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FDA approves first monthly injectable to treat HIV infection

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Re: FDA approves first monthly injectable to treat HIV infection

#91

Post by rtx »

joshuaissac wrote: post #84
abeppu wrote: post #73

> The cost, however, is steep — the list, or wholesale, price is $3,960 a month, or more than $47,500 a year. The list price for the one-time initiation dose is $5,490. Median income in the US is ~$31K apparently. So even in a rich country, this is like 50% more than the income of a typical person. My understanding is the funding for the trials was partly from NIAID. This seems like yet another case where public fund…

> So even in a rich country, this is like 50% more than the income of a typical person. Generic versions of expensive American drugs tend to be released by Indian pharmaceutical companies into developing countries after a while.

They do it after the patent expires.

Re: FDA approves first monthly injectable to treat HIV infection

#92

Post by stickfigure »

daniel957 wrote: post #81
damnyou wrote: post #39

Earlier quoted context omitted.

I'm not sure about this one but subcutaneous and intramuscular injectables are pretty easy to self-administer. I self-inject once a week myself. https://www.poz.com/drug/cabenuva seems to suggest it is intramuscular (administered in the buttocks, which is not hard to do by oneself) but requires a healthcare provider. Not sure why, there might be storage requirements and such.

I think people would rather prefer to take a pill than give themselves an injection. It doesn’t matter if it’s “easy” or not. There’s the “ick” or “ahhh needle” or “breaking skin” factor at play. Even if you self-inject and find it easy, I’m sure you’re not saying it’s easier and less of a hassle than taking a pill lmao.

Depo-Provera (monthly injected contraceptive) is used by over 2 million women in the US.

Re: FDA approves first monthly injectable to treat HIV infection

#93

Post by nceqs3 »

abeppu wrote: post #73

> The cost, however, is steep — the list, or wholesale, price is $3,960 a month, or more than $47,500 a year. The list price for the one-time initiation dose is $5,490. Median income in the US is ~$31K apparently. So even in a rich country, this is like 50% more than the income of a typical person. My understanding is the funding for the trials was partly from NIAID. This seems like yet another case where public fund…

I believe that the government does own a portion of the IP.

If you read patents filed by defense contractors and pharma/universities they often say something like this "This invention was made with Government support under Contract no. F29601-03-C-0191 awarded by the Air Force Research Laboratory, Kirtland AFB, N. Mex. The Government has certain rights in the invention."

https://patentimages.storage.googleapis.com/f9/bc/b9/dd132ea...

Re: FDA approves first monthly injectable to treat HIV infection

#94

Post by fastball »

abeppu wrote: post #82
abeppu wrote: post #73

> The cost, however, is steep — the list, or wholesale, price is $3,960 a month, or more than $47,500 a year. The list price for the one-time initiation dose is $5,490. Median income in the US is ~$31K apparently. So even in a rich country, this is like 50% more than the income of a typical person. My understanding is the funding for the trials was partly from NIAID. This seems like yet another case where public fund…

Or to approach the same issue from the other direction: Does public funding for research of this type self-sabotage, if it enables pharmaceutical companies to set pricing at a level which meaningfully limits the use of the results of that research?

How exactly are is big pharma limiting the result of that research? Anyone can use the research.

Re: FDA approves first monthly injectable to treat HIV infection

#95

Post by hn_throwaway_99 »

nceqs3 wrote: post #93
abeppu wrote: post #73

> The cost, however, is steep — the list, or wholesale, price is $3,960 a month, or more than $47,500 a year. The list price for the one-time initiation dose is $5,490. Median income in the US is ~$31K apparently. So even in a rich country, this is like 50% more than the income of a typical person. My understanding is the funding for the trials was partly from NIAID. This seems like yet another case where public fund…

I believe that the government does own a portion of the IP. If you read patents filed by defense contractors and pharma/universities they often say something like this "This invention was made with Government support under Contract no. F29601-03-C-0191 awarded by the Air Force Research Laboratory, Kirtland AFB, N. Mex. The Government has certain rights in the invention." https://patentimages.storage.googleapis.com/f9…

So then why is the government letting the company reap so much of the benefits of their IP?

Re: FDA approves first monthly injectable to treat HIV infection

#96

Post by slg »

jliptzin wrote: post #75
slg wrote: post #54

Earlier quoted context omitted.

The death toll in the US for COVID over the last year is up to 60% of the total for AIDS deaths over the last 50+ years. That leads to an urgency for COVID data that doesn't quite exist for HIV/AIDS which presumably hasn't been changing as rapidly.

1. I would be curious how these stats compare when measured in lost person-years. COVID primarily kills the elderly, AIDS (when untreated) kills everyone. 2. We have a 40 year head start on HIV vs. COVID. Surely it can't be that hard, in the digital age, to set up a central database with the following columns, updated in real time: [Datetime of Test, Zip code, Result (pos/neg)]

It isn't that it is hard to set this up. The question is what value is there to setting this up? Especially the way that HIV/AIDS was originally and to a certain extent still is stigmatized. Many people have had friends or family die of AIDS and still refuse to acknowledge that was the reason for their death.

