Cambalik's concern is supported by studies. In March, the journal Clinical Infectious Diseases reported an increase of STDs among PrEP users who engaged in unprotected sex. While the number of PrEP users is relatively small now, new national guidelines for clinicians hope to change that. And the concern of properly educating patients about unprotected sex while using the medication is something providers must be conscious of now that the US Preventive Services Task Force has recommended expanded use of PrEP.
The panel's draft guidance, if finalized, would for the first time call for clinicians to offer PrEP to patients at high risk for contracting HIV. The recommendation received the highest grade of "A," which means the guidelines would require Affordable Care Act-compliant health plans to fully cover the cost of the daily medication, which has a list price of $1,300 a month.
"If this goes into clinical practice then it has to go with the whole package," Cambalik warns, referring to regular follow-up care and sexual health counseling.
Dr. John Elping, professor of family and community medicine at the Virginia Tech Carilion School of Medicine in Roanoke, VA., also is a member of the task force that made the recommendation.
"We hope that this opens another door for additional prevention," Elping said. "I think this does represent progress in how we look at HIV,."
Despite the drug's benefits, use of PrEP has remained low since it was first approved in 2012. Of the estimated 1.1 million Americans identified in 2015 as possibly benefitting from taking PrEP, only 90,000 prescriptions were filled that year, according to the Centers for Disease Control and Prevention. Most of those who could have benefited from PrEP that year were African-American and Latinx adults, who together accounted for 800,000 of the 1.1 million at risk but who had a combined total of only 14,000 PrEP prescriptions filled.
A University of California Santa Cruz survey of how a small group of gay and bisexual men perceived PrEP found that men who visited a clinic catering to LGBT patients were most likely to use PrEP, adding fuel to the debate that providers may stigmatize the drug or that it's not being widely promoted. That's despite drugmaker Gilead hosting regular informational dinners for providers like Cambalik who get invited two to three times a year.
Those dinners don't appear to make much of a difference.
"For the average private practice that has maybe 1% of at-risk population, they will probably be oblivious to PrEP," said Dr. David Zich, an internal and emergency medicine physician at Northwestern Medicine in Chicago.
Zich points to federal data to show the impact expanded PrEP use could have.
The CDC reports that PrEP, if taken consistently, can reduce the risk of HIV infection by up to 92%. Consistent use of condoms with the drug can reduce the risk of infection even further.
But Zich doubted the USPTF recommendation would have any impact toward reducing the 40,000 new HIV infections that occur in the U.S. each year.
"Unfortunately, many of the people who are at the highest risk are at the highest risk because they just don't care," said Zich, who added his assessment was based on interacting with a small subset of high-risk patients in the ED and did not speak for the majority of individual who could benefit from taking PrEP. "They have other issues in their life that predominate."
According to the CDC, populations at highest risk for contracting HIV are among younger gay and bisexual men, who made up 61% of new infections in 2016. According to HHS, LGBT youth are two to three times more likely to attempt suicide and experience issues such as homelessness, violence, tobacco use, alcohol and substance use at greater rates than the general population.
One way to expand use of PrEP would be to educate providers on identifying the risk factors that would make a patient an eligible candidate.
The average primary care clinician shys away from asking those questions, said Wendee Wechsberg, director of substance abuse, gender and applied research for not-for-profit research institute RTI International's Global Gender Center. "What general practitioner doctors really need to learn to do is better assessments."
And vendors are responding to that need.
Patient platform software firm Healthvana, has a PrEP mobile app that helps facilitate the conversation and keep patients on track with their medication adherence and STD screening. The firm currently works with 200,000 PrEP users.
The comment period for the USPTF guidelines ends Dec. 26.
