Finally, A SIMPLER HIV Treatment: Bixlenvo

We've seen the advent of some incredibly new cuttingedge HIV treatments as well as prep in the past few years and we've really managed to refine the once daily oral pill. Most folks don't report any noticeable side effects with their medication. But in spite of all this progress, there's been a noteworthy segment of the HIV population that hasn't been able to profit from the ease of taking a single daily oral pill. A lot of folks with HIV are still taking multiple pills and sometimes multiple pills multiple times a day due to having developed resistances to some drugs in the past. Well, Gilead has now FDA approved a brand new medication to address these people living with HIV who've been left out. It's also another option for people who for one reason or another haven't been able to tolerate other single tablet regimens. I'm Ra Dazzi. Thank you for tuning in. Joining me today is Dr. Jared Baiton to answer all our questions about this new medication. Jared Baiton, MD, PhD, is senior vice president and head of verology at Gilead Sciences where he leads clinical development and strategy across HIV and other viral disease programs. Prior to joining Gilead, Dr. Baiton was a professor of global health medicine and epidemiology at the University of Washington and a globally recognized HIV researcher. His work has focused on HIV prevention, treatment, implementation, science, and global health. Dr. Baiton has spent his entire career, nearly three decades, working in HIV research. He remains committed to advancing person- centered innovations that help address the evolving needs of people impacted by HIV. And before we start, I'll mention that Jared is joining us today as an expert in the field. And while he works at Gilead, it's important to share that I have not been paid nor compensated nor given any payment in kind for this interview. And I I will always let you know if that's the case. >> And with that said, Dr. Baitens, thank you so much for joining us. So happy to have you here. >> Good morning. It's great to be here. >> Not to mention, I love the blue glasses. Very cool. >> It's I I maxordated for you. um that your your viewers um deserve at least the best that I can get to. So, >> thank you. And um is it okay if I call you Jared? >> Totally good. Please do. >> Okay. I'll start with a high level question then. What is the most pressing aspect of the HIV epidemic on your mind recently? >> Um thanks for starting out with with the actually the most important question. Um and thanks for the intro before. you know, I've I've worked on HIV my my whole career, 30 plus years now. Um, and actually, I would say the most pressing thing for me is that I would I would love to end my career and not have to work on HIV at all anymore and for nobody else to have to work on HIV at all anymore. And when I think about where the world has come in the last decades um in terms of innovations in in treatment and in prevention and prep that um that people can take and treatments that make people uh able to live a full um and a healthy life and uh prevention medications that allow people to avoid to avoid HIV. Um, I look at a world where we could end HIV. So, that's what's most pressing. What's most pressing for me and what I work on, what gets me up every day is thinking about ways to get tools into people's hands so that they can be healthy and that aims at having a world where HIV is over. >> I'm sure a lot of my viewers can relate to that. So, thank you. >> Yeah. >> Okay. So, on to the topic of the hour. Beex Limbo is your brand new HIV treatment that has been FDA approved. Tell me what is Beex Limbo? What drugs comprise this medication? >> Yeah. Um so, so getting to that ending HIV is, you know, the part that that um I work on every day is making new medicines. Medicines for prep, for prevention, medicines for treatment for for people living with HIV. and always aiming at medicines that are um that are effective are better able to be better able to you be used and that people can use so that they can get to the treatment and prevention success and persistence that they want. Um Bixono is a new example um as you just said just FDA approved recently although of course we've been working on it for years. This is a medicine for treating HIV for people living with HIV. It's a pill once a day. In fact, it's now the smallest pill um available for that's a fully combined regimen for treating HIV. When you treat HIV, you have to have a combination of medicines because the the virus is the virus is tricky and it can get ahead of a single medicine. So, you have to put a combination together. This combination takes two medicines and puts them together. bict which has been which is uh uh hits the virus in in the in its integrates enzyme part of the the the the virus that helps it get into into cells and into people's DNA helps it be there forever. It hits that enzyme and then lenap the second medicine is lenapir which um uh is a capsid inhibitor and hits the virus at its ability to make new copies of itself and to come into cells. the those two medicines together are extraordinarily potent, demonstrated already um in other combinations and other uses to be effective for HIV and well tolerated and safe and we took them and put them together into a single medicine that people can take for treating their HIV every day. >> And licap is I think a lot of people know it as an injectable for prep. So you formulate it into tablet form. >> Yeah. So people know len you're right. So people know