No PreP status?

[SirBillybob]

2 hours ago, pubic_assistance said:

Which speaks to the unreliability of PreP in the general public rather than the pharmaceutical company's oft quoted  stellar efficacy in their own controlled studies.

It’s very poor real world effectiveness -wise in nested case-control study for behaviourally high-risk men (ie, STI occurrence corroborating condom practices) younger than 30 that report categorical use of oral PrEP … about 25% effective, not differentiating insertive from receptive anal. In fact the low end of the metric confidence interval for that age group drops below nil efficacy.

HIV incidence is much much lower than overall STI incidence but oral PrEP certainly has its limits. For men over 40, real world effectiveness is much better, approaching that of randomized placebo-control research.

Given typical punter-scort age differential the prevention key is client PrEP uptake. That said, synergistic assumptions such as enhanced protection conferred by mutual categorical PrEP use should be made with a grain of salt, condom use making up the efficacy gap according to risk tolerance.

At some future point, fingers crossed, the long-lasting depot injection PrEP model may prove to be a real world game-changer. 

Edited February 2 by SirBillybob

[PileDriver]

negative here on prep. i always am up front in my contact with someone about that and ask for their status. and although i expect honesty i also assume that for what ever reason there the possibility of dishonesty. same goes for other std's. has worked for me. have had a few guys cancel after an std diagnosis. and a few times after the assignation received an honest alert that i may have been exposed to an std. in those cases didn't get an infection. and the honesty only made the guy's value rise in my mind.

and have used condoms when requested for a few guys. when someone has topped me i asked that the condom be left in me.

being up front, proactive, honest but also guarded works for me...had syphilis once and knew the second i met the guy there was a problem but had a lapse of judgement. but then waited, got tested, then took care of myself and never had a lapse of judgement again. 

 

 

[+ BenjaminNicholas]

8 hours ago, pubic_assistance said:

Which speaks to the unreliability of PreP in the general public rather than the pharmaceutical company's oft quoted  stellar efficacy in their own controlled studies.

That has very little to nothing to do with the effectiveness of PrEP.

Do you have a link to studies that backup claims of widespread unreliability?

Breakthrough cases are extremely rare.  Yes, they happen, but it's not a concerning number at this point:

https://www.aidsmap.com/about-hiv/prep-failures-breakthrough-infections

Many of these cases were due to user error (adherence).  

Newer formulations of PrEP are even more effective and they will continue to refine it.

PrEP is not the bad guy.  It's a fucking life saver.

Edited February 2 by BenjaminNicholas

[SirBillybob]

What fun for a nerd.

Andy Carstens, who by the way did not source his breakthrough infection case reports, would have been well advised to do his homework, reading in fact research reported a substantial period of time prior to his article date. It is likely his estimate was derived from a search of individual case reports that clinicians here and there bothered to submit, probably not structured cohort surveillance. One cannot know because the information is missing. It smacks of confirmation bias.

Expected real world infection breakthrough extrapolated from prospective study model surveillance is estimated as 1,500 per million consumers for Apretude over a year, 150-fold the erroneous waaaaay off the mark Aidsmap summation (non-adjusted by time and non-specific uptake mode, as they are episodic cases), and then translating to 1 in 133 over 5 years, and then yet a further 3-fold degree for Truvada. It is more accurate because it follows the same cohort given PrEP. See appended media piece.

As I wrote above, retrospective case control research, wherein rates of historical oral PrEP uptake, with appropriate data-censoring following discontinuation, are compared between those later seroconverting and those counterparts that remained HIV negative, matched across key demographic characteristics, yielded poor effectiveness results. In contrast to the aforementioned randomized trial depicting 15 breakthrough cases per 10,000 person years, case control results about 22 cases per 10,000 person years, about 29% of infections PrEP users.

Of course PrEP is superior to not being on it. That is the relation between intervention and nothing. It will reduce infection risk, no argument. Questioning and appraising the apparent hyperbole associated with effectiveness simply represents appreciative inquiry however much it spurs hyperventilation response. That part is the relation between an intervention and within-group case incidence. No need to go to the mat.

The thread topic pertains to the downstream reality of delineating PrEP status. 

Breakthrough HIV reported in injectable PrEP trial; experts say drug still very effective

WWW.NBCNEWS.COM

---

Experts say breakthrough HIV should still remain rare in those receiving ViiV Healthcare’s...

 

Edited February 3 by SirBillybob

[pubic_assistance]

4 hours ago, BenjaminNicholas said:

Many of these cases were due to user error (adherence).  

