Five months ago, Gilead announced it would donate 2.4 million bottles of emtricitabine/tenofovir disoproxil fumarate (Truvada) as pre-exposure prophylaxis (PrEP) to the federal government to use as part of its Ending the HIV Epidemic by 2030 initiative.
On Sept. 27, Gilead won a $6 million contract to also distribute the drugs it donated. The money was awarded by the Department of Health and Human Services (HHS), the government agency orchestrating the PrEP rollout.
Since the donation announcement, HIV providers have been waiting for more information about how to help their patients enroll in the free PrEP program. At prices ranging from $1,600 to $2,000 per month, the drug is out of reach for many patients.
In early October, HHS representative Tammy Beckham, Ph.D., director of the Office of Infectious Disease and HIV/AIDS Policy, presented new details on the government's plan for PrEP rollout at the annual IDWeek conference in Washington, D.C.
"We've been very busy working on this," said Beckham.
According to Beckham, the donated product will be available within the next few months. HHS has committed to covering the cost of laboratory testing, pharmacy services, and wraparound care associated with a PrEP prescription.
To qualify, patients must lack health insurance for outpatient prescription drugs; have a valid, on-label prescription; and have appropriate testing to show they are HIV negative. Beyond that, there are no other eligibility criteria.
Normally, HHS would solicit bids from major vendors to help orchestrate the rollout of such a major government program. But Beckham said HHS has already partnered with Gilead to leverage its existing patient assistance program, awarding the company a $6 million contract.
Gilead has faced sharp criticism for its decision to set a high price for a powerful HIV prevention tool. HHS, meanwhile, has been criticized for its cozy relationship with the Big Pharma company -- even as the Centers for Disease Control and Prevention hold several Truvada PrEP patents that could undercut Gilead's pricing power.
Perhaps anticipating further backlash, Beckham emphasized that HHS chose Gilead as a preferred vendor to ensure "we get drugs into people's hands as quickly as possible."
"It's a six-month contract with an option for six additional months," she said. "Basically it allows us to start moving product much faster than it would have if the federal government would have opened a contract for competition."
During those six months, Beckham said, "we will be working to look for vendors that can provide a longer-term contract with the federal government for distributing those medications."
The 2.4 million bottles donated by Gilead should cover approximately 200,000 patients per year.
But realistically, Beckham said it will take HHS at least a year to scale the program up to that level. During the first six months, the donation will go to 4,250 patients, with an additional 5,750 under the optional six-month extension.
"Obviously, we would hope we can get as many patients on day one as possible, but [we are] being a little realistic about the ramp-up time it's going to take to get patients enrolled and get people familiar with the program and how to access the program," she said.
HHS has awarded another contract to a vendor that will develop an education and awareness campaign to spread the word about the PrEP program, according to Beckham. The awareness campaign will focus its efforts on the 57 jurisdictions that have been identified as part of "Phase One" of the Trump administration's Ending the HIV Epidemic by 2030 initiative. However, Beckham assured providers outside those jurisdictions that their patients would have access to the program.
"This is a nationwide rollout," she said. "This will not be limited to the Phase One jurisdictions."
In early October, the Food and Drug Administration approved Gilead's emtricitabine/tenofovir alafenamide (Descovy) for PrEP among cisgender men and transgender women. Eventually, the Gilead PrEP donation program will include emtricitabine/tenofovir alafenamide as well as emtricitabine/tenofovir disoproxil fumarate (Truvada).
"HIV has cost America much too much, for too long," said Beckham, adding that PrEP will be a central pillar of the effort to end HIV by 2030. "If we do nothing over the next decade, we have a very real possibility of losing an additional 400,000 lives."