FDA approves long-lasting HIV-prevention drug

UPI

6 hours ago

1 of 2 | A man photographs a portion of the AIDS quilt during an HIV/AIDS rally on the National Mall in Washington, D.C., in 2021. The Food and Drug Administration has said that it has approved a new drug that could prevent HIV infections with just two shots every year. File Photo by Kevin Dietsch/UPI | License Photo
June 18 (UPI) -- The Food and Drug Administration has approved a new drug that could prevent HIV infections with just two shots every year and possibly eradicate the disease.
The drug's scientific name is lenacapavir and it will be marketed as Yeztugo, which requires one injection every six months to maintain its effectiveness in preventing HIV infections.
Other drugs exist that also prevent HIV, but they require daily dosages in pill form and have not significantly affected the disease on a global level.
"We're on the precipice of now being able to deliver the greatest prevention option we've had in 44 years of this epidemic," AVAC executive director Mitchell Warren told the New York Times. AVAC is an anti-HIV organization.
He said recent funding cuts by the Trump administration will make it hard to distribute the drug globally.
"It's as if that opportunity is being snatched from out of our hands by the policies of the last five months," Warren said.
Gilead Sciences is producing the drug, which is the second long-lasting HIV prevention drug available.
The other option is cabotegravir, which is sold under the brand name Apretude and requires an injection every two months.
About 21,000 Americans use Apretude, while about 500,000 use daily oral medications to prevent HIV.
Clinical trials showed most participants who received two shots of lenacapavir every year had nearly full protection against HIV.
More than 39,000 people in the United States contracted HIV in 2023, which carries an estimated lifetime treatment cost of $1.1 million per patient, Gilead Chairman and Chief Executive Officer Daniel O'Day told the New York Times.
Lenacapavir already is being prescribed to treat people with HIV infections that resist other medications and at an annual cost of $42,000 per patient, but most patients don't pay the full cost.
Health insurance coverage and patient-assistance programs would cover the cost for most people using lenacapavir, according to Gilead.
The cost for oral pills taken daily is just $1 per pill, while Apretude carries an annual cost of about $24,000.
Proposed funding reductions for Medicaid and the President's Emergency Program for AIDs Relief, commonly called PEPFAR, might greatly reduce access to the drug, according to advocacy groups.
The PrEP oral treatment still would be available, but it does not work for many people, Health Gap Executive Director Asia Russell told the New York Times.