[happybuy]

As with all drugs, efficacy is only one part of the equation.

What's the potential side effects, both short term and long term, of this treatment?

For this treatment, it may be negligible, but without saying so we are only hearing one side of the story.

[hyrix]

They stopped the study because of the incredible efficacy and lack of side effects. This was a phase 3 clinical trial so they have already cleared substantial hurdles in safety requirements (clinical trials are about both efficacy and side effects).

But for argument’s sake, there are even more sides than efficacy and safety: there are substantially different risk profiles for different potential patients, and a long acting treatment with no daily pill is more valuable for some people.

One of the reasons that long acting injectables could have a big impact on transmission in Africa is because there’s stigma around PrEP usage, especially for women. Obviously, there is now a big conversation about the cost and who pays, but the potential here is indisputable.

https://www.niaid.nih.gov/news-events/nih-statement-prelimin...

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10879468/

[breck]

> They stopped the study because of the incredible efficacy and lack of side effects.

Are you aware that historically when this has happened, it almost always turns out to have negative side effects and marginal efficacy?

Don't you think an easy con is to flip a coin 3 times, and if you get heads all 3 times, tell everyone it always comes up heads, and there's no need to continue to measure it, but just to trust them?

[hyrix]

Usually when a study is halted early it’s because of obvious harm to the experimental group from the treatment which means there would be no possible benefit and it would make continuation unethical.

A meta analysis of early stopping in randomized clinical trials has found no evidence that early stopping hides side effects or inflates benefit—and I challenge you to produce any examples of a phase 3 trial of an infectious disease treatment that was stopped early which later showed unduly harmful side effects for marginal benefit.

This trial showed 100% efficacy.

A major consideration of RCTs is also the benefit denied to the public by withholding a viable treatment. HIV remains a global epidemic with no existing good solutions for poor countries.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5133138/

[breck]

Your account is new and has no profile and for all we know could be a bot.

However, in adhering to the HN guidelines [0] I must "assume good faith".

And indeed, you provided an excellent, intelligent reference! Very interesting paper and debate.

In the paper the authors review the debate on early stopping, and then created a model/simulation to examine what one might expect.

I should note that the paper came out in 2016, which was before the December 2020 early stopping of the COVID vaccine trials, a real world example of an early stopping debacle, where trials were stopped and then efficacy turned out to be vastly less than originally reported (even worse than the "29% exaggeration of effect" Bassler et al originally reported).

I think your argument has convinced me that my position is not correct. However, it has not convinced me that early stopping is correct either. I think the obviously dumb thing is having these rigid trials, and a far better idea is to have real-time adjustable ongoing data collection and experimentation that never stops.

Thanks for the article. Good read!

[0] https://news.ycombinator.com/newsguidelines.html

[dyauspitr]

I don’t think anything is going to be as devastating as 60%+ of Eswatini’s women between the ages of 25-39 being HIV+. Anything that can put a dent in that is going to far outweigh any potential risks and side effects. That whole country is going to be dead in 5-10 years unless they all get a daily dose of ART for the rest of their lives.

On a side note, that number is absolutely unbelievable considering that heterosexual intercourse has a 0.08% chance of infection. Do they all have 100s of sexual partners and tens of thousands of sexual interactions before they’re 30?

[Bost]

> Anything that can put a dent in that is going to far outweigh any potential risks and side effects.

Ha! Explain that to the anti-vaxxers.

[fzeroracer]

Historically according to who and what, exactly? Are you going to actually supply a citation here?

[Bost]

This story is not about viruses and vaccines, but what about the 1949 Nobel Price for lobotomy? https://www.nobelprize.org/prizes/medicine/1949/moniz/articl...

"Sure. We're smart, we're scientists, we know what we're doing... except when we don't."