Correct.

That's the difference between the controlled study and real life efficacy (which is significantly lower). 

Yes, there are multiple studies that show ACTUAL efficacy in the gay community closer to 79% and not the 99% touted by pharmaceutical companies.

[Guest]

As I read some of the studies (and I’m no scientist) the real-world drop in efficacy is largely due largely to adherence and early discontinuance, not break-through cases. So, is it wrong to conclude that efficacy is considerably higher (>90%) if used correctly? I guess I’m missing the point here.

[+ nycman]

1 hour ago, Km411 said:

I guess I’m missing the point here.

No, I think you nailed it. 

As a population scientist, you worry about the "n" of 100 million. 

As a human, you worry about the "n" of one. 

[SirBillybob]

5 hours ago, Km411 said:

As I read some of the studies (and I’m no scientist) the real-world drop in efficacy is largely due largely to adherence and early discontinuance, not break-through cases. So, is it wrong to conclude that efficacy is considerably higher (>90%) if used correctly? I guess I’m missing the point here.

No, not wrong. It is useful to know and calculate ideal condition efficacy to understand poorer real world non-experimental outcomes, in fact, to determine whether differences are due to chance.

Paradoxically, overestimating true efficacy risks obscuring breakthrough infection rates owing to treatment failure versus suboptimal adherence. If true efficacy is claimed to be close to 100% then treatment failure would point exclusively to uptake deficiency (eg, lapse) and that is specious. 

Practice wisdom conjecture and inevitable contradictions regarding infection breakthrough arise as many variables are complex to measure. Hence the disparity between the Aidsmap and NBC news articles.

Some research employs adherence in binary categorical terms (full versus not depending on an arbitrary cut-off) and other research on a continuum based on standardized scales, some based on pill count possibly even ‘smart lids’ and others based on self-report. What is universally known is that for any intervention involving medication adherence is far from ideal. The majority of folks living with HIV demonstrate nonadherence levels that their providers are continually attempting to mitigate. If treatment as prevention (TASP) is fraught with inconsistent uptake why wouldn’t prophylaxis as prevention? 

PrEP failure is worse because viremia is high upon infection. In contrast, the volume of viral load categorized as undetectable / untransmissable has been determined to be much higher than previously thought for a satisfactory TASP standard.

‘Negative on PrEP’ is at most a rough estimate. 

Edited February 3 by SirBillybob

[pubic_assistance]

5 hours ago, Km411 said:

As I read some of the studies (and I’m no scientist) the real-world drop in efficacy is largely due largely to adherence and early discontinuance, not break-through cases. So, is it wrong to conclude that efficacy is considerably higher (>90%) if used correctly? I guess I’m missing the point here.

Correct.

Failure of the medication if taken as prescribed is low. But the real-world statistics show that a low number of people actually remember to take their medication consistently enough to be assured of avoiding a break-through infection. Thus the big difference between real-world and controlled studies

If you're not fastidious you're playing Russian Roulette with a 20% risk of infection.

[SirBillybob]

49 minutes ago, pubic_assistance said:

Correct.

Failure of the medication if taken as prescribed is low. But the real-world statistics show that a low number of people actually remember to take their medication consistently enough to be assured of avoiding a break-through infection. Thus the big difference between real-world and controlled studies

If you're not fastidious you're playing Russian Roulette with a 20% risk of infection.

Popular misconception.

80% efficacy does not translate to 20% risk. The roulette analogy is misguided. Risk with zero drug prophylaxis, as has been previously discussed, is entirely based on HIV status of partner, transmission probability estimate (1.4%) per episode of receptive anal intercourse, if poz partner has detectable viral load. 20% risk would be based on number of such episodes based on the 98.6% probability of non-infection to the power exponent of number of risk episodes. These consecutive episode numbers and infection probability percentages are unrelated to efficacy metrics.

That said, the estimated risk metric is on a downward sliding scale according to degree of any uptake of PrEP, however adherent, as PrEP protection is scaled to adherence. There would, of course, be some threshold of nonadherence that does not at all mitigate the 1.4% risk in spite of some degree of PrEP consumption. That trend is evident among young men. 

Edited February 3 by SirBillybob

[pubic_assistance]

15 minutes ago, SirBillybob said:

80% efficacy does not translate to 20% risk.

Obviously the 20% risk factor assumes an HIV positive partner.

You are correct in your comment that this number doesn't assume the other Russian Roulette factors of wondering whether or not your partner is HIV negative, poz, undetectable poz, or also recently infected from lazy adherence to medication schedules.

