TDF-Based HIV Drugs - Consumer Justice Foundation

TDF-Based HIV Drugs

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Possible side effects of TDF-based antiretroviral drugs include kidney disease, bone fractures, bone density loss and other serious side effects in individuals with HIV.

Some of the best-selling HIV medications in the world have been linked to a host of serious side effects ranging from kidney damage and kidney failure to bone density loss and bone fractures. Truvada, Atripla, Viread, Stribild and Complera are all HIV medications containing the antiretroviral drug tenofovir disoproxil fumarate (TDF), and these medications, manufactured by Gilead Sciences, have been tied to devastating bone and kidney injuries in users. In light of the potential for TDF medications to cause serious kidney and bone problems, HIV patients taking TDF-based drugs are now filing lawsuits against Gilead, alleging that the company could have prevented their injuries had the drug company not waited to introduce tenofovir alafenamide fumarate (TAF), a less toxic version of the blockbuster HIV drug that was allegedly tested in clinical trials more than a decade before its eventual release in 2015. If you believe you have been adversely affected by a TDF-based HIV drug like Truvada, Atripla, Viread, Stribild or Complera, contact our consumer advocates at Consumer Justice Foundation for help. We may be able to put you in touch with a product liability lawyer who can help you determine whether you may be eligible to file a tenofovir injury lawsuit against Gilead.

What are TDF Drugs?

Top-selling HIV antiretroviral medications that have been linked to chronic kidney disease, bone density loss and other serious side effects.

Tenofovir was first discovered in the 1980s, but the original formulation of the drug had to be administered intravenously, which made it a hard sell for HIV patients. In order to increase its sales potential, Gilead modified the chemical composition of tenofovir to create an HIV medication that could be taken orally, and that medication was approved by the FDA in 2001, under the brand name Viread. In 2006, Gilead further expanded its control of the HIV medication market by combining tenofovir with other antiretroviral drugs to create the first once-daily single tablet regimen for patients with HIV, sold under the brand name Atripla. Today, Gilead sells a number of tenofovir disoproxil fumarate (TDF)-based drugs, including the following:

  • Truvada (emtricitabine/tenofovir disoproxil fumarate)
  • Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate)
  • Viread (tenofovir disoproxil fumarate)
  • Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate)
  • Complera (emtricitabine/rilpivirine /tenofovir disoproxil fumarate)

Possible Side Effects Leading to a TDF Lawsuit

Some side effects potentially associated with TDF drugs for HIV treatment include:

  • Chronic kidney disease
  • Kidney damage
  • Kidney failure
  • Fanconi syndrome
  • Renal tubular dysfunction
  • Bone fractures
  • Bone density loss
  • Osteopenia
  • Osteoporosis

Link Between TDF Drugs and Kidney Disease, Bone Density Loss

Nearly 20,000 people with HIV taking TDF drugs like Truvada, Atripla, Viread, Stribild and Complera have been diagnosed with kidney disease, and studies have shown that these widely used HIV medications may also increase the risk of bone density loss possibly leading to bone fractures in users. In a study published in Current Opinion in HIV and AIDS in 2016, researchers stated that “Several studies have demonstrated an approximately 1% to 3% greater bone mineral density loss with TDF compared with other agents,” while recent tenofovir alafenamide fumarate (TAF) studies “have shown improved bone (and renal) safety with similar virologic efficacy when compared to TDF.” That same year, the LA Times published an article claiming that Gilead Sciences could have developed its less toxic TAF formula sooner, but intentionally delayed its release, in an effort to patent the new formulation separately and save it for development when its patent on TDF ran out. According to the article, early trials of the improved TAF compound indicated that patients could get the same therapeutic benefits from TAF medications at a fraction of the dose required with TDF drugs, making treatment less toxic to the kidneys and bones and potentially decreasing the risk of dangerous side effects.

