People living with HIV who took tenofovir disoproxil fumarate (TDF) drugs—Viread, Atripla, Complera, Stribild, and Truvada—have been diagnosed by a physician or other healthcare provider with kidney and bone injuries.
Lawsuits will allege that Gilead Sciences withheld releasing a safer variation of TDF—tenofovir alafenamide fumarate (TAF).
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 the lives of people living with HIV.
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 allegedly causes a number of severe side effects, primarily affecting the kidneys and bones.
TDF is allegedly linked to kidney disease in some users. Chronic kidney disease is a gradual loss of kidney function, which can result in kidney failure, and may require 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 can include:
- Loss of appetite
- Poor concentration
- Swelling of feet and ankles
- Itchy skin
- Need to urinate frequently
- High blood pressure
- Renal failure requiring dialysis
- Low kidney function requiring dialysis
- Low kidney function diagnosed by a physician or other healthcare provider
- High creatinine levels diagnosed by a physician or other healthcare provider
- Abnormal glomerular filtration rate (GFR) levels (15 to 90) as determined by tests and blood work
- Renal failure and hospitalization
- Death due to renal failure
- Abnormal protein levels in the urine
Since kidneys easily adapt when damaged, symptoms may only appear when irreversible damage has been done.
Other kidney injuries that are allegedly 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
Some studies claim that TDF drugs increase the risk of bone fracture by 40 percent. Since the beginning of 2009, there have allegedly 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 allegedly results in increased bone resorption and decreased bone formation, and ultimately allegedly causes bone loss.
TDF drugs allegedly increase the risk of bone fracture by 40 percent.
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 allegedly 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 with physician or healthcare provider diagnosis of bone weakening or demineralization
- Bone density loss, bone demineralization, or weakening of the bones diagnosed by a physician or other healthcare provider
Other TDF side effects allegedly 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
Gilead allegedly tried to minimize TDF side effects by creating a safer formula, TAF. But lawsuits will maintain that the timeline of Gilead’s drug research and development shows that Gilead may have allegedly delayed TAF’s market release.
- 2001: FDA approves tenofovir disoproxil fumarate (TDF); Viread is released.
- 2001: Gilead starts to develop 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 (and later files patent applications protecting the drug).
- 2010: Gilead resumes TAF development.
- 2015: FDA approves TAF; Genvoya is released.
- 2018: 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—Viread, Atripla, Complera, Stribild, or Truvada —and were diagnosed by a physician or other healthcare or provider with kidney or a 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 14 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.
YOU SHOULD SPEAK WITH YOUR DOCTOR BEFORE DISCONTINUING ANY MEDICATION.