Report on "PrEP Safety Concerns" from 2017

The first lawsuits against Gilead for Truvada were filed in 2018

Today we’ll be diving into the paper Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns, by Raymond A. Tetteh et al, and published in the journal Drug Saf. in January 2017. The full paper is available at the link above. I’ll try not to get too technical, but at some points that may be impossible.

This study conducted a literature review of multiple clinical trials of “bad Truvada”—the tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) combination, which at the time was the only formulation available for PrEP. From the abstract:

We performed a literature search on PrEP in PubMed, AVAC (AIDS Vaccine Advocacy Coalition), clinical trials registry, and scholar.google […] We present findings associated with safety issues on the use of PrEP based on a review of 11 clinical trials on PrEP with results on safety and efficacy as at April 2016. We also reviewed findings from routine real-life practice reports.

When it comes to “safety concerns,” the authors have the following to say. Recall that this paper was published before any lawsuits had been filed against Gilead for Truvada.

Both products are efficacious for PrEP and seem to have a good safety profile. Regular monitoring is recommended to prevent long-term toxic effects. The main adverse effects observed with PrEP are gastrointestinal related; basically mild to moderate nausea, vomiting and diarrhea. Other adverse drug effects worth monitoring are liver enzymes, renal function and bone mineral density. PrEP as an intervention to reduce HIV transmission appears to have a safe benefit-risk profile in clinical trials. It is recommended for widespread use but adherence monitoring and real-world safety surveillance are critical in the post-marketing phase to ensure that the benefits observed in clinical trials are maintained in real-world use.

The “basically mild to moderate” gastrointestinal symptoms are effectively brushed off and referred to as “transient;” however, a quick perusal of Reddit will find you stories such as this, from a user who goes by Paul-centrist-canada:

At the beginning of August I started taking Truvada daily, and I did so for 4 weeks. Initially I had awful side effects (intense nausea, feeling sick, vertigo). It kinda died down after a week, but a low level constant nausea remained.

After week 4, I went back to the STI clinic, explained the problem and they insisted I just need to keep going with it and the symptoms will "go away". Easy for them to say, so I stopped anyway, and 3 days later I feel normal again, finally.

It doesn't happen when I take the pill so taking it with or without food makes no difference. It happens after my body has absorbed it and is like a low level vertigo type nausea, a sea sick feeling that is constant until I stop.

There are many more such stories, and we have discussed a few here, but this man’s story as well as those of many others indicate that the “mild to moderate” symptoms are certainly not “mild.” However, as we know, Truvada’s safety profile is significantly more concerning than simply some transient nausea.

The introduction is very long and rambling, and begins with the predictable scolding about what a serious public health problem “HIV” is and how people just won’t use condoms consistently, darn it. (What makes these authors and so-called public health experts think that people that won’t use condoms will be so eager to take a pill, anyway?) They also discuss the 2014 CDC guidelines that were released upon the approval of Truvada for PrEP, which include quarterly testing for “HIV” and monitoring kidney function. Interestingly, the CDC did not recommend testing bone mineral density (BMD), which has turned out to be one of the more common and debilitating adverse effects of Truvada, per the content of the many lawsuits.

There is also the following interesting comment about “drug resistance.” It’s interesting to me, because in mainstream discussions of PrEP, we almost never hear any concerns about the high number of patients taking these drugs potentially developing some kind of resistance.

Poor adherence during PrEP is especially an important factor that may reduce effectiveness and lead to an increase in HIV infection rate with a possible development of HIV-resistant strains and subsequent transfer among the population. Factors that can affect adherence include adverse drug reactions (at regular doses) or toxicity (adverse drug reactions at probable high, intolerant doses or long-term use).

This is really interesting to me that this has been completely overlooked. We know PrEP failure is far from “rare,” and we know that people on PrEP “seroconvert” a lot while on these drugs; we also know that the mainstream has long been warning people living with “HIV” must remain perfectly adherent or they will risk their “viral infection” becoming “resistant.” So why would we want to put millions of healthy people with no hint of “HIV” onto a toxic regimen of chemotherapy that, by the mainstream’s own admittance, could lead to drug-resistant strains of “HIV” that might then circulate throughout the population? No wonder they’re pushing the long-acting injectables so hard—that at least solves the compliance problem, but the other issues of toxicity (or “resistant strains,” if you believe that such strains exist) remain unresolved. There is also the ominous possibility that PrEP might be simply masking some signal the body is emitting that has nothing to do with “HIV”—remember the case study of the individual was said to have a measurable viral load but never developed any antibody response to that VL while on PrEP?

