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 antiretroviraldrugs 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.

FDA, TDF Drugs and Side Effects

October 2001 – The FDA approves the first tenofovir drug, Viread, but requires Gilead to study whether the medication could cause kidney and bone damage in humans, the same way it did in the company’s early animal studies.

May 2002 – The FDA warns Gilead in a letter that company sales reps violated the law by providing patients and doctors with false and misleading information about tenofovir. According to the FDA, a Gilead salesperson at a medical conference in 2001 claimed that the drug had “no toxicities” and was “extremely safe,” and another Gilead rep called tenofovir a “miracle drug.”

July 2003 – The FDA issues a second warning to Gilead, indicating that company sales reps are downplaying the danger of kidney failure from tenofovir and promoting the drug for non-approved uses.

March 2006 – European drug regulators ask Gilead to remind doctors to monitor the renal function of patients taking tenofovir, in response to reports of kidney failure and other kidney injuries in patients taking the drug.

June 2014 – A third warning is issued by the FDA, this time over a sponsored web link touting tenofovir’s safety, which failed to mention the potential risk of kidney problems from tenofovir.

TDF Drugs Side Effect Studies

May 2011 – At a medical conference, Gilead reveals the results of a 2003 study of patients at Stanford and clinics in Chicago and New York, indicating that TAF drugs are more effective than TDF drugs at one-sixth of the dose.

April 2012 – Upon analyzing a database of more than 10,000 HIV patients at the Department of Veterans Affairs, doctors at the University of California San Francisco conclude that the risk of chronic kidney disease increases by 33% with each year HIV patients take TDF drugs.

August 2013Research published in the Journal of Acquired Immune Deficiency Syndromes highlights TAF’s “more potent antiviral activity, higher peripheral blood mononuclear cell intracellular tenofovir diphosphate levels, and lower plasma TFV exposures, at approximately 1/10th of the dose,” compared with TDF. According to researchers, “This may translate into greater antiviral efficacy, a higher barrier to resistance, and an improved safety profile relative to TDF.”

October 2013 – A study of 213 patients taking TDF drugs finds that these patients have a 2.25-times increased risk of developing chronic kidney disease when compared with patients taking non-TDF drugs.

2014 – The results of the 2002 clinical trial involving Los Angeles patients and the effects of TAF medications are finally published.

May 2016 – A study published in Current Opinion in HIV and AIDS finds “an approximately 1–3% greater bone mineral density loss with TDF compared with other agents.” Researchers also note that “TAF [drug studies] have shown improved bone (and renal) safety with similar virologic efficacy when compared to TDF.”

Why We Think Gilead Should Be Held Liable for TDF Drug Side Effects

While tenofovir was associated with less severe side effects than other HIV medications on the market back when the first TDF-based antiretroviral drug was approved, early animal studies showed that the drug could cause damage to the kidneys and bones, and patients taking the medications today have reported serious injuries allegedly associated with their TDF treatment, like bone fractures, kidney disease and kidney failure. The maker of these HIV drugs, Gilead Sciences, has been accused of knowing for years that its TDF-based drugs could cause serious side effects in users, and yet delaying the development of a safer version of the drug. TDF drug lawsuits alleged that Gilead:

  • Developed and manufactured a defective HIV medication
  • Knew about the potential for its HIV drug to cause kidney disease, bone density loss and other problems
  • Failed to provide adequate warnings to consumers and the medical community about the potential risks of its TDF-based medications
  • Intentionally withheld a safer version of its TDF-based drugs (TAF drugs)
  • Repeatedly misrepresented the safety and effectiveness of its TDF drugs, using deceptive marketing strategies
  • Downplayed the potential health risks of TDF medications

What should you do? If you have experienced kidney disease, bone density loss or other side effects, you should contact a lawyer as soon as possible to discuss filing a TDF drug injury lawsuit.

TDF-based drugs are taken by more than 627,000 patients in the United States – or roughly 80% of all patients being treated for HIV – and nine million more worldwide. Unfortunately, reports indicate that these medications can put users at risk for devastating kidney and bone problems possibly resulting in kidney disease, kidney failure and crippling bone fractures. A number of lawsuits have already been filed against Gilead on behalf of HIV patients who aim to hold Gilead accountable for its alleged negligence in developing, manufacturing and marketing potentially dangerous HIV drugs. These product liability lawsuits allege that Gilead failed to warn users about the potential for its TDF medications to cause devastating kidney and bone injuries, injuries that may have been avoided had Gilead not waited to develop its safer TAF formulation. If you or a loved one took a TDF-based HIV drug, like Truvada, Atripla, Viread, Stribild or Complera, and you have since suffered bone density loss, bone fractures, chronic kidney disease or another serious medical problem, contact an experienced tenofovir drug injury attorney as soon as possible to discuss your legal options.

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