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PrEP Rally: As Numbers Rise, Advocates Want Wider Access

The number of people using pre-exposure prophylaxis, or PrEP, to prevent HIV infection has risen steadily over the past year, according to data presented this week at a San Francisco community engagement forum. But PrEP advocates -- including 3 city supervisors -- say more needs to be done to overcome barriers to access for all who want it.

"San Francisco has been at the forefront of efforts to combat the spread of HIV/AIDS through innovative measures and needs to continue that tradition," said Supervisor David Campos, who introduced a resolution to help city residents access PrEP regardless of income. "TheAIDS movement started in San Francisco, and it's only fitting we begin to eradicate HIV here in the city once and for all."

Campos' resolution calls on the city's Department of Public Health to submit by December 1 a plan "to achieve an increase in the use of PrEP that addresses the educational and affordability issues." The measure urges the DPH to work in conjunction with HIV testing programs, public and private clinicians, HIV prevention agencies, health insurance providers, and Gilead Sciences, which makes the PrEP pill Truvada (tenofovir/emtricitabine).

The resolution was discussed at a meeting of the board's Neighborhood Services and Safety Committee on September 18, preceded by a "PrEP Rally" on the steps of City Hall. Health officials, researchers, service providers, and community members spoke in favor of the city taking a role in expanding access to PrEP. No one spoke in opposition to PrEP at either the rally or the hearing.

Deputy health officer Susan Philip said at the hearing that the DPH "fully supports PrEP as an effective HIV prevention strategy." San Francisco was one of 2 U.S. sites for the pivotal iPrEx Truvada PrEP trial of gay and bisexual men, and the city conducted one of the first PrEP demonstration projects (along with Miami and Washington, DC). The local demo project showed that there is high demand for PrEP and that participants were "able and willing to take PrEP in a way that provides protection."

In 2010, San Francisco was the first city to offer antiretroviral treatment to everyone diagnosed with HIV regardless of CD4 count, years ahead of national guidelines, Philip recalled. The city now has an opportunity to take the lead in implementing a new prevention strategy.

Rising Numbers on PrEP

The September 16 community engagement meeting, sponsored by the HIV Prevention Planning Council and the SF DPH, brought together experts and community members to discuss PrEP's effectiveness, who is using it now, and how to improve access.

Jonathan Volk, a PrEP researcher and doctor at Kaiser Permanente, reviewed clinical trial data showing that the overall efficacy of Truvada PrEP ranged from approximately 40% to 75% percent in various populations. Among people with blood drug levels showing that they took PrEP consistently, effectiveness was closer to 80% to 90% percent, and it is "likely much higher with regular use," he said.

The conflicting numbers were at the heart of a debate regarding a recent ad from the AIDS Healthcare Foundation. AHF's ad emphasized only the low efficacy reflected in overall or "intent-to-treat" data that includes all participants assigned to take PrEP, whether they actually did so as directed or not. PrEP advocates argue that it is more useful to focus on effectiveness among people who take Truvada every day, which may be as high as 99%-100%. Recent data from iPrEx OLE showed that while overall efficacy was only about 50%, there were no new infections among men who took Truvada at least 4 times per week.

"[PrEP] is approved by FDA, recommended by the CDC and by the World Health Organization, it works if you take it, and [adherence] doesn't have to be perfect," iPrEx investigator Robert Grant of the Gladstone Institutes said at the forum. In his testimony at City Hall he added that "the good news from studies is that people who need it the most, use it the most."

Volk reported that a total of 307 people seen at Kaiser in San Francisco had started PrEP as of July 2014, with numbers with numbers rising steadily since around September 2013. The number of PrEP referrals climbed even more steeply -- especially after May of this year -- but many of these did not lead to people actually starting Truvada. For all of Kaiser Northern California, Volk estimated that 600-700 people were taking PrEP. To date, there have been no new HIV infections among Kaiser patients on PrEP.

Citywide, Grant said that fewer than 1000 people had been prescribed PrEP in San Francisco -- probably closer to 800. In 2013, there were 359 newly diagnosed HIV infections in the city. According to an informal calculation of "numbers needed to treat," he estimated that we should be giving PrEP to about 6000 San Franciscans, which would be expected reduce annual infections to less than 50.

