Yet another HIV drug lawsuit claims Gilead maximized profits by deliberately delaying the development tenofovir alafenamide (TAF), despite a better safety profile compared to tenofovir disoproxil fumarate (TDF).
The U.S. Food & Drug Administration (FDA) approved Gilead’s Viread – the first TDF medication — in October 2001 for the treatment of HIV. In August 2008, the agency expanded Viread’s approved indications to include chronic hepatitis B.
Gilead has also obtained FDA clearance for several other TDF-based HIV anti-viral drugs, including:
The FDA approved Truvada for Pre-Exposure Prophylaxis (PrEP) in 2012.
In November 2015, Gilead’s Genvoya became the first TAF-based HIV anti-viral drug to gain FDA approval. The agency has since approved two other TAF-based medications marketed by Gilead: Biktarvy and Odefsey.
With its TDF patents soon to expire in 2021, Gilead openly markets Genvoya, Biktarvy, and Odefsey as safer alternatives toits TDF-based drugs.
Gilead currently monopolizes the market for HIV anti-viral drugs and has made billions from its TDF and TAF franchises. However, a growing number of legal filings suggest patients have paid a steep price – both financially and physically – for Gilead’s success.
On November 17th, for example, an HIV drug lawsuit filed in U.S. District Court, Northern District of California, accused Gilead of deliberately delaying development of TAF for over 15 years in order to extend the profitability of its TDF patents. (Cause No. 3:18-cv-06972)
Among other things, the complaint charges that Gilead knew TDF was toxic to the bones and kidneys when Viread was approved. At the time, the company also knew that TAF did not pose the same risks. Yet the Gilead stopped development of TAF, purportedly because of an “internal business review” and the inability to distinguish TDF from TAF.
Over the next decade, evidence of TAF toxicity continued to mount, through adverse event reports and post-marketing data. However, the filing asserts that Gilead only began warning doctors about these dangerous side effects when its patents neared expiration.
Furthermore, the HIV drug lawsuit claims that Gilead stopped development of TAF under false pretenses. By doing so, it was able to maximize profits during the TDF exclusivity period.
Finally, by waiting until 2015 to seek FDA approval for TAF, Gilead could encourage patients to switch to the safer alternatives well before the TDF patents expired.
Similar HIV drug lawsuits have been filed in Los Angeles Superior Court and Louisiana federal court.
Several complaints seek compensation for individuals who allegedly suffered kidney problems, broken bones, or low bone mineral density associated with TDF-based HIV drugs.
However, others are class action lawsuits representing patients who purchased potentially harmful TDF medications because of Gilead’s alleged misrepresentations and wrongful conduct.