9 ms·

FDA has approved Yeztugo, a drug that provides protection against HIV infection

369 points by MBCook 1y ago

gschizas 1y ago
I'm a little wary with "100% effective". Not even 99.9% effective?
- pkulak 1y ago
  Not a great title, it would seem: > provides HIV-negative individuals around 99% protection from contracting the devastating virus through sex
  - randcraw 1y ago
    Not a well written article in other ways too. What's the booster interval? What's the expected market coverage? How expensive is it, especially in poor countries where it's needed most? Are there challenges in transportation or storage that will limit its adoption? How does its efficacy as a preventative compare to its efficacy as a treatment (the reason it was approved in 2022)? Lots was left unsaid by this article. You'll note also, the sole source for the article is Gilead (mentioned at the end), the drug manufacturer.
    - freeone3000 1y ago
      These are better covered by Gilead’s actual press releases, of which this is a very poor summary. For pricing, Gilead will likely carry over its policy for Truvada, by charging fairly high rates to western countries (with vouchers available) to subsidize its operations in Africa, where it will be provided cheaply or freely. (Disclosure: I’m an investor. I truly believe that if any company can be morally good, Gilead qualifies.) https://www.gilead.com/news/news-details/2024/gileads-twice-yearly-lenacapavir-demonstrated-100-efficacy-and-superiority-to-daily-truvada-for-hiv-prevention https://www.gilead.com/news/news-details/2024/gileads-twice-... https://www.gilead.com/news/news-details/2025/gilead-finalizes-agreement-with-the-global-fund-to-accelerate-access-to-twice-yearly-lenacapavir-for-hiv-prevention-for-up-to-two-million-people-in-primarily-low--and-lower-middle-income-countries https://www.gilead.com/news/news-details/2025/gilead-finaliz... https://www.gilead.com/news/news-details/2025/gilead-receives-positive-chmp-opinions-under-accelerated-review-from-european-medicines-agency-for-twice-yearly-lenacapavir-for-hiv-prevention https://www.gilead.com/news/news-details/2025/gilead-receive...
      - haswell 1y ago
        > I truly believe that if any company can be morally good, Gilead qualifies. The primary reason Gilead exists in my memory is the headline years back about their exorbitantly high prices for a life saving hepatitis C drug and the resulting questions this was raising in congress ($84K for a 12 week supply) [0]. While it may be admirable that they are providing these drugs freely to countries in need, I’d be more hesitant to accept at face value the claim that US prices in particular are somehow reasonable on that basis. I also question the framing that those high prices are necessarily high. I’m less familiar with how they’ve priced things in recent years. - [0] https://news.ycombinator.com/item?id=7529435 https://news.ycombinator.com/item?id=7529435
        wbl 1y ago
        Do you know how much a liver transplant is? That was the alternative.
        freeone3000 1y ago
        They created a way to live with AIDS. They were the first. They did it in the 90s, where even working on this had significant stigma still. Friends are alive because of them.
  - ksherlock 1y ago
    Wikipedia says: In 2024, lenacapavir was named the "2024 Breakthrough of the Year", citing its "astonishing 100% efficacy" in one large efficacy trial in women to prevent HIV and "99.9% efficacy in gender diverse people who have sex with men," https://en.wikipedia.org/wiki/Lenacapavir https://en.wikipedia.org/wiki/Lenacapavir It's curious that the article (and wikipedia) specifically refer to sexual acquisition.
    - deleted 1y ago
      [deleted]
    - aerostable_slug 1y ago
      Wouldn't sexually active people who have sex with men be the primary market? It makes sense this would be the focus of the drug's development. They may also have issues trying to conduct robust clinical trials with IV drug abusers. If a subject entered rehab or were incarcerated for a period of the trial, would that invalidate their data? I don't know enough about the subject but it intuitively feels like it could present a real challenge.
      - pitpatagain 1y ago
        Prep has been studied for IV drug users. It works, enough that it is recommended, but is much less effective. IV drug use is a massively more efficient transmission route than any type of sexual contact.
        42772827 1y ago
        >IV drug use is a massively more efficient transmission route than any type of sexual contact. Yes, and people who take IV drugs are much less likely than men who have sex with men in general to take a pill daily.
    - kstrauser 1y ago
      Asking here instead of searching, for conversational purposes: In the 90s, some STD training I took said it was highly unlikely for otherwise healthy bio women to contract HIV from a man (ie compared to sex trafficked women in poor health), with the claim that vaginal sex is less susceptible to micro tearing that allows easy transmission than anal sex is. I didn’t really question this at the time because it seemed plausible and I believed the people who were telling us this. (Note: this was in a medical context, not someone trying to scare us.) Is there any credibility to that idea now that we have more data, and hopefully leased biased science than we had in the 80s?
  - deleted 1y ago
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bapak 1y ago
For those wondering, it's two injections a year compared to the daily PrEP pill.
