a day and you're in a high-risk setting, and that means you have a profoundly lower risk of getting HIV, like, what's the problem? Like, I feel like great work. Thank you for doing that good work. And, like, it seems like you're there.

I'm sure there were moments where I thought, it seems like we're there. This seems obvious to me as well. I remember well, the first days, actually years after the first medication for PrEP was approved, where...

Something like this hadn't been rolled out in clinics. So doctors didn't have the conversation pieces to talk about this. Patients or individuals who wanted preptin always have heard about it or didn't have the practice that asking for it. And it was slow. It was slow going, slow going in this country, slow going around the world.

Slow going, meaning people just didn't take it that much. Healthy people didn't want to take a pill every day. Yeah. I was like, yes, this is hard. Like new innovations in health are hard because none of us make health decisions differently.

Or at least I think most of us. Most of us do not make health decisions just because someone tells us to or because the science is really excellent. We make health decisions because we think it's going to be meaningful for us. And whether that's like what we eat or going to the gym or like what we buy off Instagram or whatever else for our health. We make those decisions because we think it's meaningful for us. And something like PrEP, which can be extraordinarily meaningful, has to be extraordinarily meaningful for someone to want to...

make the effort to go, to get it, and to continue it. There are many, many people who take PrEP every single day. It fits into their lives. It brings benefit. And it brings meaning. And they can make it workable within their lives. And then there have been many people who have tried and stopped or not tried at all. And that's like setting up for, I think, the rest of our discussion. Just because you have something that

for some people that carrying that bottle home or it could be found by an aunt, a partner, a brother, whatever, is too much, too much disclosure, too much revealing. It means you're having sex, probably. Right, exactly. Or the complexity of taking something every day when you've got two jobs and three kids or whatever the things are that...

for something that you don't really want to think about every day. Yeah. It's a very good qualitative description. Is there a quantitative piece? Like, have you estimated the population that, you know, might be relevant but doesn't want to take a pill every day in the first place? Yeah. In the U.S., CDC has estimated that maybe about a third of the people who would most benefit from taking PrEP

Not even like benefit at all, but like most benefit from taking PrEP are taking it sort of today. They're taking it day to day. Wait, one third of the people who were at highest risk for getting HIV are taking it. So two thirds of the people are not. Exactly. So a third are about a third are two thirds are not. So, OK, so there is this idea that PrEP is great, but most people who could most benefit from it don't take it.

One thought is, well, if instead of having to take a pill every day, it was less frequent, simple behavioral thing, maybe people would do it more often. And so there's this search for a new drug that is longer lasting, right, that you in fact have found. Spoiler alert. But tell me about the search for that drug.

The idea was that HIV has a structural element called its capsid, where it encloses the nucleic acid of the virus within the virus. It's like it's the bag, right? It's the protein. Yeah, it's a protein. I always want to think it's stronger than the bag. It's stronger than a bag. It's like a flask. A case. A flask. Okay, okay.

And as the virus is coming into the cell, it opens and dumps the nucleic acid out so the virus is infecting. And when it leaves, it encapsulates it again and floats away. And targeting that is particularly hard. And the work on it began...

A dozen years before, it took a dozen years from the work to start before we even tested a human being for the first time. And 4,000 molecules were synthesized and screened in test tubes and animal studies and other things to be able to bring forward, one, to be able to test in human beings, which then became Lonicapivir. We'll be back in a minute. This message is a paid partnership with AppleCard.

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Join over 9,000 global companies like Atlassian, Quora, and Factory who use Vanta to manage risk and prove security in real time. For a limited time, our audience gets $1,000 off Vanta at vanta.com slash special. That's V-A-N-T-A dot com slash special for $1,000 off. A virus like HIV has a certain number of proteins that make it function, right? And capsid had not been targeted.

And as a result, it's a great question to say, could we target this part of the virus in a way that's different? This is important for HIV broadly because...

What has been the success of treating HIV is being able to target the virus in multiple places, in multiple components of its life cycle. And that is what makes up a treatment cocktail for HIV. Multiple medications, usually that target different parts of the virus life cycle at the same time. And from a safety point of view, actually ones that are very specific to the virus itself and don't have effects on us. And so it's...

A enzyme that only the virus makes, or in this case, a protein-protein interaction that only the virus has, is a great target because there's nothing that looks like that in our regular systems. So basically that means people are likely to have fewer side effects because our own cells aren't going to be bothered. So it seems like a promising target because it's this weird thing that the virus does that we don't do.

