A few notes on oddities in the Lenacapavir long-acting injectable trial—“ZERO Infections?”

Not so fast, Gilead.

Well, it appears that the search for an “HIV” vaccine really has gone to die, in favor of twice-yearly massive doses of the antiretroviral drug, lenacapavir. No doubt you have heard the stunning headlines touting “ZERO new ‘HIV’ infections” in Gilead’s Phase I trial. We have discussed this briefly before, but there are a few curious items of note in the following piece, which appeared July 5.

No HIV Infections After Twice-a-Year PrEP

Pardon my skepticism here. Gilead, the manufacturer of the disastrous drug Truvada, are going to “end the ‘HIV’ epidemic” with a twice-yearly antiviral injection? What were the safety signals in this trial? None of the articles I have found give that information, except to say that it is “generally well tolerated.” Furthermore, the trials were so stunningly successful that they were halted early, so that all participants could receive lenacapavir, rather than the “placebo,” which in this case was either Truvada (TDF, or “bad Truvada”) or Descovy (TAF, or “good Truvada”). When has this happened before? Oh, right, AZT. That ended well. As always, emphasis is mine throughout.

Lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, has shown 100% efficacy in preventing HIV in women at a high risk for infection, according to an interim analysis of the phase 3 PURPOSE 1 trial.

The results were so promising that the independent data monitoring committee recommended that Gilead Sciences stop the blinded phase of the trial and offer open-label lenacapavir to all participants.

As we have discussed previously, this phase of the trial lasted two years, from November 2021 to November 2023, and enrolled over 5300 biological women. Here is the link to the study details if you’re interested. According to the Phase I results:

There were no cases of HIV infection among the more than 2000 women in the lenacapavir group; in contrast, the incidence of HIV in the Descovy group was 2.02 per 100 person-years and in the Truvada group was 1.69 per 100 person-years.

The background incidence of HIV, one of the primary endpoints of the trial, was 2.41 per 100 person-years with lenacapavir. All the drugs were shown to be safe and well tolerated, and the full interim data from the trial will be released at an upcoming conference, according to Das.

All the drugs were safe and well tolerated? Really? That’s quite amazing, considering the tens of thousands of patients are currently engaged in litigation with the very company manufacturing the drugs in this study for the severe adverse effects associated with, in particular, “bad Truvada” (TDF). This reminds me of the reports that PrEP failure is “exceedingly rare,” except of course in clinical trials, where it is fairly commonplace. Weird, that.

There are a few more oddities with this article. There were no “infections” in the lenacapavir group, and the incidence rate for “bad Truvada” was 1.69 per 100 person-years (meaning that out of 100 people exposed for one year, you would expect 1.69 “seroconversions,” or, equivalently, a 1.69% expectation of “seroconversion” after 100 years of exposure for a single individual). For Descovy, the rate was 2.02 per 100 person-years. The estimated “background incidence” of “HIV” was only slightly higher, at 2.41 per 100 person-years. All of a sudden, “no ‘infections’” doesn’t sound quite so impressive. This is because we are dealing with a population of biological women, whose “background incidence” of “HIV” is already very low. We’ve discussed this before; I’m not saying anything new here, but it bears repeating. And another thing—how useless does this study indicate either “good Truvada” or “bad Truvada” is, when comparing “seroconversion” rates? Looking at the numbers, I’d say these drugs are not only toxic but ineffective at what they are purported to do. And one last thing—why are combinations of NRTIs/integrase inhibitors being trialed against capsid inhibitors? It’s almost as if the distinction between these allegedly cutting-edge, highly specific “anti HIV” drugs is one without a difference—yet more sleight of hand from the pharmaceutical industry and the HIV AIDS gatekeepers.

The article goes on to discuss stigma, which I agree is terrible, especially stigma against people testing positive on a test not testing for a virus. Injectable PrEP is seen as more discreet and convenient than oral PrEP—of course it is. We don’t need a two year long clinical trial to know that most people would prefer taking fewer medications. However, there are a few interesting tidbits in the conclusion.

The company has not signed up for the Medicines Patent Pool (MPP) to allow companies to manufacture generic formulations of lenacapavir, which Gandhi said is the traditional route to provide cheaper alternatives in poorer countries. The "disastrous" roll out of injectable cabotegravir, which is still not widely available in lower-income countries, is a worrying precedent, she said.

Gilead Sciences confirmed that all 5300 participants in the PURPOSE 1 study will have the option to continue receiving lenacapavir until the drug is generally available in their country. The company has committed to ensuring a dedicated Gilead Sciences supply in the countries where the need is the greatest until voluntary licensing partners are able to supply high-quality, low-cost versions of lenacapavir.

And rather than going through the third-party MPP, Gilead Sciences is negotiating a voluntary licensing program directly with other partners to supply generic versions of the drug in poorer countries.

Again, I’m skeptical of anything Gilead does. Take note of their lack of willingness to allow lenacapavir to go generic—this seems to be a real problem for this company. We also need to keep in mind that these results are only Phase I—there are still two more phases the trials must complete before final approval. Supposedly.

Finally, what about lenacapavir for “risk groups” other than biological women, which form the large majority of the “HIV” positive population? Don’t worry, those are ongoing as well.

Lenacapavir is already approved for the treatment of multidrug-resistant HIV but is not yet approved for HIV prevention. A sister trial, PURPOSE 2, is ongoing and is testing lenacapavir in men who have sex with men and in transgender men, transgender women, and nonbinary individuals who have sex with partners assigned male at birth. Should those results, expected by the end of 2024 or early 2025, be positive, the company will move forward with regulatory filings for lenacapavir PrEP.

There we have it. “Should those results be positive,” Gilead will move forward. I’m not holding my breath. The history of AIDS medicine is full of full on, disastrous iatrogenocide in the form of AZT and now, Truvada, as well as so-called “miracle drugs” whose use is almost entirely abandoned once the severity of their adverse effects proves too obvious to hide. Let’s not even discuss the completely failed search for an “HIV” vaccine. All we have left are these intentionally cell-killing drugs, designed now to be given in massive doses, twice yearly, to patients having no hint whatsoever of “HIV” infection. Back in March 1984, did we ever think that forty years later, this would be as far as we’ve come? Disgraceful.

As always, let me know what you think in the comments.

One final note: My new Kindle ebook, The Truvada and PrEP Disaster, is available TODAY for the low price of $2.99. Please spread the word to anyone you know that still believes the insane lies about the “lifesaving antiretroviral drugs.” Thank you!