HIV Drug Study Highlights Difference In Kidney, Liver Risks Between Older and Newer Gilead Drugs

As Gilead faces thousands of HIV drug lawsuits over side effects of Truvada, Viread and other TDF-based medications, the findings of a new report highlight key safety differences between those medications and new versions, which the complaints allege were withheld for years to maximize profits.

The data has been published as a special communication in the Journal of the American Medical Association (JAMA), outlining recommendations of the International Antiviral Society’s USA Panel on October 14.

For years, Gilead has sold an evolving line of tenofovir disoproxil fumarate (TDF) HIV drugs, including Truvada, Viread, Atripla, Complera and Stribild. However, according to a number of lawsuits filed against Gilead in recent months, Gilead has known for years that a less toxic version of the drugs could be developed, involving the antiviral tenofovir alafenamide fumarate (TAF), yet the drug maker continued to sell the more toxic versions without adequate warnings.

It was only after the blockbuster drugs were about to face generic competition that the drug maker introduced TAF-based drugs, marketing them as safer and less toxic than the TDF-drugs they had sold for years.

The differences between the safety profiles in the TDF and TAF drugs are highlighted in the data supporting the panel’s recommendations for HIV drugs, supporting much of the concerns over risks associated with TDF drugs, including kidney damage and bone fractures.

In the portion of the recommendations dealing with kidney disease, the panel recommends any patients taking TDF-based drugs who develop a type of kidney disease known as proximal tubulopathy be switched to a TAF-based HIV drug instead, but only after common causes of kidney disease have been excluded.

The recommendations also note that bone loss appears to occur with greater frequency with TDF drugs like Truvada, than with the “newer” TAF based medications. Again, it calls for moving away from TDF-based drugs if there are signs of osteoporosis or other forms of bone loss.

In litigation being pursued by former users left with severe kidney and bone injuries, plaintiffs claim that Gilead intentionally delayed the introduction of safer TAF-based drugs for years, to maximize profits from the more toxic TDF versions while they still enjoyed exclusivity for the blockbuster medications.

Plaintiffs allege that the decision to withhold development of TAF versions was part of a scheme intended to allow Gileaad to maintain an essential monopoly on HIV treatments until at least 2032. However, in doin so, the drug makers failed to warn consumers about the risks associated with the blockbuster TDF drugs that were sold for years, exposing the company to substantial liability.