[dropcap]T[/dropcap]ruvada as PrEP has been the biggest breakthrough in the fight against HIV/AIDS since antiretroviral therapy, yet its maker, Gilead Sciences Inc., launched a slow and quiet rollout of the drug in its use to prevent transmission of HIV.
Truvada has been used since 2004 for people with HIV and was expanded in 2012 as a pre-exposure prophylaxis, or PrEP. Truvada interferes with the reverse transcriptase protein used by HIV-infected cells to make copies of the virus. The drug can prevent infections over ninety percent of the time if taken daily. A study conducted by Stanford University in 2010 predicted that just 20 percent of men who have sex with men (MSMs) took Truvada daily, there would be nearly 63,000 fewer infections in twenty years.
With such potential to make a dramatic reduction in new infections in sexually active HIV-negative gay men, one could assume the PrEP regimen would arrive with great fanfare.
But Gilead’s rollout did not include promoting the drug to the general public or even to primary care doctors. Instead, the drug maker has been paying to train HIV specialists in more than fifty community organizations around the U.S. Those specialists have been doing the outreach to general practice physicians.
And with the U.S. Centers for Disease Control waiting to provide Truvada guidelines to providers in 2014, two years after it was approved to prevent HIV transmission, a lot of doctors around the country have been scrambling to catch up to PrEP, if they care to learn about it at all. The result has been a slow-growing awareness, and oftentimes it’s the patients that know more than their physicians.
In an e-mail statement to A&U, Ryan McKeel, a spokesperson for Gilead, suggests that no doctors are left out of its educational program for PrEP:
“We support multiple educational efforts to increase both awareness of PrEP and quality of PrEP delivery, including direct mailing of educational materials to healthcare providers (HCPs) and support for PrEP-related continuing medical education courses. Our educational efforts are aimed at primary care providers as well as at HIV treating clinicians. We have a field-based staff of medical scientists who provide education to healthcare providers across the country upon request.”
Mckeel said Gilead also provides grants to community organizations that are raising awareness among at-risk populations about the availability of PrEP.
But infectious disease specialists tell A&U that, for general practice doctors, the information that Gilead provides on PrEP is opt-in. And PrEP specialists that have worked with Gilead tell A&U that they face resistance from some physicians, who either don’t want to learn about PrEP or are opposed to it because they think it will lead to riskier sexual behavior.
Finding a doctor who can prescribe PrEP, and, importantly, offer follow-up services that go with it, is not a big obstacle for at-risk people who live near active and well-staffed STD clinics. But the lack of physician knowledge about PrEP nationwide puts people who live in smaller towns at a disadvantage, according to Gretchen Weiss, senior program analyst for HIV/STI/HCV at the National Association of City and County Health Officials.
“You don’t need every physician in town to know about PrEP, but it’s critical to have at least one or two [who understand it],” Weiss tells A&U.
Weiss says that in most cases it’s up to county health departments to identify providers in a region who might be willing to offer PrEP services, and develop referral lists and, if there’s enough staff, educate the individual doctors on what’s required for PrEP.
“That’s not my sandbox.”
It’s not just Gilead’s unique educational rollout that has made for a slower PrEP rollout nationwide.
A big roadblock to PrEP access for at-risk patients in much of the country is that too few general practitioners think HIV prevention is in their wheelhouse.
Using PrEP to prevent HIV infection requires more than just a prescription for Truvada. Infectious disease specialists understand that the regimen requires strict adherence, plus an HIV re-test every three months. PrEP specialists say counseling patients on how to use Truvada as part of an overall harm reduction strategy is important too. But many general practitioners are unwilling or unable to provide those “wraparound” services, if they are willing to consider prescribing Truvada at all.
Jim Pickett, director of prevention advocacy and gay men’s health at the AIDS Foundation of Chicago, sees a Catch-22 for people who might be good candidates for PrEP in many parts of the country.
“Many general practitioners will say, ‘that’s not my sandbox’ when a patient asks about PrEP,” Pickett tells A&U. “So they’ll refer the patient to an infectious disease specialist. But that specialist, who may know about PrEP but isn’t used to seeing HIV-negative patients, will send that patient right back to the G.P.”
Pickett adds that the challenges to finding PrEP services in smaller cities are not unlike some of the roadblocks that make HIV services in general harder to come by.
“Patients can access PrEP services, but they’ll probably have to travel.”
