Gilead HIV Drugs Unnecessarily Toxic, Lawsuit Claims

According to allegations raised in a recently filed lawsuit, the Gilead HIV drugs Truvada, Viread, Atripla, Complera and Stribild are unnecessarily toxic, causing a number of plaintiffs to suffer various kidney and bone injuries.

The complaint (PDF) was filed in California Superior Court on December 30, on behalf of Glen Roske, Richard Wollschleager, Anna Eversole and Johnene Barras. Gilead Sciences is named as a defendant in the case, together with a number of unnamed corporations and individuals.

Each of the plaintiffs indicate that they suffered side effects from Gilead HIV drugs, which all contain the antiviral tenofovir disoproxil fumarate (TDF), which is toxic to the kidneys and bones, resulting in acute kidney injuries, chronic kidney disease, kidney failure, bone fractures, dental injuries and other complications associated with bone density loss.

According to the lawsuit, 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 withheld the safer alternative for years, until the patent protections expired on TDF drugs and generic equivalents were introduced.

“Beginning in 2001, Gilead manufactured and sold prodrug form of tenofovir called tenofovir disoproxil fumarate, or TDF. Unbeknownst to Plaintiffs and the general public, Gilead had also developed another prodrug form of tenofovir called tenofovir alafenamide fumarate, or TAF, which it knew to be more efficacious and less toxic to kidneys and bones,” the lawsuit states. “Yet, despite knowing of the disparity in safety between TAF and TDF, Gilead shelved the TAF project in 2004 to artificially and unreasonably maximize profits on the existing TDF patent.”

The company did not begin to sell TAF-designed drugs until 2015, plaintiffs point out, which extended Gileads essential monopoly on HIV treatments until 2032. TDF drug patents began expiring last year. While generic versions have been introduced, Gilead now markets TAF drugs as a safer and superior alternative, preserving the profits generated from the brand-name medications.

Plaintiffs indicate that they have suffered various injuries to kidneys, bones and teeth, which could have been prevented if the safer TAF versions of the drug had been introduced earlier. They present claims of negligence, strict product liability, breach of warranties and fraud and concealment.

Gilead Sciences currently faces several other complaints in different U.S. District Courts, which involve hundreds of plaintiffs, each raising similar allegations that consumers and the medical community have not been adequately warned about the potentially toxic side effects of TDF drugs used for treatment of HIV.