- cosmotic 1y ago
  There's also an existing option of a 6 times a year injection
ldoughty 1y ago
"Lies, ** lies, and statistics" There was one study that saw 0 participants who contracted HIV during the trial according to the data on the FDA PDF [0]. Was 2,000 participants in Africa who were identified as potentially at risk, aged 16-25. > YEZTUGO demonstrated superiority with a 100% reduction in the risk of incident HIV-1 infection over TRUVADA (Table 13). ~2,000 given YEZTUGO with 0 infections by the end. ~1,000 given TRUVADA with 16 infections by the end. Now, this is a great study result if accurate. Substantially better. However, 100% protection is misleading clickbait article. The company does not claim to be 100% effective anywhere I can see... and at best they lifted this statement from this study to use as clickbait. 0: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220020s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/22...
- dr_test 1y ago
  Yeah, it's not 100% protection in all studies. One study did have no participants contract aids which is fantastic and would be one data point for 100% prevention. Another had 2 participants contract HIV out of about 2000 "Person-years". This was compared to another HIV treatment where 9 people contracted HIV (with only 1k "person-years" in that cohort). This equated to 89% reduction in HIV contraction compared to the other PrEP drug. And that IS a fantastic result and if everyone could take this we'd probably be in a great spot HIV wise. ~90% improvement over current PrEP is great, and it's way easier to take and not mess up. [1] https://www.askgileadmedical.com/len4prep/understanding/#studies https://www.askgileadmedical.com/len4prep/understanding/#stu...
  - pitpatagain 1y ago
    I think it's pretty clear that being easier to take and not mess up is the reason for the difference in statistical effectiveness. The reason for lower numbers for effectiveness of daily oral Truvada prep is primarily measuring differences in adherence.
    - Ericson2314 1y ago
      Just so where clear, from a public health as opposed to basic science standpoint, that's a distinction without a difference. people magically get more vigilant is as leakly as virus magically goes away on its own.
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nerdjon 1y ago
First, on the article itself. That title is just misleading clickbait. In the same article we go from: > The first 100% effective HIV prevention drug is approved and going global to a couple paragaphs in: > sold under the brand name Yeztugo – a class of drugs known as capsid inhibitors, which provide almost 100% protection against HIV infection To a little bit later: > The pre-exposure prophylaxis (PrEP) provides HIV-negative individuals around 99% protection from contracting the devastating virus through sex. So... that is terrible writing about a topic like this. From what I have seen there is no difference in effectiveness of this drug compared to the pills we already have if you actually take them properly. I would love to be proven wrong, but this seems basically the same efficacy numbers we see for truvada and descovy. That doesnt mean it is not still valuable, properly taking the pill every day is a huge component of that. I know I plan on looking at the shot personally. But the reporting on this article is extremely shady.
- cguess 1y ago
  The difference is it's twice a year injection, not daily or monthly pills. For many at-risk populations (unhoused, people living in the rural developing world) taking a pill once a day, or even monthly, much less making you can refill your prescription is insanely difficult.
  - duskwuff 1y ago
    There's an ugly social aspect to it, too. In South Africa, for a woman who is in a relationship to take PrEP is often seen as an admission of her infidelity. https://www.researchgate.net/publication/262227835_Concerns_about_partner_infidelity_are_a_barrier_to_adoption_of_HIV-prevention_strategies_among_young_South_African_couples https://www.researchgate.net/publication/262227835_Concerns_...
- croemer 1y ago
  Yeah, terrible article. This one should be the link target instead: https://www.nbcnews.com/news/amp/rcna208387 https://www.nbcnews.com/news/amp/rcna208387
sheepscreek 1y ago
All aside from the healthy criticism on the clickbait title, I found the approach to make it royalty-free (presumably for generic production) and free of cost access to uninsured individuals incredibly fascinating. How will they manage to cover R&D costs? That’s the primary reason pharmaceutical companies use to justify exorbitant drug prices. Was this a result of a philanthropic endeavor?
- 42772827 1y ago
  They bill the insurance companies a lot, plus they take public and private (i.e., government and Gates Foundation) investment.
  - erikig 1y ago
    A quick online search revealed that the HIV prevention drug Yeztugo (lenacapavir), is priced at $28,218 per year in the US. This translates to $14,109 per injection, as it is administered twice a year. I wonder what this will look like worldwide, especially in countries where this is needed the most, once production ramps up.
    - spjt 1y ago
      Would be nice if I could just directly get paid $28K/year to not have sex.
    - dfadsadsf 1y ago
      In practical terms it means public subsidizing gay lifestyle in US by 28k/year - it’s the only demographic outside of sex workers for whom this drug make sense and will be routinely offered. It’s just not sustainable.
- pavlov 1y ago
