FDA has approved Yeztugo, a drug that provides protection against HIV infection
143 comments
·July 28, 2025sheepscreek
philipkglass
It was developed by Gilead Sciences, Inc. The way they can afford to make it cheap for people who can't pay is by charging high prices for insured Americans. You can see this with their earlier developed treatment for hepatitis C:
https://en.wikipedia.org/wiki/Gilead_Sciences#Pricing
Gilead came under intense criticism for its high pricing of its patented drug sofosbuvir (sold under the brand name Sovaldi), used to treat hepatitis C. In the US, for instance, it was launched at $1,000 per pill or $84,000 for the standard 84-day course, but it was drastically cheaper in the developing world; in India, it dropped as low as $4.29 per pill.
Low priced HIV drugs for the poor is part PR and part pragmatism. Poor people can't pay the sorts of drug prices that insured Americans do, and poor countries aren't going to enforce drug patents purely for the benefit of American corporations, e.g.:
https://en.wikipedia.org/wiki/Medicines_and_Related_Substanc...
Gilead looks gracious by preemptively embracing the situation that was going to occur anyway (poor patients aren't going to pay high prices).
oldandboring
> The way they can afford to make it cheap for people who can't pay is by charging high prices for insured Americans
This is a hugely underappreciated aspect of why the cost of health care, including insurance premiums, is so high in the US. Well-meaning folks have called for decades for the US to transition to single-payer, citing the overall lower cost experienced in other countries as a primary motivator. Meanwhile, US companies remain the global leaders in the development of pharmaceuticals and medical equipment. That development is often subsidized by US taxpayers and the remainder is largely recovered from US patients because the single-payer systems in other countries often impose price controls that largely don't exist in the US.
(This is not meant to argue against single-payer in the US. All things being equal, a single-payer system would likely solve many more problems than it would cause. I'm just pointing out what many before me already have about how Americans disproportionately subsidize the development of the healthcare the rest of the world benefits from).
heavyset_go
> Meanwhile, US companies remain the global leaders in the development of pharmaceuticals and medical equipment. That development is often subsidized by US taxpayers and the remainder is largely recovered from US patients because the single-payer systems in other countries often impose price controls that largely don't exist in the US.
From the first link in the OP you're replying to:
> The United States Senate Committee on Finance launched an 18-month investigation of Gilead's Sovaldi pricing, and argued in its 2015 report that Gilead set prices high in disregard of the human cost and in order to set the stage for a higher eventual price for Sovaldi's successor, Harvoni. The committee's investigation, based in part on internal documents obtained from Gilead, revealed that the company had considered prices ranging from $50,000 to $115,000 per year, trying to strike a balance between revenue and predicted activist and public relations blowback, with little regard to research and development costs.
The pricing was found to be intentionally divorced from R&D costs. They are charging as much as they can because they can, not because of R&D.
jonahhorowitz
As long as they spend so much on marketing, it's hard to believe them when they say the only way they can recoup their R&D investments is to charge high prices.
- *For many large pharmaceutical companies ("Big Pharma"), marketing costs often exceed R&D spending.* In analyses of the top 10 drugmakers by revenue in 2020, 7 companies spent more on sales and marketing than on research and development. For example, Johnson & Johnson spent $22 billion on marketing compared to $12 billion on R&D; Bayer spent $18 billion on marketing vs. $8 billion on R&D[1][2].
- The combined marketing spend for these top 10 companies exceeded R&D by $36 billion (about 37%) in 2020[1][2].
[1] https://www.ahip.org/news/articles/new-study-in-the-midst-of... [2] https://www.csrxp.org/icymi-new-study-finds-big-pharma-spent...
skissane
> Meanwhile, US companies remain the global leaders in the development of pharmaceuticals and medical equipment
No denying the US plays a huge role in the global pharmaceutical industry - but Europe does too - semaglutide (Ozempic/Rybelsus/Wegovy) was developed by Novo Nordisk, headquartered in Denmark.
The popular ADHD drug lisdexamfetamine (Vyvanse/Elvanse) was developed by a US-based research team, but they ended up being acquired by a British pharmaceutical company (Shire), which in turn was acquired by a Japanese company (Takeda), who owned the patents (which expired last year or the year before, depending on country), and remain one of the major manufacturers of it.
If you want a career in drug development, there are huge opportunities in the EU and Switzerland; by no means are you limited to the US. As usual, in the US you will almost certainly get paid more, but some people find the social setting of Europe more to their liking, and view that as a compensating advantage which makes up for lower pay.
