FDA Approves Twice-Yearly Antiviral Injection for Prevention of HIV
Onyebuchi Ezigbo in Abuja
The world is about to witness what may signal an end to decades long epidemic caused by the HIV virus, with a powerful and convenient prevention option.
The United States Food and Drug Administration on Wednesday approved Gilead’s twice-yearly antiviral injection for preventing HIV — a milestone that the company and some experts say could help end the threats posed by the virus.
According to report by the CNBC in the two groundbreaking clinical trials in 2024, Gilead’s injection proved to be capable of virtually eliminating new HIV infections when taken every six months.
The injection is taken in a less frequent dosage than for all existing HIV prevention medications, including daily pills from Gilead and another injection, from GSK, taken every other month.
“That makes Yeztugo a valuable and far more convenient tool for addressing an epidemic that led to around 1.3 million new infections and contributed to the deaths of 630,000 people globally in 2023, according to the World Health Organization,” said the report..
CNBC however said that the launch of the injectable drug, which will be marketed under the name Yeztugo, faced a set of potential threats, including the Trump administration’s proposed cuts to federal funding for HIV prevention efforts.
“The U.S. alone sees 700 new cases and 100 HIV-related deaths each week, Gilead CEO Daniel O’Day said in an interview ahead of the approval.
HIV continues to have a disproportionate impact on people of color, gay and bisexual men, other men who have sex with men and transgender women.
It’s hard to overstate the importance of this for global public health,” O’Day said, adding that the injection “really will bend the arc of the epidemic as we roll this out across the globe.”
On his part, Executive Director of PrEP4All, an organization focused on expanding access to HIV prevention medications. Jeremiah Johnson, said the magnitude of drug impact will also depend on how easy it is to get,
With regard to cost and efficacy, the report quoted a Gilead spokesperson as saying that Lenacapavir, the generic name of Yeztugo, has an annual list price of $28,218 in the U.S. before insurance.
“That is in line with existing branded medications approved for the same use: pre-exposure prophylaxis, or PrEP, which reduces the risk of getting HIV.
“A month’s supply of Truvada and Descovy, Gilead’s daily pills for PreP, are both around $2,000 without insurance, which amounts to around $24,000 per year.
“One dose of GSK’s Apretude, which is taken once monthly for the first two months and then once every other month thereafter, costs roughly $4,000 before insurance.
“We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage,” the Gilead spokesperson said, adding that there is broad insurance coverage for existing prevention options”.
The company said it has a copay savings program for eligible insured patients that may reduce out-of-pocket payments for Yeztugo to as little as zero dollars. Gilead also has a program for eligible uninsured people to receive the injection for free.
In addition, the company said that Lenacapavir is already approved for treating HIV under the brand name Sunlenca, which has a price tag of more than $42,200 per year.