Gilead Accused Of Withholding A Safer, More Effective HIV Remedy For Over A Decade

DrugsLegal News

According to Raleigh, NC-based news website WRAL, Gilead Sciences, the same pharmaceutical company behind Remdesivir, the antiviral medication that was granted emergency use authorization by the FDA for COVID-19, introduced the HIV drug, tenofovir disoproxil fumarate for HIV-positive patients. 

Also an antiviral, tenofovir was considered a breakthrough medication when it reached the market in 2001. But since 2018, claims have been filed against Gilead Sciences, in which plaintiffs allege that the company failed to inform consumers about the potential risks or side effects of tenofovir. 

Moreover, the claims allege that Gilead intentionally withheld a safer and more effective HIV medication in order to increase their own profits. 

Tenofovir, or tenofovir disoproxil fumarate, is known as a so-called TDF drug, and works by stopping the cell-division process in HIV, which if left untreated can result in the AIDS virus. TDF medications such as Truvada, Viread, Atripla, Complera and Stribild have been shown to cause serious side effects, most notably kidney disease and osteoporosis. 

HIV-positive patients that have sued Gilead say that the Bay Area-based pharmaceutical company deliberately withheld a safer class of tenofovir HIV drug, known as TAF (Tenofovir alafenamide). 

TAF was approved by the FDA in 2015. According to POZ.com, an online lifestyle magazine for people living with HIV, TAF is absorbed more quickly than TDF and produces higher levels of active tenofovir diphosphate in cells. Because of this, TAF can be administered in smaller doses, which results in lower plasma levels of the drug. This means that TAF is safer for the kidneys, bones and other organs.

According to WRAL.com, plaintiffs allege that Gilead knew about the significant side effects linked to its TDF drugs like Truvada and that the company had developed a safer alternative to treat HIV, TAF. 

Essentially, Gilead has a monopoly on TDF drugs, and as such are in complete control of HIV drugs. “By making TDF the only product line available for this type of treatment, the company was positioned to benefit significantly financially,” said Ben Whitley, partner at Whitley Law Firm in Raleigh, per WRAL.com. 

“Without any other competition in the market, Gilead waited to release the safer version of their TAF drug for almost 10 years in order to boost earnings on their patent — knowingly exposing individuals to a number of harmful side effects for years,”  added Whitley, whose firm is representing HIV-positive patients.

TDF has been linked to several serious side effects, in addition to osteoporosis and kidney disease including bone fractures and kidney failure. 

Whitley accuses Gilead of risking the health and wellbeing of individuals living with HIV, as well as those using this specific class of drugs. “The company made sure TDF was the sole option available to those who needed it, and instead of working to better the lives and conditions of those affected, they instead exploited them for their own gain.”

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