TDF-based HIV drugs have been on the market in the U.S. for nearly 20 years, and there is evidence that Gilead scientists were working on developing a new tenofovir formula that would reduce the drug’s toxicity even before the FDA approved the first-ever TDF drug in 2001. In 2002, Gilead allegedly tested its new TAF formula, later sold under the brand names Genvoya and Odefsey, and found that it offered the same therapeutic effect as the original TDF formula, but at a lower, safer dose. The company reportedly recruited 30 patients in Los Angeles, Philadelphia, New York and Palo Alto for preliminary studies to see how TAF worked in humans, and the trial found that the new formula “had greater antiviral potency” at one-sixth of the dose of TDF drugs. Despite these promising findings, Gilead executives inexplicably halted the TAF research in 2004, and the results of the early trials went unpublished for years, while Gilead’s original drug – tenofovir – became one of the best-selling HIV drugs in the world, with $11 billion in annual sales. It wasn’t until 2010 that Gilead finally restarted the TAF trials, and the first version of the new tenofovir compound was approved five years later, in November 2015, more than a decade after the original TAF trial.

As more information comes to light about the potential health risks associated with TDF-based medications, HIV patients who suffered bone loss, kidney damage and other serious side effects allegedly caused by the HIV drugs are filing product liability lawsuits against Gilead, alleging that the company not only intentionally delayed the introduction of a safer version of tenofovir, but also hid the risks of its original tenofovir treatment while letting people with HIV take a drug that could cause serious damage to their kidneys and bones. Gilead is now aggressively marketing its TAF medications for the treatment of HIV, and a growing number of lawsuits are claiming that, had the company valued patient safety over its bottom line, it could have developed this new, less harmful drug formulation nearly a decade earlier. Says Tim Horn of the Treatment Action Group, an organization that advocates for AIDS patients, “That’s a decade of potentially avoidable kidney and bone toxicity.”

Lawsuits Against TDF Drugs for Kidney Disease and Bone Density Loss

January 2016 – The LA-based AIDS Healthcare Foundation sues Gilead in federal court, arguing that the company employed a “calculated, anticompetitive maneuver” by delaying the release of its less toxic HIV drugs in order to manipulate the patent system, keep prices artificially high and keep lower-cost generic drugs off the market. May 2018 – Two California men living with HIV file a personal injury lawsuit against Gilead, alleging that the drug company intentionally delayed the development of a safer tenofovir treatment and concealed the potential health risks of its original tenofovir formulation. May 2018 – A class action lawsuit is filed against Gilead by two Californians, on behalf of “All persons located within California who were prescribed and ingested Viread, Truvada, or Atripla from October 26, 2001, through the present, who were personally or whose physician was exposed to Gilead’s misrepresentations.” July 2018 – Two Louisiana patients living with HIV file personal injury lawsuits against Gilead, alleging that the company’s Viread HIV drug caused them to suffer bone and kidney damage.

Possible side effects of TDF-based antiretroviral drugs include kidney disease, bone fractures, bone density loss and other serious side effects in individuals with HIV.Some of the best-selling HIV medications in the world have been linked to a host of serious side effects ranging from kidney damage and kidney failure to bone density loss and bone fractures. Truvada, Atripla, Viread, Stribild and Complera are all HIV medications containing the antiretroviral drug tenofovir disoproxil fumarate (TDF), and these medications, manufactured by Gilead Sciences, have been tied to devastating bone and kidney injuries in users. In light of the potential for TDF medications to cause serious kidney and bone problems, HIV patients taking TDF-based drugs are now filing lawsuits against Gilead, alleging that the company could have prevented their injuries had the drug company not waited to introduce tenofovir alafenamide fumarate (TAF), a less toxic version of the blockbuster HIV drug that was allegedly tested in clinical trials more than a decade before its eventual release in 2015. If you believe you have been adversely affected by a TDF-based HIV drug like Truvada, Atripla, Viread, Stribild or Complera, contact our consumer advocates at Consumer Justice Foundation for help. We may be able to put you in touch with a product liability lawyer who can help you determine whether you may be eligible to file a tenofovir injury lawsuit against Gilead.

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