On Tuesday, June 11, 2019 the U.S. Preventive Services Task Force (USPSTF) finalized its long awaited recommendation statement for pre-exposure prophylaxis (PrEP), giving it an A grade – the highest grade that a service can receive. The A grade indicates a strong recommendation for the service, and as a key provision under the Affordable Care Act (ACA) most private insurance plans and Medicaid expansion programs are required to cover all USPSTF A and B rated services without any patient cost-sharing. The grade also establishes that there is convincing evidence that PrEP is of substantial benefit for decreasing the risk of HIV infection in persons at high risk of HIV infection, either via sexual acquisition or through injection drug use. The USPSTF also found convincing evidence that adherence to PrEP is highly associated with its efficacy in preventing the acquisition of HIV infection. The final recommendation advices clinicians to offer preexposure prophylaxis with effective antiretroviral therapy to persons who are at high risk of HIV infection.

USPSTF’s final recommendation included guidelines and recommendations from CDC’s 2017 guideline in regards to “PrEP with tenofovir disoproxil fumarate/emtricitabine as an HIV prevention option for men who have sex with men, heterosexually active men and women, and persons who inject drugs…”. The American College of Obstetricians and Gynecologists suggestion that “PrEP may be a useful tool for women at highest risk of HIV acquisition and that such women should be considered candidates for PrEP” was also added, along with 2016 guidance from the World Health Organization in regards to offering PrEP containing tenofovir disoproxil fumarate as another preventative option.

Prior to the final recommendation, USPSTF allotted time for public comments on the recommendation which NCSD and others submitted. Although NCSD offered a handful of suggestions with evidence to support them for USPSTF to consider, not all of the comments were added. Of the comments not included were:

• A slight change to the final recommendation for clarity, so that it would read: “The USPSTF recommends that clinicians offer pre-exposure prophylaxis (PrEP) using effective antiretroviral drugs to persons who are at high risk of HIV acquisition and provide associated clinical services including regular screening for HIV and sexually transmitted infections and monitoring of renal functioning in addition to adherence counseling.”
• STD testing should occur every three months and include testing at extragenital sites
• Including public health providers – including STI clinics, state and local health departments, and family planning clinics—in Task Force recommendations

However, even though USPSTF did not add the above suggestions in their entirety, the final recommendation does touch on the need for STI testing. It states that “…testing for other STIs… be conducted at the time of or just before initiating PrEP. Ongoing follow-up and monitoring, including HIV testing every 3 months, is also suggested.” It also cites the CDC’s recommendation of “regular screening for STIs in men who have sex with men who are at high risk of STIs, and testing in anyone with signs or symptoms.” STIs are mentioned throughout the final recommendation, and notes that while PrEP will help decrease acquisition of HIV, it does not prevent STIs.

USPSTF’s response to all public comments:

The draft version of this recommendation was posted for public comment on the USPSTF website from between November 20, 2018 and December 26, 2018. In response to comments, the USPSTF clarified language describing risk groups and high-risk activities in the Clinical Considerations section. It also provided additional information about the high burden of HIV in transgender women and the risk of HIV transmission in persons living with HIV who have a suppressed viral load. USPSTF included information about stigma, barriers to access care, and racial/ethnic disparities  as obstacles to the use of PrEP by individuals and groups at high risk. Lastly, in response to requests of USPSTF including a meta-analysis examining the effects of PrEP on the risk of STs in the evidence reviewed for this recommendation, USPSTF concluded that “because of basic methodologic limitations of the studies included in the meta-analysis, such as not adjusting for differential STI testing rates and use of self-report to determine baseline STI rates, it was not included in the body of evidence considered for this recommendation.”