Long-acting injectable PrEP on the horizon
January 21, 2021 5:22 PM Subscribe
The first injectable treatment for HIV-infected adults has been approved in Europe, Canada, and (as of today) the US. Monthly injections of cabotegravir/rilpivirine (brand name Cabenuva) were found to be as effective as daily oral antiretrovirals at maintaining viral suppression, and injections every other month were effective too. Also, the same drug given every other month is highly effective in preventing HIV but not yet approved.
According to two parallel phase 3 studies in cisgender men and transgender women who have sex with men, and cisgender women, cabotegravir/rilpivirine is even more effective than daily oral PrEP for prevention of HIV. Interim results from the first study (HPTN 083) were announced by the US NIH and presented in more detail at the AIDS 2020 conference (video). NIH announced results from the second study (HPTN 084) in early November 2020, when all eyes were on other current events.
Not everyone wants injectable meds, but still, an exciting development for those who do. For those who prefer pills, generic Truvada is on the way in the US. It’s pricey, though there are workarounds and non-exclusive generics should drive the price down. (More on Truvada patent controversies here.)
No long-activing HIV prevention tools have been approved, but methods in testing include antibodies, implants, and intravaginal rings.
Interested in learning more about HIV research? The entire AIDS 2020 virtual conference is posted for free online. POZ magazine has approachable coverage for a general audience.
According to two parallel phase 3 studies in cisgender men and transgender women who have sex with men, and cisgender women, cabotegravir/rilpivirine is even more effective than daily oral PrEP for prevention of HIV. Interim results from the first study (HPTN 083) were announced by the US NIH and presented in more detail at the AIDS 2020 conference (video). NIH announced results from the second study (HPTN 084) in early November 2020, when all eyes were on other current events.
Not everyone wants injectable meds, but still, an exciting development for those who do. For those who prefer pills, generic Truvada is on the way in the US. It’s pricey, though there are workarounds and non-exclusive generics should drive the price down. (More on Truvada patent controversies here.)
No long-activing HIV prevention tools have been approved, but methods in testing include antibodies, implants, and intravaginal rings.
Interested in learning more about HIV research? The entire AIDS 2020 virtual conference is posted for free online. POZ magazine has approachable coverage for a general audience.
Oh, esoterrica, thank you so much for this fantastic news.
I really, really hope approval wasn't held up in the US due to politics ... although looking at the date of approval in Europe (just about a month ago), it doesn't seem like it was held up for very LONG, anyway, if in fact it was. (And I have no reason to think it was, other than the infuriating hostility of the recent administration toward science generally and anything that might be beneficial to the LGBTQ communities in particular.)
To think of the lives that can be saved, the symptoms not suffered.
And thank you SO MUCH for all the excellent background and links - especially the link to approachable coverage. What a great collection of info.
(Mods, I think the "approachable coverage" link is broken - might you fix it?)
You know, even in the midst of my vast relief at having a new, compassionate administration, I'm still hungry for good news. (It's been a REALLY long stretch of horrific news.) I so appreciate this.
Thank you, esoterrica!
posted by kristi at 7:39 PM on January 21, 2021 [2 favorites]
I really, really hope approval wasn't held up in the US due to politics ... although looking at the date of approval in Europe (just about a month ago), it doesn't seem like it was held up for very LONG, anyway, if in fact it was. (And I have no reason to think it was, other than the infuriating hostility of the recent administration toward science generally and anything that might be beneficial to the LGBTQ communities in particular.)
To think of the lives that can be saved, the symptoms not suffered.
And thank you SO MUCH for all the excellent background and links - especially the link to approachable coverage. What a great collection of info.
(Mods, I think the "approachable coverage" link is broken - might you fix it?)
You know, even in the midst of my vast relief at having a new, compassionate administration, I'm still hungry for good news. (It's been a REALLY long stretch of horrific news.) I so appreciate this.
Thank you, esoterrica!
posted by kristi at 7:39 PM on January 21, 2021 [2 favorites]
This post is such wonderful, hopeful news!
posted by corey flood at 7:58 PM on January 21, 2021
posted by corey flood at 7:58 PM on January 21, 2021
It's just amazing how far our understanding of viral infection and immunity has come in the last decade.
posted by Joe in Australia at 9:00 PM on January 21, 2021 [1 favorite]
posted by Joe in Australia at 9:00 PM on January 21, 2021 [1 favorite]
It's estimated that a >95% compliance rate is required with antiretroviral therapy in order to maintain undetectable viral loads. That means missing no more than one or two doses a month. Real world compliance is in the range of 27-80%. A long-acting injectable could have a significant impact, particularly for patients for whom compliance is a challenge. Unfortunately those tend to be the same kinds of patients that can't afford pricey new drugs.
posted by dephlogisticated at 9:02 PM on January 21, 2021 [4 favorites]
posted by dephlogisticated at 9:02 PM on January 21, 2021 [4 favorites]
A long-acting injectable could have a significant impact, particularly for patients for whom compliance is a challenge. Unfortunately those tend to be the same kinds of patients that can't afford pricey new drugs.
I'm sure I don't need to convince anyone here of this, but this is why we need universal healthcare, everywhere. Poor compliance promotes resistance, and further infections, and anything we can do to alleviate it will not only help the patients but all of us.
posted by Joe in Australia at 9:23 PM on January 21, 2021 [8 favorites]
I'm sure I don't need to convince anyone here of this, but this is why we need universal healthcare, everywhere. Poor compliance promotes resistance, and further infections, and anything we can do to alleviate it will not only help the patients but all of us.
posted by Joe in Australia at 9:23 PM on January 21, 2021 [8 favorites]
I don't think politics were involved in the timing of approval. This drug was submitted to FDA mid 2019 and FDA had concerns about manufacturing practices that the developer had to address.
It's too soon to know about pricing in the US but hopefully Viiv/GSK will have a program for discounted or free injections for people with low income or no insurance. A shot every 4-8 weeks is so much less of a burden than daily pills!
posted by esoterrica at 9:06 AM on January 22, 2021
It's too soon to know about pricing in the US but hopefully Viiv/GSK will have a program for discounted or free injections for people with low income or no insurance. A shot every 4-8 weeks is so much less of a burden than daily pills!
posted by esoterrica at 9:06 AM on January 22, 2021
ABC:
ViiV said the shot combo would cost $5,940 for an initial, higher dose and $3,960 per month afterward. The company said that is “within the range” of what one-a-day pill combos cost now. How much a patient pays depends on insurance, income and other things.
posted by Comrade_robot at 11:42 AM on January 22, 2021
ViiV said the shot combo would cost $5,940 for an initial, higher dose and $3,960 per month afterward. The company said that is “within the range” of what one-a-day pill combos cost now. How much a patient pays depends on insurance, income and other things.
posted by Comrade_robot at 11:42 AM on January 22, 2021
This is incredible news! Thank you so much for posting - I don't work in STIs anymore, but things like this blow my mind because they are going to help so many people! Thanks - you've put a smile on my face!
posted by esoteric things at 11:41 PM on January 22, 2021
posted by esoteric things at 11:41 PM on January 22, 2021
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