lenaper because it's it's the again it's the first medicine the only one so far that's been developed against the HIV capsid and the capsid is sort of the the the structural tent that's around the nucleic acid of the virus and just a little bit of licaper gets into that tent and disrupts the whole thing. Um the history of licap is a great story to tell. At some point it was took it's 20 years in the making and almost all of that um was was grit and determination by scientists and our chemists and and biologists in our laboratories trying to figure out how to target the HIV capsid and what they made with licapiger was the most potent antiretroviral that's ever been made and the first thing to be able to attack to attack a capsid and >> so it's the first it's like its own class of drug. >> It's own class. It's its own class. There's nothing there's nothing yet in this class other other than >> Okay. Well, I am noting your commitment to have yourself or someone come on and talk about the history of the development of L capir. >> It's a great story all on its own. And >> yeah, no, it's >> is is flexible because it because it's because of its potency and has a really long halfife. So it so it can stick. So you use a little bit of it and it stay and then it can be used for a long time. It actually can be dosed as a shot. It's an injection um up to every six months. In fact, in investigations right now, we've got a prep version that's being tested that's once every 12 months longer. Um and it can be dosed as a pill. And it can be dosed as a pill in this case once a day. Just a little bit of it once a day because it's so potent. Um can be for formulated into a pill and and and absorbed through the stomach. >> You're teasing it. I got a lot of questions but I a lot of rabbit holes I'm gonna try not to go down. Um [laughter] so I got licaper um and then big victra which a lot of people are familiar with through victar been very successful for many people. >> So that's I mean that's kind of it seems like a a no-brainer to combine two drugs you already have into this new drug new medication. >> Well thank you for the no-brainer. I mean I like we did think about it a lot but you [laughter] Yes, as a scientist you had to go through a lot I'm sure >> but you're but you're absolutely right like you take two medicines btegrapher which you're absolutely right is the core of big a medicine that is that helps so many people today uh living who who are living with HIV um you know in the United States for example it's the it's the most commonly prescribed medicine for treating HIV already so it's it's it takes those two medicines victra that's corore cordotherapy and lenapir which is which is which is so um um you know the so which is newer and in a class by itself and puts them together into one pill and into one pill that that provides something new and something very useful for for for people living with HIV and I'm sure we're going to talk about it in a minute how we tested it and tested it really to make sure would make a difference for people. Mhm. So there were two big studies, artistry 1 and artistry 2 that lent this um this new mix lenote. Um in artistry one, what did that reveal about the efficacy and safety? >> And this is what's really important and one of the things I'm uh makes me really proud to be able to do this the work that I do. The artistry one study enrolled people people volunteered for the artistry one study who were on what I would call a complex regimen. So for 20 years now um there have been combinations of HIV medicine for treatment that we're taking multimone medicines and um smashing them into a into a pill and many many in fact most people living with HIV all around the world take one pill once a day but there are some people um either because of medication the intolerance to some medication and often because of their virus has gotten ahead of previous medicines they took and now they have resistance who can't take the one tablet once a day options that are out there and many of them are many of them are older living with um a and as because they're older that living with the the coorbidities heart disease and and high cholesterol and diabetes and such that people have when they get older >> and it was really important when we planned the artistry one study that we that we were focused on that population because we don't really want to leave anyone behind for HIV treatment. So we so the artificial population was entirely people who could not take one tablet once a day and some of them took two some of them took 11. >> Wow. >> Yeah. Yeah. It was and and >> talk about pill fatigue. >> Talk about pill fatigue. Talk about you know there you know someone who's worked on a very long time. It felt very 1999 to think about people who were who were still taking a handful of pills a day. And they all of those individuals came into study and we tested whether Bix Bagraphy the combination of BTG capix could be effective and safe for that population and and and it was and and what's really meaningful is that when I think when I heard about some of the people who had volunteered for that trial and how how much it meant to them to go from 5, 6, 8, 10 pills a day down to one. >> And and and how it was um you know, how many of them had, you know, had had diabetes, heart disease, other things, and how this one pill could fit into into those into into the rest of their life, the other medicines they took, but also the ability to be used effectively without drug interactions with with all the other medicines