Lawsuit Alleges Truvada, Other TDF-Based HIV Drugs Caused Kidney Disease, Bone Deterioration, Other Side Effects

A group of nearly 30 people have joined together in a lawsuit against Gilead over side effects of TDF-based HIV drugs, alleging they suffered kidney injuries, bone damage and other injuries after taking antiviral medications like Truvada, Atripla, Viread, Complera and Stribild.

The complaint (PDF) was filed in the U.S. District Court for the Northern District of California on April 8, alleging the drug maker sold medications toxic to patients’ kidneys and bones, while withholding development of other formulations known to be less toxic and safer.

Each of the medications contain the compound tenofovir disoproxil fumarate (TDF), which plaintiffs allege Gilead knew had a high toxicity level. However, the drug maker failed to adequately warn about the risk of bone deterioration, fractures, kidney disease and other injuries users may experience.

The lawsuit also alleges that before introducing the medications, Gilead had already discovered a safer compound, tenofovir alafenamide fumarate (TAF), which is less toxic since it can be taken at much smaller doses for the same or better effectiveness, reducing the risk to patients. However, instead of developing and releasing the safer product, Gilead engaged in a plan to maximize products and extend patent protections for both formulations.

Gilead pressed forward with the marketing and sale of Truvada and other TDF-based drugs, while sitting on the development of safer TAF versions of the medications. It was only after patent protection ran out and the older HIV drugs faced competition from generic TDF equivalents that Gilead introduced TAF-drugs.

“Falsely claiming that TAF was not different enough from TDF, Gilead abruptly shelved its TAF design in 2004. However, as John Milligan, Gilead’s President and Chief Executive Officer, later admitted to investment analysts, the real reason Gilead abandoned the TAF design was that TAF was too different from TDF,” the lawsuit states. “Once Gilead’s first TDF product, Viread, was on the market, Gilead did not want to hurt TDF sales by admitting that its TDF-based products are unreasonably and unnecessarily unsafe.”

Now that various TAF-based HIV drugs are sold by Gilead, including Descovy, Genvoya and others, the drug maker promotes the medications as safer alternatives to the TDF-based generic competitors to their older medications.

Plaintiffs allege the decision to withhold development of TAF-based drugs was part of a scheme intended to allow Gilead to maintain an essential monopoly on HIV treatments until at least 2032. However, as a result of this decision to place profits before consumer safety, thousands of individuals nationwide have been left with severe injuries that may have been avoided.

The manufacturer faces a growing number of complaints filed by plaintiffs nationwide, who say they suffered Gilead HIV drug side effects. Most of the complaints are currently pending in California state court, but a number have also been filed in various federal district courts nationwide over the past year.