The Department of Health and Human Services is launching a program that will provide drugs to prevent HIV infection at no cost to people who do not have prescription drug insurance coverage.
HHS said Tuesday that it had launched Ready, Set, PrEP, to provide drugs for pre-exposure prophylaxis. The department noted that while more than 1 million people in the U.S. are at risk of HIV and could benefit from PrEP, only a small fraction of those people actually receive it. The program is part of a larger program called Ending the HIV Epidemic: A Plan for America, or EHE. EHE hopes to reduce new HIV infections in the U.S. by 75 percent in five years and 90 percent in 10 years.
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Two drugs are currently approved for PrEP, both made by Foster City, California-based Gilead Sciences: Truvada (emtricitabine, tenofovir disaproxil fumarate) and Descovy (emtricitabine, tenofovir alafenamide), the latter of which the Food and Drug Administration approved for PrEP in October. Teva Pharmaceutical Industries is expected to launch a generic version of Truvada next September.
In an email, HHS spokesperson Mia Heck noted that Gilead had agreed to donate PrEP medications for up to 200,000 uninsured people every year for 11 years, including Truvada and Descovy. The company will cover the cost of the medications, but not clinic visits, lab tests or dispensing costs. However, retail pharmacy chains Walgreens, CVS and Rite Aid are donating their dispensing services to HHS as part of the program. Patients will also be able to obtain their drugs via mail order starting on March 30, 2020.
“Ready, Set, PrEP is a historic expansion of access to HIV prevention medication and a major step forward in President Trump’s plan to end the HIV epidemic in America,” HHS Secretary Alex Azar said in a statement. “Thanks to Ready, Set, PrEP, thousands of Americans who are at risk for HIV will now be able to protect themselves and their communities.”
The approval of Descovy as a PrEP medication was based in part on its lower incidence of the renal and bone toxicity that has been associated with Truvada. A Phase III head-to-head study comparing the two drugs in men and transgender women who have sex with men showed that Descovy was non-inferior to Truvada, but showed lower incidence of reduced bone mineral density and kidney function, including among patients who switched to Descovy from Truvada.
Still, some medical experts have said that Truvada is generally well-tolerated, and the concerns about bone and renal toxicity, while present, are minimal in otherwise healthy individuals. But Descovy was seen as a good option for patients with underlying bone or kidney issues, notwithstanding the lack of data for women or intravenous drug users.
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