USPSTF Gives PrEP a Grade A Recommendation for HIV Prevention

The US Preventive Services Task Force (USPSTF) has issued a new recommendation that clinicians should offer pre-exposure prophylaxis (PrEP) for the prevention of HIV infection to patients who are at a high risk of acquiring the virus.

In order to make an informed decision, the USPSTF reviewed the evidence on the benefits of PrEP with oral tenofovir disoproxil fumarate monotherapy or combined tenofovir disoproxil fumarate and emtricitabine. The task force also evaluated whether the benefits of PrEP vary by risk group, population subgroup, or regimen or dosing strategy; rates of adherence and effectiveness of PrEP; and the harms of PrEP when used for HIV prevention.

“The USPSTF concludes that with high certainty that the magnitude of benefit of PrEP with oral tenofovir disoproxil fumarate-based therapy to reduce the risk of acquisition of HIV infection in persons at high risk is substantial,” the recommendation reads on the USPSTF website.

The recommendations are also explained in an evidence report published in JAMA.

The decision was based upon a review of 14 randomized clinical trials, 8 observational studies, and 7 studies of diagnostic accuracy. In this review, the task force reports finding convincing evidence that PrEP is of substantial benefit in decreasing the risk of HIV infection in persons at high risk of HIV acquisition.

The evidence review also found that adherence to PrEP is highly associated with its efficacy in preventing the acquisition of HIV infection, and therefore adherence to PrEP is central to producing benefits. Although there are clear benefits, the task force also found adequate evidence that PrEP is associated with small harms, including kidney and gastrointestinal adverse effects.

Based on the findings of the evidence review, the task force recommends that PrEP should be considered for: men who have sex with men who are sexually active and are in a serodiscordant relationship, do not consistently use condoms, or have had syphilis, gonorrhea, or chlamydia in the past 6 months; heterosexual women and men who are sexually active and are in a serodiscordant relationship, do not consistently use condoms, or have had syphilis or gonorrhea in the past 6 months; or individuals who inject drugs and share injection drug equipment or have a high sexual risk of acquiring HIV.

When making recommendations, USPSTF assigns a letter grade to the guidance. The PrEP recommendation received a Grade A recommendation status, which indicates that USPSTF found that there is high certainty that the net benefit of use is substantial.

In a statement issued by W. David Hardy, MD, chair of the HIV Medicine Association, the recommendation is referenced as a critical milestone for improving accessibility to PrEP and working towards ending the HIV epidemic.

“The recommendation, once implemented in 2021, will require insurers to cover PrEP with no cost-sharing to patients. As noted in the USPSTF recommendation, the Centers for Disease Control and Prevention recommends that individuals taking PrEP receive medical services every three months that include HIV and STD screening, laboratory monitoring and adherence counseling,” Hardy writes. “Health insurer coverage of these clinical services as essential components of PrEP, without cost sharing, will be critical.”

According to Hardy, if future PrEP options are approved, such as drug formulations, generic medications, long-acting injectables or implants, they should be considered in insurance coverage for PrEP following approval by the US Food and Drug Administration.

Hardy is hopeful that the new recommendation will increase provider’s knowledge of PrEP and lead to more frequent prescribing to patients who are at risk.

“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,” he concludes.