Their Methods section is short, so I’ll just summarize by saying that of the 189 clinical trials identified by the research team, only 29 were deemed worthy of inclusion in this review. Let’s move on to Results, which might be interesting. We open with the following whopper (emphasis mine throughout):

Numerous trials involving both humans and animals have tested oral and vaginal routes of administration of PrEP and have been found efficacious in preventing HIV. The basis for PrEP stems from results of clinical and epidemiological research [22–25]. We reviewed 11 clinical trials on PrEP among different risk groups conducted from 2005 to 2015. These trials had results at the time of our study and allowed for review. Results from literature on PrEP studies are not necessarily universal. The efficacy ranges from lack of protection to protection levels of as high as 96%, attesting to the complex nature of PrEP implementation.

In mathematics and statistics, an efficacy range that encompasses basically every possible efficacy value (but only up to 96% effective) is totally meaningless, and it should be in real life and in medicine as well. Also, this quote mentions “vaginal routes of administration”—they’re referring to an insertable ring (like those used to administer hormonal birth control). There are only a handful of studies on the ring, and I haven’t covered them yet, and we don’t hear about the ring very often because its efficacy is—wait for it—underwhelming.

They delve a bit into the FEM-PrEP study from 2020, which enrolled 2120 women and indicated an efficacy rate of only 6%, which is admittedly something of an outlier when you consider the chart on page 280 of the paper linked in paragraph 1, which has efficacy rates all over the place, but averaging under 50% throughout. There were 56 new “HIV” infections in this group within 14 months, but here is the important part: The “infections” were evenly distributed between the Truvada and the control group, “clearly indicating the lack of protection in the use of Truvada,” per the study authors. They discuss a few other studies with varying efficacy rates, including the iPrEx study, which we have discussed extensively. All this meandering discussion of varying efficacy—all the while the media claim PrEP to be “99% effective,” which is a blatant lie—is really intended to set the stage for a lecture on the importance of adherence. Remember, the goal here is “retention in care” for a lifetime—again, why do you think they’re pushing the long-acting injectables, whose known problems continue to mount? Haven’t we been subjected to enough jab propaganda, already?

I find it amusing that in an 11 page paper whose title includes the term “PrEP safety concerns,” the actual “Safety Concerns” section is less than half a page long. We’ve already spent more time lecturing the audience about compliance. (Hasn’t that always been the name of the game with “HIV,” and with other issues such as Covid?) There isn’t much meat to that section, but I will give the authors credit for the following:

In this review, we acknowledge that the trials discussed are short term and do not give the opportunity to assess the long-term, real-world safety profile of the products used for PrEP. Pre-exposure prophylaxis is premised on ARV medications that have been used by people living with HIV and AIDS for quite some time now, since the inception of ARVs.

I feel like I could almost just end this piece right here, although we have a few more sections to get through. All I have to say about the quote above is that, since 2018 and continuing to the present day, we are seeing via the multiple lawsuits against Gilead that the “long term, real world safety profile of the products used for PrEP” is, well, abysmal. They give some lip service to monitoring of adverse effects, because they kind of had to, as indicated by the use of language:

Because of the importance of PrEP in reducing the spread of HIV, it is critical that these concerns are addressed and fears alleviated to allow for the promising potential of PrEP.

Translation: “Because we want to get as many people as possible on PrEP/ARVs for life, we have to at least pretend to address these very serious concerns.” I’ll try to get through the rest of this very quickly; it’s all a bunch of propaganda, as you know.

Following the “Safety Concerns” section, we have a slightly longer section on “Adverse Effects.” It opens with a reassurance, once again, that GI symptoms are “transient” and of no concern at all. Discussing risk factors in long-term use (which is the only type of use these drug manufacturers are concerned about—is anyone ever told to discontinue PrEP?), there was one item that caught my eye. One of the risk factors for adverse effects arising from long term use is being treated with a protease inhibitor. No wonder those medications are so rarely prescribed nowadays—the toxicities are just too much to tolerate. Recall, again, that these drugs somehow provided “proof of concept” of the HIV AIDS story, yet they have been abandoned almost entirely in favor of the use of older drugs. Some “breakthrough” those were. They remind me of the Covid vaccines, actually—useless at best, often toxic. We’re almost done.