Nationwide, Reuben Gamundi, Gilead's associate director of community medical affairs, said that the latest available data from a company survey of about half of U.S. pharmacies indicate that roughly 2500 people had been prescribed Truvada PrEP. He stressed that this number does not include participants in PrEP trials or demonstration projects or people who get their drugs through Medicaid, and does not reflect the recent increases seen in the Kaiser numbers.

Costly but Cost-Effective

In recent months, Volk noted, people seeking PrEP have shifted from advocates and other "early adopters" to people whose friends are on it. "We're now getting 100 referrals a month," he said. "We've seen a change in conversations about PrEP -- now it's 'my roommates are all on it and I want it too'."

But at $1000 per month or more, cost is a major barrier to PrEP access for many people.

While a growing number of private insurance plans will cover PrEP, some make people jump through extra hoops such as prior authorization or using a mail-order pharmacy, according to David Evans of Project Inform. In addition, some people who chose a cheaper Affordable Care Act plan with a high deductible have been shocked by how much they have to pay.

Speaking at the City Hall hearing, community advocate Erik Gibb said that while he is able to get Truvada PrEP though his private insurance, he has an annual co-payment of $3000.

Gamundi explained that Gilead has both a medication assistance program for individuals without insurance coverage -- who get Truvada for free -- and a co-pay card to help people with insurance cover their out-of-pocket costs.

Contrary to some media reports, Campos' resolution does not call for free PrEP for everyone paid for by the city. Instead, he is introducing a supplemental budget request to hire "navigators" to help people access PrEP through existing financing mechanisms including private insurance, Medicaid (Medi-Cal), and Gilead's programs, in order to minimize the impact on the city's general fund. In addition, $500,000 would go toward co-payment assistance for people who fall through the cracks.

Grant noted that Truvada PrEP would be cost-saving if HIV incidence is greater than 6% -- as it is among some groups of men who have sex with men, especially young gay men of color -- and can be cost-effective even at low incidence levels.

"To those who say we can't afford it, it is not only morally the right thing to do, but financially it makes sense," as every new HIV infection prevented saves $355,000 in lifetime treatment costs, Campos emphasized.

Other Barriers to PrEP

But cost is not the only barrier to PrEP, according to comments at the forum, PrEP rally, and City Hall hearing.

"It hasn’t been insurance companies, cost, or people's willingness that have been the biggest barriers," according to Evans, "it's been providers with judgment about people's sex lives."

Among those speaking at the rally and forum was Supervisor Scott Weiner, who this week came out as a PrEP user in a Huffington Post article.

"There's still enormous stigma, as we see every time there's a public health measure that addresses sex,"Wiener said, comparing the furor over PrEP to claims that contraception or the HPV vaccine will cause women to become promiscuous. "Stigma, shaming, and stereotyping have to end," he said, and we have to "take a scientific and public health- based approach to making PrEP available to our community."

Though gay men have received the most attention around PrEP in the U.S., they are far from the only group that stands to benefit. As Gamundi noted at the forum, nearly half of people prescribed PrEP in Gilead's survey were women, many of them living in the south.

Speaking at the rally, Shannon Weber from the Bay Area Perinatal AIDS Center said that PrEP is a "game-changer" as "the first female-controlled method of HIV prevention," and one that women can use without their partners' knowledge.

Weber explained that an earlier form of PrEP -- giving HIV positive women antiretrovirals both for their own health and to prevent mother-to-child transmission -- has been standard practice for many years. For the past decade, no babies born to women with HIV in San Francisco have been infected. Now, Truvada PrEP offers an option for HIV negative women who want to conceive a child with an HIV positive man.

Similarly, Jae Sevilus from UCSF's Center of Excellence for Transgender Health stressed that women doing commercial sex work or survival sex do not always feel empowered to ask for condoms and cannot always be selective about their partners. "PrEP could bring the power back to these women to protect themselves from HIV," she said. Another concern for transgender women is the dearth of relevant PrEP research and trans-friendly providers.

"Our society, our doctors, and our scientists have aspired to find a way to prevent transmission of HIV," Edwin Lindo of the San Francsico Latino Democratic Club testified. "Well, it's here. We have the opportunity to save a generation of people who can say, San Francisco stood up for us first, and the rest of the country is going to follow."

"The most effective option is many options," Stephany Ashley of the St. James Infirmary for sex workers said at the rally. "PrEP is a powerful new tool in our HIV prevention toolkit, and every one who needs and wants PrEP should have access to PrEP."

9/19/14