Lawsuit Accuses Gilead of Misrepresenting TDF Side Effects, Delaying Safer HIV Drug

Published on November 7, 2018 by Sandy Liebhard

Gilead is facing yet another lawsuit over its TDF-based HIV medications, Viread and Truveda.

The complaint, which was filed in the U.S. District Court, Central District of California, on November 1^st (Case No. 18-1865) names four plaintiffs:

• A Louisiana resident treated with Truveda from 2015 through the present, who experienced acute kidney failure, stage III kidney disease, and severe bone mineral density loss.
• A New York resident treated with Viread from 2003 through the present, who suffered bone density loss, bone necrosis, various bone fractures, and complete kidney failure.
• A Pennsylvania resident treated with Truveda from 2010 through August 2016, who developed kidney failure.
• A Virginia resident treated with Truveda from 2007 through 2017, who suffered complete kidney failure.

Viread and Truveda Labels Downplayed Kidney and Bone Risks

All of the plaintiffs were taking the tenofovir-based medications either to manage HIV or prevent the infection. They claim that their injuries were the direct result of their treatment and accuse Gilead of concealing these risks from the public.

“Viread and Truvada, both of which deliver tenofovir through the TDF drug design, have been shown to cause kidney damage, loss of kidney function, acute kidney failure, chronic kidney disease, severe loss of bone mineral density, premature and severe fractures and bone breaks, and bone necrosis,” the complaint states.

Rather than warn doctors and patients about these potential side effects, the prescribing information for Viread and Tenofovir indicated that bone or kidney damage would only affect patients with pre-existing kidney or bone issues.

Gilead’s Delay Tactics Allowed it to “Reap Outsized Profits” From TDF HIV Drugs

The plaintiffs also accuse Gilead of delaying development of a safer and more effective HIV treatment – tenofovir alafenamide or TAF -in order to protect its valuable TDF patents.

“After learning that TAF had a higher absorption rate and largely avoided the bone and kidney toxicity associated with TDF, Gilead shelved its development of TAF and instead kept HIV infected patients and their doctors in the dark about the true risks associated with TDF, along with the solution to those risks, for over a decade,” the lawsuit continues.  “In 2014, as Gilead’s patent on TDF approached its expiration and Gilead faced a sharp decrease in profits that would result from competition entering the market for TDF-containing drugs, Gilead decided to release the results of the TAF studies it began conducting in 2001.”

Plaintiffs contend that Gilead’s tactics have allowed it to “reap outsized profits” from the high costs of its TDF drugs, which ultimately “limit patient access either through exorbitant out-of-pocket costs or co-pays, limitations in existing insurance, and rationing of these high-priced pills.”

Additional TDF HIV Drug Lawsuits Pending in California, Louisiana

The U.S. Food & Drug Administration (FDA) approved Viread (tenofovir disoproxil fumarate) in 2001.

Since then, the agency has approved several TDF-based combination HIV drugs, including:

• Truvada (emtricitabine/TDF)
• Atripla (efavirenz/emtricitabine/TDF)
• Complera (emtricitabine/rilpivirine/TDF)
• Stribild (elvitegravir/cobicistat/emtricitabine/TDF)

In 2012, Truvada became the first TDF drug approved by the FDA to prevent HIV infection.

Gilead is facing a growing number of legal claims involving its TDF HIV medications, including additional personal injury lawsuits that have been filed in Louisiana and California.

The company is also the subject of a class action lawsuit that seeks to represent California residents who were “prescribed and ingested TDF HIV antiviral drugs since October 26, 2001 through the present and who were personally or whose physicians were exposed to Gilead’s alleged misrepresentations.”