Truvada Lawsuit (TDF)

We are currently evaluating cases involving the HIV drug known as TDF (Tenofovir DF), or “Truvada,” on behalf of patients who suffered bone density loss, kidney damage, and lactic acidosis. Gilead, TDF’s manufacturer, failed to warn HIV patients about the drug’s serious side effects, and allegedly withholding the release of a safer drug for as long as ten years in order to maximize their profits.

TDF falls in a class of HIV drugs that block the action of an HIV enzyme, which helps to keep the virus from multiplying. It is used in combination with other medications to help contain the HIV virus and extend the lives of HIV patients. Because it is not readily absorbed into the body, however, higher doses are required to maintain its effectiveness. These high doses have been shown to create severe side effects, damaging the users’ kidneys and decreasing bone density.

TDF and Kidney Damage

Below are some results of studies conducted on TDF that have linked the drug to kidney disease.

2010: A review of 17 studies on TDF treatment revealed that TDF was associated with “a statistically significant loss of renal function.”
2013: Another study noted the link between the drug and kidney disease, recommending that doctors “measure kidney function carefully and assess kidney disease risk before prescription.”
2017: Researchers analyzed data from HIV patients taking TDF drugs and found that TDF use was associated with chronic kidney disease, with longer exposures increasing the risk.
2018: Scientists in another study noted that TDF could impact kidney function, and that TDF toxicity could present as chronic kidney disease or Fanconi syndrome (disorder of kidney tubule function). They recommended careful patient testing and monitoring and stated that TAF “appears to have less renal toxicity and is likely to replace TDF in future.”
2018: Researchers tested TDF in patients with chronic hepatitis B, and noted that it decreased kidney function, adding that old age, diabetes, and prior kidney problems could increase rthe isk of TDF-linked kidney dysfunction.

TDF and Bone Density Loss

Below are some results of studies conducted on TDF that have linked the drug to bone density loss.

2010: A study showed strong correlation between treatment with TDF and loss of bone density, particularly in young children and adolescents. “These observations strongly suggest bone density is being affected during active bone growth and development, implicating a role for tenofovir in bone loss.”
2015: Scientists found that HIV patients treated with alternative medications had significantly better outcomes related to kidney and bone health than those treated with TDF-containing medications.
2016: Researchers found that TDF created a 1-3% greater bone mineral density loss in patients than other HIV drugs. The scientists concluded that because of these findings, TDF-containing treatments “may be gradually replaced with non-TDF containing regimens for the treatment of HIV infection, especially in those at higher risk for fragility fracture.”
2018: Study noted that bone mineral density loss, a risk factor for osteoporosis, had been linked to HIV infection and treatment with TDF. They followed HIV-infected adults who had taken the drug for six months. One group received an alternate medication, while the other continued to take TDF. Results showed that those who switched medications had a significantly greater increase in total hip bone mineral density than participants who stayed on their TDF medications.

Gilead’s HIV Drug by Many Names

Although the TDF drug was released under the name “Viread,” Gilead later sold the TDF drug combined with other HIV medications and sold it under the following other brand names:

  • Atripla
  • Truvada
  • Stribild
  • Complera

The Gilead Cover Up

Evidence now shows that Gilead’s scientists knew as early as 2001 that their drug could cause such serious side effects. That very year, Gilead’s research and development department had been developing another version of the drug, known as “tenofovir alafenamide fumarate (TAF).” After conducting animal studies, scientists saw that TAF was more effective at suppressing HIV and had far fewer side effects. Gilead, however, hid the results of these studies and ceased all research on the drug in 2004.

Why would a drug manufacturer suppress a more effective drug? The answer lies in the system of patents that governs the pharmaceutical industry. Drug patents are expensive, and as soon as a manufacturer patents a particular drug, it only has a number of years that it can enjoy a virtual monopoly on the marketplace. When the patent expires, other manufacturers can access the formula and begin making generic versions that the majority of patients will purchase at a much lower cost. The years when a drug is under patent protection are the most profitable years for that drug’s manufacturer. So allegedly, Gilead was hiding the better (TAF) version of the drug so that it could reap every dollar possible out of its inferior TDF drug before its patent expired. 

A few years after Gilead stopped researching the TAF medication, they applied for FDA approval for the drug. TAF was approved in November 2015, under the name “Genvoya.” Finally, in 2018, the TDF patent expired.

Although TDF was approved by the FDA, the FDA sent warning letters to Gilead concerning its deceptive marketing practices. In 2002, the FDA warned Gilead to stop making illegal statements, including that TDF had “no toxicities,” was “extremely safe” and “extremely well tolerated.” Gilead pharmaceutical representatives reportedly also claimed that TDF (under the name of Viread) was a “miracle drug.” In 2003, the FDA warned Gilead to provide its sales representatives with more accurate information concerning the drug’s side effects.

TDF Side Effects

Patients who have taken medications containing TDF have reported the following injuries:

  • Kidney damage and kidney failure
  • Chronic kidney disease
  • Acute kidney
  • Fanconi syndrome (a disorder of kidney tubule function)
  • Tubular dysfunction (tubular acidosis)
  • Osteopenia
  • Osteoporosis
  • Bone fractures

How TDF Causes Bone and Kidney Damage

The body’s cells use chemical reactions to carry out tasks such as turning food into energy and repairing tissue. These chemical reactions generate acids. Some acid in the blood is normal, but too much acid—acidosis—can disturb many bodily functions. Healthy kidneys help maintain acid-base balance by excreting acids into the urine and returning bicarbonate—an alkaline, or base, substance—to the blood. This “reclaimed” bicarbonate neutralizes much of the acid that is created when food is broken down in the body. The movement of substances like bicarbonate between the blood and structures in the kidneys is called transport.

In high doses, TDF has been found to disrupt the healthy functions of a patient’s kidneys. When the kidneys fail to excrete acids into the urine, a person’s blood will remain too acidic. If this continues, chronic acidity of the blood can lead to growth retardation, kidney stones, bone disease, chronic kidney disease, and possibly total kidney failure.

TDF Truvada Lawsuit

If you or someone you know have experienced any of the above side effects after undergoing treatment with a TDF medication, you don’t have to face this battle alone. Call us today for a confidential case evaluation.