An HIV drug treatment with tenofovir alafenamide (TAF) was allegedly postponed for twenty years by Gilead Sciences, one of the major manufacturers of medications used to treat this disease.

According to an article by PrideSource, Gilead engaged physicians in running small batch clinical trials with this less toxic version of another HIV drug treatment known as tenofovir disoproxil fumarate (TDF) after seeing positive signs in initial animal studies.

These studies in turn produced data which looked good for the formulation, but this information was purportedly suppressed by Gilead for profit purposes. TDF was currently marketed by itself as Viread and part of a formulary with other HIV drug treatment as Atripla, Stribild, Complera, and Truvada.

HIV drug treatment with TDF is complicated in that it is prescribed in high doses due to the body’s limited ability to absorb it. Its excess is deposited into the bony tissue or excreted through the kidneys, allegedly contributing to skeletal disorders such as osteoporosis and kidney injury.

According to a new class action and personal injury lawsuit filed with help from the AIDS Healthcare Foundation (AHF) in May, two Southern California men allegedly suffered bone and kidney damage while undergoing HIV drug treatment with TDF.

The first plaintiff that is part of this lawsuit is Michael L. who seeks to hold Gilead liable for taking advantage of his trust in the name of profit during a time in his life when he struggled to survive a horrible, ravaging disease that was killing many of his peers.

The second plaintiff is Jonathan G., an AIDS patient who had HIV drug treatment with one of the TDF combination drugs, like Stribild, and was later diagnosed with an unusual disorder of the kidneys eight years ago and osteoporosis last year.

According to the lawsuit narrative, Gilead failed to act on the positive data from TAF clinical trials in order to minimize marketplace competition for TDF marketed as Viread and for TDF-combination drugs like Atripla, Stribild, Complera, and Truvada.

The lack of competition helps to increase drug prices and profit margins, claim the lawsuit. Data from the studies was available as early as 2001—17 years ago. This data demonstrated reduced risk and relative safety of the TAF formulation.

Gilead stands accused of minimizing the risks of TDF by alluding that they primarily were risks that affected patients with already compromised renal and skeletal systems. According to counsel working with the plaintiffs, prescribing physicians were equally affected by these misrepresentations by the defendant.

The U.S. Food and Drug Administration (FDA) warned Gilead, according to the plaintiffs, that its salespersons were making false claims, understating the toxicity of TDF. The FDA suggested at one point to consider overhauling their sales representative training program to avoid this allegedly misleading promotion.

The class action lawsuit is geared toward California HIV patients that took Atripla, Truvada, and Viread from as early as Oct. 26, 2001 through the present day.