that they're taking. That was really meaningful. really meaningful with why we how we develop medicines here at good is make sure that we're not going to um that we're that we're meeting or you know meeting the needs of the people that are out there that really responding to what uh people wanted. It's also one more thing on article one the it was also the oldest average age population in an HIV trial ever. Um which which I find uh super important aging the aging aging with HIV brings its its own set of of of particular challenges. It's so wonderful as a world that we're able to talk about aging with HIV and we have to make sure we do it best and right. >> Thank you. you took the words right out of my mouth. You know, I've been on a number of advisory boards and it seems so often that the clinical trials uh the protocol is there's a cut off for for age at a time when you think, you know, it's going to be so meaningful to someone of that age group. And it's not necessarily based on their individual health, but age as a marker of health, which as we know, you know, health can vary widely depending on your age, depending on so many factors. So it's it's just it's always felt so unfair that you know a whole group of people are left out simply because of their age. So that's I think that's really cool. >> Absolutely. >> We're about health for everybody. We should be seeking everybody. Yeah. >> And so I also I'm on the board of um a hope collaborator. It's one of the Martin Delaney laboratories for HIV cure research. And so a lot of those guys and gals are long-term survivors. So I, you know, I'm constantly hearing aging cohort, people who've been living with it for a long time, dealing with, um, you know, fat loss issues and other other stuff related to their med past medications and stuff. So that's really cool. Um, okay, here's a kind of like weird random question related though. We also I noticed we also have a fairly low percentage of people who are virally suppressed in the US compared to other high-income countries. I think it was like 69% in 2024. >> Um, do you think part of that is resistances that people have and also the burden of multi-pill regimens that this might help ease a little bit? >> I think you're I think you're you're you're on to exactly the right thing. you know, we we everywhere in the world um there's room to go in terms of uh in terms of trying to get everyone to viral suppression because so just for for your listeners, you know, when people are living with HIV, viral suppression is key to long-term health and effectively turning turning down turning off the virus so that that people's that people can have um um their immune systems can be healthy and they can live the full lifespan that people treated with HIV are built to live. And it also um really importantly really important for for your listeners, viral suppression eliminates HIV transmission risk to partners. And it's really important to to emphasize that. And why aren't we there yet? Um, one of the reasons is that one of the reasons really is that the medicines that that are that we have don't always fit into the lives of people. So they so because they have to use them every day every day for the long term people have to take HIV medicines and the medicines that we that we have don't always are not while they might work they're not always workable is is kind of what I say. And so the the big funo for example, it's hard like you said before, it can be hard to take five, six, seven, eight pills a day and to take it today, but also every day from now until a year from now and every year from every day from now until 10 years from now. And people may have per periods where that's too challenging, where the fatigue is too much. Um, and so making options like this new one that we talked about where you can make treatment better for people, better a better able to be used for people is really really key. Um, and it's actually part of what what we do every day here, what I get to do every day here is think about making treatment options that uh make treatment better able to be used and better able to use for the long term. Whether that's in this case taking a complex regimen and being able to make that um into one tablet for somebody or some of the things that I hope we'll talk about in the future which is taking medicines uh for HIV that won't be every day. It'll be once a week or once every six months or something in between. >> Yeah. >> Yeah. Totally. Okay. Okay. So before we jump to artistry 2, >> uh I'm curious about any positive impacts to I think I saw something about lipids and metabolic health. >> Excellent. Um you know in the artistry one population uh you know the for the people who were in art one many of them like we talked about before had other coorbidities of of aging. you know, the the um diabetes, high blood pressure, uh cardiovascular disease. And one of the factors that that stood out is that um that people's cholesterols were actually better did better um uh in the in the people who were taking Bix Bixono, the Bict Capir um new medicine compared to people who have been on the complex regimens, particularly individuals who were taking um protease inhibitors. And so um which are known to have to which are known often in some people to be to push people's cholesterol levels. >> What a great thing to think about >> and then and that that's always been the case in HIV medicine seeking with every new medicine that gets developed something that is effective for treating HIV. So keeps viral levels suppressed