Pharmaceutical company Gilead is ‘intentionally withholding’ a safer drug used for HIV treatments, a US lawsuit claims.
The company holds the patent on Tenofovir Disoproxil Fumarate (TDF), an antiretroviral drug for people living with HIV. If routinely taken, this can regulate the viral load.
However, a lawsuit filed in US federal court on 17 November alleges that the company is withholding a new version of the drug with fewer side-effects to exploit patent laws.
Why is Gilead still using TDF when it has TAF?
The Food and Drug Administration (FDA) greenlit the new drug, Tenofovir Alafenamide Fumarate (TAF), in November 2015. TAF was later marketed as Genvoya and Odefsey. In other countries, Gilead HIV medications such as Descovy also include it.
The lawyers behind the lawsuit are critical of Gilead. They say the company continues to produce and market its existing TDF medications (Viread, Atripla, Complera, Stribild, or Truvada) to HIV patients, knowing they can increase the chance of kidney disease and bone damage, despite having approval for a safer alternative to TDF.
It suggests TAF versions of the HIV medications will be rolled out when the patent of TDF expires in 2021.
Patent expiration means that cheaper, generic versions of the drug can be produced by other companies. If Gilead is timing the full rollout for TAF to the patent expiration on TDF, they could continue to charge premium rates for the new drug for longer.
The lawsuit claims that the company is ‘intentionally withholding [TAF] …from hundreds of thousands of patients in order to extend the profitability of the patent’. It says this has particularly impacted LGBTI individuals and ethnic minorities.
TDF side effects include kidney disease and bone density loss
‘We are filing lawsuits on behalf of people with HIV who took one or more of Gilead’s TDF drugs—Truvada, Viread, Atripla, Complera, and Stribild—and then allegedly suffered kidney disease and/or bone density loss,’ the law firms announced on their website.
‘Gilead is accused of knowing that these drugs could cause serious side effects, but allegedly withheld a safer version of the medication (TAF drugs). Our law firms—Morgan & Morgan, Ben Crump Law, and Hilliard Martinez Gonzales—aim to hold Gilead accountable and recover money for people who claim they were harmed by these drugs.’
GSN has approached Gilead for comment.