Today is World AIDS Day, a day of awareness started in 1988 by the World Health Organization and the United Nations to drive action and reduce stigma around the deadly autoimmune disease. The first treatment for HIV came in 1987, known as AZT. As more treatments hit the market in the ensuing decades, what had been a death sentence became a condition well managed
with daily medications. Today, preexposure profile laxis, better known as Prep, is the standard of care and is recommended for anyone at risk for HIV. Originally available only as a daily pill, the FDA approved an injectable form of Prep in late 2021, adding yet another tool in the fight against HIV and AIDS. Our colleague David Reich hale sat down with Dr. David Rosenthal from Northwell
Health, dr. Daskalakis, MD, director of the Division of HIV/AIDS Prevention for the Centers for Disease Control and Prevention (CDC) and Dr. Dr. Charles Gonzalez with the New York State Department of Health. Welcome back to 20 minutes health talk. I'm David Reich Hale. This is part two of our conversation with Dr. David Rosenthal of Northwell Health Demetre Daskalakis, MD, from the CDC and Dr. Charles Gonzalez from the New York State Department of Health.
In this episode, we cover the benefits and implementation of the recently approved Prep injectables. Dr. Rosenthalk. What is prep? And how significant are these new injectables in the effort to end the HIV epidemic? Great. So Prep has been around for about ten years now. It's a biobehavioral intervention, which means it's both medication as well as being contact and working with a healthcare provider to decrease your risk for transmission of HIV.
So we used to call Prep one pill once a day to prevent HIV, but in December, we actually had a new injectable medication which was released that allowed us to be able to get an injection every two months once you get through the startup period. And that helps you be able to prevent yourself from getting HIV to decrease your risk. Sort of like some people are interested in birth control to prevent pregnancy. Prep is a preventative modality that helps you prevent yourself getting HIV.
You said it's every two months. Right. So the injectable right now is actually the way it's dosed is it's once and then it's another month. So it's two months in a row, and then it's every other month is what the current guidance is for that injectable medication. And how long has this been, you said in market, it's only been since the end of last year. Right. So it's brand new.
So it came out basically with FDA approval in December, and Dr. Deskalakis' group actually was able to kind of put together some guidelines in anticipation of that coming out with some new guidelines in 2021 that I'm sure he can tell us about kind of the importance of being able to use the injectable prep as part of the changing the direction of prep and how we see that. Dr. Daskalakis.
Great. Thank you. No, so really, we've heard what this adds it is really about know there are people who are interested in not having HIV medicines around their home and I think that for some people this could mean a really important innovation that makes them more comfortable engaging with HIV prevention.
And I really agree and the sort of spectrum of interventions that come along with Prep, whether that's testing or other counseling, harm reduction and other services that are critical to preventing HIV as well as other infections, I think that one of the challenges for injectable Prep is that its implementation is complex. So I think we're hearing from frontline providers that really working this new injectable into the flow of what they do every day can be challenging and also complex.
But I think that not dissimilar from other Prep interventions in the past. There is definitely a lead in period. Speaking of that, this drug also has an interesting complexity which is that there's a long tail. And what I mean by that is when you stop the drug, it requires some additional pre exposure Prophylaxis strategy for about a year after.
So though it, I think is really wonderful from the perspective of giving people options who are interested in not having HIV medicines in their home or around or don't want the burden of taking a pill once a day. Or for that matter, for some populations, gay, bisexual and other men who have sex with men and transgender women and others take on demand preexposure prophylaxis.
So that two, one one strategy that is not technically recommended above daily prep, but is an option that's provided in our new guidance or guidelines that came out just recently. So that tail is actually a big deal because people potentially will have drug levels in their bodies for up to a year after they stop the injection. So it's really important to have a really good conversation with patients so they know what they're getting themselves into.
Though again, I think that it has a really important role for lots of people given the addition of a choice. So I think the implementation challenges you talked about are really important. One of the ones that I know I've seen is that there's a huge need for young adults or people that are younger that don't necessarily take any other medications. And so starting a daily prep medication was very challenging for them for medication adherence purposes.
