Two California men living with HIV have filed a personal injury lawsuit against Gilead Sciences, claiming that the drugmaker intentionally delayed the development of a safer version of the widely used HIV med tenofovir. The original form, tenofovir disoproxil fumarate (TDF), is sold under the brand name Viread and found in Atripla, Truvada, Stribild and Complera.
As The Los Angeles Times reports, the lawsuit also claims Gilead hid the risks of the less-safe version of tenofovir while letting people with HIV take a medicine that was harmful to their kidneys and bones.
The men’s lawsuit is being funded by AIDS Healthcare Foundation (AHF), which operates HIV clinics across the globe. According to an AHF press release, “a class action lawsuit against Gilead by two other Californians living with HIV who suffered bone and kidney damage from taking TDF was filed on behalf of all persons located within California who were prescribed and ingested Viread, Truvada, or Atripla from October 26, 2001, through the present, who were personally or whose physician was exposed to Gilead’s misrepresentations.” (This is not AHF’s first lawsuit against Gilead regarding tenofovir. A judge from a similar 2016 case ruled that Gilead did not illegally manipulate the patent system, but an appeal is currently pending.)
A quick history of the med: The Food and Drug Administration approved Gilead’s TDF as an HIV med in 2001. According to the lawsuit, Gilead had already begun research on an improved version of the med, called tenofovir alafemanide fumarate (TAF), but withheld the research and delayed the release of TAF. The FDA approved TAF in 2015 as part of Gilead’s single-tablet combo pill Genvoya. Since then, TAF has been included in other HIV single-tablet regimens, such as Biktarvy and Descovy (for more in POZ, click #TAF).
According to the Times, the lawsuit claims that “by holding on to its research and shelving TAF, Gilead could patent TAF separately and save it for development when their patent and exclusivity on TDF ran out, in 20 years.”
The Los Angeles Times reports that both men in the lawsuit took the older tenofovir and developed related health issues. Michael Lujano of Los Angeles County took TDF from 2004 to 2015 and has developed osteopenia and osteoporosis of the spine, neck and hip. Jonathan C. Gary of San Diego County took TDF for 10 years beginning in 2001. In 2010, he was diagnosed with the rare kidney disorder Fanconi syndrome, and last year he was also diagnosed with osteopenia and osteoporosis.
“A company I trusted with my life took advantage of that trust by misrepresenting the side effects of TDF, calling it the ‘Miracle Drug’ and using other deceptive marketing strategies,” Lujano said in the AHF press release. “Gilead shelved a far safer drug, TAF, simply to increase its long-term profits. I’m bringing this lawsuit to try to hold Gilead responsible for their reckless focus on profits over patient safety.”
In related news, a recent analysis found that the updated version of tenofovir may not actually offer any safety benefits. For details, read the POZ feature “Is Gilead’s Entire HIV Enterprise Built on a False Promise?”