“PrEP and Women”

The future is high dose injectables

Today we’ll be reacting to a document from AIDSMap attempting to convince more women to take PrEP. (How soon do you think they will just put it in the water like fluoride?)

PrEP and women: A research briefing

The majority of people who have initiated PrEP are cisgender women.

This statement may come as a surprise to PrEP advocates in high-income countries, where PrEP awareness and provision is far higher among gay and bisexual men and trans people than it is among cisgender women.

I’ve heard that before and I have my suspicion as to why that’s the case. Let’s see if I’m right.

However, an exponential growth in PrEP adoption, starting in the last quarter of 2019, has resulted in huge numbers of women starting PrEP in Africa.

Yup, I was right. What is with this incredible hubris of Western society that we imagine we can take medical control of the population of an entire continent? And you know we’re paying for it, thanks to PEPFAR. Go on telling yourself the HIV AIDS story isn’t racist.

In the UNAIDS Global AIDS Update, there were about 470,000 female and 260,000 male PrEP users in 2021. This is considerably less than the reported global total, not only because many countries don’t separate users by sex, but because high-income countries tend not to report to UNAIDS. The global total includes the US, with nearly 400,000 users, only 28,000 of whom (7%) are cisgender women. Europe adds another 150,000 users, very few of them women.

Well that’s alarming. This can’t possibly be only about money can it? Actually, I think the main principle behind this fraud isn’t actually money at all. The giant profits are a great fringe benefit. Something else is going on.

There’s some discussion as to breakdown of PrEP use among genders and it’s not very interesting so we’ll move on. I think I know where we’re going—long term injectable PrEP, which is approved but very infrequently prescribed. I can’t imagine the massive amount of drug that must be given to be administered every other month. It also makes no sense because the entire explanation for how HIV drugs work is that they “stop the virus at every stage of replication.” I’m sure replication happens far more frequently than every other month, so it makes no sense at all for treatment of “HIV positives” (which it is used for ), but really makes you wonder how in the hell it works for PrEP if there is no virus there whose replication can possibly be stopped. I admit that these are basic questions.

But this is to ignore an entire history of failed trials, fewer trials for women, low adherence and persistence, and lack of uptake of PrEP among women, with occasional exceptions. Awareness and availability are particularly low among women outside Africa. What works for gay men has worked, until recently, less well for women.

‘Until recently’, because in the last three years a new method of PrEP administered by injection has, excitingly, proved not only to work well for women, but to work for them even better than it does for gay men. Injectable PrEP stands on the verge of widespread provision, but matters of cost and infrastructure need to be solved first.

So, let me get this straight. There is this new methodology for administering drugs for a condition the patient doesn’t even have in massive doses, which has only recently been approved and whose safety has not been established, so to get around establishing safety we’re going to market it to women first, and cloak it in a veneer of “empowerment” to justify using mostly poor, minority women as Guinea pigs.

There also are not a lot of clinical trials for PrEP in women, and results have been mixed, along with a few that have been “abandoned for futility.” The only consensus among researchers seems to be that, for reasons no one can figure out, PrEP seems to be “less effective” at “preventing HIV” for women than it is for men.

This next part is interesting (emphasis mine throughout):

Two FEM-PrEP analyses revealed that participants often joined the study for reasons other than HIV prevention. Some distrusted the efficacy of PrEP, while others saw PrEP and condoms as an additional benefit, but not the main point of joining the study.

Interviews with a randomly selected 5% of participants found that they liked the regular HIV testing and used it as a reassurance they did not have HIV. The three benefits of the trial most commonly cited by participants were the monthly HIV test (32% of participants said this was an important reason for joining the trial), the behavioural support the trial gave them to stay negative (25%) and the monitoring offered for other health problems (22%).

A second study found that, despite repeated reassurances by researchers that they would not be penalised for not taking their pills, participants feared being excluded from the trial if they admitted low or no adherence, or simply feared confrontation with the trial staff and saw adherence counselling as a reprimand.

Participants also feared side effects; these fears were amplified by participants discussing the subject with each other. Some stored their pills up for use should the study report a positive effect.

So, it sounds like a lot of participants enrolled for access to health care services they would have otherwise have been unable to access, and PrEP was the price of admission. I also note the critical tone when they mention participants discussing side effects with one another—oh no!

And there was one “study that didn’t happen”—the “good Truvada” study!

Tenofovir has one characteristic toxicity. It is eliminated from the body by being filtered out through the kidneys rather than by being chemically broken down in the liver, as the majority of antiretrovirals are. This can sometimes irritate the kidney tubules and lead to a decrease in the efficiency with which they filter the blood (kidney dysfunction or renal insufficiency). While tenofovir does not cause problems for most people, toxicity is more common in older people and those with previous kidney disease. Injury to the kidneys also leads to too much calcium being filtered out, which can cause deficiency of the calcium in bones that gives them their stiffness and density.

Because of this, TDF‘s manufacturers devised a second prodrug of tenofovir, tenofovir alafenamide or TAF. This is incorporated much faster into cells, so less is left in the bloodstream to damage the kidneys. [We all know about this. -Ed.]

