HIV Drug Lawsuit Signed Cases
Gilead HIV Treatment Litigation
More than a thousand of people who’ve been treated for HIV infection by medications made by US pharmaceutical company Gilead Sciences, Inc., are suing the company due to serious side effects they suffered. The company is accused of maximizing profits while preventing the release of a less toxic alternative that would caused less harm.
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Allegations against Gilead
The company is accused of:
- Intentionally continuing to promote the HIV medication tenofovir disoproxil fumarate (TDF) while withholding from the market a far safer version of the drug tenofovir alafenamide (TAF), which it knew would more effectively treat HIV without causing the serious side effects caused by TDF
- Developing both drugs at the same time, in the mid to late 1990’s, and shelving TAF until 2004. When its monopoly on TDF drugs was about to expire, Gilead received approval from the U.S. Food and Drug Administration (FDA) to sell and market TAF-based drugs, allowing it to extend its exclusivity on tenofovir and keep its HIV drugs branded and high-priced to increase profits
The side effects in questions include debilitating and sometimes fatal harm to the kidneys and bones as well as tooth damage. Also harmed by TDF, according to the lawsuits, are HIV-negative patients who used Gilead’s drug Truvada, which contained TDF, as part of the HIV prevention regimen known as PrEP.
Gilead accused of harming patients to benefit its bottom line
TDF’s history goes back to the 1980’s, according to the Los Angeles Times, citing a California lawsuit, when it was first developed. Gilead bought the right to sell the drug and in 1997 it showed TDF fought the HIV infection. The original formula had little sales potential because it had to be given intravenously. Gilead changed its chemical composition so it could be taken orally. That medicine was approved by the FDA in 2001.
It was originally sold as Viread. It was later combined with other HIV medicines and sold as Atripla, Truvada, Stribild and Complera. Plaintiffs claim Gilead knew when Viread was approved in October 2001 to be effective it had to be given in such high doses it could damage patients’ kidneys and bones. But there was no such warning when the drug was sold.
In the meantime, Gilead scientists worked on ways to reduce TDF’s toxicity. In April 2001 they published research on a different chemical version of TDF, TAF. An animal study showed TAF had a thousand times more activity against HIV than the original medicine developed in Europe, raising the hope that it could be just as, if not more, effective with less toxicity.
Gilead paid doctors across the US to give TAF to patients in small clinical trials. The positive results were not published until years later, secrecy that the lawsuit describes as “an act of extreme malice.” Instead, in October 2004, Gilead announced that it was ending TAF research due to an “internal business review.” TDF received company support, not TAF, bringing in billions of dollars in revenue each year.
The company applied for new patents for TAF, though officially the company wasn’t developing it. In 2010, as TDF’s patent protection was running out, a Gilead executive told investors about a new molecule added to its research plans, which turned out to be TAF. The company then started publishing the results of the earlier studies.
In November 2015, the FDA approved TAF in a combination pill with three other medicines. The drug was called Genvoya. Other new pills also containing TAF include Odefsey and Descovy. Gilead is now urging doctors to switch their patients to TAF reduce the chances of possible harm to their kidneys and bones posed by TDF.
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