And then drug researchers find this molecule, right, this potential drug that'll eventually be called lenacapavir. But there's what seems like a problem with this molecule, right? And the problem is that it's not very soluble in water. It doesn't dissolve well in water. Tell me about that part of it.

And the people who work on medicinal chemistry do a lot of work to try to figure out the best, what's got the best attack on the virus itself or on the enzyme you're trying to target itself. And then it's not particularly soluble. Problem. Because they're like medicines that we take through our mouth, for example, like most medicines for HIV need to dissolve in order for us to absorb them.

And actually, a lot of work goes into when one's doing drug development, maybe you figure out the thing that targets best, and then you figure out how to modify it ever as best you can to be able to absorb it. Because if you can't absorb it, it doesn't have that. Right. You want it to dissolve in water. You want to take it, and then it dissolves and goes off into your bloodstream, right? Correct. Exactly.

It's the tremendous advantage of lenacapravir has been, or what it eventually became, is that when it's formulated as an injection, it forms a depot of the drug, a little deposit of the drug that dissolves slowly over time because it isn't immediately soluble.

And like, was there a moment when somebody sort of just realized like, oh, this bug could actually be, you know, like an amazing feature? You know, the fact that it's not soluble, like it might mean we could give this drug to people and it would last a really long time. I don't think that there's an exact moment. I think there's actually many moments along the way. Yeah. Or a discovery like this, it's what do we have? How do we improve on that? Where could we get to? And I think the...

I will tell you the very first testing of lenacapir was not a six-month injection. So over time, a lot of whiteboards, a lot of rooms full of people, you get to this idea of

oh, we could do this as an injection that lasts for months and months, right? Yeah. So there's two big sort of pivotal trials that you run, right? Tell me about them. It's actually an entire program called PURPOSE. And there are two trials, PURPOSE 1 and PURPOSE 2. What's the acronym? You say PURPOSE, I got to ask you for the acronym. Do you know it? So actually, the acronym is really complicated. It is not a clear P-U-R. Okay, never mind. Yeah, no, no.

Yeah, I don't make these up. But the trials are run across five continents, thousands of people, almost 10,000 people in total. And the two trials, Purpose 1 and 2, were the trials that specifically are phase three pivotal trials for testing whether something is safe and effective. And what were the results?

Yeah, so Purpose 1 is among adolescent girls and young women in South Africa and Uganda. Almost 5,000 people in the trial who were either taking the daily pill or taking the injection. And among people who were assigned the injection, zero infections occurred for the primary endpoint of the trial, which had never been seen before for an HIV prevention trial.

So, OK, so zero, absolutely no one of the 2000 or so people who got Lenacapavir, none of them got HIV in the control group. So they were taking in the control group of the antiretroviral pills that are standard. Now, how many of those people got HIV? For people who are getting the control group?

pill, which is ActivePrep, the approved ActivePrep. 16 out of about 1,000 got HIV. So 16 out of 1,000 is kind of a lot. This is like over the course of what, a year or something? About a year. Yeah. About a year follow-up. And in almost all the cases of the 16, it's because we tested blood samples from those individuals. They weren't using it.

And a testament to, for some people, how challenging it can be to use something every day and how something that injection twice a year for many people both could be very effective, but also is something that they can make workable because you can set it and not think about it.

AKA forget it. What's the other, what was the result of the second pivotal trial? Yeah, the second pivotal trial was the more geographically diverse group and was men, transgender women and men, and gender non-binary people in Asia, North and South America, and Africa. So really broad. Global. Yes. And that study, again, among about 2,000 people, there were only two infections that occurred. Okay. Okay. And

compared to nine infections among about 1,000 people who received the control. So also quite a difference. Yes. I mean, presumably the larger audience or the larger patient population is the people who aren't taking oral PrEP at all. Precisely. And you can't randomize ethically to that. You can't have a control group where it's like, we're not going to give them anything and we're going to see how they do. But in real life, that is probably the population you're looking for, right? Exactly. So, okay. Right.

Congratulations on the successful outcome of the trials. Where are you now? So, yeah, big reminder. We talked about it before. You know, just because science can be, the science may be fantastic. You may have a great publication or a great p-value for science. It doesn't mean that people actually get medicine. And so the medicine on the cover has been submitted to regulatory agencies because drug approvals are unquestionable.

a necessary step for people to receive them and that rigorous process is ongoing now and regulatory therapies all around the world from the beginning um the thought has been for a lot of kevri that's a medicine that can have a global impact and then readying for being able to make

make it and distribute it for people all around the world. As we have been doing all of those steps, the dissemination of the science, the regulatory submissions, we've been simultaneously making plans for global access, particularly access for low and lower middle income countries. And that part of the story is as important as everything else, because success for ending HIV has to be a global success.

