Nurse Maureen‘s Health Show Podcast
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Nurse Maureen‘s Health Show Podcast
What If You Could Have An Injection Every Two Months to Prevent HIV? Apretude in Canada
Discover how a groundbreaking medical advancement is set to transform HIV prevention! Listen as Jean-Francois Fortin, Medical Director of Viive Canada, breaks down the approval process for Apertude—an extended-release injectable suspension for pre-exposure prophylaxis (PrEP), recently green lit by Health Canada. Compare its unique dosing regimen with traditional daily oral PrEP options and learn how Apertude's innovative approach promises to significantly enhance medication compliance and reduce HIV transmission rates in Canada.
We also delve into the pivotal clinical trials HPTN 083 and HPTN 084 that established the efficacy and safety of Apertude across diverse populations. Michael Kwagg from the Community-Based Research Center (CBRC) joins the conversation to highlight the profound impact this approval could have on various communities affected by HIV. Together, we explore the essential role of community organizations and healthcare providers in ensuring these advancements reach marginalized groups, encouraging more widespread testing and engagement in prevention strategies. Don't miss this crucial discussion on the future of HIV prevention.
Good evening and welcome to yet another episode of Maureen's Health Show podcast. Thanks so much for tuning in. I really appreciate that. I'm very excited about the topic for tonight's podcast.
Speaker 1:Last month, in June of 2024, veeve Healthcare's Apertude was approved by Health Canada for pre-exposure prophylaxis, or Pr PrEP, to reduce the risk of sexually acquired HIV infection in at-risk individuals. This is a combination of tablets and an extended release injectable suspension. Hiv remains a critical public health issue in Canada. You may not have known that 62,790 reported cases of HIV occurred in 2020, with 1,833 new cases in 2022. New HIV infections increased by a whopping 24.9% from 2021 to 2022, and close to 7,000 people were living with but remained undiagnosed at the end of 2020. The announcement by the healthcare is an important step toward ending the HIV epidemic in Canada by providing Canadians increased options for HIV prevention, which is so important. We're going to be talking about longer dosing intervals with Apertude so important. We're going to be talking about longer dosing intervals with Apertude. It allows users to reduce their dosing regimens for effective HIV prevention from daily oral pills to as few as six injections annually. This is very exciting. Joining me on the line to talk about this is Vive Canada Medical Director, jean-francois Hortin. Good evening, jean-francois.
Speaker 2:Good evening, Maureen. Very happy to be here with you today.
Speaker 1:I'm delighted to have you here. This is really exciting because I think in part, people have this idea about HIV that it's a chronic illness. People are living with it. Now All is good, the lifespan has been extended, but it's a difficult diagnosis and prevention is critical.
Speaker 2:Yes, indeed, you know, as you very well said, it's become, you know, a chronic disease. But you know people living with HIV face all kind of challenges you know you mentioned. When you're diagnosed, you have to take medication for the rest of your life and although, as you said, the life expectancy is very much or close to normal, there's still a lot of conditions that the people living with HIV have to go through. So preventing infection is a key objective.
Speaker 1:It certainly is. Can you tell us more about the recent approval of Apertude by Health Canada for PrEP or pre-exposure prophylaxis?
Speaker 2:Yeah, so this came after. As you know, like any other medication that comes into the country, health Canada will go through a very thorough process of review assessing the safety, the efficacy of the medication and really at the end of that process, if Health Canada sees that the benefits are positive versus, you know, the risk that can come with a medication, it's going to be approved. And that was the outcome of this review for Apertude. It was going to recognize that the efficacy of the drug you know overall warranted an approval. So that went through what we call, what's interesting, a priority review process, which means that it's for drugs that bring a significant benefit versus options that are already in the market. So we are very happy of that recognition as well. As you know, the approval that came so right now it means that very soon, you know, the drug will be able to be distributed, sold, prescribed in Canada.
Speaker 1:This is awesome. Apertude is described as the first long-acting injectable PrEP option in Canada. How does the dosing regimen compare to traditional daily oral PrEP options?
Speaker 2:Yep. So, as you just said, there are options already available in Canada, very good options, where people need to take a pill every day and it's providing very, very good protection. However, this is sometimes not suitable or appropriate with everybody. So thus you know, they need to have, as you mentioned in your introduction, additional options. So in the case of Apertude, there is at the beginning what we call kind of a loading or an initiation phase where people, depending on the discussion they will have with their physician, their HCP, they may go through a phase that's called an oral lead-in. They will take for a month.
