Truvada Kidney Failure

Patients taking Truvada face an increased risk of developing kidney failure and severe renal problems. In a 2016 Truvada lawsuit, Gilead was accused of purposefully halting the development of a new, safer version of Truvada in order to extend its patent into the 2030s and safeguard its global market dominance. As a result, HIV positive patients taking Truvada were exposed to the risk of kidney failure for a decade longer than necessary. Lawyers handling Truvada kidney lawsuits believe persons and the family members of persons who have suffered from Truvada renal failure may be eligible for significant compensation. This page provides a comprehensive look at Truvada kidney problems and other side effects of Truvada.

Truvada Treatment

Truvada (tenofovir or TDF) became available in the United States in 2001 and grew to dominate the global market for nucleoside reverse transcriptase inhibitors (NRTIs). A vital ingredient in HAART (highly active antiretroviral therapy) Truvada and tenofovir are considered front-line drugs for HIV positive patients worldwide. In fact, more than 600,000 patients in the U.S. rely on antiretrovirals containing tenofovir, as do 9 million more patients globally. Tenofovir drugs, which include Truvada, Viread, Stribild, Atripla, Symfi Lo, AccessPak for HIV PEP Expanded with Kaletra, AccessPak for HIV PEP Expanded with Viracept, Complera, Cimduo, and Genvoya, garner $11 billion in annual sales.

The kidneys serve as a filter for substances put into the body, and serve to break down the cocktail of antiretroviral drugs many HIV patients rely upon. While kidney problems are common in people with HIV in general, Truvada has been found to heighten a patient's risk for chronic kidney disease and acute renal failure more than other treatments. A study conducted at the University of California - San Francisco in 2012 found that among 10,000 HIV positive patients, the risk of chronic kidney disease rose 33% each year from taking Truvada. In other words, the risk of Truvada kidney failure increased significantly each year. Additionally, signs of Truvada kidney disease remain for at least a year following the end conclusion of treatment.

The kidneys are small organs that contain millions of nephrons, which are made of blood vessels and fluid-collecting tubes. This system of vessels and tubes typically process the body's entire blood supply 30 to 40 times during the course of a day. Processing a total of 200 quarts of blood, the kidney remove two quarts of waste and water each day in the form of urine. By releasing essential circulatory and bone hormones and removing waste materials, the kidneys function as a filtration system for the blood. Truvada kidney problems occur when tenofovir accumulates in the kidney tubules, causing harm to the nephrons. When taxed with substances like Truvada, the kidneys can become compromised or fail altogether:

Kidney disease: Renal function falls below 25% capacity, causing health problems such as heart attack and stroke
Kidney failure: Renal function falls below 10 -15%, dialysis required for survival
End-stage renal disease: Total kidney failure which requires dialysis or transplant for survival

FDA Truvada Kidney Warning

Three separate times, Gilead Scientific has been issued a FDA Truvada warning letter for minimizing the risk of kidney failure from Truvada:

FDA Truvada Warning 1

March 14, 2002, in which the drug company was chastised for oral statements claiming the drug was not toxic and did not pose a risk of kidney failure -- despite the fact that Truvada kidney failure had been documented through clinical research and was included on the drug's warning label.

FDA Truvada Warning 2

July 29, 2003. The second letter was a repeat of the first, but called for a more clear response from Gilead. Again, sales representatives were caught downplaying the danger of kidney failure from Truvada and promoting the drug for non-approved indications.

FDA Truvada Warning 3

June 27, 2014. The third Truvada FDA warning was issued, this time concerning a sponsored web link that touted the drug's safety and failed to mention the risk of kidney problems from Truvada. The company was required to remove the link.

Truvada Drug Development

A new tenofovir drug known as TAF was developed shortly after Truvada was first available in the United States. The drug showed promising patient outcomes and a significantly reduced risk for kidney problems when compared to TDF / Truvada. Despite the promising outlook of TAF, development of the drug was halted in 2004 and not resumed again until 2010. Critics say Gilead executives withheld TAF purposefully in order to protect its market dominance by extending its patent on tenofovir antiretrovirals. In 2016, the AIDS Healthcare Foundation filed a Truvada lawsuit against Gilead for "blocking affordable access to a lifesaving HIV drug". Gilead's delay of TAF caused patients to suffer serious Truvada kidney problems such as renal failure and chronic kidney disease for a decade longer.

When TAF was finally released, it became available only in concert with other drugs and not as a stand-alone -- which critics again say was a strategic move to protect Gilead's multi-billion dollar annual earnings for tenofovir, and again had negative impacts on patients by limiting the prescribing freedom of physicians. The new version of the drug would not have been deemed unique enough to warrant a new patent on its own, which would have enabled other companies to offer generic versions much sooner. As it stands, Gilead has a patent on TAF products such as Genvoya, Odefsey, and Descovy through 2032.

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Truvada Kidney Lawsuits

Filing a lawsuit will allow you to hold the pharmaceutical company accountable for damage it has caused you or a loved one, while also providing real compensation for your medical expenses, suffering and loss. Contact us today for a free consultation.