CommenterPerson
What are the development costs for Insulin, discovered 100 years ago? Americans overpay not to subsidize others but because Pharma Bros.
LargeWu
I think there's a case to be made for incentive programs for development of key drugs, akin to the way Operation Warp Speed operated for the COVID vaccines. Provide up-front cash for initial research and large guaranteed returns if a drug is approved; in exchange, the drugs become public domain.
Or, just fund government research endeavors with no profit motive. If we can have a JPL for aerospace engineering, why not for pharmaceuticals?
cycomanic
> Meanwhile, US companies remain the global leaders in the development of pharmaceuticals and medical equipment. That development is often subsidized by US taxpayers and the remainder is largely recovered from US patients because the single-payer systems in other countries often impose price controls that largely don't exist in the US.
Citation needed. The US is neither dominating the list of big pharma (see e.g. Novartis, Roche, Astrazenica...), nor are the US exceptional in R&D spending per GDP (South Korea and Israel are the outliers). https://ourworldindata.org/grapher/research-spending-gdp?tab...
vjvjvjvjghv
The US taxpayer is mostly subsidizing stock buybacks.
jsbg
> All things being equal, a single-payer system would likely solve many more problems than it would cause.
That has not been the case at all in the countries that did go that route. The US system has serious issues but I would take it over Canada's any day.
tossandthrow
Privatized progressive tax?
IMHO this is great - broadest shoulders shoulder most.
However, it likely should be more organized? Maybe do more of this research in public institutions and make it freely available to commercialize.
nwienert
It's been like this, Americans heavily subsidize the world in healthcare/research.
Which becomes annoying when fairly rich Europeans ride these coattails (and defense) while being incessantly snobbish about their healthcare superiority, in large part paid for by us.
Though a big part of the Trump win comes from this - yea some Americans are rich, but a lot of them are really poor and justly mad at how much more expensive things are that we produce.
limagnolia
But if they are offering royalty-free production to generic manufacturers, why wouldn't insurance companies simply insist on using the cheaper generic?
TuringNYC
>> But if they are offering royalty-free production to generic manufacturers, why wouldn't insurance companies simply insist on using the cheaper generic?
I'm not an expert on this, but my PBM insists on going with stores that have higher prices. If I go with the less expensive store, they do not cover it. Sometimes, it makes sense to co with the less expensive store, but then it doesnt even draw down your annual deductable. Damned if you do, damned if you dont.
bee_rider
I don’t mind regional pricing, I mean, supply and demand works out differently in different markets, right?
But $84k seems a little pricey. Imagine paying that out of pocket.
42772827
Nobody pays that. It's a pre-negotiation price that exists as a factor of many other costs and payments to various stakeholders like PBMs.
ninetyninenine
This drug is cheaper if you don't buy insurance? What?
CodeWriter23
> The way they can afford to make it cheap for people who can't pay is by charging high prices for insured Americans
Well, fuck that. I'm already paying $24K annually for my health care that covers about half of anything short of a catastrophe.
42772827
They bill the insurance companies a lot, plus they take public and private (i.e., government and Gates Foundation) investment.
erikig
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
Would be nice if I could just directly get paid $28K/year to not have sex.
os2warpman
>How will they manage to cover R&D costs?
Seeing that pharmaceutical companies, on average, spend much more on marketing than R&D I would eliminate marketing.
Most of the rest of the world has banned drug advertisements, and sales reps whose activities more resemble bribery than anything else, and they're doing fine.
Don't even eliminate it. Just halve it. The typical drug "researcher" spends $2 on commercials and sports sponsorships for every $1 spent on R&D.
In addition to marketing, pharmaceutical companies spend, again on average, MUCH MUCH WAAAAAAAAY more on stock buybacks and dividends than they do R&D. Between $2 and $4 for every $1 spent on R&D.
That could also be a source of, oh who the hell am I kidding...
Modern drugmakers aren't biotechnology companies, they are financial instruments that just so happen, by coincidence, to employ chemists.
Marsymars
> In addition to marketing, pharmaceutical companies spend, again on average, MUCH MUCH WAAAAAAAAY more on stock buybacks and dividends than they do R&D. Between $2 and $4 for every $1 spent on R&D.
Stock buybacks and dividends are basically just a proxy for profits, and the fact that a company has greater profits than R&D spending isn’t a ratio that’s especially meaningful.
