Patients have filed lawsuits alleging drug company Gilead Sciences knew and failed to warn them of the dangers of tenofovir disoproxil fumarate (TDF), the active ingredient in Complera, Atripla, Stribild, Truvada and Viread.

At least one lawsuit also alleges Gilead has been sitting on another anti HIV medication that is less toxic to the bones and kidneys, but the company purportedly has chosen to exhaust all possible profits from TDF-based formulations.

Problems with Complera Anti HIV Medication

A lawsuit against Gilead claims that Complera and similar anti HIV medications that have TDF as the active ingredient have low bioavailability. Because the body has difficulty absorbing useful amounts of Complera, it purportedly must be ingested at unusually high doses in order to produce a therapeutic effect.

Patients allege their bones and kidneys have suffered as a result of the high doses of Complera needed to control the HIV virus.

One lawsuit filed by two California men alleges Gilead’s top management became aware in the year 2000 that a medication less harmful than TDF had been created by its own scientists, but chose to shelve that anti HIV medication, known as tenofovir alafenamide fumarate (TAF).

An animal study allegedly indicated that TAF could be much more effective against HIV because of greater potency. Patients who went through clinical trials showed indications that a smaller dose could mean fewer adverse side effects, but the research data was not released for years. The lawsuit by the two California men calls the withholding of these results “an act of extreme malice.”

Gilead said in 2004 that it was no longer pursuing research on TAF, and opted to continue selling the more dangerous TDF drugs, including Complera.

Interestingly, even though Gilead publicly stated it was no longer working on TAF, Gilead later applied for new patents on the anti HIV medication.

Gilead is accused of holding the better anti HIV medication TAF on its shelves until the patent on TDF was nearly up, which would allow the company to extend the length of time it was either drug’s sole patent holder. In 2011, Gilead allegedly released the promising results of its old clinical trials and touted TAF as a new discovery.

The two California men who have filed the lawsuit against Gilead say they have both suffered from years of taking TDF medicines such as Complera. One man claims he was diagnosed with osteopenia and osteoporosis in his spine, neck, and hip in 2016 when he was only 35 years old. He says he had taken the TDF-based anti HIV medication for 11 years.

The other California plaintiff, age 59, alleges he took Complera or a similar anti HIV medication from 2001 through 2011. By 2010, he says, he developed a rare kidney disorder known as Fanconi syndrome. In the past year, he has been diagnosed with both osteopenia and osteoporosis. Osteopenia indicates bones are becoming porous, but are not as brittle as in the more advanced osteoporosis.

Did you or a loved one suffer from decreased bone density or kidney issues after taking Complera or a similar anti HIV medication? If you have suffered kidney injuries or bone loss after taking Complera or another TDF-based anti HIV medication, you could be eligible to participate in this lawsuit investigations.