The United States Justice Department has launched a review of a government patent on PrEP, providing the first real indication that officials might be looking to take legal action against Gilead, the manufacturer and patent owner of the drug’s brand-name version, Truvada.
According to The Washington Post, Justice Department officials stopped by the Centers for Disease Control and Prevention (CDC) earlier this month to question the researchers who pioneered the use of PrEP for HIV prevention more than a decade ago.
Although the U.S. government has yet to formally take action against Gilead, the drug manufacturer has publicly rebuffed the government’s 2015 patent on the drug, refusing to pay royalties. Meanwhile, Gilead continues to rake in billions of dollars in profit from Truvada—and as The Post reported last month, HIV/AIDS activists are urging the government to take a stand against the company.
The fight to break Gilead’s patent on Truvada isn’t exactly new: As NewNowNext reported last July, prominent HIV/AIDS advocates within the LGBTQ community have been pushing for years for a generic version of Truvada, effectively making the life-saving drug more accessible to Americans at a high risk of contracting HIV.
— ACT UP NY (@actupny) July 17, 2018
Without insurance, Truvada can cost upwards of $1,600 for a 30-day supply, which costs Gilead significantly less money to manufacture. However, government assistance is available for low-income Americans in need of Truvada. Gilead also offers its own assistance program for people without health insurance who earn less than $60,700 per year.
“Most people in the U.S. on PrEP pay zero out of pocket, or close to it,” PrEP educator Damon Jacobs told NewNowNext last August. “The process can be cumbersome, and fighting with insurance companies can be arduous. But between their insurance, Gilead’s assistance programs, and Patient Advocate Foundation support, most people in the U.S. can afford PrEP.”
— Access to Meds (@PCMedsAccess) July 17, 2018
According to a recent CDC report, more than a third of gay or bi men in America at a high risk of HIV infection are currently on PrEP.
Still, Gilead earned some $3 billion from Truvada sales in 2018—and if the company’s patent remains unchallenged by the U.S. government, a lower-cost version of Truvada is out of the question until at least 2021.