The next section is devoted to one of the HIV AIDS proponents’ favorite topic, drug resistance. It’s mostly a bunch of technical nonsense that sounds fancy and says very little; however, I did find the following disturbing nugget:

The other area of concern is sexual and reproductive health because women of childbearing age are prone to HIV infection and the use of PrEP in discordant relationships could be useful. The Partners PrEP and the FEM-PrEP studies showed that TDF based PrEP does not affect the effectiveness of hormonal contraception and neither does hormonal contraception affect PrEP efficacy [14, 28]. There were not significant differences in pregnancy related and infant adverse reaction including premature births, congenital anomalies and growth throughout the early years of life for infants born to women who received PrEP as against placebo in the Partners PrEP study. Therefore, PrEP is relatively safe to be used by women of child-bearing age [14] though, like all medicines, its benefits should be weighed against any risks that it may pose in specific individuals.

They’re trying to put these drugs into pregnant women. We’ve discussed this already; I can’t add to what I said previously. Appalling.

We then discuss “Feasibility and Acceptability,” which could alternatively be titled “How to retain patients in care.” No more needs to be said about that. We then come to the topic that really, really super excites AIDS activists, “Adherence.” I guess that’s part 2 of “how to retain patients in care.” The section on adherence contains a lot of sound and fury about patients not accurately self-reporting their medication intake, or just not being properly “adherent.” It’s all so creepy, but it at least clarifies why the injectables are being promoted so heavily. Finally, we come to the Discussion and Conclusion, which doesn’t give us a whole lot of information. The study authors, to their credit, do point out that Truvada does have serious potential toxicities, but as time has passed and more and more victims’ stories come to light, it is clear that they severely underestimated these toxicities, especially when it comes to bone density loss, which has been serious enough to result in hip fractures and even double hip replacements. So the toxicities of TDF are acknowledged, but check out what they say about TAF (“good Truvada”):

A new formulation, tenofovir alafenamide that provides 90% lower plasma levels of TDF concentrations compared with standard TDF, has recently being approved by the FDA. It is claimed to have favourable renal and bone safety profile better than original TDF, unfortunately as at the time of this review efficacy and safety in PrEP has not been established in HIV-negative populations.

Of course, we now know that “good Truvada” has its own set of problems, most especially when it comes to cardiovascular events, but it is still marketed as Descovy for PrEP.

Finally—finally—we come to the conclusion:

The medications currently studied for PrEP (TDF and FTC) are efficacious and seem to have a good safety profile within the average short period of 3 years studied.

Three years, folks. Three years of observation of a drug that is meant to be taken in perpetuity, and whose adverse effects typically take a few years to develop, but as the 26,000+ Truvada plaintiffs can tell you, develop they will. It’s all designed to keep people enslaved in the testing/medication/more testing cycle, forever, and at great profit to our health care regulatory agencies and the pharmaceutical giants. I find it fascinating that the first lawsuits for Truvada were filed just a year after this review was published.

Finally, the article ends on an extremely ominous note.

PrEP as an intervention to reduce HIV transmission appears to have a safe benefit-risk profile in clinical trials. It is recommended for widespread use but adherence monitoring and real-world safety surveillance are critical in the post-marketing phase to ensure that the benefits observed in clinical trials are maintained in real-world use. Behavioural counselling and assurance of safety and efficacy are important components of PrEP. Other factors of PrEP implementation that have been suggested include improving access, averting stigma, cost effectiveness, and education on PrEP to improve knowledge and assure people of the efficacy profile of products used for PrEP. Further studies must ultimately look at how safe and beneficial PrEP could be for pregnant women and women seeking to get pregnant.

I have only two comments to make and then I’ll close this already very long post. First, as we have discussed already, PrEP has nowhere near even a 90% efficacy rate in clinical trials, yet we are meant to believe that somehow, in the real world, PrEP is basically perfect. We know how they pull that trick, and it is by excluding any seroconversions that happen under imperfect adherence. This has to be the case, because, as implied in the quote above, “real life” results typically underperform those in clinical trials. Also, what methods might be proposed for “adherence monitoring?” Perhaps a not creepy at all wearable device?

Lastly, this is the second time these authors have mentioned the urgency of PrEP for pregnant women, which is extremely disturbing to me. It’s also disturbing to me that in 2024, a paper such as this would never use the term “pregnant women,” but that is a topic for another discussion.

So to conclude: the problems with Truvada have always been known, but what might not have been anticipated is quite so common and far reaching they are. It will be interesting to see what happens as these lawsuits move through the courts. If you’ve made it to the end of this very long post, you’re a real one, and thank you all for reading and for your support. As always, let me know what you think in the comments.