  Here’s a detailed account of the development spanning over thirty years: https://www.aaas.org/news/road-lenacapavir-breakthrough-hiv-treatment https://www.aaas.org/news/road-lenacapavir-breakthrough-hiv-... Seems to be a combination of university funding (University of Utah), big pharma (Gilead), and global HIV advocacy groups working together. Sadly this kind of university research and non-profit advocacy groups are both prime targets of the Trump administration’s funding cuts. The next breakthrough drugs may have to be developed in some other country.
octo888 1y ago
A twice-yearly injection with the same efficacy as daily PrEP is a fantastic development
pqdbr 1y ago
What is the target audience for these bi-anual shots? Only populations at high risk or are we supposed to start vaccinating everyone that is sexually active? Btw, nothing on the article about potential side effects.
- 42772827 1y ago
  >What is the target audience for these bi-annual shots? In the US, there are certain patients who are at high risk for HIV infection. They are men who have sex with men, intravenous drug users, and people who have sex for money or housing. In Southern Africa, young women experience some of the highest incidence rates of HIV infection in the world [0], so that would be the high risk population there. In terms of side effects, there are practically none for the once-every-two-months drug Apretude, which is prescribed in the US for the high risk population I mentioned. They are mostly around the physical injection itself/ [0]https://pmc.ncbi.nlm.nih.gov/articles/PMC4430426/ https://pmc.ncbi.nlm.nih.gov/articles/PMC4430426/
- okaram 1y ago
  That would be up to individuals or health departments, who decide what risk is high enough. The risk for non-promiscuous people in 'western' countries is so low, that I don't see any country giving this to everybody. This is not a vaccine, BTW, and it needs to be given every 6 months.
rendleflag 1y ago
What's to prevent HIV from evolving past the protection? Strains of gonorrhea (a bacteria) has evolved to get around antibiotics. Won't that happen with HIV? Or is a virus not able to adapt?
- tonyhart7 1y ago
  same like always, we develop a better antibiotics???
- jerojero 1y ago
  It depends on the drug but generally the principle is trying to target a part of the virus that is so fundamental to its structure that it simply cannot adapt to function without it. The redundancy on a bacteria is degrees higher than on viruses which are extremely efficient so they're more prepared to survive if that were to happen. But it also depends on the way you're doing the drug. That doesn't mean virus can't adapt, they do. But if you manage to hit the right pieces it might just not be possible for them to do so fast enough. Obviously finding that particular protein and figuring out a mechanism to target it while at the same time for your drug not to have undesirable side effects on the host is an expensive, long and difficult process. For this drug in particular, it doesn't function the same way PrEP does; this targets a different protein which previously was thought to be too difficult to target but new research on it showed that perhaps there was an easier way to do it and that's how this drug (lenacapavir) came to be. However that was not the end of the story as there was also a problem on how to actually deliver the drug to the cells as the drug is relatively insoluble and isn't easily absorbed by the body so although the drug was promising when it comes to affecting the virus it didn't seem to be possible to develop a drug that could be deliverable to people. Eventually though they did figure this part out and that's how we got where we are. But generally, to answer your question, finding the right molecule to target; a right way to target it and a right way to deliver it is really the problem when it comes to drug development, being so targeted and specific makes it extremely unlikely for the virus to develop a resistance because it would mean it has to become a whole new virus basically.
- yieldcrv 1y ago
  the war on retroviruses is based on taking new approaches that aren't limited by this issue, while also slowing down existing infection long enough for your natural immune system to deal with what's there. correct that it isn't over because of this potential, but the way this one works is by targeting the capsid the body's immune system goes after infected cells based on the coating and signature of those cells. HIV and retroviruses replicate far too quickly for our immune system to follow along, as well as experiencing rapid selective evolution within our body that eventually in nearly all scenarios results in complete immune deficiency, where the body no longer recognizes the cells as infected because they both blend in, while another population has exhausted the immune function as the body continues to fight too many infected cells. This is the AIDS part of HIV. The iteration takes a predictable amount of time to occur, but they are convergent evolutions in everyone's body. by targeting the capsid specifically, this is destroying the container for HIV's RNA before it gets to a cell at all this should be an evolutionary dead end, only controversial to say because its been 44 years of this, but should gain confidence in the future
inasio 1y ago
Beyond efficacy, having a drug that only needs to be taken twice per year is a huge deal. Adherence is critical for treatments to succeed, and it's much easier to ensure that patients are on their meds twice per year. It's also much safer for vulnerable people, where getting caught with HIV medications (say daily pills) could be dangerous