[…].

On the basis of DISCOVER, US drug regulators approved TAF/FTC for use as PrEP in gay and bisexual men and trans women in October 2019.

But not for cisgender women. The DISCOVER 2 study was proposed for cisgender women and adolescent girls in Africa but never materialised; as a result, TAF/FTC has never been approved as PrEP for them.

This situation is finally being remedied because the PURPOSE 1 study, which is investigating the efficacy of the injectable drug lenacapavir as PrEP in adolescent girls and young women, also includes a direct comparison of TDF/FTC and TAF/FTC for the first time. Primary results are expected in March 2024. See more in ‘Future directions’ below.

They really can’t get Truvada into enough bodies, can they? We continue with discussion of concentration of TDF in rectal versus vaginal tissues as a possible explanation for differing efficacies among men and women. It seems like reaching, and weirdly obsessive, but who am I to say?

We finish with a discussion of administering PrEP via a “microbicidal vaginal ring:”

Unlike tablet-based PrEP, these topical preparations were always seen as products that might specifically benefit women. This is partly because of anatomy; the vagina/cervix is essentially a closed-end pouch more suited to gels and devices than the open-ended tube of the rectum, where devices may not stay in place. In addition, the epithelium (mucous membrane) lining the vagina is several cells thick, whereas the rectal epithelium is only one cell thick, so it was thought there was less risk of a topical product causing inflammation and irritation.

The first randomised controlled study of a microbicide upset this assumption. This study, of the spermicide nonoxynol-9 used as a vaginal microbicide among 700 female sex workers in Côte d’Ivoire, started as early as 1996. When it was ended in 2001 it was found that, far from it protecting the women against HIV, it actually made HIV transmission more likely. As aidsmap commented at the time, “The results of the trial have raised ethical questions that may affect the future study of all microbicides” and affected attitudes towards early studies of systemic PrEP in women.

Oops. We had a negative result, rather than abandonment for futility. But they kept going. I’ll just compile the results:

One development pathway conducted studies of a tenofovir-containing gel for vaginal application that culminated in the CAPRISA 004 study, which announced a positive result in 2010. The gel reduced HIV infections by 39% – not a result that would be hailed as a great success today

[…]

Unfortunately, however, two later studies produced negative results: the microbicide arm of the VOICE study, already mentioned, and FACTS 001, the open-label (no placebo) extension of the CAPRISA 004 study, which announced no effectiveness in 2014.

[…]

When effectiveness was announced in June 2015, it seemed disappointingly low in both studies – just 27% in ASPIRE and 31% in RING. In the case of ASPIRE, there was zero effect in young women aged 18-21, but 51 to 56% in women over that age.

But they keep pushing the ring to women, and they justify it by saying that “Of considerable importance, however, was that some women liked the ring.” Oh, okay then. It doesn’t matter that it doesn’t work, it doesn’t matter that it’s toxic, but we want to get this drug into as many bodies as possible and the best justification they can come up with is that some women like it.

Also, I’ve asked this before and I’ll ask it again. If HIV positivity is this terrible thing to be avoided at all costs, wouldn’t we want perfect efficacy or there would be no point? Why even bother with something 67% effective if it is certain to fail at that efficacy rate?

The article ends with comparisons of PrEP uptake among women in different regions of the world. It’s not got anything really relevant to this article, so we’ll move on to the end in which they discuss the wonders of injectable PrEP—didn’t we start with this? That’s how you know it’s propaganda.

HPTN 084 [study of injectable PrEP] demonstrated not only by far the best effectiveness seen in any study of PrEP in women, it is the best ever reported for any randomised, placebo-controlled study of PrEP.

[…]

In HPTN 083 (the study with gay and bisexual men and trans women), there were a handful of puzzling HIV infections in participants who became infected despite having efficacious blood levels of PrEP. There have been none so far among the women taking part in HPTN 084, and only one infection in a woman with cabotegravir levels even slightly above averagely protective levels.

[…]

It is important to emphasise that this does not just attest to the efficaciousness of injectable PrEP. Retention in the study was excellent, with only 6% of women (in either arm) discontinuing permanently in the first year. In women on the cabotegravir arm, 11% missed one or more of their injections or had it more than four weeks late, but most only missed one. This means that the injections did not just work medically; they fitted in with the lifestyles and priorities of the women who took part in this study, who were happy to come to the clinic to receive them.

Note the creepy language. “Retention in the study was excellent.” “The injections… [women] were happy to come to the clinic to receive them.” No comment.

The article wraps up as what it was always intended to be, which is an advertisement for barely tested bimonthly injectable drug, administered in massive doses. The fact that it’s women’s turn to be the Guinea pigs for this real time experiment (because other methods of PrEP have failed but somehow our bodies magically absorb PrEP like fairy dust) is just icing on the cake.

My theory is that this push for injectables is a tacit admission that there will never be a vaccine (why would that be?), but there may be something more sinister going on. What do you think?

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