So one of the real advantages of this medication is that you can get your injection in the doctor's office on a regular basis. But the challenge that we're meeting with them is that those patients want to start prep fast. And unfortunately, the implementation challenges we're having is that currently we need to order the medication, wait for it to be delivered, wait for that to happen, do an authorization, and that takes time.
And so that's the biggest challenge that we've really had, at least in my hands for getting prep with Cabotegravir injectable into the hands of younger patients specifically. And can any of you talk a little bit about how we got to this point? There have been two large HIV prevention trials in the order of hundreds of people who have been on the intervention. There's one that they're continuing as an open label extension as well throughout the world.
So it's a fair amount of folks that have gone through the intervention. And the studies are remarkable in that when you look at the just effectiveness of the injectable, probably because of the lack of issue around adherence, it looks like it's better than oral prep. That doesn't mean that actually oral prep is probably worse if used close to perfectly. But perfection is easier when you don't have to take a pill a day. So that's, I think, where the injectable is really exciting.
I'll also add there's a lot coming through the pipeline and I will say, and I think it's fair to say only some of them will look demedicalized because many of them are going to be long acting potentially injectable or implants. Some of them could be an implant once a year, which means that there's an opportunity to sort of loosen up some of the medical interventions. And one thing I think that's also important, right, is that there's differences.
So just because the injectables work really well for some people does not mean that the oral daily medications are necessarily inferior for some people. A lot of people find it very easy to take a pill once a day. They find it very effective to be able to have control over that on their own and to be able to kind of take that intervention on their own. And so I think that the key option, which I think both of you mentioned, is that different strokes are different folks, right?
So different people are allowed to pick the option that's going to work best for them. And this is just talking about possibilities and options about ways we can get interventions into the hands of more people that need it. Exactly so. And it's not as if oral prep is a second hand here. There is no evidence that one is more potent than the other or it just matches to adherence.
And the more we can tailor prevention to one's lifestyle, the easier it will be for its acceptance and for its general use. And there's no reason why you can't switch back and forth what works for periods of time, right? The other thing is the question of adherence, how this fits into lifestyles perfectly. Injectable works fantastic for a long haul trucker, for example. Anyone who changes time zones, an airline steward, any of those things. These things are marvelous.
You. There are still about 38,000 new HIV cases each year. What other strategies are in place to reduce these numbers? Now, of course, they're nowhere near where they were during the peak of the HIV AIDS Cris. Dr. Doscalakis give us the national view on this. Yeah, I think that we've seen it. There's been about an 8% decrease between 2025 years before, so that's good. But to accelerate that decrease, it's really not just all about prep.
It's really about the sort of full toolkit that we have for HIV prevention. And so that spans the Gamut from testing because that really is the key that unlocks the door to so many wonderful status neutral strategies that are good for people regardless of their HIV status.
And so that means prep for people who could benefit from it and actually just engagement in prevention, even if they don't go on prep to make sure that that conversation continues in an assessment and reassessment and then also you equals you. So from the perspective that treatment is in fact prevention, I think that that's all a part of it. So we have work to do, not only in prep. So about 23% to 24% of people with indications for prep are on it in the United States based on our estimates.
And our viral suppression rate is a little bit under 65%. And so there is work to do. And I think when you put all of these things together, what happens is you hit a sweet spot and potentially you get to drive infections down faster. And so places with very high viral suppression as well as good prep uptake tend to do really well. And so we could even leave the US. For a moment and talk about London.
They're fascinating with a high viral suppression rates, like in the really high prep uptake in some of their key populations. And the effect is really like it's potentiating to decrease infections more rapidly. And so when you look at the country, that means a lot of work to do in the south and some of what that has to do with know health care access and stigma, along with a lot of other complexity.
Not to say that there's not work to do in New York, but I think that there's some really good things and good models of how when you get to that sweet spot, you're able to drive infections down even faster. So, Demetri, I want to pick up on a couple of those themes and I think Charles will then can talk about the New York experience with that. But what you talked about was the concept of really status neutral HIV prevention. And what that means is starting the whole concept of this with a test.
