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Public Comment on USPSTF Draft Recommendations for PrEP and HIV Screening

Treatment Action Group submitted the following comment on December 21, 2018.
 

Treatment Action Group Applauds US Preventive Services Task Force “A” Ratings for Pre-Exposure Prophylaxis and HIV Screening

Treatment Action Group (TAG) strongly supports the draft recommendations recently released by the US Preventive Services Task Force (USPSTF) regarding pre-exposure prophylaxis (PrEP) for individuals highly vulnerable to infection and HIV screening for all Americans between the ages of 15 and 65, including pregnant women. Both essential services received a recommended “A” grade, sending a strong signal to health care providers and policy makers that vulnerable individuals should have unfettered access to screening and PrEP. If upheld following a public comment period through December 26, 2018, these ratings will also require private insurers to provide coverage for PrEP without cost sharing and to continue to do the same for HIV testing. This is a vital boost to efforts to implement PrEP in the U.S. where, as noted by the USPSTF in their draft recommendation, less than 80,000 individuals used the intervention in 2016i while the CDC has estimated that 1.2 million Americans could benefit from it.ii It also provides ongoing support for HIV testing at a time when an estimated 15% of Americans living with HIV are unaware of their status.iii

We are also pleased to see that within their recommendation USPSTF has followed the lead of the World Health Organization (WHO) in recognizing that tenofovir (TDF) alone may have substantial benefit in averting HIV infection when Truvada (TDF/FTC) is not easily accessible.iv At a time where generic TDF and Mylan’s Cimduo (TDF/3TC) are now available in the U.S., and given the substantial price of Truvada ($1600 per month)v and systemic burden of Gilead’s current monopoly on biomedical primary prevention (the company made approximately $2.2 billion on Truvada in 2017 in the U.S.),vi competition and cost reduction may play an important role in scaling up PrEP for uninsured populations, particularly in the southern U.S. and other states without Medicaid expansion.

We are hopeful that this recommendation will quickly translate into increased coverage and access for insured individuals. Again, with Truvada continuing to be offered at luxury prices, ensuring that coverage entities do not institute barriers for access– such as stringent prior authorization requirements in order to avoid payment– will be key for advocates and stakeholders to monitor.

In order to avoid the possibility that insurers may attempt to narrowly define for whom this recommendation applies, we would encourage USPSTF to better emphasize the disproportionate vulnerability to infection experienced by adolescents and transgender people. According to the CDC, youth aged 13 to 24 accounted for 21% of all new HIV diagnoses in the U.S. in 2016.vii A 2013 meta-analysis estimated that around a quarter of transgender women in the U.S. were living with HIV, and that over half of black transgender women may be living with the virus.viii We would also strongly encourage language indicating that any individual who requests PrEP is likely a candidate for the intervention and should be considered highly vulnerable to infection regardless of demographic background or even reported risk behaviors. Given that HIV, sex, and drug use remain highly stigmatized within the U.S., a patient should not be denied PrEP and left vulnerable simply because they underreported their risk factors to avoid the possibility of discrimination and judgment.

While we understand the ongoing emphasis on condom usage and behavioral counseling within the draft recommendations for both HIV screening and PrEP, particularly as we continue to have limited options for STI primary prevention, we recommend that the USPSTF make clear that lack of condom usage or behavioral modification is not a contraindication for PrEP; in fact, individuals who cannot or do not use condoms are those most in need of this intervention. We also caution that behavioral counseling should only be offered to those who want it, and that prevention service providers ensure that these resource-intensive and often invasive interventions not create a barrier to access for PrEP and screening. Particularly following the 2011 Project AWARE study, which found that behavioral counseling did not lead to a reduction in HIV incidence compared to a control group receiving only testing, and that there was actually a statistically significant increase in STIs for men who have sex with men in the treatment group compared to control,ix it is important that health care providers primarily emphasize ease of access to PrEP and screening as these interventions have a much stronger evidence base.

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About TAG: Treatment Action Group (TAG) is an independent, activist and community-based research and policy think tank fighting for better treatment, prevention, a vaccine, and a cure for HIV, tuberculosis, and hepatitis C virus. TAG works to ensure that all people with HIV, TB, or HCV receive lifesaving treatment, care, and information. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions. TAG catalyzes open collective action by all affected communities, scientists, and policy makers to end HIV, TB, and HCV.


i Huang YA, Zhu W, Smith DK, et al. HIV Preexposure prophylaxis, by race and ethnicity - United States, 2014-2016. MMWR Morb Mortal Wkly Rep. 2018;67(41):1147-50.

iiSmith DK, Van Handel M, Wolitski RJ, et al. Vital signs: estimated percentages and numbers of adults with indications for preexposure prophylaxis to prevent HIV acquisition—United States, 2015. MMWR Morb Mortal Wkly Rep. 2015;64(46):1291-5.

iiiDailey AF, Hoots BE, Hall HI, et al. Vital signs: human immunodeficiency virus testing and diagnosis delays - United States. MMWR Morb Mortal Wkly Rep. 2017;66(47):1300-6.

ivWorld Health Organization. WHO Expands Recommendation on Oral Pre-Exposure Prophylaxis of HIV Infection (PrEP). Geneva. November 2015. http://apps.who.int/iris/bitstream/handle/10665/197906/WHO_HIV_2015.48_e...

vCenters for Medicare & Medicaid Services. National Drug Acquisition Cost: NADAC as of 2018-05-09. Baltimore, MD. https://data.medicaid.gov/Drug-Pricing-and-Payment/NADAC-as-of-2018-05-0...

viGilead Sciences. Fourth Quarter and Full Year 2017 Financial Results. Foster City, CA. 6 February 2018. https://www.gilead.com/news/press-releases/2018/2/gilead-sciences-announ...

viiCDC. HIV Among Youth. Atlanta. https://www.cdc.gov/hiv/group/age/youth/index.html.

viiiCDC. HIV Among Transgender People. Atlanta.  https://www.cdc.gov/hiv/group/gender/transgender/index.html.

ixMetsch LR, et al. Effect of risk-reduction counseling with rapid HIV testing on risk of acquiring sexually transmitted infections: the AWARE randomized clinical trial. JAMA. 2013 Oct 23;310(16):1701-10. doi: 10.1001/jama.2013.280034.