I would like to discuss the O’Neill Institute’s contribution to a recent public comment. The content of the public comment will be reviewed by the U.S. Preventive Services Task Force (USPSTF), but also may be of interest to general audiences. On March 22, 2017, Jeffrey S. Crowley and I partnered with researchers at The Fenway Institute and Emory University’s Rollins School of Pubic Health to submit comments on the USPSTF’s draft research plan for the use of pre-exposure prophylaxis (PrEP) in preventing the transmission of HIV. Once finalized, the research plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center and will form the basis of the USPSTF’s Recommendation Statement on PrEP. While it may take several months or even years before the USPSTF makes its final recommendation, we submitted comments to inform the process and encourage the USPSTF to consider specific issues and relevant evidence within its research plan. PrEP is an important HIV prevention tool, and the USPSTF’s recommendation has the potential to make PrEP more accessible to individuals and communities most impacted by HIV.
The USPSTF is a federally-appointed independent body of physicians and other experts that conducts evidence-based reviews of various prevention interventions. Once the USPSTF conducts a review, it provides a rating: An A or B rating means that the evidence is strong in support of an intervention, whereas a rating of a C means that an intervention is recommended, but that the evidence for it is weak. Medicare and health plans operating on health insurance marketplaces in accordance with the Affordable Care Act are required to provide prevention services free of enrollee cost-sharing for all interventions with an A or B rating by the USPSTF. Medicaid programs are encouraged to extend the same coverage, although state programs have the discretion to make their own coverage determinations.
Based on the draft research plan posted for public comment from February 23, 2017 through March 22, 2017, the USPSTF seeks to assess the benefits of PrEP use and how these benefits differ by regimen, dosing strategy, and population sub-groups. It also aims to assess rates of adherence and how adherence impacts the effectiveness of PrEP.
Our comments highlight research completed and underway. While it may be appropriate for the USPSTF to consider a range of PrEP agents in the future, we recommend that the USPSTF limit its current review to evaluating clinical effectiveness of oral tenofovir disoproxil fumarate and emtricitabine (TDF-FTC), the medication approved by the U.S. Food and Drug Administration in 2012 for use as PrEP for HIV prevention. Beyond assessing the effectiveness of PrEP regimens, the comments encourage the USPSTF to place emphasis on looking at how different population sub-groups benefit from PrEP. This is particularly important, given that certain population sub-groups (men who have sex with men, transgender people, and heterosexual women in communities with high HIV prevalence, i.e. Black and Latina women) are particularly at risk in the U.S. The comments also note that consideration should be given to a recommendation for persons that self-identify to their providers as being at high risk of HIV infection, which may be particularly important in the context of population sub-groups.
With respect to adherence, our comments emphasize that adherence rates should only be systematically reviewed from studies powered and designed to test the effectiveness of PrEP, not studies designed to demonstrate the initial efficacy of PrEP. Efficacy studies may demonstrate substantially lower adherence because researchers and participants do not know if the drug will produce the intended outcome even with perfect adherence. Placebo-controlled trials, for instance, have been found to have lower rates of adherence than primary care-based service delivery. Adherence counseling and support interventions can also increase adherence.
Given that the USPSTF has the potential to greatly facilitate access to PrEP, the O’Neill Institute will continue to work with partners on subsequent public comments. For more information on this work, please check out our webpage.
The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.