TDF (tenofovir disoproxil fumarate) HIV anti-viral drugs, including Truvada, Viread, Atripla, Complera, and Stribild have been linked to bone demineralization, as well as chronic kidney disease and other serious kidney complications.
Recent legal filings accuse Gilead of misrepresenting TDF side effects and withholding a safer version of tenofovir until its original TDF patents expired.
Tenofovir disoproxil fumarate (TDF) is indicated to treat chronic hepatitis B and prevent and treat HIV/AIDS.
TDF was initially synthesized in 1984. However, it was not until 1997 that researchers from Gilead and the University of California, San Francisco demonstrated that tenofovir had anti-HIV effects in humans when administered via subcutaneous injections.
Tenofovir disoproxil fumarate (Viread) was approved by the U.S. Food & Drug Administration (FDA) on October 26, 2001 for the treatment of HIV. The agency would go on to clear the drug as a treatment for chronic hepatitis on August 11, 2008.
Since then, the FDA has approved other TDF drugs, including:
Truvada was the first TDF drug approved by the FDA for pre-exposure prophylaxis (PrEP) to prevent the transmission of HIV.
Tenofovir disoproxil fumarate is now one of most-prescribed HIV medications in the world, with $11 billion in annual sales. In fact, TDF drugs are now taken by some 627,000 Americans, or roughly 80% of those being treated for HIV.
TDF can cause serious, life-threatening side effects, including a buildup of lactic acid in the blood (lactic acidosis) and severe liver problems.
Patients taking TDF HIV anti-viral drugs should contact their doctor right away if they experience signs or symptoms of lactic acidosis, including:
Patients should also contact their doctor immediately if they notice signs of a potential TDF-related liver problem, including:
Other possible TDF side effects include:
TDF has been linked to serious kidney injuries when used to treat HIV, including:
In rare cases, kidney side effects have also been seen in patients using TDF for PrEP.
TDF HIV anti-viral drugs have also been linked to bone demineralization, which can compromise bone density and lead to:
According to one recently published paper, several studies have demonstrated an approximately 1% to 3% greater bone mineral density loss with TDF compared to other agents.
Gilead began working on a new version of tenofovir (tenofovir alafenamide or TAF) more than a decade ago. However, the company halted its TAF research in 2004 and chose to not to publish findings that suggested TAF was less toxic to the bones and kidneys compared to TDF.
Gilead’s research into TAF would not resume until 2010, several years before the company’s TDF patents were set to expire.
The FDA finally approved TAF as part of a combination drug called Genvoya in November 2015. The agency has since approved several other TAF drugs, including Biktarvy and Descovy.
Gilead is now facing several personal injury lawsuits filed on behalf of patients who allegedly experienced serious kidney side effects or bone demineralization related to their use of TDF HIV anti-viral drugs.
Among other things, the TDF HIV anti-viral drug lawsuits accuse Gilead of downplaying the potential for serious renal complications and bone demineralization by misrepresenting these risks “as primarily for already-renally impaired or bone-compromised patients.”
Plaintiffs further claim that Gilead intentionally delayed the development of TAF to protect its valuable TDF patents, allowing HIV positive patients to continue using a medicine that was harmful to their kidneys and bones.
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