The overall point is that we don't live in a laboratory so the controlled study numbers are giving people a false sense of security with their 99% efficacy claims.

Bareback sex always comes with a degree of risk.

[SirBillybob]

24 minutes ago, pubic_assistance said:

Obviously the 20% risk factor assumes an HIV positive partner.

You are correct in your comment that this number doesn't assume the other Russian Roulette factors of wondering whether or not your partner is HIV negative, poz, undetectable poz, or also recently infected from lazy adherence to medication schedules.

The overall point is that we don't live in a laboratory so the controlled study numbers are giving people a false sense of security with their 99% efficacy claims.

Bareback sex always comes with a degree of risk.

You cannot compute infection risk by subtracting efficacy from 100. Why don’t you just look up efficacy as described in the public domain? If the arithmetic I think you employed is not how you arrived at it, how did you come up with 20%?

You seem to be extending the roulette analogy in a way that undermines your points. The 20% risk factor does not assume anything because it doesn’t exist in the context of PrEP effectiveness.  

But yes, your emphasis on realistic appraisal of PrEP effectiveness is bang on and I have supported that notion throughout. You lost me at risk math. 

Edited February 3 by SirBillybob

[pubic_assistance]

7 minutes ago, SirBillybob said:

You cannot compute infection risk by subtracting efficacy from 100.

Already acknowledged above.

No need to repeat the math.

My point was only that the real-world efficacy is different from what the pharmaceutical company advertising wants you to believe. This puts people at risk because they believe in a false sense of security.

[+ DrownedBoy]

I'm no doctor, so I'll just post this, which has a link to the official studies:

 

Pre-Exposure Prophylaxis (PrEP) | HIV Risk and Prevention | HIV/AIDS | CDC

WWW.CDC.GOV

---

PrEP is a way for people who do not have HIV but who are at substantial risk of getting it to prevent HIV infection by taking a pill every day.

 

My understanding was that under controlled studies (not field-based research where doctors couldn't accurately monitor the patients), PrEP worked unless someone forgot their pills.

However, the same research shows that while PrEP supposedly protects against HIV in 99% of sexual cases, it only protects in 74% of cases involving infected needles. This tells me that PrEP doesn't work as well if the virus is spread directly into the bloodstream.

[+ nycman]

25 minutes ago, pubic_assistance said:

This puts people at risk because they believe in a false sense of security.

And that’s the most important point.

Everything else is angels on a pinhead.

1, 10, or 1,000.….It’s never zero.

Am I the only one that thinks @SirBillybob might be an AI robot?

Edited February 3 by nycman
Angles, angels, fuck off.

[SirBillybob]

57 minutes ago, pubic_assistance said:

Already acknowledged above.

No need to repeat the math.

My point was only that the real-world efficacy is different from what the pharmaceutical company advertising wants you to believe. This puts people at risk because they believe in a false sense of security.

What advertising? Gilead’s Oct2023 Truvada package insert reflects exclusively two PrEP placebo control randomized clinical trials (RCTs), 42% and 75% efficacy respectively. And the research has been plowing along for well over a decade. 

Edited February 3 by SirBillybob

[SirBillybob]

9 minutes ago, nycman said:

And that’s the most important point.

Everything else is angels on a pinhead.

1, 10, or 1,000.….It’s never zero.

Am I the only one that thinks @SirBillybob might be an AI robot?

No bot is capable of programming handling the convoluted reasoning evident throughout these threads. 

Edited February 3 by SirBillybob

[Guest]

That’s just what I’d expect an AI bot might say…. 😜 

[SirBillybob]

Tangent alert.
Any more obnoxious attempts to throw me off my game and I’m going to have to siphon off power from the EV charger. 

Edited February 3 by SirBillybob

[+ nycman]

4 minutes ago, SirBillybob said:

Tangent alert.
Any more obnoxious attempts to throw me off my game and I’m going to have to siphon off power from the EV charger. 

"Shall we play a game?"

 

 

[SirBillybob]

Missed breakie, time for brunch, or as the mods say, pizza.

Edited February 3 by SirBillybob

[DWnyc]

On 2/2/2024 at 8:54 AM, pubic_assistance said:

Which speaks to the unreliability of PreP in the general public rather than the pharmaceutical company's oft quoted  stellar efficacy in their own controlled studies.

Not necessarily - could be a lapse in them following the regimen. I do wonder when I see ads or hookup posts from those who boast about their stamina to party all weekend if they kept up with their mess during that time.