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smsm42 1y ago
That sounds great, but the "100%" part makes me worry. I don't know a lot of 100% effective medicines, there are always corner cases, and if they are claiming there aren't they are either exceptionally awesome, or lying. The experience teaches me liars are more common that exceptional awesomeness...
thighbaugh 1y ago
Given that sugar pills still have a curative effect on some portion of patients and that 100% effective sounds pretty unscientific as a figure (nothing is 100% hence the need to use statistical confidence). I pray that I am wrong in smelling something being rotten in this lot but only time will tell.
jl34tz 1y ago
[dead]
magicloop 1y ago
In terms of difficulty was the HIV drug harder to develop than the COVID vaccine? If so, how much harder? The resolution of the AIDS epidemic, granted the logistics and targeting now needed, is such a brilliant milestone.
raylad 1y ago
The problem with this drug is that it inhibits one of the final stages in viral replication. This means that before it can work the virus has already infected the cell and added its RNA to the host cells DNA permanently. So if a patient is exposed to HIV while on the drug, this will not prevent their cells from being infected with the virus. The infected cells will not subsequently create any virus, and therefore additional cells will not be infected, however nothing prevents actual exogenous HIV from infecting cells while on this drug. That means that if someone discontinues the drug, cells that have been infected with HIV during the time they were on the drug can start producing it causing AIDS. It’s great that there’s a drug that works as well as this for chronic use, but nobody should think that it’s actually preventing infection. It’s allowing infection but inhibiting viral replication post infection.
- amluto 1y ago
  This sounds like a sort of plausible mechanism, but do you have any actual evidence that this occurs in real life? I admit that I’ve wondered whether the PrEP studies with lenacapavir actually measure what they thing they measure given that the same lenacapavir may prevent HIV from replicating enough to be detectable. That being said, Wikipedia doesn’t really agree with your mechanism. See: https://en.m.wikipedia.org/wiki/HIV_capsid_inhibition https://en.m.wikipedia.org/wiki/HIV_capsid_inhibition It seems that the drug may inhibit disassembly of the capsid.
  - brianleb 1y ago
    Agree that it sounds 'close to correct.' I think, though, that the underlying assumption is that the old virus hangs out, forever waiting for the moment to strike. Cells senesce and die and get replaced, and the immune system is always active in the background. If the virus particles are released, the immune system is going after it and cleaning up. As essentially no new virus is being created, this is the body's opportunity to clear the virus at a slower, manageable pace where it doesn't have to contend with a rapid, expanding infection. It feels like one of those ideas that's technically true in all the right ways, but misses one crucial piece that would make the whole thing accurate.
qgin 1y ago
Yeztugo Yes, (ready) to go I would love to sit in on branding meetings for pharmaceuticals.
- amadeusw 1y ago
  I appreciate your insight, the first association that came to my mind was a generic brand name on Amazon
croemer 1y ago
The drug's name sounds like "Yes to go", most certainly not a coincidence
yieldcrv 1y ago
Unless low-risk people are getting shots twice a year too, I don't see this as reaching the goals that are as monumental as the article and Gilead suggests. Sure, vaccinating high risk sexually active preteens in regions of Africa will dramatically reduce infection in ways that have been insurmountable to those on the frontlines. But for everyone else, this doesn't seem to materially change anything. A sexually active adult or accidental/intentional polycule in western nations has no change in user experience. The risk remains both low and essentially the same. Test often if you are in "sex-positive" communities where testing and sharing results isn't taboo. Or do nothing and just imagine you're being responsible. Its the same as before. PreP users can switch to a 2x yearly regime instead of the current frequency, but that's only for people with partners already. I just don't see this as good enough unless it turns into like a one time vaccination, done as part of a cocktail in a normal routine checkup.
- deleted 1y ago
  [deleted]
throwawaylaptop 1y ago
Should we mandate that all school children take this? Maybe make it a requirement for employment? I'm sure there's negative side effects, but all vaccines and drugs have that. If we did, we could end a lot of suffering in a decade or two for many at risk people.
thehappypm 1y ago
Sidebar but HIV has led to some really amazing antiviral research. I really hope that this research will be helpful during the next pandemic. That’s a silver lining for a truly horrible disease.
- Ey7NFZ3P0nzAe 1y ago
  Can't source but I've heard that the study of virus really only took off after HIV started, so most papers on viruses are actually about HIV. Could be wrong though
  - dekhn 1y ago
    You're wrong (at least on the first half of your first sentence; I am not sure about the second half).
    - Ey7NFZ3P0nzAe 1y ago
      Maybe funding viruses took off only after aids started.

