Any individual who took the antiretroviral drug Truvada was exposed to a risk for kidney failure. Kidney failure is a serious and life-threatening condition requiring dialysis or kidney transplant. A 2016 lawsuit blamed Gilead pharmaceutical executives for delaying the development of a safer version of Truvada in order to maximize profits, resulting in an extra decade that HIV positive patients were exposed to the risk of kidney damage from Truvada. Attorneys handling Truvada kidney claims believe persons and the family members of persons who developed kidney problems while taking Truvada may be eligible for significant compensation. This page provides a complete overview Truvada kidney research and kidney failure rates.
Truvada (generic name tenofovir or TDF) is an essential component of HAART (highly active antiretroviral therapy) and is regarded as a front-line antiretroviral treatment around the world. Truvada was first approved as an HIV treatment by the FDA in 2001. Over time, the drug’s popularity grew, eventually becoming the leading drug in its class of nucleoside reverse transcriptase inhibitors (NRTIs) and yielding annual sales over $11 billion. Tenofovir drugs 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. Today, the number of HIV positive patients taking tenofovir drugs in the U.S. exceeds 600,000; another 9 million take Truvada or a similar drug around the globe.
The kidneys are made of millions of nephrons, comprised of blood vessels and fluid-collecting tubes. Each day, this interconnected system of vessels and tubes routinely filters the bodyâ€™s entire blood supply 30 to 40 times, removing waste materials. Like any other substance put into the body, drugs we take are filtered and broken down by the kidneys. The kidneys process approximately 200 quarts of blood on a daily basis, released waste through urine.
Many drugs tax the kidneys to some extent, but Truvada has been found to increase the risk for developing renal problems and kidney failure more than other HIV treatments. Research indicates tenofovir accumulates in the kidney tubules, causing harm to the nephrons and resulting in Truvada kidney problems.
One prominent research study conducted in San Francisco at the University of California examined 10,000 patients taking Truvada for HIV. On average, these patients experienced a 33% increase in Truvada kidney failure risk for each year they took the drug. In other words, the risk of Truvada kidney failure increased significantly each year. The study also found that symptoms of Truvada kidney disease persist for a year after the patient has stopped taking Truvada.
Research published in 2017 compared patient outcomes for Truvada, also known as TDF with a new tenofovir drug, TAF. The study found that the risk of kidney problems from Truvada is far greater than from TAF. TAF has higher absorption rates meaning it is effective at a much lower dosage and is not considered toxic to the renal system.
TAF was developed in the early 2000s and showed great promise for a safer alternative to Truvada. Mysteriously, drug development was halted in 2004, only to be resumed in 2010 and finally approved by the FDA in 2016. Drug safety experts allege the company intentionally delayed the development of Truvada in order to extend the company’s patent on tenofovir drugs and protect its market dominance. As a result, HIV positive patients experienced an extra decade of Truvada kidney problems that could have been prevented.
In 2016, the AIDS Healthcare Foundation filed a Truvada lawsuit against Gilead for blocking affordable access to a lifesaving HIV drug. Even today, the safer version is not freely available to patients or physicians: TAF has only been released in combination with other component of HIV therapy and not as a standalone drug. Critics say the substance would not have qualified for a unique patent had it been released singularly. The move protects profits and compromises patient health by reducing access to a valuable and effective drug. Gilead currently has a patent on TAF products such as Genvoya, Odefsey, and Descovy through 2032.
Gilead Scientific has received multiple FDA Truvada warning letters, each for minimizing the known risks of Truvada and making false claims in regards to its efficacy.
FDA Truvada Warning 1, March 14, 2002: Gilead sales representatives were observed making false claims about the Truvada, stating it was “extremely safe”, “extremely well-tolerated”, and a “miracle drug” that had “no toxicities”. Truvada kidney failure, which was listed as a potential side effect on the warning label, was not mentioned by the representatives.
FDA Truvada Warning 2, July 29, 2003: This was a second warning along the same vein as the first, calling for Gilead to take action to ensure its representatives were portraying Truvada risks and uses accurately.
FDA Truvada Warning 3, June 27, 2014: A decade later, the company received another letter from the FDA, this time calling out online advertising which failed to mention Truvada kidney and bone risks.
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The most effective means individuals have for holding a pharmaceutical company accountable for public safety is filing a lawsuit for harm done to your family. Filing a Truvada kidney failure lawsuit can yield real compensation for medical expenses, suffering and loss. Contact us today for a free consultation.