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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

#101
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.

It is in fact much easier and less of a hassle (for me) than taking a pill everyday, which is what I used to do before I switched to injectables.

Injectables seemed scary right until the moment when I started taking them, after which they became a normal part of my life.

Re: FDA approves first monthly injectable to treat HIV infection

#102

Earlier quoted context omitted.

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.

Ok... and 10.6 million use birth control pills according to the CDC.

Also, just because something appears convenient doesn’t mean that it actually is.

Have you looked up how many women use one of those invasive contraceptive implants?

Technically, a woman only has to get a new implant once every 4 years+. But have you not read the horror stories about the implants becoming dislodged and causing internal bleeding and severe damage?

Re: FDA approves first monthly injectable to treat HIV infection

#103
post #91

Earlier quoted context omitted.

> 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.

Not always, the cancer drug lenalidomid (Revlimid) is around 20 000$ for 21 pills in the US, the indian generica is around 200$.

Re: FDA approves first monthly injectable to treat HIV infection

#104

Earlier quoted context omitted.

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.

It is in fact much easier and less of a hassle (for me) than taking a pill everyday, which is what I used to do before I switched to injectables. Injectables seemed scary right until the moment when I started taking them, after which they became a normal part of my life.

In what way is it easier besides you saying that it’s easier? You have a hard time swallowing pills I guess? Or do you remember to take injections more because they stand out more in your mind than pills do?

EDIT: Not sure why this is getting downvoted. Since when on HN is it acceptable for someone to say “I think this way so it must be a fact” without providing an explanation? Even when it comes to subjectivity, there’s an expectation that people share why they believe in their opinion, right?

I swear I dislike this site and the people who use it more and more every week.

Re: FDA approves first monthly injectable to treat HIV infection

#105
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…

> can we create an independent non-profit which receives ownership, and whose charter aligns with actually treating as many people as possible?

There is a proposal for such an entity: https://en.wikipedia.org/wiki/Health_Impact_Fund

Re: FDA approves first monthly injectable to treat HIV infection

#106
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…

Cabotegravir is somewhat novel -- not a recompounding of current therapy with different pharmacokinetics.

Americans aren't going to develop an efficient approach that is not highly encumbered because the FDA stacks the deck against approval of efficient solutions in favor of whatever makes the most total profit. So you'll see that sort of thing approved overseas and we'll get it (or not) in a decade or maybe never.

Re: FDA approves first monthly injectable to treat HIV infection

#107

Earlier quoted context omitted.

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 ov…

Yikes. There's absolutely no reason to do this. You get equally useful results by comparing to current standard of care, and that's the thing you ultimately need to measure for approval of a treatment for which existing treatments exist anyway (the FDA wouldn't approve a drug that's better than nothing but markedly worse than the current standard of care, so that's the benchmark).

Re: FDA approves first monthly injectable to treat HIV infection

#108
post #83

Earlier quoted context omitted.

> 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 expendit…

Genuinely curious - why do these drugs cost so much? Can we make it cheaper? I know there’s a lot of hit & miss and that the cost of the drug also covers the misses, but it feels like we should be able to do this for millions, not billions.

Re: FDA approves first monthly injectable to treat HIV infection

#109

Earlier quoted context omitted.

> 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 ov…

Yikes. There's absolutely no reason to do this. You get equally useful results by comparing to current standard of care, and that's the thing you ultimately need to measure for approval of a treatment for which existing treatments exist anyway (the FDA wouldn't approve a drug that's better than nothing but markedly worse than the current standard of care, so that's the benchmark).

Then why isn't it done as such in all instances?

It seems that whenever a perfect placebo be permissible, that is what is being used rather than the current standard of care.

Soldiers can be sent to their death for oil and other resources that benefit the larger majority? but this is “yikes”?, not a phrase I find to occur in conjunction with rational decisions often.

Re: FDA approves first monthly injectable to treat HIV infection

#110
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…

In contrast, the napkin estimate for the cost of a year's worth of HIV drugs (latest generation integrase inhibitors) was 20K as of around 2 years ago, for western countries. Dolutegravir became generic, but prices likely won't change dramatically (specifically in western countries).
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