Gilead Sciences can’t seem to shake the lawsuits over its tenofovir-based HIV drugs. In the latest, the company faces claims from two plaintiffs that it caused injuries with its older HIV medicines while shelving a safer generation of new products.
The drugs in question are Viread, Truvada, Atripla, Complera and Stribild. They contain a form of tenofovir called tenofovir disoproxil fumarate (TDF), which plaintiffs Darren Johnson and Roslyn Rochester took.
The plaintiffs argue Gilead knew TDF can cause “significant” kidney and bone damage, and that its knowledge of the situation swelled as more patients sustained injuries.
Meanwhile, Gilead also knew about a different type of tenofovir called tenofovir alafenamide fumarate (TAF), the plaintiffs say. TAF has a better safety profile than TDF and can be given at a lower dose, according to their lawsuit.
But Gilead shelved that compound for years so as to not pull sales from its TDF products, the plaintiffs say.
In this case, one of the plaintiffs suffered bone demineralization in his right hip, leading to a hip replacement. The other plaintiff incurred kidney failure as well as bone damage, leading to a diagnosis of chronic kidney disease and osteoporosis.
“TDF medications have been approved by FDA for more than two decades,” a Gilead spokesperson noted in an emailed statement to Fierce Pharma. “They are safe and effective, and continue to successfully treat and prevent HIV in millions of people.”
The company will “vigorously defend ourselves in this matter” and remains “committed to developing and improving upon therapies that address the unmet needs of people living with HIV.”
This is not the first lawsuit that has raised these allegations. Back in 2019, 140 patients sued the company based on the same arguments. Before that, in 2018, two patients sued Gilead over the same safety issue.
Earlier, in 2016, the company had a legal dispute with the AIDS Healthcare Foundation, which accused Gilead of delaying TAF in a “calculated, anticompetitive manner” to keep Viread prices high and prevent generic entries. Gilead won out in that case.