A large group of plaintiffs have filed a Gilead TDF lawsuit against Gilead Sciences, Inc., alleging that the biotechnology company manufactured and sold HIV medications that caused serious complications, including bone density and kidney problems.

Gilead manufactures a number of HIV drugs, including:

• Atripla
• Complera
• Stribild
• Truvada
• Viread

These drugs contain a form of the compound tenofovir, which belongs to a class of drugs known as NRTIs that are used to treat HIV. Tenofovir itself is not safe to be taken by mouth, so Gilead developed a version known as tenofovir disoproxil fumarate (TDF) that could be taken orally. However, a high dose of TDF—300 mg—is generally required for treatment.

Unfortunately, these medications have been linked with kidney problems, including kidney damage and kidney failure, as well as bone demineralization that can lead to bone fractures. Patients claim in this new Gilead TDF lawsuit that the company has the ability to release a safer HIV drug, yet has chosen not to in order to maximize its profits from these drugs first.

Gilead Drug History

Gilead’s first TDF drug meant to treat HIV was Viread, which was approved by the U.S. Food and Drug Administration (FDA) back in 2001. Its latest was Stribild, approved in 2012. However, the group of plaintiffs involved in this lawsuit allege that even before Gilead began selling Viread, it knew that TDF-based medications could increase the risk of kidney and bone problems in patients, according to preclinical data.

Two factors increase this risk, both of which Gilead would have been aware of, the lawsuit claims. Firstly, the higher dose of TDF required for effective HIV treatment creates a greater risk of toxic side effects. Secondly, HIV has no cure, so these HIV drugs are meant to be taken long-term. Long-term use of TDF, especially at a higher dose, would compound to create an even greater risk of these complications.

After Gilead began selling each of its TDF-based drugs, patients began reporting serious side effects, so by the time Gilead released Stribild in 2012, the lawsuit claims, the company had amassed 10 years’ worth of evidence connecting TDF with kidney and bone injuries.

Despite the company manufacturing and selling five different versions of the toxic TDF medication, Gilead has developed a safer form of tenofovir, known as tenofovir alafenamide fumarate, or TAF. A much lower dose of TAF (25 mg) is required than of TDF (300 mg) for the same effect, without the same risks.

The lawsuit alleges that Gilead chose to shelve its TAF design in 2004, not wanting to admit that its TDF drugs are, by comparison, “unreasonably and unnecessarily unsafe,” which would inevitably hurt TDF sales, the lawsuit claims. Notably, Gilead used to promote Viread as a “miracle drug” with “no toxicities,” according to the lawsuit.

Patient advocates agree, calling for Gilead to pay plaintiffs who suffered.

In 2015, Gilead finally began selling its TAF-based medicines on the grounds that TAF is safer than TDF due to kidney and bone toxicity.

The Gilead TDF lawsuit was filed on Sept. 17, 2019, in the U.S. District Court for the Northern District of California, and alleges that Gilead failed to adequately warn doctors and patients alike about the risks of TDF-based drugs.

The Gilead TDF Lawsuit is Case No. 4:19-cv-05816-DMR, in the U.S. District Court for the Northern District of California.