as this new one does and provide is better tolerable and has add has a better um better overall health profile including in this case um cholesterol levels. >> Very cool. Okay. Artistry 2 um this was focused on weight gain or weight loss correct there was any changes. >> Yeah. So it well so that's one of the elements. So artistry 2 is the complimentary study. So when you're making a new medicine, you want you often want to do two trials because you want to be really sure that something is is effective and safe. And RS32 uh was was uh among individuals who are already taking Victari who are virally suppressed on PCR and then half of them switched to Bixonvo and half of them stayed on Victari. It was the the it is the most rigorous way to test that we could f think of to test whether Bixon vo was um was effective and had a good uh tolerability and safety profile because we were testing against what is a guideline recommended therapy in in Victoria and what >> um um and what it showed is equivalently effective to Victar to to to Victarvey and had a comparable safety profile. Very reassuring um in in probably the most rigorous randomized trial way possible. And on top of that, we looked at a lot of other factors including um a lot of other factors to see how how people were tolerated, including weight gain. And as you said, there was no there's no there was no weight gain seen in the in the um uh on average in the in the Artistry 2 study. Very reassuring. taking the entire set of information um on how it was taken, tolerated, adhered to, persisted side effects and having put that all together and saying this is this medicine is comparable to the medicine that is actually very well known um and used all over the world right now. >> Yeah. Um is isn't Burvy associated with some small amount of weight gain? Inspect. So so antiretrovirals are associated with with uh with weight gain you when people start them for the first time. Got So there's been a lot of of study on on this to understand particularly when people are starting for the first time particularly if they've uh maybe had HIV for a while HIV replicating um all the time is quite um uses a lot of energy and if you turn that off the you the energ that energy is no longer being used into HIV and comes um would have of course come as weight and um people rise up to the natural place where they would otherwise where their weight with our other be. >> Yeah, I think like HIV medication is the easy punching bag for weight gain. And I like to remind my viewers sometimes when they like they'll comment or they'll DM me and be like, I'm gaining weight. I'll be like, well, it could be a product of getting older and being less physically active and maybe having stress and all these other factors in your life. Are you addressing those things first? because it's it's you know it's easy when you have HIV and you're going through like the psych psychological burden of that to suddenly be like oh my god I'm gaining a couple pounds it must be the medication without you know looking at all the factors. >> Yep. I you know you know as as someone who is aging u like we all we all we all naturally gain weight as we as we get older and um you know on average it's a little bit every years as as we age and the um you know I think when I think about weight gain and HIV treatment I think um I I do think about some of the patients that that I've seen who um you you you see it because It's a marker of health, right? I I I I think of some of the patients I saw who didn't know they had HIV, like didn't didn't think uh they they didn't think they needed to test, didn't want to test maybe, and learned a little bit later in the course of their disease that they had HIV and um were quite thin, probably unnaturally um you know, excessively thin as as a result of using so much of their energy to try to fight the virus. Um and then once on effective treatment gain gained some weight back and really it was it was the when I used to see them I would be like this is the mark that I know you're taking your medicines and are healthy. >> Yeah. >> Yeah. Are you still working in the clinic now? >> I am not going to say how do you find time for both >> which which you know thanks for pulling at my heart a little bit today. I I I missed it I miss it terribly. Um but my schedule doesn't doesn't have enough predict. >> Well, you're busy saving. >> It would be the right thing for it wouldn't be the right thing for pat for my patients. Yeah. >> To not to not be around in a regular way. >> Okay. >> Who c is who can take this treatment? Is it just for people who are treatment experienced or can treatment naive first- timers aka also take this? Yeah, this this medicine um is is for people who who are viologically suppressed already. So, it's it's really the the short hand is it's a switch medicine. In fact, it's it's the it's the >> it's the first and only medicine like really dedicated for dedicated for switch in in in this important way. And it is though for people who are sort of across the spectrum that we talked about in the artistry one and two studies. You know, it's for it's that includes really importantly people who are on complex regimens that 2, three, five, eight, 10 pills a day. Folks who could who couldn't take anything else but could consolidate onto this as well. for people who um for whatever variety of reasons might be thinking might be thinking about something new. And so if it it's if they are effectively taking medicines now and looking for something to switch, this offers