December 5, 2019

HHS on Tuesday unveiled a new program called Ready, Set, PrEP, which will provide uninsured U.S. residents with HIV-prevention medication at no cost as part of the Trump administration's goal to nearly eliminate new transmissions of HIV in the United States within the next 10 years, The Hill reports.

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Background: Trump pledges to nearly eliminate HIV transmission, but CDC finds slow progress

President Trump during his 2019 State of the Union address announced a new goal to reduce new transmissions of HIV in the United States by 90% by 2030. Trump during the address said recent scientific advancements have brought "a once-distant dream" of eliminating HIV "within reach."

However, CDC officials in a report released Tuesday said the United States needs to make drastic improvements in HIV testing, treatment, and prevention to reach Trump's goal.

For the report, CDC researchers examined the United States' progress in reducing the number of new HIV infections. They found that the rate of new HIV infections remained relatively unchanged from 2013 to 2017, at about 38,000 per year. According to the researchers, about 40% of new HIV infections in 2016 were contracted from individuals who did not know they had HIV, while 60% of the infections were contracted from individuals who knew they had HIV but were not receiving medical care for the condition or were not consistently taking medication to control the virus.

Likewise, the researchers found that, in 2017, an insufficient number of patients with HIV had received medical care for the condition or the daily medication needed to control the virus. According to the researchers, just 62.7% of patients who knew they had HIV in 2017 had the virus under control through effective treatment.

The researchers also found that, in 2018, pre-exposure prophylaxis (PrEP) had not been prescribed to enough of the 1.2 million individuals in the United States who could benefit from the HIV prevention drug. Specifically, the researchers found that only 18.1% of patients who could benefit from PrEP had been prescribed the medication in 2018, though that was up from 12.6% in 2017.

CDC officials noted that, to reach the administration's goal of eliminating HIV transmission in the United States:

  • At least 95% of HIV infections would need to be diagnosed;
  • At least 95% of patients with diagnosed HIV would need to reach viral suppression by receiving appropriate medical care and taking necessary medications as prescribed; and
  • At least 50% of individuals who could benefit from PrEP would need to receive a prescription for the drug.

Administration officials in February said efforts to eliminate HIV transmission in the country would center on 48 U.S. counties where about 50% of new HIV infections emerge. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said officials would focus on providing U.S. residents in those 48 counties with increased access to antiretroviral drugs to treat HIV, as well as PrEP to prevent the spread of HIV infections.

Trump in May announced that his administration had reached an agreement with Gilead Sciences, under which the drugmaker will donate up to 2.4 million bottles of its HIV-prevention drug Truvada to CDC each year to help uninsured and at-risk U.S. residents access the medication. Truvada is more than 90% effective at preventing HIV infection when the medication is taken daily.

HHS launches program to offer no-cost PrEP to uninsured

In light of that agreement, HHS on Tuesday announced the launch of a national program called Ready, Set, PrEP that will provide PrEP at no cost to U.S. residents who do not have prescription drug insurance. Under the program, HHS will use the Truvada donations from Gilead to provide the drug to uninsured patients who test negative for HIV and receive a prescription for PrEP. Mia Heck, a spokesperson for HHS Assistant Secretary for Health Brett Giroir, said the program will not cover the costs of lab tests and clinic visits needed to obtain PrEP prescriptions.

HHS said Gilead will distribute the drugs to patients until March 2020 at thousands of participating pharmacies. HHS Secretary Alex Azar said the federal government will pay Gilead about $200 per bottle of PrEP to cover distribution fees, but Gilead will pass through the full total of those payments to other companies in the drug supply chain, such as distributors and dispensers.

HHS said it expects to bring down those costs by at least 50% by the end of March through a new partnership with CVS Health, Rite Aid, and Walgreens. Under the partnership, the companies will begin to dispense the drugs at no cost to the federal government and qualifying patients no later than March 30, 2020. The companies will distribute the medication under the program at their pharmacy locations throughout the United States and through their mail-order services. According to HHS, the companies also will offer patient counseling and work to promote medication adherence among PrEP users.

Azar estimated that about 200,000 uninsured U.S. residents will be eligible to receive PrEP at no cost through the program (Sullivan, The Hill, 12/3; Bernstein, Washington Post, 12/3; Stein, Bloomberg Law, 12/3; Kounang, CNN, 12/3; Branswell, STAT News, 12/3; Harris et al., "Vital Signs," CDC's Morbidity and Mortality Weekly Report, 12/3; HHS release, 12/3).

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