Clinical trials to begin for TWICE YEARLY PrEP

We thought the Truvada disaster was bad—this has the potential to dwarf that

I’ll be addressing this in much more detail later this week, but I wanted to draw your attention to the fact that a clinical trial is set to begin in the United States involving a medication for “HIV” that is ordinarily used only for treatment-experienced, drug-resistant “HIV” positive patients, only this time it will be trialed in “HIV”-negative individuals for PrEP. Read the story here:

U.S. clinical trials begin for twice-yearly HIV prevention injection

Two clinical trials have launched to examine a novel long-acting form of HIV pre-exposure prophylaxis (PrEP) in cisgender women and people who inject drugs. The mid-stage studies will assess the safety, acceptability, and pharmacokinetics (how a drug moves through the body) of lenacapavir, an antiretroviral drug administered by injection every six months. The studies are sponsored and funded by Gilead Sciences, Inc., and implemented through the HIV Prevention Trails Network (HPTN). The HPTN is supported by grants from the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID), with scientific collaboration on this study and others from the National Institute on Drug Abuse (NIDA) as well as co-funding from NIDA and other NIH institutes.

What a surprise—our old friend Gilead Sciences is behind this. Apparently damaging the lives and health of at least 26,000 Truvada users isn’t enough for them; it’s full steam ahead in administering these drugs to people with no hint of “HIV”-associated genetic material. And of course NIH and NIAID are involved.

There is plenty to be concerned about here. As we know, the medications most commonly used for PrEP are Truvada (containing TDF) and Descovy (containing TAF, aka “good Truvada”). These medications contain two active ingredients—the tenofovir-based drug is a nucleoside “reverse transcriptase inhibitor” or NRTI, and emcitricabine is an integrase inhibitor.

The new medication to be trialed is lenacapavir, sold under the brand name Sunlenca, and it is a novel type of medication known as a capsid inhibitor. Per Wikipedia, “Lenacapavir works by binding directly to the interface between HIV-1 viral capsid protein (p24) subunits in capsid hexamers, interfering with essential steps of viral replication, including capsid-mediated nuclear uptake of HIV-1 proviral DNA, virus assembly and release, production of capsid protein subunits, and capsid core formation.” You may recall that p24 has been shown not to be specific to “HIV,” but this may be the least of the potential problems with this medication. Continuing (emphasis mine throughout):

Lenacapavir is already approved by the Food and Drug Administration for HIV treatment, in combination with other antiretroviral therapy, of heavily treatment-experienced individuals, whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations with other drugs and developed multidrug resistance. Lenacapavir is the first of a class of drugs called capsid inhibitors to be FDA-approved for treating HIV infection. It is the first long-acting injectable to be offered with administration just once every six months.

Lenacapavir is a very new medication; in just 2021 it was being trialed as an ARV. Again, according to Wikipedia, “The safety and efficacy of lenacapavir were established through a multicenter clinical trial with 72 participants whose HIV infections were resistant to multiple classes of HIV medications. These participants had to have high levels of virus in their blood despite being on antiretroviral drugs.”

You could be forgiven for wondering what incredible mental leap had to have been taken to repurpose a drug that is specifically indicated for those with a high “viral load” and “treatment resistance” as a drug for PrEP, which is specifically indicated for people with NO “viral load,” BY DEFINITION. Even worse, this is intended to be given in presumably massive doses, once every six months. What could possibly go wrong? (Also, the trial for lenacapavir only enrolled 72 participants? Talk about underpowered.)

Finally, let’s look a little at how the trials will be designed and whom they will enroll.

The studies will take place at HPTN sites in the United States and enroll people who might benefit from taking PrEP. The first trial will enroll cisgender women, with a focus on making enrollment accessible to women who self-identify as Black and/or Latina. The second trial will enroll a diverse group of people who inject drugs. In both studies, participants will be randomly assigned to receive either injectable lenacapavir or an FDA-approved PrEP formulation consisting of oral tenofovir disoproxil fumarate and emtricitabine. Participants’ health will be monitored closely throughout the study. Participants will provide laboratory samples and give qualitative feedback on their experience taking each form of PrEP.

So the “placebo” in this trial will be “bad Truvada.” Except it isn’t a placebo at all, not only because it’s an active medication, but also because this study is necessarily unblinded, given that one drug is injectable and the other is oral. That’s a design problem. Also, there has certainly been plenty of hand-wringing about Black, cisgender women not “accessing PrEP” in numbers sufficient to satisfy the public health authorities, so I guess this trial represents an attempt to try and lure them in yet again. I’m skeptical whether this will work; as we have seen, the Black community is well aware of the potential damage that the regulatory agencies have historically been able to inflict upon them, and they’re proving themselves too smart to fall for it again.

Regardless, we should all be very concerned about this development. Clearly, when it comes to treating “HIV,” no medication or medication regime is too toxic; there is simply no other explanation as to why they are being so reckless in prescribing these toxic “anti-HIV” drugs as PrEP to the general public as a kind of vaccine. This needs to stop, or the AZT scandal and the Truvada disaster will look like child’s play in comparison to the disaster that will eventuate if this continues.