Advocates to Government: 'Go Big' on HIV Prevention Efforts

The U.S. needs a dramatic overhaul of its HIV prevention program, revamping everything from cost to access, according to a panel of experts and advocates.

At a session at the 73rd Presidential Advisory Council on HIV/AIDS Tuesday, the big takeaway message was that the system for access to pre-exposure prophylaxis (PrEP) is broken, with systemic barriers well entrenched. "If you take nothing else from this presentation, it's 'go big,'" said Amy Killelea, JD, of Killelea Consulting in Arlington, Virginia. "We will not get the change we want and we need without systems-level response" to PrEP access.

Killelea recently co-authored a JAMA Viewpoint, discussing how access, equity, and cost are barriers to PrEP uptake among the most vulnerable populations.

Kenyon Farrow, of advocacy organization PrEP4ALL, pointed out that generic tenofovir/emtricitabine (TDF/FTC Truvada) was approved by the FDA 10 years ago, but progress on PrEP uptake has been sluggish since then. He noted that in 2020, only 25% of the 1.2 million people who would be eligible for PrEP actually take it. Of those, two-thirds are white, while only 16% are Hispanic/Latino and 9% are Black/African American.

Farrow pointed to the CDC as being reluctant to prioritize this strategy for HIV prevention as a public health tool, adding that it took about 2 years from FDA approval of TDF/FTC for PrEP in 2012 for the agency to issue its first guidance on it. Even today, no federal programs exist that cover the PrEP continuum for uninsured individuals, he said.

"If PrEP uptake is going to be increased equitably, a nationwide, universal access program must be designed and implemented for PrEP access that covers the entire continuum of care," Farrow said.

Killelea added that reforming access to PrEP starts with cost. Long-acting injectable cabotegravir (Apretude), which was recently approved by the FDA for prevention, is $3,700 per dose, which is 79 times the cost of generic TDF/FTC. She added that manufacturer assistance with drug pricing is "not a stand-in for a functioning public health system."

When asked about the issue of adherence, particularly among young people, Carl Schmid, MBA, of the HIV + Hepatitis Policy Institute, said that patients are "lacking education, outreach, and ongoing support that they need to stay on PrEP" and recommended a program for PrEP similar to the Ryan White HIV/AIDS Program for antiretroviral therapy (ART), which negotiates cost of medications.

Killelea also called for "a federal mechanism to negotiate a fair public-health price" for drugs and laboratory testing, starting with generic TDF/FTC, which costs "78 cents a pill."

"Instead of a comprehensive health approach to PrEP, we've asked providers to patch together programs with glue and tape," she said.

Despite research showing that HIV treatment is more effective if you "hit hard and hit early" at the beginning of disease, Farrow said that providers can unwittingly hinder access to people who want the drug.

He emphasized the importance of asking people who might be at high risk simpler screening questions, like "Are you having sex or do you want to be having sex"; testing them for HIV and hepatitis B virus; and then getting them started on PrEP, as opposed to "long, drawn-out conversations about people's sex lives."

Killelea proposed having an "easy mechanism" for clinicians to order PrEP, and having an "untapped non-clinical" network to offer PrEP via non-traditional providers, such as local health departments, domestic violence organizations, or even through telehealth.

"It does not supplant the existing PrEP infrastructure, it builds off it," she said. "We don't have to recreate the wheel on some of this stuff."

Carl Baloney, Jr., of the advocacy organization AIDS United, suggested that the government should apply some of the lessons it learned from the COVID pandemic to HIV, namely the idea of "HIV test kits free in a pharmacy, library, or even a post office." He added that PrEP "can and should be able to be prescribed at a pharmacy."

Killelea said that the U.S. is at an "inflection point" for PrEP, and that the government needs to recognize that the current system is not working as is -- and do something different or this same conversation could happen in 10 more years.

"In another 10 years, we [could be] talking about the turning point in the epidemic that didn't turn," she said.

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