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Primary care clinicians should offer pre-exposure prophylaxis (PrEP) to patients at high risk of HIV infection, the U.S. Preventive Services Task Force (USPSTF) said.

There is "high certainty" of "substantial" benefit in offering PrEP (oral tenofovir disoproxil fumarate–based therapy) to reduce the risk of HIV infection in high-risk populations ("A" recommendation), reported USPSTF members Douglas Owens, MD, of Stanford University in California, and co-authors.

Moreover, there was "convincing evidence" of the efficacy of PrEP when used correctly and consistently, with only "adequate evidence" of small harms, such as kidney and gastrointestinal adverse effects, the authors wrote in .

The USPSTF HIV screening in adolescents and adults ages 15-65, as well as pregnant women (A recommendation), which was published , as well as in JAMA.

The recommendation for PrEP now means that insurers will be required to cover PrEP with no cost sharing to patients, HIV Medicine Association chair David Hardy, MD, noted in a statement shared with 口袋女优. Under the Affordable Care Act, private insurers must provide from USPSTF.

Hardy added that health insurer coverage of other medical services related to PrEP, such as screening for HIV and sexually transmitted infections, laboratory monitoring, and adherence counseling, will be "critical."

"In addition to addressing insurance coverage issues, the USPSTF's strong support of PrEP provides needed impetus to increase medical provider awareness of this essential prevention tool, and to address providers' reluctance to prescribe PrEP," Hardy said. "Today's announcement has the potential to markedly expand PrEP access and to reduce new HIV infections -- a key component of the administration's initiative to end HIV as an epidemic."

To that end, he noted that HHS can help by ensuring that not only are medical services related to safe and effective PrEP offered, but that "new options for PrEP are covered as they are approved."

An editorial in by Rochelle Walensky, MD, of Massachusetts General Hospital in Boston, and David Paltiel, PhD, of Yale University in New Haven, Connecticut, subtitled "Straight A's," addressed the issue of cost more explicitly. The editorialists said that "cost-effective does not imply affordable," and that a $25 HIV test could trigger a lifetime of expense, with antiretroviral therapy costing at least $40,000 annually.

"At an annual cost of $20,000 per person, the drug component alone of a complete PrEP rollout for all those eligible would cost $24 billion annually," Walensky and Paltiel wrote. "Attempts are already being made to shift prescribing to emtricitabine/tenofovir alafenamide, which will entail higher costs with relatively modest differences in clinical outcomes."

They characterized the idea of ending the HIV epidemic as "a worthy aspirational target," but pointed to areas where PrEP interventions have previously failed -- in the most marginalized and stigmatized communities at the highest risk of infection.

Risk and the Role of Clinicians

Indeed, risk was a theme echoed by both the Task Force and other editorialists. The Task Force acknowledged that research gaps mainly involved underserved populations, specifically those who would benefit most from PrEP, such as racial/ethnic minorities including black/African-American and Hispanic/Latino populations.

An by Hyman Scott, MD, and Paul Volberding, MD, both of the University of California, San Francisco, noted that current individual risk behavior assessments often underestimate the true risk for acquiring HIV for populations, such as black men who have sex with men.

"All clinicians must improve the assessment of HIV acquisition risk to identify all individuals for whom this prevention tool is appropriate, regardless of their demographic group and activity of risk," Scott and Volberding wrote. "While acknowledging these concerns, many recommend reframing PrEP assessment as part of a larger strategy of supporting sexual health, moving away from a 'risk' framework to encourage uptake."

The Task Force also explicitly addressed the topic of risk in changes to the draft recommendation statement. They noted that information was added to clarify language "describing risk groups and high risk activities." This included studies alluding to "undetectable equals untransmittable," where a seropositive partner with a suppressed viral load and treated with antiretroviral therapy has not transmitted HIV to a seronegative partner. The Task Force also included language to address the issue of "stigma, barriers to access care and racial/ethnic disparities as obstacles to PrEP."

An editorial in by Diane Havlir, MD, and Susan Buchbinder, MD, both also of the University of California, San Francisco, called upon clinicians to help combat these issues. In addition to focusing testing to try and find individuals with undiagnosed infections, and linking HIV testing services to treatment for people living with HIV, the editorialists said clinicians should support PrEP expansion, noting that it has disproportionately lower uptake among women, people younger than age 25, those living in the South, and those in states without Medicaid expansion.

"Expanding PrEP availability will require that clinicians ask their patients about sexual practices and drug use, explain the benefits to those at risk, and prescribe the medication and monitor its use," Havlir and Buchbinder wrote. "Clinicians, however, have often been reluctant to offer patients PrEP prescriptions, out of concern about prescribing antiretroviral agents, or fear that providing the medications may cause their patients to reduce condom use and increase their risk of acquiring sexually transmitted infections."

Hardy noted in his statement that these recommendations will not be implemented until 2021.