Speaker 2:We also have, you know, aperture in the form of pill and this is to test, you know, their tolerability right, and then after that they will initiate the injection. So that initiation phase we provide at the time zero, you know, first injection and these injections actually are done in the buttock muscles, so it's an intramuscular injection. So you're going to receive the first one and then to do that initiation to make sure that you have quickly enough drug levels to protect, you're going to have another injection after one month and then one month later you start your continuation injection and thereon it's going to be every two months.
Speaker 1:Which is great. You know, I see patients in my clinical practice and compliance is a big issue. Medication compliance They've you know they'll run out of it, they forget to take it, it's not the right time of day for them. I mean, there's so many you know many reasons that people forget to take daily medication, so this sounds like a much better option to me. A little bit later in the program we're going to be talking with Michael Quagg, the Executive Director, community-based Research Center. But the statistics on new HIV infections in Canada have demonstrated an increase, and how does this approval contribute to efforts in curbing the trend With the new increase in HIV diagnoses in Canada? How does Aperture fit into the strategy to reduce HIV transmission rates?
Speaker 2:Yeah, so you also mentioned earlier in the introduction, right, the beginning of it all is really the initial transmission. So a drug like Apertude. The goal is really to provide additional protection in people that are not infected against the risk of acquiring the infection. So it's really attacking, if you want, the dynamic of the epidemics from the onset. People that will take Apertude or other prevention medication have a decreased risk of infection. So it really helps to decrease the virus in circulation in the community and by by such, you know, reducing the transmission you mentioned also maybe I'm going to throw in one of my buzzwords here this is an additional tool right For proper prevention. You need to have, you know, a lot of tools in your toolbox and Aperture is really an additional one of there, in addition to oral medicine, to, you know, safer sex practices and so on. So it's really providing choice for people to protect themselves.
Speaker 1:I couldn't agree with you more, and that really supports the shared decision making model we're're seeing in clinical practices across the country. Today I wanted to talk a little bit about the UN AIDS global AIDS strategy 95-95-95 targets, where they're aiming for 95% of people who are living with HIV to know their HIV status, 95% of people who know they are living with HIV to be on life-saving antiretroviral treatment and 95% of people who are on treatment to be virally suppressed. This is a lofty yet beautiful goal, I have to say. Can you explain the significance of prevention in achieving the UNAIDS 95-95-95 goal?
Speaker 2:Yeah. So first off maybe to mention a few numbers, because right now in Canada I think we have where we stand in those 95-95-95 objective we have. For the first 95, which is people being infected and knowing about their status, we're at 90%, so still some work to do. In the second 95, it's people being infected that are on treatment. There we're doing a little bit less good. We're at 87%. And then for the last 95, which is being totally suppressed on your medication, we're doing good. There we have reached actually the 95. Oh, congratulations.
Speaker 2:Yeah, and that speaks, I think, of the health system that we have, that we're able to provide good, effective medication for people that need it. Now I think, going back to your original question, which is what does it mean? It means that we're going to reduce the infection. So that's going to mean less people that are going to be, you know, diagnosed and that need to go through to that treatment. So we're going to reduce, hopefully by better prevention methods and using preventative medicine, reduce the number of new infections and increase, you know, the first 95.
Speaker 1:That's amazing and that reduces the burden on the health care system and also improves quality of life for individuals as well, which is fantastic. Thank you. If you enjoy the show, there's one simple way you can show your support Just hit the follow button on the app you're using to listen to the show. Right now, I'm working so hard to take everything on the show to the next level, and your follow means a lot to me. It's the only free thing I'll ever ask of you, and it truly makes a big difference. Thank you sincerely for your support. I truly appreciate it.
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Speaker 1:Ladies. Do you leak with cough, sneeze and or exercise. Did you know that leaking urine is never normal? Hi, it's Maureen McGrath, registered nurse and nurse continence advisor. It's time to stop letting bladder leaks hold you back. And time to say goodbye to bladder leaks and hello to Moxie Patch, a revolutionary new device to treat stress urinary incontinence. Moxie Patch is ultra-discrete, effective, reusable and eco-friendly, empowering you to live life to the fullest, free from the worries and limitations of stress urinary incontinence. With Moxie Patch, you can choose freedom from the hassle of bulky pads and embrace life again. Stop letting bladder leaks hold you back. Say goodbye to embarrassing moments and hello to unstoppable confidence with Moxie Patch. For more information or to order your. Thank you so much for joining me today, also available at select retailers and on amazoncom. Thank you so much for joining me today to get the word out. What are the next steps or initiatives that Vive Healthcare is planning to ensure Apertude's accessibility and awareness among healthcare providers and at-risk communities?
