Lawsuit Alleges Gilead HIV Drugs Placed Patients At Risk of Kidney and Liver Injuries To Maximize Profits

According to allegations raised in a recently filed product liability lawsuit, Gilead exposed HIV patients to an unnecessary risk of kidney and liver injuries which may result from side effects of Truvada, Viread, Stribild and other older TDF-based medications, as part of a plan by the drug maker to maximize profits on its portfolio of HIV drugs.

In a multi-plaintiff complaint (PDF) filed in the U.S. District Court for the Northern District of California on July 9, a group of five former users of HIV drugs containing the antiretroviral tenofovir disoproxil fumarate (TDF) are attempting to hold Gilead Sciences, Inc. liable for placing profits before consumer safety.

According to the lawsuit, by the time TDF drugs were introduced, Gilead had already discovered a safer compound, known as tenofovir alafenamide fumarate (TAF), which was less toxic, yet equally effective. However, rather than introducing safer versions of the HIV treatments, Gilead sat on development of the TAF-based drugs and continued to market TDF drugs that placed patients’ kidneys and livers at risk.

“Gilead knowingly designed its TDF drugs with TDF rather than safer TAF to maximize profits on its portfolio and extend the lifecycle of its HIV franchise, which formed the backbone of Gilead’s operations,” the complaint states. “Gilead withheld its safer TAF design to make more money at the expense of patients’ health.”

It was not until patent protection expired on TDF-based drugs that Gilead began to introduce TAF-versions, including Descovy, Genvoya and others, which are now marketed as safer and more effective than the older drugs, which are now available as generics at much lower costs.

This scheme has extended the Gilead monopoly on HIV drugs for the next decade or more, while causing users to be left with devastating bone problems, liver and kidney injuries.

“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.”

The manufacturer currently faces hundreds of similar lawsuits over the HIV drugs, brought by individuals who have been left with severe and often life-altering injuries that may have been avoided if safer TAF-based drugs had been introduced earlier.