The US Preventive Services Task Force (USPSTF) has updated its 2013 recommendations on HIV screening and has assigned a Grade A for a new recommendation to offer pre-exposure prophylaxis (PrEP) for all persons at high risk for HIV infection. The recommendation was published in Journal of the American Medical Association.1 In addition, as in 2013, the USPSTF continues to provide a Grade A recommendation for routine HIV screening among individuals age 15 to 65 years and all pregnant women.
At present, the average monthly retail cost of a once-daily oral treatment with combined tenofovir disoproxil fumarate and emtricitabine, the only formulation of PrEP approved by the United States Food and Drug Administration, is nearly $2000 without insurance. Therefore, the benefit of this endorsement could be substantial, because insurers will be required to cover PrEP with no cost sharing to patients. As Havlir and Buchbinder noted in an editorial commentary, under the Affordable Care Act, private insurers must cover, without contributions from patients, all services with a recommendation Grade A or B made by the USPSTF.2
The recommendations provide useful guidance for which patients should be considered for PrEP by demographic group (men who have sex with men, heterosexual women, and persons who inject drugs) and by risk (serodiscordant sex partners, recent sexually transmitted infection, and sharing injection equipment).
With regard to HIV treatment during pregnancy, Scott and Volberding highlight in another editorial commentary, a report from Botswana, which found a higher than expected incidence of neural tube defects in infants born to women whose HIV treatment at conception included the integrase inhibitor, dolutegravir, with 4 neural tube defects occurring among 426 infants.3,4 This report has led to “rapid changes in international treatment guidelines and is considered the most pressing question regarding treatment of pregnant women with HIV, yet it is not discussed in the USPSTF guideline.”3 Scott and Volberding note that if data emerge that confirm or refute this observation, it will likely be included in future iterations of USPSTF recommendations.
While the recommendations bolster the evidence in support of HIV screening and PrEP, the guidelines do not explicitly address the HIV continuum of care and do not address facilitating linkage to care at the time of positive test, as Walensky and Paltiel aptly note in their editorial commentary.5 The guidelines list adverse effects associated with antiretroviral therapy (ART), such as renal and gastrointestinal effects as well as bone loss, but overlooked “the more proximal and care-limiting issues of stigma, gender-based violence, and medical care coverage.”5
Given that effective ART allows patients to achieve undetectable levels of HIV viral load, thus eliminating risk for transmission, the U=U (Undetectable Equals Untransmittable) campaign was created to help “ensur[e] that virtually all adults in the United States know their HIV infection status, [and to link] all persons with identified HIV to ART, and achieving rates of virologic suppression in excess of 90%…[which] could eliminate the need for PrEP.”5
There are substantial challenges to decreasing HIV infection rates, particularly in areas with widespread stigma. Clinicians “must offer widespread and nonjudgmental testing, treatment, and prevention and endorse multisector, local coalitions to address the epidemic,” concluded Havlir and Buchbinder.
1. US Preventive Services Task Force, Owens DK, Davidson KW, et al. Preexposure prophylaxis for the prevention of HIV infection: US Preventive Services Task Force recommendation statement. JAMA. 2019;321(22):2203-2213.
2. Havlir DV, Buchbinder SP. Ending AIDS in the United States – if not now, when? [published online June 11, 2019] JAMA Intern Med. doi:10.1001/jamainternmed.2019.1577
3. Scott H, Volberding PA.HIV screening and preexposure prophylaxis guidelines: following the evidence. JAMA. 2019;321(22):2172-2174.
4. Zash R, Makhema J, Shapiro RL. Neural-tube defects with dolutegravir treatment from the time of conception. N Engl J Med. 2018;379(10):979-981.
5. Walensky RP, Paltiel AD. New USPSTF guidelines for HIV screening and preexposure prophylaxis (PrEP): straight A’s. JAMA Netw Open. 2019;2(6):e195042.