Over a 14 year period, Gilead Sciences, Inc. ("Gilead") profited from exposing its patients to TDF-based medications by actively concealing and failing to bring to market safer, more effective TAF-based alternatives. Had Gilead acted reasonably under the circumstances in which it developed tenofovir as an antiretroviral treatment for HIV-1, it would have abandoned TDF in favor of TAF, thus reducing the risk of foreseeable and avoidable injuries like chronic kidney disease, renal failure and bone mineral density disorders.
The Tenofovir Litigation Group aims to educate members and provide a forum to brainstorm ideas about the way to most effectively represent clients negatively impacted by tenofovir. The group provides member benefits such as access to pleadings, discovery, legal research, listserves, education programs, a medical literature database, and opportunities to share ideas in educational meetings.
Tenofovir is a nucleotide reverse transcriptase inhibitor (NRIT), one of the classes of antiretroviral medications used to prevent and/or treat certain viral infections like HIV-1 by blocking an enzyme needed in the replication process. Although tenofovir is extremely effective at inhibiting viral replication, it is highly toxic to human kidneys, bones, and teeth. From approximately 1990 to the present, Gilead has held the exclusive license to synthesize, develop, manufacture and sell tenofovir-based medications for the prevention and/or treatment of HIV-1.
In exploring new ways to orally deliver highly toxic tenofovir into the body, Gilead simultaneously synthesized two “prodrug” formulations of the drug – tenofovir disoproxil fumarate (“TDF”) and tenofovir aladenamide fumarate (“TAF”). Following initial testing of both “prodrug” formulations between 1993 and 1998, Gilead learned that patients needed approximately 12 times more TDF than TAF in order to achieve the same therapeutic effect on viral replication. These differences in dosing also revealed significantly higher risks of long-term renal, bone, and teeth injuries for those patients treated with TDF as opposed to TAF.
Although Gilead knew throughout the development of both “prodrugs” that TAF was a safer, more effective, and overall better drug than TDF, it chose to elevate its own financial interests over patient health by abandoning the approval, manufacture, and sale of TAF in favor of the less effective, less safe TDF. Between 2001 and 2015, Gilead proceeded to maximize its stranglehold on tenofovir-based antiretroviral medications by developing, manufacturing and distributing five (5) TDF-based medications – Viread®, Truvada®, Atripla®, Complera® and Stribild® - all the while concealing the availability of TAF as an alternative tenofovir-based medication. Under this guise, Gilead was able to generate record profits in the market for antiretroviral medications before finally unveiling TAF as a “new”, “safer” drug in 2015, thus cementing its monopoly on tenofovir-based medications well into the 2030s.