4 ms·

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

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 half were given the daily oral treatment. The study notes a "high level of adherence to oral therapy"; however, the actual numbers on adherence are: > Adherence to oral FTC/TDF was high, based on a random subset sampling that detected tenofovir (> 0.31 ng/ml) in 87% of all samples tested. I'm not qualified to say if this actually indicates 87% adherence, or if a fully compliant patient may get a negative result on that test. The result of this study was that 50 particpants got HIV, of which 12 were on the injectable and 38 were on the oral. By my calculation, this gives a relative effectiveness of (38-13)/38 = 68.4%, although the paper reports 69%. [0] https://viivhealthcare.com/en-us/us-news/us-articles/2020/global-hiv-prevention-study-to-stop-early-after-viiv-healthcares/ https://viivhealthcare.com/en-us/us-news/us-articles/2020/gl...

dougmwne 6y ago
This is awesome, thank you! The likelihood of pill compliance does seem to be probably higher than normal since everyone had 2 month follow-up appointments for injections, plus presumably they knew they were being blood tested. This looks like a game changer for HIV prevention. 6 shots a year and you can have better protection than any other known method. To me it looks like this is something that should be rapidly adopted.
Blikkentrekker 6y ago
> 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.
- apendleton 6y ago
  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).
  - Blikkentrekker 6y ago
    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.
    - apendleton 6y ago
      > Then why isn't it done as such in all instances? It is. Control groups are no-treatment if no approved treatment exists, or current standard of care if there's an approved treatment. That's standard practice. > It seems that whenever a perfect placebo be permissible, that is what is being used rather than the current standard of care. If by "perfect placebo," you mean "no treatment," that's not correct, and is considered unethical.
      - Blikkentrekker 6y ago
        > It is. Control groups are no-treatment if no approved treatment exists, or current standard of care if there's an approved treatment. That's standard practice. I've read plenty of pharmaceutical trials where the control was a plain placebo, not the current standard of care, when it not involve a life threatening illness. https://clinicaltrials.gov/ct2/show/NCT00061802 https://clinicaltrials.gov/ct2/show/NCT00061802 Clearly this antipsychotics trial does not evaluate the drug 's effectiveness against the current standard of care's, but against a placebo's. > If by "perfect placebo," you mean "no treatment," that's not correct, and is considered unethical. I mean giving them a drug that lacks an active ingredient but is otherwise not to the lay eye discriminatable from an effective drug. And that is very much what is done in the case of the antipsychotics medicine I showed. So it's only unethical when human lives be at stake, apparently.
erosenbe0 6y ago
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.

dougmwne 6y ago

This is awesome, thank you! The likelihood of pill compliance does seem to be probably higher than normal since everyone had 2 month follow-up appointments for injections, plus presumably they knew they were being blood tested. This looks like a game changer for HIV prevention. 6 shots a year and you can have better protection than any other known method. To me it looks like this is something that should be rapidly adopted.

Blikkentrekker 6y ago

> 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.

apendleton 6y ago
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).
- Blikkentrekker 6y ago
  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.
  - apendleton 6y ago
    > Then why isn't it done as such in all instances? It is. Control groups are no-treatment if no approved treatment exists, or current standard of care if there's an approved treatment. That's standard practice. > It seems that whenever a perfect placebo be permissible, that is what is being used rather than the current standard of care. If by "perfect placebo," you mean "no treatment," that's not correct, and is considered unethical.
    - Blikkentrekker 6y ago
      > It is. Control groups are no-treatment if no approved treatment exists, or current standard of care if there's an approved treatment. That's standard practice. I've read plenty of pharmaceutical trials where the control was a plain placebo, not the current standard of care, when it not involve a life threatening illness. https://clinicaltrials.gov/ct2/show/NCT00061802 https://clinicaltrials.gov/ct2/show/NCT00061802 Clearly this antipsychotics trial does not evaluate the drug 's effectiveness against the current standard of care's, but against a placebo's. > If by "perfect placebo," you mean "no treatment," that's not correct, and is considered unethical. I mean giving them a drug that lacks an active ingredient but is otherwise not to the lay eye discriminatable from an effective drug. And that is very much what is done in the case of the antipsychotics medicine I showed. So it's only unethical when human lives be at stake, apparently.

erosenbe0 6y ago

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.