369 points by MBCook 1y ago

gschizas 1y ago

I'm a little wary with "100% effective". Not even 99.9% effective?

pkulak 1y ago
Not a great title, it would seem: > provides HIV-negative individuals around 99% protection from contracting the devastating virus through sex
- randcraw 1y ago
  Not a well written article in other ways too. What's the booster interval? What's the expected market coverage? How expensive is it, especially in poor countries where it's needed most? Are there challenges in transportation or storage that will limit its adoption? How does its efficacy as a preventative compare to its efficacy as a treatment (the reason it was approved in 2022)? Lots was left unsaid by this article. You'll note also, the sole source for the article is Gilead (mentioned at the end), the drug manufacturer.
  - freeone3000 1y ago
    These are better covered by Gilead’s actual press releases, of which this is a very poor summary. For pricing, Gilead will likely carry over its policy for Truvada, by charging fairly high rates to western countries (with vouchers available) to subsidize its operations in Africa, where it will be provided cheaply or freely. (Disclosure: I’m an investor. I truly believe that if any company can be morally good, Gilead qualifies.) https://www.gilead.com/news/news-details/2024/gileads-twice-yearly-lenacapavir-demonstrated-100-efficacy-and-superiority-to-daily-truvada-for-hiv-prevention https://www.gilead.com/news/news-details/2024/gileads-twice-... https://www.gilead.com/news/news-details/2025/gilead-finalizes-agreement-with-the-global-fund-to-accelerate-access-to-twice-yearly-lenacapavir-for-hiv-prevention-for-up-to-two-million-people-in-primarily-low--and-lower-middle-income-countries https://www.gilead.com/news/news-details/2025/gilead-finaliz... https://www.gilead.com/news/news-details/2025/gilead-receives-positive-chmp-opinions-under-accelerated-review-from-european-medicines-agency-for-twice-yearly-lenacapavir-for-hiv-prevention https://www.gilead.com/news/news-details/2025/gilead-receive...
    - haswell 1y ago
      > I truly believe that if any company can be morally good, Gilead qualifies. The primary reason Gilead exists in my memory is the headline years back about their exorbitantly high prices for a life saving hepatitis C drug and the resulting questions this was raising in congress ($84K for a 12 week supply) [0]. While it may be admirable that they are providing these drugs freely to countries in need, I’d be more hesitant to accept at face value the claim that US prices in particular are somehow reasonable on that basis. I also question the framing that those high prices are necessarily high. I’m less familiar with how they’ve priced things in recent years. - [0] https://news.ycombinator.com/item?id=7529435 https://news.ycombinator.com/item?id=7529435
      - wbl 1y ago
        Do you know how much a liver transplant is? That was the alternative.
      - freeone3000 1y ago
        They created a way to live with AIDS. They were the first. They did it in the 90s, where even working on this had significant stigma still. Friends are alive because of them.
- ksherlock 1y ago
  Wikipedia says: In 2024, lenacapavir was named the "2024 Breakthrough of the Year", citing its "astonishing 100% efficacy" in one large efficacy trial in women to prevent HIV and "99.9% efficacy in gender diverse people who have sex with men," https://en.wikipedia.org/wiki/Lenacapavir https://en.wikipedia.org/wiki/Lenacapavir It's curious that the article (and wikipedia) specifically refer to sexual acquisition.
  - deleted 1y ago
    [deleted]
  - aerostable_slug 1y ago
    Wouldn't sexually active people who have sex with men be the primary market? It makes sense this would be the focus of the drug's development. They may also have issues trying to conduct robust clinical trials with IV drug abusers. If a subject entered rehab or were incarcerated for a period of the trial, would that invalidate their data? I don't know enough about the subject but it intuitively feels like it could present a real challenge.
    - pitpatagain 1y ago
      Prep has been studied for IV drug users. It works, enough that it is recommended, but is much less effective. IV drug use is a massively more efficient transmission route than any type of sexual contact.
      - 42772827 1y ago
        >IV drug use is a massively more efficient transmission route than any type of sexual contact. Yes, and people who take IV drugs are much less likely than men who have sex with men in general to take a pill daily.
  - kstrauser 1y ago
    Asking here instead of searching, for conversational purposes: In the 90s, some STD training I took said it was highly unlikely for otherwise healthy bio women to contract HIV from a man (ie compared to sex trafficked women in poor health), with the claim that vaginal sex is less susceptible to micro tearing that allows easy transmission than anal sex is. I didn’t really question this at the time because it seemed plausible and I believed the people who were telling us this. (Note: this was in a medical context, not someone trying to scare us.) Is there any credibility to that idea now that we have more data, and hopefully leased biased science than we had in the 80s?
- deleted 1y ago
  [deleted]

bapak 1y ago

For those wondering, it's two injections a year compared to the daily PrEP pill.

