More bad news for Truvada & Gilead

Switching to “Good Truvada” won’t help the kidneys

This will be a short one, but since there are so very few of us reporting on the dark side of the “anti HIV” drug industry, I remain committed to reporting on news items relevant to this industry, especially when it comes to Truvada and PrEP. Also, I’d like you to note that this is a study involving Truvada for PrEP.

Kidney Function Not Improved in Patients With HIV Who Switch to TAF-Based PrEP

Before we even get started, I want to quit. “Patients with HIV who switch to TAF-Based PrEP”? I thought PrEP was for patients without “HIV.” I’m going to chalk this up to a typographical error or total brain melt moment on the part of the copyeditor, take one for the team, and move on, but it does make one wonder.

Gilead just can’t get ahead, apparently. Not only are they under a massive class action lawsuit for allegedly covering up the fact that they withheld a less toxic alternative to TDF (“bad Truvada”) by covering up known kidney and bone toxicities related to that drug, but now it turns out that “good Truvada” isn’t that great for the kidneys, either. The lawsuits allege that Gilead covered up the fact that they knew that the TAF (“good Truvada”) formulation had been shown to be less toxic to the kidneys than “bad Truvada.” Except, oops, that turned out not to be true.

Researchers conducted a retrospective cohort study using data sourced from Kaiser Permanente Southern California. Adult patients (N=528) with HIV infection who initiated TDF-based PrEP between 2014 and 2021 were included in the analysis. Patients who switched to TAF between October 2019 and May 2022 were matched 1:4 against those who continued TDF via time-varying propensity score matching. The primary outcome was kidney function for up to 18 months post-switch, which was assessed via estimated glomerular filtration rate (eGFR).

This is extremely tortured language, and if what they were saying were actually interesting I’d attempt to decipher it, but it isn’t, so I won’t. The only thing worth noting is that they looked at kidney function up to 18 months post switch, which does seem ample time for metabolic markers to calm down.

The entire basis for this study is comparison of the estimated glomerular filtration rate (eGFR), itself a surrogate marker, which might perhaps suggest that suspicion ought to be warranted, but it’s the only marker we have, so let’s carry on. Here’s the summary (emphasis mine):

The researchers used the recorded switch date for patients who switched to TAF and an assigned switch date for those who continued TDF as the index date for the follow-up period. Bayesian linear mixed-effects models were used to evaluate eGFRs among patients in the TAF group in a counterfactual scenario in which the switch had never occurred. The model was adjusted for patient sex, age at TDF initiation, race and ethnicity, insurance type, smoking status, cardiometabolic comorbidities, and body weight.

[…]

There was no clinically meaningful difference in eGFR observed between the groups, and similar trends were observed in weighted and inverse propensity matching analyses.

Limitations of this study include the retrospective design, missing data, the short follow-up period, and the use of eGFR measurements to assess kidney function rather than clinical events.

“Our results do not support that switching from TDF to TAF would improve eGFR in our sample of insured patients using PrEP,” the researchers noted. “Confirmatory studies with larger cohorts and longer follow-up or randomized switch or crossover trials are needed to confirm our findings,” they concluded.

I guess “good Truvada” isn’t so good after all. Is anyone even the slightest bit surprised? After all, this is the industry that quietly abandoned the miracle protease inhibitors. It’s like a dog chasing its own tail at this point. (Also, how did they get that title so self contradictory?)

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