apretude approved by health canada: what it means for hiv high-risk populations
a new prep drug brings more options to high-risk individuals in the prevention of hiv transmission in canada.
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new hiv prep injectable approved in canada can make prevention easier.
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a new prep (pre-exposure prophylaxis) drug known as apretude and produced by viiv healthcare was recently granted health canada approval to help curb the spread of sexually acquired hiv-1 infections.
the drug works to reduce the chances of someone in a high-risk group contracting hiv by hindering the virus’ ability to copy itself and multiply within the body, essentially stopping the infection from taking hold.
the approval of the first-of-its-kind drug marks an important step toward reducing hiv transmission in canada, with the end goal of ending the hiv epidemic in the country.
prep and why it’s important
pre-exposure prophylaxis, or prep for short, is a preventative medication used by those who have more risk of hiv exposure than other groups. according to the centers for disease control and prevention, using prep can reduce a person’s chances of contracting sexually transmitted hiv by 99 per cent and hiv transmitted through injectable drug use by 74 per cent.
the medication works by blocking an enzyme that hiv uses to copy itself within the body. when this enzyme is blocked, the virus cannot replicate, therefore it cannot survive.
dr. sean rourke, a neuropsychologist and hiv specialist, sees prep for what it is: a “game-changer.” the injectable route that prep is taking, especially, opens the doors to new avenues of hiv prevention.
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“it’s actually quite practical,” dr. rourke said. “it’s like vaccinations we have to take every year now. i mean, eventually, there might be one that you just have to take for a year. i’m not in drug development, but is that possible? i think everything’s possible.”
randy davis, communication manager with the canadian aids society and hiv advocate, also sees how the potential of having options can change the way people prevent the spread of hiv.
“we have all the tools to stop new infections. this is just another amazing option that we can get into the hands of folks if there’s issues with taking a pill a day. so, if you can have the option of just getting, in this case, a single injection every two months, and you know by far the biggest side effect that we hear about from injectable medications is the injection site soreness. you know after a while it lessens and then goes away eventually,” randy said. “so, it’s a small price to pay to have that level of protection without having to worry about, ‘oh, did i remember to take my pill today?’”
the hiv epidemic in canada
cases of hiv continue to increase in canada. between 2021 and 2022, the number of new hiv infections rose by 24.9 per cent. currently, there are over 64,000 reported cases. the number of undiagnosed cases is not included in the statistics, which means that the number of canadians living with the infection could be higher than reported.
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jean-francois fortin, the country medical director for viiv healthcare, helps to ensure the safety and proper use of medication, including the new prep option. jean-francois acknowledges that the hiv epidemic, while less talked about, is still rampant across the country, and drugs like apretude can provide a fundamental change in numbers.
“it’s really (important) to emphasize that hiv is still important in canada. there’s still an epidemic ongoing,” jean-francois said. “it’s been mostly out of the news or much less than it used to be, but it’s still a very important issue across the country.”
approval of a first-of-its-kind drug
currently, two forms of prep are on the market in canada: truvada and descovy. both are available in a daily pill, meaning that people who are at risk of contracting hiv are tasked with taking their medication as prescribed, and that means every single day—or every single day for a set period, depending on their needs.
while that sounds like an easy task, not everyone lives the same lifestyle, and unfortunately, remembering to take a preventative medication every day isn’t always the reality.
jean-francois notes that not all people live the same lifestyles, so having more prep options to suit the lives of more people will further digress the growing cases of hiv in the country simply because it allows more people to fit the medication into their lives.
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“where this can make an impact is, for example, with people (who) may struggle to take their pills daily. it could also be in the case of the people that are travelling or maybe they have a hectic lifestyle also. so, it’s not to restrict the use. it’s really dependent on what’s best for people,” he said.
he continues, “it’s also, in certain cases, not everybody would be comfortable to take their pills with them all the time for various different reasons, could be cultural, familial, social, so an injection may provide for some people that reassurance, that confidentiality.”
apretude allows people to take their prep injection once every two months, giving people in high-risk groups more freedom while still keeping them and others protected against the transmission of hiv.
dr. rourke has worked with many people in the hiv space and sees how valuable something as simple as changing the way people take their prep can have on the hiv landscape in canada, especially for those who lead certain types of lifestyles or those with other health challenges.
“people who have housing instability, people who have concurrent mental health and addiction challenges, substance use where (they’re) managing another medication,” dr. rourke said. “when they don’t have a safe or stable place to sleep or to live. many of those people i think are going to benefit likely the most.”
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“people who are in life circumstances or challenging health issues where this takes the load off of them,” he continued.
accessibility for canadians at risk of hiv
the approval by health canada is only the first step in helping people gain access to apretude. accessibility to newer drugs is often difficult because there’s the added step of getting it on the formulary, which is a list of drugs that have public drug coverage for eligible populations.
randy sees the value in newer drugs being approved but knows the barriers that are often involved when getting them into the hands of the right people.
“(it’s) great that we are at the stage that it’s been approved. obviously, we need to now work on making sure that it’s on the formulary so that provinces can actually access it,” he said.
getting apretude on the formulary is so vital because when it’s on that list, people don’t have to pay as much out of pocket for the drugs. in the current economy, cost is a massive issue for most things, and in the case of apretude, it could be a deterrent if those who need it simply can’t afford it.
“we believe in canada, a fair approach in terms of pricing our product and so on,” jean-francois said. “i don’t want to state in a way a percentage or anything. we’re going in with a fair and balanced (approach).”
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the next steps for apretude involve opening the conversation with health authorities to figure out the reimbursement process so that coverage is available and canadians, regardless of their economic status, can take part in the prevention of new hiv cases.
“we’re really actually quite excited now to enter into discussions with all the provincial and territorial health authorities to go and discuss how to get the reimbursement for this drug following the regular reimbursement process,” jean-francois said.
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