(You could, however, make a good argument that if profits are too high, it’s an indicator that the market isn’t adequately competitive, and regulation or anti-trust enforcement is merited to ensure competitiveness.)
bee_rider
It would be kind of interesting to require companies to limit marketing budgets to half of R&D, or whatever.
The obvious objection is that this will result in inflated research budgets and maybe marketing-adjacent research (like benchmarking). But actually, more benchmarking could be good. Or maybe they’ll inflate their research budgets by dropping money into basic research.
nineplay
To what end? Companies spend $X on marketing to make $X + $Y. If you force them to reduce $X than assuming they don't come up with creative financial workarounds, you've just made them make less money. What has this accomplished for the betterment of anyone?
pavlov
Here’s a detailed account of the development spanning over thirty years:
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.
ldoughty
"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/2025/22...
dr_test
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/#stu...
kstrauser
What’s a typical rate for infections per person-year among people not using these precautions? For those who don’t know follow the epidemiology here, how good effective are the older drugs compared to not taking them?
Having grown up when AIDS was peaking, the idea of this scourge preventable and treatable feels damn near like sci-fi, and I’m thrilled at the progress we’ve made.
okaram
This heavily heavily depends on the population you choose, given the difference in sexual habits.
As a data point, the paper below shows 1,213 out of 18,401 high-risk people in France got infected in 4 years (and 260 out of 31,992 with the previous gen prep, it seems this one reduces it by ~10x again)
https://www.thelancet.com/journals/lanpub/article/PIIS2468-2...
pitpatagain
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.
Fomite
We actually have terms for this.
"Efficacy" is how well something works under ideal conditions.
"Effectiveness" is how well something works in the real world.
So yes - "This is more effective because adherence is easier" is both true and intended.
Ericson2314
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.
dr_test
[dead]
MostlyStable
I'd be interested in a modeling study looking at the equilibrium infection rate, assuming everyone was on the drug, but otherwise did not change their behavior with regards to risky sex (or maybe even under a few scenarios of increased risky behavior from risk compensation [0]. You don't actually need 100% protection for the longterm equilibrium to be eradication of HIV (that's the whole idea of herd immunity).
How long would it take for a drug with this level of protection to result in ~no cases of HIV? What level of adoption would it require?
soared
Be sure to model in an anti-vax effect as well
levocardia
A good use case for the "rule of 3":
>if a certain event did not occur in a sample with n subjects, the interval from 0 to 3/n is a 95% confidence interval for the rate of occurrences in the population.
SamuelAdams
The cited article is a better source, and it was written a month ago. I am not sure why this is making the rounds now.
They cite 99.9%, and “reduce the risk”, not 100% like this sub article claims.
https://www.gilead.com/news/news-details/2025/yeztugo-lenaca...
raylad
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
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
It seems that the drug may inhibit disassembly of the capsid.
brianleb
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.
amluto
> 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.
If this really applied to HIV, then people with HIV who take effective antivirals for long enough would be cured. But they generally aren't.
pitpatagain
This is incredibly misinformed, the drug has been specifically studied as prep, and this is in fact not at all what happens, despite your theories about the drug's mechanism of action. It does prevent infection.
tremon
If the virus doesn't replicate, does that also means it doesn't transfer from an infected person to their partners? If so, that would also fall under "provides protection against HIV infection" for me.
brookst
It’s an insightful and society-forward observation, but I do think a person taking the drug who found they were infected but not contagious might take issue with the “prevents infection” framing.
Assuming GP is correct, from other comments it sounds like that’s in question.
est31
Initial infection and persistence are different things, and the reservoir for HIV builds up early on, but not immediately. There is definitely at least one reproductive cycle in between the first infected cells and the creation of a reservoir.
nerdjon
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
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
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_...
croemer
Yeah, terrible article. This one should be the link target instead: https://www.nbcnews.com/news/amp/rcna208387
thehappypm
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.
inasio
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
bapak
For those wondering, it's two injections a year compared to the daily PrEP pill.
cosmotic
There's also an existing option of a 6 times a year injection
croemer
The drug's name sounds like "Yes to go", most certainly not a coincidence
octo888
A twice-yearly injection with the same efficacy as daily PrEP is a fantastic development
smsm42
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...
rendleflag
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?
jerojero
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.
tonyhart7
same like always, we develop a better antibiotics???
yieldcrv
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
null
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?