Pre-exposure prophylaxis (PrEP) was supposed to usher in an end to the HIV epidemic. Now, seven years after its approval, it's clear that the once-daily pill has failed to reach the very patients who need it most.
For veteran HIV researcher Michael Saag, M.D., with the University of Alabama at Birmingham, the reason is simple: PrEP is too expensive.
In a blistering speech at the 2019 National HIV Prevention Conference (NHPC) in Atlanta, Saag argued that the $1,600 per month cost of the HIV prevention pill is the single largest barrier to widespread uptake in the United States.
The reasons for this uptake failure are many -- they include systemic racism, lack of Medicaid expansion, and PrEP's association with elevated sexually transmitted infection rates -- but Saag believes the cost barrier supersedes all others.
Though his diatribe against drug pricing resonated with the many activists who have fought to make medicine more affordable, Saag's comments were unusual when compared to those of the other high-profile plenary speakers at NHPC, the majority of whom did not address drug pricing directly.
In his remarks, Saag clarified that he was expressing his personal opinion over high PrEP pricing, and not speaking on behalf of the Presidential Advisory Council on HIV/AIDS (PACHA), of which he is a newly appointed member.
His comments came as part of the opening plenary session, in which researchers were meant to argue the pros and cons of PrEP in the United States. Saag's co-panelist, Judith Aberg, M.D., with the Icahn School of Medicine at Mount Sinai in New York, put forward strong arguments for PrEP that were familiar to the attendees of the NHPC conference.
Instead of arguing against PrEP itself, Saag argued against the U.S. health care system, which incentivizes price gouging and keeps medicines out of reach for the underinsured. Of the 1.1 million Americans eligible for PrEP, only 10% have received it -- and most of those are affluent white men.
In the United States, PrEP costs an average of $1,600 per month, putting it out of reach of many Americans. And a CDC analysis published at NHPC found that PrEP is too expensive to be cost-effective, even at current low-volume prescription rates.
Despite these sobering statistics, "people are uncomfortable talking about" price, even at large medical conferences, Saag told TheBody. Curiously, Saag doesn't blame Gilead, the maker of PrEP, for setting a high price for its HIV prevention drug. After all, Gilead is a for-profit company, he said. Rather, he put the responsibility on his colleagues to rise up on behalf of their patients, driving prices down through activism and indignation.
For Saag, the time has come to start thinking outside the box to bolster access to pre-exposure prophylaxis medication. Addressing conference attendees, Saag proposed a seemingly radical off-label use -- swapping out brand-name Truvada (FTC/tenofovir disoproxil fumarate) for a generic two-pill combination of tenofovir disoproxil fumarate (TDF) and lamivudine (3TC).
Though there have not been any in-human studies confirming this two-drug combo would work for PrEP, the scientific rationale is sound, Saag argued. In fact, the World Health Organization has endorsed this approach in its effort to bring low-cost generics to the world's low-income countries.
In the U.S., switching to two generic pills instead of Truvada for PrEP would drop the price from $1,600 per month to about $50 per month, Saag estimated. While the idea hasn't yet taken off in the United States, Saag is confident enough in the safety and efficacy of this generic alternative that he says he would prescribe it to his own patients.
"I would argue that in a public health emergency," Saag said, "TDF/3TC would do just fine." In fact, "it becomes necessary because of the outrageous pricing of the brand product."
On stage at the NHPC conference in Atlanta, Saag spoke with the conviction of someone who believes he's on the right side of history. He knew that conjuring the elephant in the room would ruffle feathers, but he didn't care. In fact, that was his goal.
In his speech, Saag harkened back to HIV activist and ACT UP founder Larry Kramer. If this were the 1980s, Saag posited, people would be marching in the streets.
Echoing Kramer's words, he challenged the audience to break the taboo against talking about drug pricing and start advocating on behalf of patients.
Where's the outrage?" he said.