cosmotic 1y ago
There's also an existing option of a 6 times a year injection

ldoughty 1y ago

"Lies, ** lies, and statistics" There was one study that saw 0 participants who contracted HIV during the trial according to the data on the FDA PDF [0]. Was 2,000 participants in Africa who were identified as potentially at risk, aged 16-25. > YEZTUGO demonstrated superiority with a 100% reduction in the risk of incident HIV-1 infection over TRUVADA (Table 13). ~2,000 given YEZTUGO with 0 infections by the end. ~1,000 given TRUVADA with 16 infections by the end. Now, this is a great study result if accurate. Substantially better. However, 100% protection is misleading clickbait article. The company does not claim to be 100% effective anywhere I can see... and at best they lifted this statement from this study to use as clickbait. 0: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220020s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/22...

dr_test 1y ago
Yeah, it's not 100% protection in all studies. One study did have no participants contract aids which is fantastic and would be one data point for 100% prevention. Another had 2 participants contract HIV out of about 2000 "Person-years". This was compared to another HIV treatment where 9 people contracted HIV (with only 1k "person-years" in that cohort). This equated to 89% reduction in HIV contraction compared to the other PrEP drug. And that IS a fantastic result and if everyone could take this we'd probably be in a great spot HIV wise. ~90% improvement over current PrEP is great, and it's way easier to take and not mess up. [1] https://www.askgileadmedical.com/len4prep/understanding/#studies https://www.askgileadmedical.com/len4prep/understanding/#stu...
- pitpatagain 1y ago
  I think it's pretty clear that being easier to take and not mess up is the reason for the difference in statistical effectiveness. The reason for lower numbers for effectiveness of daily oral Truvada prep is primarily measuring differences in adherence.
  - Ericson2314 1y ago
    Just so where clear, from a public health as opposed to basic science standpoint, that's a distinction without a difference. people magically get more vigilant is as leakly as virus magically goes away on its own.

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[deleted]

nerdjon 1y ago

First, on the article itself. That title is just misleading clickbait. In the same article we go from: > The first 100% effective HIV prevention drug is approved and going global to a couple paragaphs in: > sold under the brand name Yeztugo – a class of drugs known as capsid inhibitors, which provide almost 100% protection against HIV infection To a little bit later: > The pre-exposure prophylaxis (PrEP) provides HIV-negative individuals around 99% protection from contracting the devastating virus through sex. So... that is terrible writing about a topic like this. From what I have seen there is no difference in effectiveness of this drug compared to the pills we already have if you actually take them properly. I would love to be proven wrong, but this seems basically the same efficacy numbers we see for truvada and descovy. That doesnt mean it is not still valuable, properly taking the pill every day is a huge component of that. I know I plan on looking at the shot personally. But the reporting on this article is extremely shady.

cguess 1y ago
The difference is it's twice a year injection, not daily or monthly pills. For many at-risk populations (unhoused, people living in the rural developing world) taking a pill once a day, or even monthly, much less making you can refill your prescription is insanely difficult.
- duskwuff 1y ago
  There's an ugly social aspect to it, too. In South Africa, for a woman who is in a relationship to take PrEP is often seen as an admission of her infidelity. https://www.researchgate.net/publication/262227835_Concerns_about_partner_infidelity_are_a_barrier_to_adoption_of_HIV-prevention_strategies_among_young_South_African_couples https://www.researchgate.net/publication/262227835_Concerns_...
croemer 1y ago
Yeah, terrible article. This one should be the link target instead: https://www.nbcnews.com/news/amp/rcna208387 https://www.nbcnews.com/news/amp/rcna208387

sheepscreek 1y ago

All aside from the healthy criticism on the clickbait title, I found the approach to make it royalty-free (presumably for generic production) and free of cost access to uninsured individuals incredibly fascinating. How will they manage to cover R&D costs? That’s the primary reason pharmaceutical companies use to justify exorbitant drug prices. Was this a result of a philanthropic endeavor?

