Draft guidance effectively outlines what infectious disease specialists have known for years—and leaves many unanswered questions.
Those at the frontlines of HIV prevention and treatment—namely: infectious disease specialists—know the value of pre-exposure prophylaxis (PrEP).
Now, the 2-drug (tenofovir and emtricitabine) combination pill intended for those deemed at high risk for HIV has seemingly garnered mainstream acceptance—finally. Earlier this week, the US Preventive Services Task Force, an independent, volunteer panel of national experts in prevention and evidence-based medicine convened annually under the auspices of the Agency for Healthcare Research and Quality (AHRQ), for the first time recommended PrEP as a method for stopping the spread of HIV/AIDS.
The move comes 6 years after the pill first received US Food and Drug Administration (FDA) approval for use in adults at risk for the disease. It was approved for use in high-risk adolescents earlier this year.
“The evidence is clear: When taken as prescribed, PrEP is highly effective at preventing HIV,” task force member Seth Landefeld, MD, Chair, Department of Medicine, University of Alabama at Birmingham said in a statement. “To make a difference in the lives of people at high risk for HIV, clinicians need to identify patients who would benefit and offer them PrEP.”
In a draft recommendation, on which public comment will remain open until December 26, 2018, the task force advises clinicians to “offer… PrEP with effective antiretroviral therapy to persons who are at high risk of HIV acquisition.” Although they acknowledge that they found “inadequate evidence” supporting the availability of “specific risk assessment tools [that] can accurately identify persons at high risk of HIV acquisition,” they believe clinicians can use existing epidemiologic data on risk factors to identify those for whom PrEP would be appropriate.
Notably, they write that “PrEP is of substantial benefit in decreasing the risk of HIV infection in persons at high risk of HIV infection, either via sexual acquisition or through injection drug use,” and that there is “convincing evidence that adherence to PrEP is highly correlated with its efficacy in preventing the acquisition of HIV infection.”
Given that the side effects associated with PrEP are fairly minor, they see a “substantial net benefit” for its use in at-risk patients.
Those that are seeing and treating such patients are hardly surprised by the findings.
“I support any public health organization that endorses the use of PrEP, but what I would say to the US Preventive Services Task Force is: ‘What took you so long?’,” noted Ian Frank, MD, associate chief, Infectious Diseases Division, and director, Clinical-Therapeutics Program, Penn Center for AIDS Research, the University of Pennsylvania during an interview with Contagion®. (Dr. Frank is not part of the task force and thus was not involved in the drafting of the recommendation.)
“The US Centers for Disease Control and Prevention and the US Public Health Service developed PrEP guidelines in 2014 and the World Health Organization recommended PrEP in 2016,” he continued. “We have a wealth of data demonstrating the efficacy and safety of PrEP when men and women adhere to the regimen appropriately, irrespective of the route of HIV acquisition.”
So how will the task force recommendation impact care, if at all?
“If this announcement leads to more awareness about PrEP among health care providers or potential PrEP consumers, then there may be some impact, but it's not likely to be much, since PrEP advocates have been quite vocal for some time, and there is currently some direct-to-consumer advertising about PrEP on television,” Dr. Frank explained. “PrEP awareness has increased substantially among at-risk populations. The obstacles to obtaining PrEP now are part structural, part stigma, and part disinterest in taking a daily pill among individuals who don't currently take medication.”
Indeed, the task force announcement is hardly a bad thing, but it means little unless it leads to improvements in access to PrEP for those who need it, to the creation of programs designed to help those in need pay for the drug, and the initiation of efforts to protect the privacy of young people taking it (who may be fearful of the response of family and peers if they were to find out).
Now, recommendations for how to resolve those issues would be newsworthy.
Brian P. Dunleavy is a medical writer and editor based in New York. His work has appeared in numerous health care-related publications. He is the former editor of Infectious Disease Special Edition.