Speaker 2:Especially, healthcare providers are so busy today communities, especially healthcare providers, are so busy today.
Speaker 2:Yeah, so I think there's a number of efforts that are ongoing and will be unfolding in the coming weeks and months.
Speaker 2:First is to make sure that we have the drug supply in the country. We make it available as quickly as possible, working with the provincial territorial authorities to seek public coverage for all people who could benefit from PrEP. Also, we're developing and going to roll out educational programs on prevention and treatment options, although there is already PrEP available in the country, but the goal is to make sure that more HCPs are aware about this option and know how to use it. We're going to reach out as well and I think Michael may talk more about that after to community aid service organization to also inform them about the option. We also put in place funding programs, you know, for initiatives that could help you know community organization put new journeys or efforts in place and also make a, you know, campaign for public awareness as well, because protection at first starts with the people. You got to be aware of your option, know about it and then initiate discussion with your physician or whomever I think would be appropriate to discuss about prevention options.
Speaker 1:It sounds like a great plan Beyond Canada, because this is very important. This is a global issue. How does the approval of Apertude contribute to global efforts in HIV prevention and treatment?
Speaker 2:Yeah. So it's been, quite frankly, seen as a little bit of a little revolution in the field of prevention Right now, especially in resource-limited countries, where sometimes the ability to get access to treatment is more difficult, or sometimes in resource-limited countries they may not have access to the same extent of medication. Prevention plays a very, very important role Because if you cannot very efficiently treat all the people, you're going to make sure that you decrease the infections right. So and it's already approved in a number of countries across the world in the US, australia, south Africa, recently also the European Union and the UK have approved, and there's a number of countries also in sub-Saharan Africa. So it's going well in these efforts.
Speaker 1:That's fantastic. Is it approved in the US?
Speaker 2:Yes, it's been one of the first countries where it's been approved.
Speaker 1:Fantastic. You know, no drug goes to market without having had clinical trials, and the clinical trials the HPTN 083 and the HPTN 084 demonstrated apertures, efficacy and safety. And all of that, what were the key findings that led to its approval?
Speaker 2:Yeah, so those two trials that you mentioned were very large in size, so combined there was almost 8,000 participants in those trials, so that's a very significant number. So 083, as you mentioned, was focusing on men having sex with men and transgender women, while the trial 084 was focusing on cisgender women. So the other element that's important there is to mention that it's been tested in broad and diverse populations and the goal of this trial was really to compare the prevention of transmission between Aperture and one of the leading oral options and one of the leading oral option, which is a combination of tenofovir and m-tricitabine, and the design of the trial. We've all gone through COVID and I'm sure everybody became, you know, couch experts about clinical trial. It was called an event-driven trial, so you have two arms and then you wait until a number of infections accumulate and you check between your treatment arm and your control arm is there a difference? So at the end of the trial, I think the key elements were that in OA3, there was 69% less infections on events of transmission in the arm of aperture versus the control arm and as much as 90% decrease in transmission events in the aperture arm versus the control arm.
Speaker 2:In 084, which was in cisgender women, and I want to emphasize that this is very important because in Canada currently 95% of the use of PrEP is in men having sex with men, so women don't have much to benefit for many different reasons. So we're very hopeful that with these options we're going to be able to expand to more people that are really in need. And, of course, very important, the trial demonstrated that the safety profile was appropriate.
Speaker 1:That's fantastic. It's such a phenomenal advancement in treatment and prevention of HIV. Thank you so much, jean-francois. I really appreciate your contribution. I also want to talk about the community perspective, and I've invited Michael Quagg, executive Director Community-Based Research Center, cbrc, to join me as well. Good evening, michael. How are you?
Speaker 3:I'm great. Thanks so much for having me.
Speaker 1:Thank you so much for having me. Thank you so much for joining me. Can you tell us more about what the recent approval of Apertude by Health Canada for pre-exposure prophylaxis, or PrEP, means for the community?
Speaker 3:Yeah. So this is very exciting news for Canada as a whole and specifically many people in communities who are continuing to be impacted and affected by HIV. So you know, aperture and other long-acting versions of HIV medication all of these things are going to mean different things for different people and communities, depending on their life circumstances. So you know someone who is already on effective treatment or on oral prep, that's going to be very different than you know in comparing with someone who might be eligible or would be benefiting from oral prep but isn't taking it for one reason or another, and that could be because of some super direct factors like cost, recognizing that PrEP is only free in some provinces where they live, and not just in terms of province, but whether or not they have convenient options to pick up their medication and where to get the regular testing that's associated with being on any PrEP regimen. But also things like their relationship status or how their sex life looks, or even things like their knowledge and their relationship with HIV.