42772827 1y ago
They bill the insurance companies a lot, plus they take public and private (i.e., government and Gates Foundation) investment.
- erikig 1y ago
  A quick online search revealed that the HIV prevention drug Yeztugo (lenacapavir), is priced at $28,218 per year in the US. This translates to $14,109 per injection, as it is administered twice a year. I wonder what this will look like worldwide, especially in countries where this is needed the most, once production ramps up.
  - spjt 1y ago
    Would be nice if I could just directly get paid $28K/year to not have sex.
  - dfadsadsf 1y ago
    In practical terms it means public subsidizing gay lifestyle in US by 28k/year - it’s the only demographic outside of sex workers for whom this drug make sense and will be routinely offered. It’s just not sustainable.
pavlov 1y ago
Here’s a detailed account of the development spanning over thirty years: https://www.aaas.org/news/road-lenacapavir-breakthrough-hiv-treatment https://www.aaas.org/news/road-lenacapavir-breakthrough-hiv-... Seems to be a combination of university funding (University of Utah), big pharma (Gilead), and global HIV advocacy groups working together. Sadly this kind of university research and non-profit advocacy groups are both prime targets of the Trump administration’s funding cuts. The next breakthrough drugs may have to be developed in some other country.

octo888 1y ago

A twice-yearly injection with the same efficacy as daily PrEP is a fantastic development

pqdbr 1y ago

What is the target audience for these bi-anual shots? Only populations at high risk or are we supposed to start vaccinating everyone that is sexually active? Btw, nothing on the article about potential side effects.

42772827 1y ago
>What is the target audience for these bi-annual shots? In the US, there are certain patients who are at high risk for HIV infection. They are men who have sex with men, intravenous drug users, and people who have sex for money or housing. In Southern Africa, young women experience some of the highest incidence rates of HIV infection in the world [0], so that would be the high risk population there. In terms of side effects, there are practically none for the once-every-two-months drug Apretude, which is prescribed in the US for the high risk population I mentioned. They are mostly around the physical injection itself/ [0]https://pmc.ncbi.nlm.nih.gov/articles/PMC4430426/ https://pmc.ncbi.nlm.nih.gov/articles/PMC4430426/
okaram 1y ago
That would be up to individuals or health departments, who decide what risk is high enough. The risk for non-promiscuous people in 'western' countries is so low, that I don't see any country giving this to everybody. This is not a vaccine, BTW, and it needs to be given every 6 months.

rendleflag 1y ago

What's to prevent HIV from evolving past the protection? Strains of gonorrhea (a bacteria) has evolved to get around antibiotics. Won't that happen with HIV? Or is a virus not able to adapt?

tonyhart7 1y ago
same like always, we develop a better antibiotics???
jerojero 1y ago
It depends on the drug but generally the principle is trying to target a part of the virus that is so fundamental to its structure that it simply cannot adapt to function without it. The redundancy on a bacteria is degrees higher than on viruses which are extremely efficient so they're more prepared to survive if that were to happen. But it also depends on the way you're doing the drug. That doesn't mean virus can't adapt, they do. But if you manage to hit the right pieces it might just not be possible for them to do so fast enough. Obviously finding that particular protein and figuring out a mechanism to target it while at the same time for your drug not to have undesirable side effects on the host is an expensive, long and difficult process. For this drug in particular, it doesn't function the same way PrEP does; this targets a different protein which previously was thought to be too difficult to target but new research on it showed that perhaps there was an easier way to do it and that's how this drug (lenacapavir) came to be. However that was not the end of the story as there was also a problem on how to actually deliver the drug to the cells as the drug is relatively insoluble and isn't easily absorbed by the body so although the drug was promising when it comes to affecting the virus it didn't seem to be possible to develop a drug that could be deliverable to people. Eventually though they did figure this part out and that's how we got where we are. But generally, to answer your question, finding the right molecule to target; a right way to target it and a right way to deliver it is really the problem when it comes to drug development, being so targeted and specific makes it extremely unlikely for the virus to develop a resistance because it would mean it has to become a whole new virus basically.
yieldcrv 1y ago
the war on retroviruses is based on taking new approaches that aren't limited by this issue, while also slowing down existing infection long enough for your natural immune system to deal with what's there. correct that it isn't over because of this potential, but the way this one works is by targeting the capsid the body's immune system goes after infected cells based on the coating and signature of those cells. HIV and retroviruses replicate far too quickly for our immune system to follow along, as well as experiencing rapid selective evolution within our body that eventually in nearly all scenarios results in complete immune deficiency, where the body no longer recognizes the cells as infected because they both blend in, while another population has exhausted the immune function as the body continues to fight too many infected cells. This is the AIDS part of HIV. The iteration takes a predictable amount of time to occur, but they are convergent evolutions in everyone's body. by targeting the capsid specifically, this is destroying the container for HIV's RNA before it gets to a cell at all this should be an evolutionary dead end, only controversial to say because its been 44 years of this, but should gain confidence in the future

inasio 1y ago

Beyond efficacy, having a drug that only needs to be taken twice per year is a huge deal. Adherence is critical for treatments to succeed, and it's much easier to ensure that patients are on their meds twice per year. It's also much safer for vulnerable people, where getting caught with HIV medications (say daily pills) could be dangerous

