HIV patients taking tenofovir disoproxil fumarate (TDF) drugs—Truvada, Viread, Atripla, Complera, and Stribild—have reported kidney and bone injuries.
Gilead Sciences, the manufacturer of the antiretroviral drugs, has a monopoly on HIV drugs. Lawsuits allege that they withheld releasing a safer variation of TDF—tenofovir alafenamide fumarate (TAF)—until the TDF patent expired in order to maximize profits.
What Are TDF Drugs?
Tenofovir disoproxil fumarate (TDF) drugs are part of a class of antiretroviral drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). These drugs block an enzyme called reverse transcriptase, which stops HIV from multiplying.
TDF is used in combination with other medications to help improve the quality and length of HIV patients’ lives.
There are five TDF drugs currently on the market, all made by Gilead Sciences:
In 2017, these drugs earned a combined $11 billion in sales.
What are the Side Effects of TDF Drugs?
TDF can cause a number of severe side effects, primarily affecting the kidneys and bones.
Since the beginning of 2009, nearly 20,000 HIV patients reported being diagnosed with kidney disease after taking TDF.
Nearly 20,000 HIV patients have reported being diagnosed with kidney disease after taking TDF.
Chronic kidney disease is a gradual loss of kidney function. It can result in kidney failure, which requires patients to undergo dialysis or receive a kidney transplant.
Kidneys filter waste from our blood into our urine. If they don’t function properly, it may result in dangerously high levels of electrolytes, wastes, and fluids in the body.
Common symptoms include:
- Loss of appetite
- Poor concentration
- Swelling of feet and ankles
- Itchy skin
- Need to urinate frequently
- High blood pressure
Since kidneys easily adapt when damaged, symptoms may only appear when irreversible damage has been done.
Other kidney injuries that are associated with TDF include:
- Acute kidney injury (AKI) or acute renal failure (ARF)
- Fanconi syndrome: A kidney tubule disorder that causes excess levels of glucose, potassium, and bicarbonate to be excreted in the urine.
- Tubular dysfunction
Studies claim that TDF drugs increase the risk of bone fracture by 40%. Since the beginning of 2009, there have been nearly 6,000 reports of bone breaks connected to TDF use.
A 2010 paper in the Therapeutics and Clinical Risk Management journal suggested that TDF affects osteoclasts (cells that resorb bone) and osteoblasts (cells that form bone). This results in increased bone resorption and decreased bone formation, and ultimately causes bone loss.
TDF drugs increase the risk of bone fracture by 40%.
Bone tissue constantly grows to replace older tissue. When the body fails to produce enough bone tissue or loses too much bone tissue, it can lead to conditions like osteoporosis.
People with osteoporosis have bones that are so weak and brittle that minor falls or stresses, like simply bending over or coughing, can cause bones to fracture. TDF use may also cause osteopenia, a precursor to osteoporosis, when bone density levels are lower than peak density levels.
Common symptoms for osteoporosis include:
- Back pain
- Stooped posture
- Loss of height
- Bone fractures that happen from a minor stress or fall
Other TDF side effects include liver problems and lactic acidosis—a condition that causes lactic acid to build up in the body, resulting in low pH levels.
Timeline of TDF and TAF Development
Drug companies have a responsibility to minimize harm and warn consumers if there are known adverse reactions to their product.
Gilead knew of TDF’s effect on the kidneys and bones when the FDA approved it. They tried to minimize these side effects by creating a safer formula, TAF. Yet, lawsuits suggest that the timeline of Gilead’s drug research and development shows that Gilead may have purposefully withheld TAF’s market release in order to maximize their profits while the TDF patent was still valid.
- 2001: FDA approves tenofovir disoproxil fumarate (TDF); Viread is released.
- 2001: Gilead tries to minimize TDF side effects and develops tenofovir alafenamide fumarate (TAF).
- 2002: Gilead pays doctors to test TAF with patients. Results are favorable.
- 2003: Gilead places a warning on TDF labels that the drug is linked to kidney failure and bone loss.
- 2004: Gilead stops TAF testing but files patent applications protecting the drug.
- 2012: Gilead resumes TAF development.
- 2015: FDA approves TAF; Genvoya is released.
- Dec. 2017: TDF patent expires.
- 2020: Gilead’s TAF exclusivity ends.
- 2031: Gilead’s TAF patent expires.
Were You Injured by a TDF Drug?
Our attorneys are pursuing legal action against Gilead Sciences for allegedly failing to bring their less toxic TAF drug to market in order to maximize TDF profits.
If you took a TDF drug—Truvada, Viread, Atripla, Complera, or Stribild—and suffered a kidney or bone injury, you may be eligible to file a lawsuit against Gilead Sciences.
Our firm is working with Ben Crump Law and Hilliard Martinez Gonzales to hold Gilead accountable. Combined, our firms have more than 400 attorneys across 13 states, many of whom have gone to trial against the largest pharmaceutical companies in the world.
To find out if you qualify for a lawsuit, contact us for a free, no-obligation case review. It never costs a thing unless we win a settlement or verdict for you.