Speaker 1:It's amazing it's going to impact so many different aspects of a person's life. In light of National HIV Testing Day, how can advancements in prevention encourage more people to get tested and engage in HIV prevention strategies?
Speaker 3:I think in a lot of ways it adds hope for people who you know have a lot of anxiety and fear when it comes to HIV. You know, for some folks this can be enough of a barrier to even seek out testing. You know, for fear of you know what to do if they test positive.
Speaker 1:Right.
Speaker 3:Yeah, I mean, I think it's important to recognize that. You know knowledge and medicine and social attitudes around HIV have improved pretty dramatically over the last 40 years. But you know, all the same, we have to recognize that there still is a lot of stigma surrounding HIV and you know, for a lot of different reasons, that fear and anxiety can impact whether or not people even seek out testing in the first place. So you know this news of having an additional tool that might actually, you know, compel more people to, you know, seek out testing.
Speaker 1:I agree with you. I think people are so afraid of you know many different medical conditions and therefore they just avoid it. You know I'm talking to people about that all the time and therefore they just avoid it. You know I'm talking to people about that all the time. You know early detection is critical. How can community organizations and healthcare providers collaborate to ensure that advancements like Apertude reach those who need it most?
Speaker 3:Well, I think it's so important that we come together in the way that we have on so many issues related to HIV and to focus on the people and the communities who are most in need. You know, in the Canadian HIV landscape, we know within our communities or who within our communities are at the margins of our efforts you know, around prevention, testing, treatment and care.
Speaker 3:You know, not just for HIV but for a lot of different health issues, you know, and that can include racialized folks, you know, people who use drugs, newcomers and refugees, people with disabilities. There are a lot of different folks that we know aren't currently being well served by the different options that are available. So you know there's different things that we need to do at different levels of this work to really have an impact and reach those who need it the most. So, you know, in community we need to make sure that we're putting out awareness campaigns to get the word out and share that. You know news about this new tool is widely shared in the communities that are most impacted, especially those where we know that the current options are not resulting in people, you know, accessing the tools that are available. For policymakers, it's really important that we ensure that they're aware of this too and that they're taking steps to ensure that, you know this tool is financially and logistically accessible.
Speaker 1:Which is amazing and it's so great. And I do think that you know healthcare providers, you know teams of healthcare providers and community organizations do need to work together to ensure that this information gets to the people who need it most. I couldn't agree with you more. What would you like our listeners to take away from our discussion about the importance of HIV awareness prevention strategies like PrEP and the role of innovations like Apertude? Michael?
Speaker 3:Yeah.
Speaker 3:So, like I said, this is an exciting new development for prevention efforts in Canada to help close the gaps in terms of who is reached and who is supported.
Speaker 3:I think it's important to mention that Apertura is not going to replace oral prep entirely, and you know the current options available.
Speaker 3:Some people are just fine with their current regimen and may have no need or interest in changing what they're doing. You know, some people don't like getting injections and may actually prefer to just stick with what they're doing, and if it works, works, you know why change it. Other folks, you know who you know, might include some people who are already on PrEP but are having difficulties with it. You know, like you and Jean-Francois spoke to, not everyone loves carrying around and having to take a pill out every day, right, and so the added convenience that's afforded with this new tool, this new approach, you know, may actually be quite attractive to those that are already on, but I think we have to recognize that not everyone is going to have the same reaction to this, and we are going to, you know, continue to use some of the other tools in our toolbox as well, and that's partly what makes this so exciting that it really expands what is possible and available to us.
Speaker 1:And I think that's such a great point. You know, we do need options for people so that they can make an informed decision. I really appreciate you coming on the podcast. Michael, thanks so much for having me. Thank you so much, and Jean-Francois, if you're still there, thank you so much for having me. Thank you so much, and jean francois, if you're still there, thank you so much as well thank you very much, it was a pleasure yeah, great work, guys.
Speaker 1:I really appreciate it and I'm certain that the communities will appreciate and health care providers will appreciate this. Uh, new approval of aptitude for pre-exposure, prophylaxis, prep as much as we all do. So thanks again. That was Jean-Francois Portin, vive Canada Medical Director, and also Michael Quagg, executive Director of CBRC, the Community-Based Research Center, and I am Maureen McGrath, and you are listening to my Health Show Podcast.