Yeah. So let's talk about that. I mean, there's obviously an interesting history of getting HIV drugs to lower income countries that largely has been a success, right? People don't talk about it that much anymore, but it's a good, happy story, ultimately. What's happening with Lenacapavir in that context? Yes, the...

We talked back about my earlier history, and I remember well when there were no medicines in lower-middle-income countries and then when there was. And that was a delay of years and years. And that's not unique to HIV. That is true for innovations in health in general, that it can take years or decades for medicines to make it from when they're discovered to even approval and then availability in low-income countries. Yeah.

For Lenacapavir,

ahead of results, truly years ahead before we had results. We were thinking about how we can compress that calendar. And that included within weeks of the purpose trials reading out an announcement that we had signed voluntary license agreements, which allow a generic manufacturer to make a version of the medicine. So we did voluntary license agreements with six generic manufacturers, covering 120 kind

low and lower middle income countries to be able to make generic versions of the medicines royalty free, no profit to be allowed as soon as they're able to.

So as soon as they can ramp up their technical capacity to be able to make these medicines. So it will be cheap for people in poor parts of the world. And what does that mean? Sub-Saharan Africa, parts of Asia? Exactly. What about, well, what's it going to cost in the U.S.? And how does insurance work for PrEP? Does insurance cover PrEP?

So insurance does cover PrEP in the United States. And CDC has done really extensive analysis to summarize a lot of really good signs there. Their conclusion is that access to PrEP is not limited by insurance coverage. That there are two-thirds of people who could most benefit not using PrEP. That's not for insurance reasons. That is for all kinds of the other reasons that we talked about. And I think that's the strategy we're looking forward to. It's not approved yet in the United States, so there's not...

both insurance coverage and other things are not set yet. Those don't happen until the FDA is able to do their rigorous assessment about the efficacy and safety of the medicine. So, okay, you've been working on HIV for a long time now, right? For decades. And I'm curious, when you sort of take the long view, when you step back, what do you see? You know, I have been doing this for a long time. And what has always motivated me is...

you know, it is actually ending the epidemic. When you say ending the epidemic, I mean, like, I think of a vaccine and a global eradication campaign. Is that what you mean when you say that? I want to stop new infections. I want to be able to stop new infections as much as we can. I want to have treatments that are available to every person living with HIV that allow them to live a full life. And as a result, turning off the tap on new infections, treating effectively the infections that are existing,

then the public health emergency diminishes and the cloud that is HIV on the world. We'll be back in a minute with the lightning round.

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You have undergraduate degrees, as I understand it, in both biochemistry and comparative religion. Which religions did you compare and which one won? No one won. Which one lost? No, I have an undergraduate degree in comparative religion, which I love. I love the interface of society and health, society and person. A religion degree was a great way to get at that.

I mean, tell me one thing, like, what were you actually interested in? Like, tell me one thing you learned in studying comparative religion. Oh, I loved many things in comparative religion. I loved...

I love complicated religious texts and how societies have thought through mystery in the world. I loved American religions because there's so much variety in the United States and it reflects a lot of the energy of the U.S. in all different directions. The dynamism of religion and what religion says about society still influences all the stuff I do now. What's your second least favorite virus?

Second least favorite virus. I'm assuming HIV is your least favorite. HIV is my, well, HIV is my favorite. There's two ways to frame it, right? Favorite or least favorite, kind of the same. What's number two after HIV? Oh, hmm.

Flu? Which ones do I want to wipe from the world? Flu would be great. Big impact. Terrible viruses. That would be like Ebola, Marburg that I'd love to see removed from the world. All the viral hepatitis viruses, there's multiples of them, that have tremendous prevalence in the world and don't get as much attention, but kill lots of people. It'd be great to eradicate them.

How many papers have you co-authored that quote Tina Turner? Oh, that quote Tina Turner, one. Yes, good. There's one with a what's love got to do with the title. Yes, which is about like the motivations to take PrEP, right? The motivations to take PrEP are not simply because someone wagged their finger at you and said, take your medicine. Yeah. Love. Jared Baton is Senior Vice President in Virology at Gilead Sciences.

Just a quick note, we'll be off for the next few weeks on a planned hiatus. We'll be back soon. Today's show was produced by Gabriel Hunter Chang, edited by Lydia Jean Cott, and engineered by Sarah Bouguere. I'm Jacob Goldstein. Thanks for listening.

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