Gilead Sciences, Inc. is a biopharmaceutical company that was founded in 1987 and operates primarily as the developer of antiretroviral therapies for people living with HIV/AIDS. It markets its products under the brand names Atripla and Truvada. Gilead also offers co-pay assistance programs to patients who cannot afford their medications or insurance copays; these programs are financed by donations from pharmaceutical companies, charitable foundations, corporations
The “truvada lawsuit settlement amounts” is a legal topic that has been in the news recently. It’s important to know what side effects are possible with this drug, as well as how much money was paid out by Gilead.
People living with HIV who used the tenofovir disoproxil fumarate (TDF) medications Viread, Atripla, Complera, Stribild, and Truvada were identified with kidney and bone damage by a physician or other healthcare practitioner.
Gilead Sciences will be sued for failing to release tenofovir alafenamide fumarate, a safer variant of TDF (TAF).
TDF Drugs: What Are They?
Tenofovir disoproxil fumarate (TDF) is an antiretroviral medication that belongs to the nucleoside reverse transcriptase inhibitor family (NRTIs). These medications inhibit reverse transcriptase, an enzyme that prevents HIV from replicating.
TDF is a drug that is used in conjunction with other drugs to assist individuals living with HIV enhance the quality and duration of their lives.
There are now five TDF medicines on the market, all of which are manufactured by Gilead Sciences:
- Viread
- Truvada
- Atripla
- Complera
- Stribild
In 2017, these medications brought in a total of $11 billion in revenue.
What Are the TDF Drugs’ Side Effects?
TDF is said to have a variety of serious adverse effects, the most serious of which are renal and bone problems.
Kidney Damage
Some TDF users have been connected to renal problems. Chronic renal disease is characterized by a progressive decline of kidney function that may lead to kidney failure and need dialysis or a kidney transplant.
The kidneys filter waste from our blood and excrete it in the urine. If they don’t work correctly, the body may accumulate dangerously excessive quantities of electrolytes, wastes, and fluids.
Typical signs and symptoms include:
- Appetite loss.
- Fatigue
- Concentration issues
- Foot and ankle swelling
- Skin that is itchy
- Urination is necessary on a regular basis.
- Blood pressure that is too high
- Dialysis is required for renal failure.
- Dialysis is required because of low kidney function.
- A physician or other healthcare practitioner may identify low kidney function.
- A physician or other healthcare practitioner may diagnose high creatinine levels.
- Tests and blood testing reveal abnormal glomerular filtration rate (GFR) values ranging from 15 to 90.
- Hospitalization and renal failure
- Renal failure causes death.
- Protein levels in the urine that are abnormal
Because kidneys adapt quickly when they are injured, symptoms may not surface until permanent damage has occurred.
TDF has also been linked to other kidney ailments, including:
- Acute kidney injury (AKI) or acute renal failure (ARF) are two terms for the same thing (ARF)
- Fanconi syndrome is a renal tubule condition that results in the excretion of excessive glucose, potassium, and bicarbonate in the urine.
- tubular insufficiency
Injuries to the bones
According to certain research, TDF medicines increase the incidence of bone fracture by 40%. There have been approximately 6,000 complaints of bone breakage linked to TDF usage since the beginning of 2009.
TDF seems to influence both osteoclasts (cells that resorb bone) and osteoblasts, according to a 2010 study published in the journal Therapeutics and Clinical Risk Management (cells that form bone). This, according to the researchers, promotes increased bone resorption and reduced bone production, which leads to bone loss.
TDF medications are said to raise the risk of bone fracture by 40%.
Bone tissue replaces itself on a regular basis. Osteoporosis is a disorder that occurs when the body fails to develop enough bone tissue or loses too much bone tissue.
Bones in people with osteoporosis are so thin and fragile that even little falls or stressors, such as leaning over or coughing, may shatter them. TDF usage has also been linked to osteopenia, a condition in which bone density levels are lower than peak. Osteopenia is a precursor to osteoporosis and occurs when bone density levels are lower than peak.
The following are some of the most common osteoporosis symptoms:
- Back ache
- a stooped position
- Loss of stature
- Fractures caused by bone weakness or demineralization, as determined by a physician or healthcare professional
- A physician or other healthcare practitioner diagnoses bone density loss, bone demineralization, or bone weakening.
Other TDF adverse effects include liver difficulties and lactic acidosis, a disease in which the body accumulates lactic acid, resulting in low pH levels.
TDF and TAF Development Timeline
Gilead reportedly attempted to reduce TDF adverse effects by developing TAF, a safer formulation. However, lawsuits will argue that the timeframe of Gilead’s medicine research and development demonstrates that TAF’s market release was allegedly delayed.
- TDF (tenofovir disoproxil fumarate) is approved by the FDA in 2001, and Viread is introduced.
- Gilead begins development of tenofovir alafenamide fumarate in 2001. (TAF).
- Gilead pays physicians to test TAF on patients in 2002. The outcomes are encouraging.
- TDF labels are updated in 2003 to include a warning that the medicine has been associated to renal failure and bone loss.
- Gilead discontinues TAF testing in 2004. (and later files patent applications protecting the drug).
- Gilead restarts TAF development in 2010.
- TAF gets approved by the FDA in 2015, and Genvoya is launched.
- TDF patent expires in 2018.
- Gilead’s TAF exclusivity expires in 2020.
- Gilead’s TAF patent expires in 2031.
Have You Been Affected by a TDF Drug?
In order to maximize TDF earnings, our lawyers are pursuing legal action against Gilead Sciences for allegedly neglecting to bring their less harmful TAF medicine to market.
If you were prescribed a TDF drug—Viread, Atripla, Complera, Stribild, or Truvada—and were diagnosed with kidney or bone harm by a physician or other healthcare practitioner, you may be entitled to pursue a case against Gilead Sciences.
To hold Gilead responsible, our company is collaborating with Ben Crump Law and Hilliard Martinez Gonzales. Our firms have over 400 lawyers across 14 states, many of whom have tried cases against some of the world’s top pharmaceutical corporations.
Contact us for a free, no-obligation case evaluation to see whether you qualify for a lawsuit. It will never cost you anything until we get a favorable settlement or judgment on your behalf.
BEFORE DISCONTINUING ANY MEDICATION, SPEAK WITH YOUR DOCTOR.
The “truvada lawsuit update 2020” is a legal case that has been ongoing for a while. The plaintiff in the case, Gilead Sciences, has released some updates on the progress of the trial and what they are doing to make sure that people who take their HIV medications have safe side effects.
Frequently Asked Questions
Does PrEP cause kidney damage?
A: No, PrEP does not cause kidney damage.
Can Truvada cause kidney damage?
A: There is no evidence that Truvada causes kidney damage, but it has been linked to high blood pressure and heart problems.
Does tenofovir cause bone loss?
A: This is not a direct answer to your question.
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