Gilead Knew About Toxic Risks from Truvada, Atripla and Other HIV Drugs, Lawsuit Alleges

According to allegations raised in a product liability lawsuit filed on behalf of about 30 plaintiffs, Gilead was aware of the toxic side effects of Truvada, Atripla and other TDF-based HIV drugs, and knew there were safer alternatives, but withheld development and warnings to increase profits.

The complaint (PDF) was filed in the U.S. District Court for the Northern District of California on February 23, pursuing damages from Gilead Sciences, Inc. over its sale and manufacturing of the HIV drugs Viread, Truvada, Atripla, Complera and Stribild.

According to the lawsuit, Gilead knew before introducing the medications, which all used tenofovir disoproxil fumarate (TDF) as an active ingredient, that the products have a high toxicity level that could threaten the kidney and bones. However, plaintiffs indicate that Gilead had already discovered an alternative, 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.

Instead of developing and marketing TAF-based HIV drugs, the lawsuit alleges Gilead decided to continue promoting the more toxic TDF drugs until its patent protection ran out, only then ramping up sales and marketing for the TAF versions of the drugs.

“In addition to withholding safer designs, Gilead failed to adequately warn physicians and patients about the risks and safe use of TDF,” the lawsuit states. “Gilead provided only the weakest, inadequate warnings to doctors and patients about the need for frequent monitoring of all patients for TDF-associated kidney and bone damage—preventing doctors from detecting early signs of TDF toxicity.”

It was only after the blockbuster drugs were about to face competition from generic equivalents of Truvada and other TDF drugs that Gilead introduced safer TAF-based versions, marketing them as safer than the toxic drugs they had sold for years without adequate warnings for consumers.

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 lawsuit indicates those drugs were “unreasonably dangerous” given its access to the TAF-based drugs.

The lawsuit joins 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.