More red flags with Lenacapavir; Biden administration adds injectable PrEP requirements for insurance providers

Why so many new drugs? I have a theory (read to the end).

Two short stories for you today:

Gilead, Merck announce from Phase 2 islatravir/lenacapavir combo study

The first thing I’d like to notice is that this is not a trial for lenacapavir for PrEP but rather for ARVs for “HIV” positive patients. Also, it is notable that this formulation is an oral medication and not a long-acting injectable. I wonder why that is. However, given that lenacapavir alone was allegedly “perfect” in preventing “seroconversions” (except when it wasn’t), why are they adding a new drug? And what is this new drug, islatravir? Well, per the article linked above, it is an “investigational nucleoside reverse transcriptase translocation inhibitor.” So it’s an NRTI—the oldest class of “anti-HIV” drug—but it’s also “investigational.” That sounds… concerning. How much would you bet it was developed “in silico”?

The results of the study are not that exciting, but I’ll summarize as follows:

At 48 weeks, the novel investigational combination maintained a high rate of viral suppression in virologically suppressed adults, a secondary endpoint of the study. Zero participants had a viral load of greater than or equal to50 copies/mL at Week 48. Week 24 results, including the study’s primary endpoint, were previously presented at the 31st Conference on Retroviruses and Opportunistic Infections. In this open-label, active-controlled study, virologically suppressed adults on Biktarvy were randomly allocated in a 1:1 ratio to receive either oral islatravir 2 mg and lenacapavir 300 mg once a week or to continue daily oral Biktarvy. The median age of participants was 40 years. Eighteen percent of participants were assigned female at birth, 50% were non-white, and 29% were Latine. The proportion of individuals with HIV-1 RNA less than50 c/mL at Week 48 by FDA snapshot algorithm, showed that participants who switched to treatment with once-weekly islatravir and lenacapavir or continued Biktarvy maintained comparable high rates of HIV suppression at Week 48. No participants treated with either ISL + LEN or Biktarvy had a viral load of greater than or equal to 50 copies/mL at Week 48. No grade 3 or 4 TRAEs related to the study drug were reported in either treatment group. Two participants discontinued ISL + LEN due to adverse events unrelated to the drug. At Week 48 no significant differences were seen between treatment groups in mean change from baseline in CD4+ T-cell counts or absolute lymphocyte counts.

So it’s no better than Biktarvy, which, as we reported, is statistically no better (as PrEP) than no treatment at all. Also, the patients were already “virologically suppressed” before entering the trial, and remained so throughout, but there was really no improvement. If the drugs already in circulation are all so “life-saving” that they reduced “HIV” to a “chronic, manageable condition”, why on earth do we need even more designer drugs? I think we know why. I’ll also note that 48 weeks isn’t even one year; the devastating side effects occur cumulatively, so there is really no way to know the toxicities of this novel combination medication. Moving on to the next piece of news.

Biden administration adds injectable PrEP requirement for insurance providers

The Biden-Harris administration announced Monday a new requirement for insurance providers to cover injectable PrEP in their policies without a co-payment for consumers. The new rule, built on previous guidance for the Affordable Care Act, also applies to increased choice in contraception. […] President Joe Biden announced the same benefit added to Medicare coverage for those over 65 in September.

We covered the Medicare issue before. Basically this requirement “needed to be” added because Medicare didn’t address the fact that a “medical device” (in this case a syringe) is needed to administer the medication. From the article, “A drug-led combination product is a therapy or diagnostic drug delivered by a medical device, including a syringe, the standard delivery device for injectable PrEP.” Anyway, there isn’t a whole lot to this story, but I want give you all the news as it pertains to PrEP, and this qualifies as news, and it is relevant for the following reason:

The multi-billion dollar “HIV” industry continues to develop and market and sell more and more drugs despite their very own narrative that by the mid-1990s, the drugs were so wonderful that they had effectively “ended AIDS.” Most alleged viral diseases don’t have dozens of associated antivirals. (But for “HIV” we need to throw money at researchers to come up with even more drugs, which always, hilariously, end up having to have an old school NRTI added to them for some reason, as stated at the top of the post. Actually, I have become increasingly suspicious that the toxicities are most of the reason they keep having to develop new iterations of these many drugs I’ll expand on this in an upcoming post.) And the government continues to expand access to PrEP, all at taxpayer expense. We are paying for this. People taking PrEP are paying for the destruction of their health, if not directly to the pharmacy then indirectly via taxes. This is insane, destructive, and it needs to stop.