The end result is that not only is this type of project more valuable for a new and rapidly spreading disease like COVID, the bar that the value needs to clear to justify this system is also higher because an HIV/AIDS status is considered more private from a societal standpoint (not necessarily a legal one).

Re: FDA approves first monthly injectable to treat HIV infection

#97

Post by Blikkentrekker »

gizmo686 wrote: post #24
dougmwne wrote: post #6

I have always heard that Truvada (prep) was extremely effective at preventing HIV infection. These new injectables are reported by the article to be 89% and 66% more effective at preventing transmission. What is this based on? Was I misinformed about Truvada's effectiveness? Is this a decrease in an already very low chance of transmission? Or is this in comparison to people forgetting to take their daily pills vs a s…

It is a decrease in already low transmission. For ethical reasons, the placebo group is not no treatment, but rather current standard of care. I had to do some digging to find any source on the effectiveness on preventing transmission (the recent FDA approval is for post infection treatment). The study I found is [0]. In a double blinded study of 4,600 participants, half were given the cabotegravir injection, and hal…

> It is a decrease in already low transmission. For ethical reasons, the placebo group is not no treatment, but rather current standard of care.

I see nothing wrong with sacrificing a few men, who consent and sign up and know the risk, for the far larger majority.

If better drugs can be developed that would serve millions by sacrificing a hundred consenting subjects that know they run this risk, that seems like an overall benefit to me.

It seems rather irrational to not be willing to do this. — It is fine if men die, so long as their blood not be on my hands directly, but only indirectly.

Re: FDA approves first monthly injectable to treat HIV infection

#98

Post by MBCook »

abeppu wrote: post #73

> The cost, however, is steep — the list, or wholesale, price is $3,960 a month, or more than $47,500 a year. The list price for the one-time initiation dose is $5,490. Median income in the US is ~$31K apparently. So even in a rich country, this is like 50% more than the income of a typical person. My understanding is the funding for the trials was partly from NIAID. This seems like yet another case where public fund…

> The cost, however, is steep — the list, or wholesale, price is $3,960 a month, or more than $47,500 a year.

Remember though that this is a replacement for an existing drug therapy, not something totally new. Does anyone know how much the daily pills cost per month?

Re: FDA approves first monthly injectable to treat HIV infection

#99

Post by akiselev »

timr wrote: post #83
abeppu wrote: post #73

> The cost, however, is steep — the list, or wholesale, price is $3,960 a month, or more than $47,500 a year. The list price for the one-time initiation dose is $5,490. Median income in the US is ~$31K apparently. So even in a rich country, this is like 50% more than the income of a typical person. My understanding is the funding for the trials was partly from NIAID. This seems like yet another case where public fund…

> My understanding is the funding for the trials was partly from NIAID. I have no particular insight into the pricing of this drug, but in general, NIAID funding doesn't get anywhere close to the level of investment needed to bring a drug to market (NIAID's total budget is something like $5Bn. A single drug can easily require that much money to go to market). Moreover, it isn't a bright-line distinction between publi…

> I have no particular insight into the pricing of this drug, but in general, NIAID funding doesn't get anywhere close to the level of investment needed to bring a drug to market (NIAID's total budget is something like $5Bn. A single drug can easily require that much money to go to market).

According to [1] "the estimated median capitalized research and development cost per product was $985 million, counting expenditures on failed trials." That billion dollar figure is risk adjusted per product meaning that's the cost of all R&D and clinical trials against the number of products that hit the market. A lucky startup can pull off a successful trial for a few hundred million (i.e. Sofosbuvir), if not tens of millions for an orphan drug.

The most expensive ("oncology and immuno-modulatory drugs" which are similar in complexity to HIV therapeutics) come in at a median of $2.8 billion and a mean of $4.5 billion but only because of an extreme outlier, Dupixent, which cost over $6 billion to develop. Dupixent costs $40k/year and has a much larger target market than this HIV treatment (IIRC on the order of 10 to 100x). This HIV injection is far more likely to be discounted in the developing world so the sticker price likely reflects that too.

A $5 billion a year budget can go very far and the people should get the rewards for taking the risk, especially for a disease like HIV that has significant quality of life impacts on vulnerable populations.

[1] https://jamanetwork.com/journals/jama/article-abstract/27623...

Re: FDA approves first monthly injectable to treat HIV infection

#100

Post by chefkoch »

MBCook wrote: post #98
abeppu wrote: post #73

> The cost, however, is steep — the list, or wholesale, price is $3,960 a month, or more than $47,500 a year. The list price for the one-time initiation dose is $5,490. Median income in the US is ~$31K apparently. So even in a rich country, this is like 50% more than the income of a typical person. My understanding is the funding for the trials was partly from NIAID. This seems like yet another case where public fund…

> The cost, however, is steep — the list, or wholesale, price is $3,960 a month, or more than $47,500 a year. Remember though that this is a replacement for an existing drug therapy, not something totally new. Does anyone know how much the daily pills cost per month?

It looks like conventional treatment is between 400$ and 1500$ per month.
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