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smsm42 1y ago

That sounds great, but the "100%" part makes me worry. I don't know a lot of 100% effective medicines, there are always corner cases, and if they are claiming there aren't they are either exceptionally awesome, or lying. The experience teaches me liars are more common that exceptional awesomeness...

thighbaugh 1y ago

Given that sugar pills still have a curative effect on some portion of patients and that 100% effective sounds pretty unscientific as a figure (nothing is 100% hence the need to use statistical confidence). I pray that I am wrong in smelling something being rotten in this lot but only time will tell.

jl34tz 1y ago

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magicloop 1y ago

In terms of difficulty was the HIV drug harder to develop than the COVID vaccine? If so, how much harder? The resolution of the AIDS epidemic, granted the logistics and targeting now needed, is such a brilliant milestone.

raylad 1y ago

The problem with this drug is that it inhibits one of the final stages in viral replication. This means that before it can work the virus has already infected the cell and added its RNA to the host cells DNA permanently. So if a patient is exposed to HIV while on the drug, this will not prevent their cells from being infected with the virus. The infected cells will not subsequently create any virus, and therefore additional cells will not be infected, however nothing prevents actual exogenous HIV from infecting cells while on this drug. That means that if someone discontinues the drug, cells that have been infected with HIV during the time they were on the drug can start producing it causing AIDS. It’s great that there’s a drug that works as well as this for chronic use, but nobody should think that it’s actually preventing infection. It’s allowing infection but inhibiting viral replication post infection.

amluto 1y ago
This sounds like a sort of plausible mechanism, but do you have any actual evidence that this occurs in real life? I admit that I’ve wondered whether the PrEP studies with lenacapavir actually measure what they thing they measure given that the same lenacapavir may prevent HIV from replicating enough to be detectable. That being said, Wikipedia doesn’t really agree with your mechanism. See: https://en.m.wikipedia.org/wiki/HIV_capsid_inhibition https://en.m.wikipedia.org/wiki/HIV_capsid_inhibition It seems that the drug may inhibit disassembly of the capsid.
- brianleb 1y ago
  Agree that it sounds 'close to correct.' I think, though, that the underlying assumption is that the old virus hangs out, forever waiting for the moment to strike. Cells senesce and die and get replaced, and the immune system is always active in the background. If the virus particles are released, the immune system is going after it and cleaning up. As essentially no new virus is being created, this is the body's opportunity to clear the virus at a slower, manageable pace where it doesn't have to contend with a rapid, expanding infection. It feels like one of those ideas that's technically true in all the right ways, but misses one crucial piece that would make the whole thing accurate.

qgin 1y ago

Yeztugo Yes, (ready) to go I would love to sit in on branding meetings for pharmaceuticals.

amadeusw 1y ago
I appreciate your insight, the first association that came to my mind was a generic brand name on Amazon

croemer 1y ago

The drug's name sounds like "Yes to go", most certainly not a coincidence

yieldcrv 1y ago

Unless low-risk people are getting shots twice a year too, I don't see this as reaching the goals that are as monumental as the article and Gilead suggests. Sure, vaccinating high risk sexually active preteens in regions of Africa will dramatically reduce infection in ways that have been insurmountable to those on the frontlines. But for everyone else, this doesn't seem to materially change anything. A sexually active adult or accidental/intentional polycule in western nations has no change in user experience. The risk remains both low and essentially the same. Test often if you are in "sex-positive" communities where testing and sharing results isn't taboo. Or do nothing and just imagine you're being responsible. Its the same as before. PreP users can switch to a 2x yearly regime instead of the current frequency, but that's only for people with partners already. I just don't see this as good enough unless it turns into like a one time vaccination, done as part of a cocktail in a normal routine checkup.

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throwawaylaptop 1y ago

Should we mandate that all school children take this? Maybe make it a requirement for employment? I'm sure there's negative side effects, but all vaccines and drugs have that. If we did, we could end a lot of suffering in a decade or two for many at risk people.

thehappypm 1y ago

Sidebar but HIV has led to some really amazing antiviral research. I really hope that this research will be helpful during the next pandemic. That’s a silver lining for a truly horrible disease.

Ey7NFZ3P0nzAe 1y ago
Can't source but I've heard that the study of virus really only took off after HIV started, so most papers on viruses are actually about HIV. Could be wrong though
- dekhn 1y ago
  You're wrong (at least on the first half of your first sentence; I am not sure about the second half).
  - Ey7NFZ3P0nzAe 1y ago
    Maybe funding viruses took off only after aids started.