Have you taken Stribild and/or Viread, Truvada, Atripla or Complera?
These HIV medications contain tenofovir disoproxil fumarate, a compound toxic to patients’ kidneys and bones. Big Pharma knew.
Hagens Berman, Hilliard Martinez Gonzales LLP and Ben Crump Law, PLLC have filed a lawsuit against drug manufacturer Gilead for knowingly designing and selling prescription drugs that it knew were toxic to many of the 1 million people in the U.S. living with Human Immunodeficiency Virus-1 (HIV) infection.
The firm’s investigation shows that Gilead intentionally designed five of its blockbuster HIV drugs to include a form of the compound tenofovir (TDF) that Gilead knew was toxic to patients’ kidneys and bones, while it withheld a far safer version of the drug (TAF) for over a decade in order to make more money.
- Viread (TDF 300 mg tablets), approved Oct. 26, 2001
- Truvada (TDF 300 mg/emtricitabine 200 mg tablets), approved Aug. 2, 2004
- Atripla (TDF 300 mg/emtricitabine 200 mg/efavirenz 600 mg tablets), approved July 12, 2006
- Complera (TDF 300 mg/emtricitabine 200 mg/rilpivirine 25 mg tablets), approved Aug. 10, 2011
- Stribild (TDF 300 mg/emtricitabine 200 mg/elvitegravir 150 mg/cobicistat 150 mg tablets), approved Aug. 27, 2012
DRUG TOXICITY EXPLAINED
Tenofovir is a type of drug that prevents HIV from infecting healthy cells. The problem with tenofovir is that it cannot be effectively absorbed by the body when taken in pill form. Gilead developed TDF to be taken orally, but a large dose of 300 mg is required in order to be effective. Because the body does not absorb TDF efficiently, patients are exposed to levels of tenofovir in the blood that can cause severe harm to kidneys and bones. Gilead developed another form of the compound, tenofovir alafenamide fumarate (TAF) that is better absorbed by the cells HIV targets compared to TDF. This allows TAF to be given at a much lower dose than TDF – just 1/10th the dose – while being just as effective. The dramatically lower dose of TAF means less toxicity and fewer side effects than TDF.
WHAT GILEAD KNEW
Before Gilead began selling its first drug containing TDF, Viread, in 2001, Gilead knew that TDF posed a safety risk to patients’ kidneys and bones. Gilead knew that two of its other antiviral drugs with structures similar to tenofovir, cidofovir and adefovir dipivoxil, had been highly toxic to kidneys, and that preclinical data showed that TDF could cause significant kidney and bone damage. And as soon as Gilead began selling TDF, patients started getting hurt.
Despite knowing this, Gilead continued to make additional variations of TDF medications that it knew were toxic to patients, for more than a decade.
Before Gilead began selling its first TDF drug in 2001, it had already discovered a safer alternative – tenofovir alafenamide fumarate (TAF), which could be given at a much lower, safer dose, but yet it continued to push TDF medications, putting patients at grave risk of injury. Gilead falsely claimed in 2004 that it was abandoning the TAF design because it was supposedly no different than TDF. But Gilead’s president and CEO later admitted to investment analysts that the real reason Gilead abandoned the TAF design was that Gilead did not want to hurt sales by admitting that its TDF-based products are unreasonably and unnecessarily unsafe.
The lawsuit seeks to represent anyone in the U.S. who suffered kidney or bone injuries from ingesting TDF-based prescriptions from Gilead. Patients had no idea that Gilead’s drugs were harmful to them due to Gilead’s wrongful conduct and false statements. The firm seeks actual damages and punitive damages against Gilead for its wrongdoing.
The lawsuit accuses Gilead of breaking state product liability and consumer laws, as well as negligence and other counts.
Hagens Berman believes action must be taken for the millions of people living with HIV who were unknowingly subjected to these toxic treatments.
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