Two men in Louisiana have filed lawsuits over TDF HIV antiviral drugs, accusing Gilead of failing to fully disclose the potential for kidney damage and bone loss associated with Viread and Truvada.
The lawsuits also accuse the pharmaceutical company of maliciously and deliberately suppressing the development of a safer alternative treatment in order to maximize profits from TDF.
Viread (tenofovir disoproxil fumarate) was the first TDF antiviral medication approved by the U.S. Food & Drug Administration (FDA) for the treatment of HIV and Hepatitis B.
The FDA has approved several TDF combination medications since Viread came to market in 2001, including:
In 2012, Truvada became the first TDF drug approved by the FDA for PrEP.
According to a complaint filed in the U.S. District Court, Middle District of Louisiana, on July 26th. Willie Hills, Jr. alleges that he developed chronic kidney disease due to Viread. (Case 3:18-cv-00718-SDD-EWD)
According to a second lawsuit filed in the U.S. District Court, Western District of Louisiana, on July 27th, Christopher Pierot’s use of Truvada resulted in severe bone density loss and necrosis in both hips. As a result, Mr. Pierot was forced to undergo a double hip replacement when he was just 30-years-old. (Case 3:18-cv-00975)
“Gilead knew that TDF toxicity led to kidney and bone damage, even in patients without pre-existing kidney or bone issues. Gilead had a duty to share its exclusive knowledge of the risks and adequately warn of any known or scientifically knowable risks associated with the use of TDF,” the complaints state. “Instead, Gilead misrepresented the safety and benefits of TDF and failed to provide prescribing physicians and their patients, including Plaintiff and his doctors, with the information they needed to safely and reasonably prescribe and take Gilead’s drugs.”
Both plaintiffs further allege that Gilead intentionally shelved a safer version of tenofovir – tenofovir alafenamide or TAF – in order to protect its valuable TDF patents, which weren’t due to expire for over a decade.
“In April 2002, as prescriptions for TDF were growing along with Gilead’s market share, Gilead’s research continued to confirm TAF’s diminished toxicity and TDF’s verified risks to bone and kidneys,” the complaints charge. “But, Gilead did not publish this research, did not conduct clinical trials of TAF, did not change its prescribing information, and did not instruct its sales representatives to begin informing doctors that the toxicities associated with TDF could be eliminated with a new, better drug.”
The Louisiana lawsuits follow the filing of similar complaints in California, including a personal injury claim and another that seeks class action status on behalf of residents of California 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.