TDF HIV Lawsuit
Gilead Sciences is facing hundreds of HIV drug injury lawsuits for bone disease and kidney damage which may be linked to its tenofovir disoproxil fumarate (TDF) based medications. Gilead TDF HIV medications like Viread, Truvada, Atripla and others have accounted for about 80% of all HIV drug sales in the U.S. and other countries.
Gilead HIV Medications
TDF medications are known to increase the risk for kidney and bone disease and Gilead has been accused of having delayed development of newer medications which would be safer. Gilead’s newer medications based on a similar drug tenofovir alafenamide fumarate (TAF), may be more effective at lower doses, making them less likely to cause harm. Gilead may have delayed introduction of these medications in order to maximize profits on the older line, exposing patients to increased risk unnecessarily.
The company is facing at least 140 lawsuits in federal and state courts and more may be expected, seeking compensation for bone and kidney injuries caused by Gilead TDF HIV drugs.
Gilead Sciences is facing hundreds of lawsuits for injuries caused by its TDF-based HIV medications. Users of the medications containing tenofovir disoproxil fumarate (TDF) claim that Gilead did not provide adequate drug warnings about serious side effects which may have resulted in bone and kidney injuries.
Gilead TDF Medications include:
- Viread
- Atripla
- Truvada
- Stribild
- Complera
The company has also been accused of delaying development of safer versions of HIV medications which contained tenofovir alafenamide fumarate (TAF) in place of the TDF. TAF medications appear to be safer but the company has been accused of delaying their introduction in order to maximize profits from the older TDF medications.
Hundreds of lawsuits have been filed against Gilead in state and federal courts by individuals and groups such as the AIDS Healthcare Foundation (AHF) representing patients who have been harmed by TDF drugs.
Gilead TDF HIV Treatments
Gilead Sciences is a global leader in HIV treatments and accounts for about 80% of worldwide HIV medication sales. The premier line of their medications, since it was first approved in 2001, has been Viread and other medications containing tenofovir disoproxil fumarate, also called TDF or tenofovir DF. TDF is also approved to treat chronic hepatitis B infection since 2008 and treatment of HIV in children since 2013.
Human immunodeficiency virus (HIV) is a virus which affects the immune system and eliminates the body’s ability to fight infection or disease. Once HIV has significantly limited the immune system, the patient will have developed acquired immunodeficiency syndrome or AIDS which is generally considered to be fatal.
TDF is an antiviral medication which prevents reproduction and spread of the HIV virus. It is a member of an antiviral medication group called nucleoside reverse transcriptase inhibitors (NRTIs) which work by blocking an enzyme known as reverse transcriptase that is needed in reproduction of the virus. Blocking the enzyme, keeps the virus from reproducing and multiplying within the body.
Viread was the first medication containing TDF as a standalone HIV treatment. Gilead later introduced other medications containing TDF which were combination products with other antivirals including:
- Viread (tenofovir disoproxil fumarate)
- Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate)
- Truvada (emtricitabine and tenofovir disoproxil fumarate)
- Stribild (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate)
- Complera (emtricitabine, rilpivirine, and tenofovir disoproxil fumarate)
Newer HIV Medications Blocked
Gilead has been accused of slowing introduction of newer, less toxic medications containing tenofovir alafenamide fumarate (TAF).
TDF has a relatively low bioavailability and is not readily absorbed for use by the body, requiring doses to be high. High dose levels of TDF have an increased risk of kidney and bone toxicity. Newer TAF medications showed to be more effective at HIV treatment and to be less toxic as they are more bioavailable and require lower doses.
Gilead announced in 2004 that they were stopping TAF research and may have suppressed results of studies which showed effectiveness and lower toxicity, however they still continued to apply for patents. Gilead delayed introduction of newer medications until the patents on the TDF drugs were close to expiration.
In addition, once patent expiration approached and newer drugs were being introduced, pricing on the older drugs was increased to encourage physicians to switch patients over to new medications before generic competition became available. In November 2015, the U.S. Food and Drug Administration (FDA) approved the first of Gilead’s new TAF medications “Genvoya,” which consists of TAF in combination with three other medications.
Other new TAF-combo medications would follow, including:
- Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)
- Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide)
- Descovy (emtricitabine and tenofovir alafenamide)
- Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)
- Vemlidy (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide)
Warnings about TDF Drugs
In 2002, the FDA issued a warning letter to Gilead regarding its advertising and marketing statements regarding Viread. The company was directed to stop making misleading statements including claims which had been made by representatives of “no toxicities”, “extremely safe” and “extremely well tolerated”. The company was also accused of calling Viread a “miracle drug” and in 2003, another letter was sent to Gilead requiring the company to retrain sales representatives who had been accused of stating that Viread was “more potent” and had “fewer side effects” than other drugs.
Viread and other TDF-based medications have been show to increase the risk for certain conditions, particularly involving the kidney and bone disease including:
- Kidney damage
- Chronic kidney disease
- Acute kidney failure
- Fanconi syndrome
- Tubular acidosis
- Osteopenia
- Osteoporosis
- Bone fractures
Viread and TDF Drug Lawsuits
In 2016, a group advocating for AIDS patients, the AIDS Healthcare Foundation (AHF) filed a lawsuit against Gilead Sciences, accusing them of delaying the development of safer TAF medications in order to extend the patent life of older, less safe TDF medications. AHF claimed that HIV patients may have taken TDF medications for up to a decade when safer TAF medications would have reduced the risk of kidney and bone disease.
Though this case was dismissed by the U.S. District Court for the Northern District of California, hundreds of new lawsuits have been filed against Gilead which claim similar issues. Gilead is currently facing at least 140 lawsuits filed in 31 states which have been allowed to progress by a federal judge in the U.S. District Court for the Northern District of Illinois. Additional lawsuits have been filed in state courts as well and dismissal has been rejected by California state courts.
People who have kidney damage or bone disease and have taken TDF medications like Viread, Truvada or others should seek legal assistance.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.