something that they might want to think about. >> And what's the pricing like compared to other single tablet regimens? >> Yeah, the pricing is comparable to other sing to other single tablet regimens including Victoria that's out there. And of course, it's really important to remember um like for your US listeners to to remember that HIV treatment is HIV treatment and coverage for HIV treatment is part of really is part of health insurance across the board in the United States and Gilead has programs um in place to help people who's who either have who are uninsured or have insurance gaps. >> Okay, great. um any plans to support access globally, generic availability, etc. >> Yeah, so um right now right now Bix is only approved in the United States and so we're working on um the the regulatory and other elements that that make medications available globally. Um you know both Victoria itself um has uh has had global availability both within Victarvi and more generally for um lowincome countries through through generic manufacturers now for a number of years. Lena Capi also has had a when we do our separate conversation on Lenna Caper someday we can talk about the very large um efforts to make sure that Lena Caper particularly for prep is available um globally for individuals um wanting new prevention options. So we Gileia, one of the things I'm so proud of is we're always committing to and we're always striving to make sure that there that we recognize that HIV is a global disease and we need to make sure that we are doing best on treatment and prevention all around the world. And that includes um particularly for that includes making sure that we're getting our medicines available to where where we can do it. and then making sure that there's availability for um for low and low and lower middle- inome countries to be able to make sure they're fighting their epidemics. >> Okay. And for the clinical trial sites, were those global or were they based in the US? >> No, they were the clinical trial sites were global. And um um I'm when I think about doing HIV clinical trials um whether that be in treatment or in prevention um HIV is a is a is a global disease and we want to make sure that we reflect the diversity and span of of of of who is either living with HIV or or wants to prevent HIV. So we always do our HIV uh trials in global settings. Um and which of course is the United States, but it's sort of we look at the at the globe. >> Yeah. And participants uh had access and have access after the clinical trials as well. >> They they do. And so in all Gilead clinical trials um in all Gilead registrational clinical trials, we ensure that people will have continued access to the medicine until it's available um in their setting. uh the the artistry one and two folks um uh volunteers are actually still in the trials because one of the things that's actually important in HIV treatment is um is continued to gather information on the safety and durability and persistence of the medicine um over time. uh HIV medicines uh um uh get registered have regulatory filings after a year of information then and that's what's available now even though there are some people who have now quite a bit more than that but we're going to be uh uh the volunteers who've been in the in the artistry one two trials um are continuing to make sure to provide the sort of longer term follow-up to make sure that um uh that's available to the world as well because we really want to make sure that people understand how to use Bixel Oo, uh, how to start it and how to use it for the long term? They're all still receiving the medicine. >> Great. Um, is that including like were people who are on the big tarv arm, were they able to switch if they wanted to to big lenbo? >> Yeah. So, in the artistry one study um, in the artistry one study with the complex regimens people have people switched over. In the RV2 study, it the RSV2 study is actually remains either Victarvy or Vixon uh the original assignment up through two years and then >> Gotcha. >> And then we're >> and I will check to make sure that that's [laughter] >> cool. Cool. Okay. So, I have a few questions to wrap up. Is there anything else before that you want to say about Big Lambo? the the the only other thing I want to add about pixon though is um you know it takes years to develop new HIV medicines you know we talked licaper was was it's 20 years of science pic um uh about in the same place now and even the what has become vix just the ideas is um uh has been over over five years in the works and and um deep science from from so many people and deep collaborations all over the world with clinicians, scientists and and study volunteers and community adviserss. Um it it takes so much partnership to get um to something new and and we do it over and over again and we'll do it over and over again until we don't until we don't have to anymore. >> Awesome. Well said. Okay. So, are there any other exciting innovations coming down the pipeline that you wanted to just briefly mention? >> There is so much exciting innovation coming up and I the um you know we've we talked before about Lena Capavir as prevention. We've talked about licap with within treatment and we have a number of programs that are going right now in treatment and prevention that are trying to that are grounded in licap but developing new options for people as treatment and as prevention that are going to give people options. Pill once a day, a pill once a week, an injection every six months so that they can make the choice