So by offering HIV testing, by offering STI testing, by opening the conversation from every healthcare provider at every point of access we can, by giving people the test, then we're able to let people know what's going on. So I always tell patients that knowledge is power and the test is giving them that knowledge. Then if the test is negative, then we're able to take people towards a prevention modality. How can we prevent you from getting HIV? How can we prevent you from getting another STI?
Is that frequent testing? Is that a prevention modality? Is it condoms? Is it knowing more about your partners, whatever choices you're making? And if your status is positive, then how can we take you from being positive to being virally suppressed like you were talking about? So really breaking down that cascade, starting with this status neutral prevention.
But the key concept that lids to the top of that is in order to do the status neutral approach, we have to have providers that are offering that testing to everyone that is opening the door all the time. And I think one of the challenges we have with Prep is people say, oh, Prep so complicated, it's so difficult. And I want to remind people, especially primary care providers, that Prep is one pill once a
day. In its simplest form, it is as easy as prescribing a blood pressure medication or an asthma medication or a diabetes medication. The labs you get to see your patients four times a year. It's a very straightforward modality that not only needs to be provided by people that have experience in the HIV and AIDS in the ID world, but really by primary care providers to really make a big difference.
Because by having more of those people out there to do it, then we're going to make a big difference. And it's hard to get folks to discuss these things in terms of risk because immediately the barriers go up and the feeling that folks are being targeted because of their race or their behavior.
And one of the things that the beautiful things that Dr. Duskalakis did when he was in New York was to develop the sort of status neutral as you're mentioning, you come in and you get an HIV test and then the discussions begin. It's incredibly helpful way of opening up the discussion in a non judgmental way, if it's standard, and that's the only way to
proceed. Well, Dr. Gonzalez, and you just touched on health equity because it underlies all of the topics we are talking about today, and its importance was outlined. And there was an annual Call to Action letter issued by the New York State's Department of Health, and it named DOH's number one priority as taking decisive action to address persistent disparities in new HIV diagnosis and HIV viral suppression rates for black New Yorkers. Can you talk a little bit about this?
Well, actually, I can talk a lot about this. Okay. But one of the things is whether we talk about institute for Healthcare Improvements White Paper 216 we have to acknowledge that health organizations alone do not have the power to affect multiple determinants of health, but they do have a responsibility to address those health inequities directly during clinical interactions and in order to improve patients health and quality of life with us.
What we've done is try to hone down as much as possible on data as opposed to misperceptions. All right, we know that communities that are marginalized or living in marginalized conditions and we use the word marginalized conditions all you have to do is think of COVID are those social, political and economic conditions contributing to health itself?
And health care inequities the term we use is to resist that tendency to define marginalization as a characteristic of individuals or groups rather than conditions in which they live. For example, mental health issues such as anxiety, depression, substance use along with the experience of trauma, whether it's interpersonal community or partner violence are more prevalent in populations experience socioeconomic disadvantage.
Another example would be like in New York's, Manhattan, Upper East Side, there's eleven year median life expectancy, expectancy rather difference between those folks and those living in Brooklyn's brownsville and these things are quite extraordinary. What we have found is that working with community based organizations, folks that know their community are the best means by which messaging both whether it be COVID or prep are the best means.
It's not that healthcare providers are not trusted, but the community needs to be to understand that or expect and should demand that we are responsible to the community for health and their population. And we've done this in certain communities by targeting not the individuals, but the community based organizations to network as best as possible with healthcare providers to be trusted community messengers as well as advocates for the community to access.
Such things as contraception, prep post exposure prophylaxis, or to deal with chronic diseases such as diabetes, which are rampant in folks with lower socioeconomics. And it's trying to get both the community based organizations and the healthcare organizations to work effectively together and not in isolation.
And with that really I think that one of the things that we've noticed is that we're seeing increased numbers of we're seeing the individuals who are acquiring HIV that are newly diagnosed with HIV that are unfortunately coming approximately two thirds from communities of color. And we're seeing unfortunately the uptake of prep to be much, much smaller in those exact same communities. So we still have work to do, I think, both in the state as well as nationally.
