Gilead Pledges 2.4 Million Annual Dose Donations of Drug to End HIV in the U.S.
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As part of a national effort from the federal government to combat HIV and prevent future infections, Gilead Sciences announced it will annually donate 2.4 million doses of its HIV treatment Truvada for PrEP to the U.S. Centers for Disease Control and Prevention (CDC) to provide treatment for uninsured Americans.
Foster City, Calif.-based Gilead said the donation is among the largest seen in the United States and is part of the company’s ongoing initiative to help ensure that all patients who can benefit from Truvada for PrEP can have access to it. PrEP, which has a list price of $20,000, is used to reduce the risk of HIV infection in individuals who are at higher risk for HIV. It has been shown to reduce the risk of new infection by up to 97 percent when taken consistently.
The annual donation pledge extends until 2030, the company said. Gilead added that if its latest HIV treatment, Descovy for PrEP is approved the donation would include that newer medication instead of Truvada for PrEP. Gilead submitted a supplemental New Drug Application for Descovy for PrEP to the U.S. Food and Drug Administration on April 5. A Priority Review voucher was submitted with the filing, leading to an anticipated review time of six months.
Truvada is indicated in combination with safer sex practices for HIV PrEP to reduce the risk of sexually acquired HIV in at-risk individuals who are HIV-negative. Descovy is already approved as an HIV treatment, but not for PrEP.
Greg Alton, chief patient officer at Gilead, said the company is proud to partner with the CDC in order to expand the use of the company’s medication in order to prevent new infections. It is estimated that about 200,000 of the 1.1 million people who are at risk for HIV in the United States already receive Truvada for PrEP. However, broader use among at-risk populations is hampered by a number of barriers, including limited awareness of PrEP among providers and patients, as well as a lack of access to healthcare.
“We believe today’s donation, combined with efforts to address the root causes of the epidemic, such as racism, violence against women, stigma, homophobia and transphobia, can play an important role in ending the HIV epidemic in the United States, particularly in parts of the country with the highest burden of disease,” Alton said in a statement.
In his State of the Union Address earlier this year, President Donald Trump announced a goal of ending HIV by the end of the next decade. Following Gilead’s announcement, Health and Human Services Secretary Alex Azar said securing the commitment from the company was a major step in achieving that goal.
“The majority of Americans who are at risk and who could protect themselves with PrEP are still not receiving the medication. This agreement will help close that gap substantially and deliver on President Trump’s promise to end the HIV epidemic in America,” Azar said in a statement.
Part of the government’s plan is to concentrate on providing assistance to “hotspots” where the disease is still common. During 2016 and 2017, half of the new diagnoses concentrated in 48 “hotspot” counties as well as Washington, D.C., and Puerto Rico.
While Gilead is donating these doses, the company has been under fire from some HIV/AIDS activists over its HIV drug patents. The company has been accused of withholding safer formulations of its HIV drugs in order to maximize profits on those medications that had already been approved, such as Truvada. Both Truvada and Descovy have boxed warnings regarding the risk of post-treatment acute exacerbation of hepatitis B. Truvada also carries a Boxed Warning for the risk of drug resistance with PrEP in undiagnosed early HIV infection.