June 13, 2019

PrEP gets an A from the U.S. Preventive Services Task Force –Could Increase Uptake

On June 11, JAMA Network announced that the “U.S. Preventive Services Task Force (USPSTF) issued its strongest strategy yet for preventing HIV” by giving PrEP an “A” grade, its highest rating. They based their assessment on their “review of 14 randomized clinical trials, 8 observational studies, and 7 studies of diagnostic accuracy, which demonstrated that PrEP was associated with decreased risk of infection after 4 months to 4 years.”

The USPSTF, established by Congress in 1984 and supported by the Department of Health and Human Services  staff, is made up of 16 volunteer members, most of them practicing clinicians. More information on the role of the USPSTF is available in the 11/29/2018 column here.

At present, 1.2 million people in the U.S. are at relatively high risk of acquiring HIV infection but fewer than of them are taking PrEP. Cost and access are inhibiting factors given that PrEP is expensive in the U.S. in the absence of insurance coverage or a copay assistance plan. The Affordable Care Act (ACA) requires that most private insurance plans and Medicaid expansion programs cover the entire cost of medications that have a USPSTF A and B rating, with no ancillary cost sharing paid by the consumer. This new USPSTF rating, therefore, should facilitate much improved PrEP access for those enrolled in ACA plans and in those Medicaid expansion states.

Long-lasting PrEP injectables and implants are now being developed for people who prefer not to take daily pills. Uptake of generic PrEP (not available in the U.S.) is rising in countries where it is available at relatively low prices. The USPSTF rating can, we hope, promote access here by compelling more payers/insurers to cover PrEP without patient co-pays.

We also hope it will increase PrEP awareness among health care providers and address the concerns of those still reluctant to prescribe PrEP. In the words of Dr. Diane Havlir, a professor at UCSF and co-creator of the San Francisco Public Health Department’s “Getting to Zero San Francisco” Program, “I hope that with this recommendationwe can garner momentum to bend the curve for new HIV infections in the U.S.”

Connecticut To Make PrEP Available to Minors without Parental Consent

Last week, Connecticut’s General Assembly and Senate passed HB 6540 entitled “An Act Concerning the Prevention of HIV.” The bill allows Connecticut health providers to prescribe PrEP without parental consent to minors who disclose that they are a risk of HIV exposure and want PrEP for protection.

The state’s Health Department data show that 34% of people living with HIV in the state were young people and that HIV diagnoses in the state rose by 4% in 2017 (most recent data available). In testimony before the legislature’s Public Health Committee, Health Commissioner Raul Pino said that the bill would, “increase access for minors to preventive care.” He also noted that, in 2004, the FDA had approved PrEP for all ages.

Last March, the Academy wrote to the CT Public Health Committee in support of the bill. We noted that, “HB 6540 essentially parallels the provision of contraceptive pills and emergency contraception to minors without parental consent. In both cases, youth seeking to protect their health are allowed to obtain and use the protection they need without parental involvement, if necessary.”

Academy member Gary Spinner and his colleague, Dr. Kristyn Wagner alerted us to this bill. Spinner wrote in his letter to the Committee that that, “of the last 12 newly infected patients who have seen me, nearly all are young men of color who have sex with men.” They needed to be “able to discuss their sexuality with a health care provider where they would not feel shame and to have access to sound HIV prevention education and access to PrEP.”

Connecticut Governor Ned Lamont is expected to sign the Bill into law soon, possibly on June 27, National HIV Testing Day.

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