Kind of talking about ways that we can help write the prevention modalities to make sure that we're really targeting them, not just to people that want to get them, but to people that need them. To the highest population that are currently acquiring HIV. And I think part of the reason that we're having challenges with that is often stigma both within the communities and also within the providers that help care for those communities.
And so I think that those are really big challenges that we need to look at. And I think one of the things Dr. Escalakis, when you were in New York City that you really kind of are a very early adopter of was the U equals u message or undetectable equals untransmittable signing onto the Prevention Access campaign.
And I think that it's very exciting that we're able to kind of take a look and see where the science is and where there is and be able to take that science and focus on the science rather than the stigma, which is the message for prevention. Ashleys campaign and how do we take that which we did for those that are living with HIV using a status neutral approach? How do we kind of maneuver that into the HIV prevention world?
Now, Dr. Daskalakis, from your time in New York City, you were integral in designing and leading many HIV and STD programs. That includes and Dr. Rosenthal just mentioned this the U equals you campaign. Can you share more details? U Equals You is an incentive to people living with HIV. And I know my personal experience providing care for folks footnote I'm about to start doing in Atlanta too, after a little pause.
But is that there's something liberating to people that they're not someone who could transmit HIV and it makes people feel like they are attractive, that they're desirable and that there's less burden. What do we need to do to have that same conversation in prevention? How do you generate not only interest in prevention but demand? And it tends to be what's good for me about this. And so I think that we need to do a better job.
And I think at CDC we're working on it and I think have done made some strides, but more to come of really how can we generate demand for people? And what does it mean to sort of make this not just something that is about ending an epidemic, but about making my life better in the prevention space as well?
And I think that though I love talking about ending epidemics because I think it's feasible, even though we don't have a cure or a vaccine, I think that sort of taking it back down to that behavioral piece of like, what do people really want out of prevention?
And how do you better make it something that is desirable rather than something that's imposed upon them as an intervention because they're in a community that is somehow stigmatized as potentially not transmitters of HIV but acquirers of HIV. So that second side of that coin is fascinating and that I think needs a lot of conversation. Some of it has to do with where you're putting the services.
And so I think that efforts to put services near sexual health environments is really important because then it becomes a part of other services. You need work to try to embed prevention, status neutral prevention in transgender health environments, in women's health environments, in drug user health environments, really sort of go to the point that this is another part of what you would do for your health as something that's desirable rather than imposed on you.
I'm not sure if you can see me, but I'm giving you snaps right now. I think that's exactly where we need to be. I can feel the snap. There you go. That sounds great. I think that's exactly where we need to be, and I think that that's so important. I take care of a number of patients that are from communities of color, that are trans individuals that are living in the city that really do need kind of those comprehensive health care services. They need primary care. They need HIV prevention.
They need hormonal care. They need to make sure that we're providing all of the sort of resources they need kind of wrapped up together. And we are fortunate being in New York because we have programs that help uninsured individuals and people that aren't documented, like some of the ADAP and prep app programs that exist here due to the resources that Charles and the New York State Department of Health have put together.
But I think that we still need to make sure that we can create more settings where people can get that kind of care, where they can get that complete holistic care to take care of them as individuals in a sex positive environment where they're positive, where they're happy, where they can make sure that they can express themselves in ways that are going to be okay.
Because just because people are having what the medical community may consider, quote, unquote, I'm giving air quotes right now high risk sex doesn't necessarily mean that what that is is that we really are having risk that needs to be done in a way that's different. We need to make sure that those individuals are getting the best kind of health care and the best kind of preventative care around the world that we can offer.
Well, Dr. Rosenthal, Dr. Doscalakis, and Dr. Gonzalez, this was extremely insightful and I think our audience would be very thankful for it. So I appreciate all of you joining us on 20 Minutes Health Talk. And to you, the listener, thanks for tuning in. I'm David Rice. Have a great day. Get more expert insight from some of the leading voices in healthcare today. Subscribe to 20 minutes Health Talk on Podbean, Pandora, Spotify, itunes and wherever you get your podcasts.