A lawsuit filed by the Trump administration against Gilead Sciences is the most direct action taken to date to bring down the high cost of HIV prevention pills – a critical component of the government’s plan to reduce new infections in the U.S. by 75% over the next five years.

Both the government and HIV/AIDS advocates have criticized the high price of Gilead’s PrEP drugs. In yesterday’s suit, the HHS cites research from the Centers for Disease Control and Prevention that found regimens of daily PrEP pills are 99% effective at halting the spread of HIV infection.

“Yet, few who could benefit use it: only about 224K of the 1.1 million people estimated to be at high risk of HIV in the U.S. (and who could benefit from PrEP) are accessing it,” Jen Kates, director of global health and HIV policy at the Kaiser Family Foundation, said in a thread on Twitter. “One barrier is price. Unlike w/HIV treatment, there is no dedicated federal grant program for PrEP.”

In the suit, the government accuses Gilead, producers of two HIV prevention pills used as pre-exposure prophylaxis, or PrEP, of infringing on patents owned by the Department of Health and Human Services. Gilead’s two drugs, Truvada and Descovy, can cost patients up to $20,000 a year, and the government argues the company has not paid royalties for medications developed via millions of taxpayer dollars. Gilead denies this and challenged the HHS’ patent claims in August.

Global VC/PE spending on HIV/AIDS prevention/research in 2019 is significantly smaller than previous years. 

According to PitchBook data, $5.6 million has been spent toward HIV-focused private investments, less than one tenth of $77.5 million last year, the highest amount spent since 2010. American companies have received all but $600,000 of this years’ private investments thus far.

The Foster City, California-based Gilead made $2.6 billion on Truvada sales alone in 2018.

In February, the Trump administration announced a new initiative to reduce new HIV infections by 75% through increasing access to PrEP medication, as well as improve early diagnosis and regional response to HIV outbreaks.

  • Critics such as Dr. Rochelle P. Walensky, who led a team at Massachusetts General Hospital that analyzed the costs of the Obama administration’s AIDS plan, argued that reducing Truvada closer to its production cost of $60 a year would be more effective in halting the spread of HIV.
  • Truvada and Descovy are the only current drugs with FDA approval to prevent HIV. A generic version of Truvada is expected to be available in the U.S. in 2020; Gilead unsuccessfully sued to extend its patent protection of the drug past 2021.
  • Gilead announced in May that it would donate enough PrEP medication to supply 200,000 patients for 11 years.

Karma’s Scarlett Kuang contributed to this story.