Campos Seeks Better PrEP Access in SF

The number of gay and bisexual men using pre-exposure prophylaxis, or PrEP, to prevent HIV infection has risen steeply over the past year, according to data presented at a community forum Tuesday, September 16.

The same day gay Supervisor David Campos introduced a resolution that aims to further expand PrEP use by providing access to all San Franciscans regardless of income.

"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," Campos said. "Embracing PrEP now will stop new infections and save lives."

On Wednesday, gay Supervisor Scott Wiener announced in a Huffington Post article at http://www.huffingtonpost.com/scott-wiener/coming-out-of-the-prep-closet_b_5832370.html that he started taking PrEP this year.

"Given the challenges many gay men have with consistent condom use as well as the continued risk of HIV transmission even for those who use condoms, PrEP provides a powerful additional level of protection," Wiener wrote.

"I hope that my being public about PrEP will raise awareness, give additional support to efforts to increase access to PrEP, and reduce stigma, which is a barrier to effective HIV prevention," Wiener told the Bay Area Reporter.

He declined to say exactly when he started taking PrEP.

The Food and Drug Administration approved Gilead Sciences' Truvada (tenofovir plus emtricitabine) for PrEP in July 2012. In May the Centers for Disease Control and Prevention recommended that people at substantial risk should consider PrEP to prevent HIV infection. The World Health Organization also recently recommended PrEP as an option for at-risk gay men.

Rising Numbers

The September 16 community engagement forum, sponsored by the HIV Prevention Planning Council and the San Francisco Department of Public Health, brought together PrEP experts and community members to discuss its effectiveness and how to get access.

Jonathan Volk, a PrEP researcher and doctor at Kaiser Permanente, reviewed study 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 they took PrEP consistently, effectiveness was closer to 80 to 90 percent, and it is "likely much higher with regular use," he said.

Data from the iPrEx OLE study of gay and bisexual men, presented by Robert Grant of the Gladstone Institutes at this summer's International AIDS Conference in Melbourne, showed that while overall efficacy was only about 50 percent, there were no new infections among men who took Truvada at least four times per week.

"Adherence does not need to be perfect," Volk said. "If someone misses a dose, I'm not going to panic about it - they're still probably getting very good protection." Nevertheless, he stressed, people should "still aim for daily use." Among Kaiser's PrEP users, "adherence is really quite excellent," he added. In contrast to studies that provide Truvada for free, in the real world "most people who are not interested in taking [PrEP] anymore will stop paying for it."

Volk reported that a total of 307 people seen at Kaiser in San Francisco had started PrEP as of July 2014, with numbers starting to rise steadily 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.

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.'"

To date there have been no new HIV infections among the Kaiser patients on PrEP, Volk reported. However, there have been many cases of other sexually transmitted infections - most often gonorrhea and chlamydia, but also a few unusual cases of acute hepatitis C among HIV-negative men who do not inject drugs.

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 approximately 2,500 people nationwide had been prescribed Truvada PrEP, with nearly half of them being women. 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 recent increases as seen in the Kaiser numbers.

Cost and Other Barriers

Among Kaiser participants who decided not to start PrEP after a referral, reasons cited included medical contraindications (such as pre-existing kidney problems), perception of being at low risk, changes in relationships, and cost.

With Truvada priced at $1,000 per month or more, cost is one of the major barriers to wider PrEP access.

While many private insurance plans will cover PrEP, some of them make people jump through extra hoops such as prior authorization or using a mail-order pharmacy, according to David Evans, Project Inform's director of research advocacy. In addition, some people who chose a cheaper Affordable Care Act plan with a high deductible, not expecting to go on PrEP, have been shocked by how much they have to pay.

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

Advocates have asked Gilead to cover more people who are underinsured, not just uninsured, Evans replied.

"A lot of people have crappy coverage," he said. "If people have very high deductibles, you should treat them as uninsured rather than insured."

But cost is not the only barrier to PrEP. Jae Sevilus, a psychologist who works with UCSF's Center of Excellence for Transgender Health, stressed that even with financial assistance, a bigger concern for trans women is the dearth of relevant PrEP research and trans-friendly providers. (A small number of trans women were included in iPrEx, but they were lumped in with men who have sex with men.)

"Until we can say this is not going to interfere with your transition-related goals and until trans-friendly doctors know more about PrEP, trans women are going to be pretty hesitant," Sevilus said. "We know even less about trans men."

Indeed, Volk estimated that at Kaiser fewer than 10 transgender women are on PrEP.

Supe's Resolution and Hearing

The resolution Campos introduced at Tuesday's Board of Supervisors meeting calls on the Department of Public Health to inform the supervisors about efforts to educate the public and providers about PrEP, as well as steps related to access and cost.

Specifically, the resolution states, "The Department of Public Health is urged to submit by December 1, 2014, a plan developed in conjunction with the HIV testing programs, public and private clinicians, HIV prevention agencies, support agencies, the manufacturer of Truvada, and health insurance providers to achieve an increase in the use of PrEP that addresses the educational and affordability issues."

"I am committed to taking the steps necessary to ensure access to all individuals wanting PrEP regardless of income," Campos said.

Contrary to some media reports, Campos's resolution does not call for "free PrEP for all" paid for by the city. Instead, the legislation is intended to help people access PrEP through existing financing mechanisms such as private insurance, Medicaid, and Gilead's patient assistance program, HIV Prevention Planning Council member Laura Thomas told the B.A.R.

The board's Neighborhood Services and Safety Committee will hold a hearing to discuss expanded PrEP access Thursday, September 18 at 10am. Thursday's hearing will be preceded by a rally on the steps of City Hall at 9 a.m.