First stop: STD clinic
Until and unless a critical mass of doctors across the country understand PrEP, it’s up to patients and advocates to spread the word. PrEP Facts, a Facebook group with more than 5,000 members, keeps lists of doctors in major cities known to prescribe the drug.
Candi Crause, director of infectious diseases for the Champaign-Urbana Public Health District in Illinois, started the educational effort in her area with the established HIV specialty clinic in town before moving on to doctors they’ve had a relationship with. But it’s taken some work to convince doctors about the efficacy of PrEP.
“Some doctors have told us they don’t want to prescribe it because patients will stop using condoms, and maybe cause drug-resistant HIV to spread,” Crause tells A&U.
Jeff Kemp-Rinderle, a program coordinator who works with Crause, says he was surprised by many general physicians’ lack of knowledge and understanding.
“One doctor had to Google ‘PrEP’ right in front of me,” he says. “We didn’t expect the education rollout effort to be so hands-on.”
Some infectious disease specialists say that, if it’s nearby, an HIV clinic might be the best place to receive PrEP, especially if they offer wraparound services that are crucial to drug adherence. But right now only a few clinics in the country have the money for a dedicated PrEP coordinator.
The Red Door Services, of the Hennepin County Public Health Clinic is the largest and oldest HIV/STD services center in Minnesota. Paula Nelson, the clinic’s operations manager, tells A&U that the demand for PrEP has exceeded their expectations.
“Right now instead of sixty clients we have more than 200 active on PrEP,” Nelson tells A&U.
Nelson says that, even though more general practitioners are learning about PrEP, a full-service STD clinic is often the best place for PrEP services.
Nelson adds that counselors take clients through an extensive intake and screening process to help understand how PrEP might fit into their sexual lives and their risk reduction strategy.
“The services we offer for sexual health in general are not a good fit for primary care practices.”
Come for PrEP, stay for healthcare
After its approval for use in preventing HIV transmission, some of Truvada’s detractors called it a “gateway drug” to sex without condoms, suggesting that the drug would make those who could afford to take it risky and careless and, possibly, leave themselves at risk of other STDs. Gilead admits that the drug is not 100-percent effective, and still advocates using condoms even while on the drug.
But some infectious disease specialists are seeing the drug as a different gateway—a gateway to healthcare in general for young MSMs who may not have insurance and may not have seen a doctor in years.
Kemp-Rinderle says that, when a client comes through the door for PrEP he will not only get an HIV test, and re-test every three months if he qualifies for the program, but also a chance to be vaccinated for HPV, even a flu shot.
“They’ll get a whole prevention management schedule that they might not have accessed on their own. We even have staff benefit counselors who can sign them up for Medicaid if they need it.”
Javier Boucher, a client intake coordinator at Red Door, tells A&U he has seen a positive, but unintended consequence of offering PrEP. “We found new patients who wanted PrEP, but hadn’t been tested yet. We’ve seen about five positive patients out of ninety in six months. So even though they’re not eligible for PrEP, those are patients who wouldn’t have come in otherwise and they wouldn’t have learned their status.”
Boucher says they don’t do a lot of advertising about PrEP. Some of the outreach is done on MSM-specific profiles on apps like Grindr and Jacked and hookup sites like Adam4Adam and they’ve put some small ads in the local LGBT paper.
“It helps that people already know about our clinic,” Boucher says. “So if they’re not coming in just for PrEP, we can tell them about it when they come in for [STD] testing.”
Paying for Truvada
Another potential roadblock to PrEP services is cost. Truvada is covered by insurers, but often comes with high copayments—sometimes hundreds of dollars a month—that can make or break most patients’ ability to stay with the program.
Gilead’s assistance program offers as much as $300 a month, which can be very helpful. And some doctors have a sliding scale for services, but many do not. For those who lack insurance but want it, living in a Medicaid expansion state means customers will often find greater insurance subsidies than those living in other states.
Pickett says that in Chicago where he works, a lot of young men show up wanting PrEP, but they have no insurance coverage. Fortunately Illinois is an expansion state, so our first step is to get them insured or on Medicaid.”
“Before PrEP, not many young guys got health insurance,” Pickett says, and adds that for that reason alone, Truvada and the services around PrEP have been invaluable for many. And it’s just a matter of time, he says, before a larger pool of doctors nationwide understand and prescribe PrEP to patients who ask about it.
Larry Buhl wrote about the HIV crisis in Indiana for the June issue.