that's going to work for them today. and that's going to work for them a year now. It's going to work for them um as long as they need to. That I find to be very exciting is I think it's a it's a new era in HIV where very driven by people making the choice that's going to that's going to be workable for them. >> Um because you mentioned it >> the once weekly. I'm going to be interviewing Louisa Stamp from Merc you guys have partnered with on the slash review. >> Yep. Excellent. Yes. Um the that that um the once a week combination of lafae from our side and it's verir from from our partners at Merc um first uh first program to read out from phase three trials for a once a week pill for treatment. Um uh potentially offering uh hopefully potentially offering next year a new option for for people in that regard. Um and it's just the beginning. the um it's it's very exciting to think about what the next years could bring for HIV and and to to your point earlier bring so that more people can find a thing that's going to work for them so we can so that everyone can reach viral suppression or can reach prevention that that's going to work for them >> and and then on top of that um at some point um we can have another conversation and talk about all the things we're working on aiming at HIV cure Aha, you said the word I was looking for. I Yeah. So, yeah, absolutely. Um, folks are as It could be basic science, it could be early development, people are appreciative to know what's happening behind the scenes and I think that in the overall narrative of where we're heading with cure in relation to pharmaceuticals, it's helpful to to share that. When I talk about Gilead HIV, it is treatment prevention and cure. And it's sort of boom boom boom every time because we have deep science going on. I'm pointing behind me where the science happens. U deep science going on in cure u both in our laboratories and in clinic. Um trying to figure out the the pathway, the scientific pathway that's going to get us there to be able to have a durable cure. Um and we're not slowing down. It is awesome. We are reaching for that. >> Where do you find joy outside of your career, outside of the work you're doing? >> Oh, well that's that's a great question. Um, so so as you can tell, I do wake up every day really excited to be able to do the work that I do. And I what what drives me in the work that I do is what it means for people. I know what when I when I work on HIV or other viruses actually it's um so important to people and people all around the world that makes really it makes big impacts and I get to think about science and I get to think about community and I get to think about access and government and everything in between. So that's that drives me a lot. Um, and I and I and it's important for everyone to have balance and refresh. And I have a wonderful family and love to cook um uh love to cook and travel um and and exercise and those things all keep me um able to like step away and then to refocus. >> Fantastic. And kind of along that line, how do you stay grounded and centered during stressful or turbulent times? >> I do like to I step away and do yoga, which is a good good refresher. Um, you step away from your phone. Um, I do love to I do we I just talked about cooking. I do um uh I cook we I cook almost every night and it actually it's a good uh cleanses away the day. Um I think everyone needs to find to find those things and then um >> um uh I have a husband and a daughter and like that it's good to it's good to be grounded in the people around you um who u who pull you away from from stress. So every everyone has to find their peace, but those are the ones that um when things are stressful, I get to I get to be reminded about um ways to pull that stress off me, but also to be reminded about how where I want everything to go. I I am I am a very much uh I'm very much an optimist, but I'm also very much a horizon looker. And so even when it's turbulent in right now and I'm sailing through that, I know where we want to get to. >> I believe you. >> Believe you. [laughter] >> Thank you. >> You Yes, you radiate optimism. So that's I think it's very plain for everybody to see. >> Good. >> Well, is there anything else you would like to share that we haven't been able to address yet before we wrap? >> No, this was lovely and you went even deeper than I was expecting. So the So thank you for thank you for the conversation. >> Thank you. I try. Um Claude helped a little bit. I'll give him credit. >> Is there anywhere folks can go to follow you and or your work? >> Um Oh yes. Well, so so I am on I am on LinkedIn. Uh which which which may not be the most exciting social media thing for you to promote. um uh we can give you some good links for um where you can find more information on on really all the medicines that we do and all the work that we're trying to develop in HIV other viruses including including Ebola and stuff all around the world. >> Awesome. Okay. Yeah, I'll look for the links. I'll put the LinkedIn for those who are into that. And uh Jared, thank you so much for taking the time to sit down with me and chat today. It's been really cool and insightful. Um, hope we can do some follow-ups. Everyone at home, please comment below your thoughts, comments, questions. Don't forget to like, subscribe, hit that bell so you get a notification every time a new video comes out. Those are the best ways that you can help support me and my channel. All right, until next time. Cheers. >> Thank you. Have a great day. >> Thank you.