Lenacapavir, made by California-based Gilead, was shown to prevent HIV infection with a twice-yearly shot.
BY CARMEN PAUN | POLITICO
America’s top global health program and other global health groups said today that they’ll work together to ensure access for two million people to a drug shown to prevent HIV infection.
The drug, lenacapavir from the drugmaker Gilead, was initially developed as a treatment for patients with drug-resistant HIV. But in clinical trials this year lenacapavir showed almost 100 percent protection against acquiring the virus.
Patients must receive shots twice a year, a less onerous regimen than other HIV-prevention medications that must be taken far more often.
Lenacapavir must still gain FDA approval and endorsement from the World Health Organization to be used for prevention, also known as pre-exposure prophylaxis or PrEP.
The President’s Emergency Plan for AIDS Relief — the U.S. global health initiative better known as PEPFAR — and The Global Fund to Fight AIDS, Tuberculosis and Malaria, a philanthropy, committed to securing access to lenacapavir for at least 2 million people over three years.
The Children’s Investment Fund Foundation, a U.K.-based philanthropy, and the Bill & Melinda Gates Foundation, will help the effort.
Why it matters: Lenacapavir, which Science Magazine named the 2024 breakthrough of the year, could make a big dent in transmission of HIV, the virus that causes AIDS, the groups believe.
“Lenacapavir offers a potentially tremendous opportunity to transform the impact of HIV programs to ensure adolescent girls and young women, key populations, and others who could benefit have access to highly effective HIV prevention, testing and treatment services and to end HIV/AIDS as a public health threat by 2030,” said Dr. John Nkengasong, the U.S. global AIDS coordinator, in a statement.
California-based Gilead signed voluntary licensing agreements with six pharma companies, including India-based Dr. Reddy’s and Pennsylvania-based Mylan, to produce generic versions of the drug for use in 120 low- and lower-middle-income countries once the drug is licensed.
But public health activists raised concerns that the deal excludes countries, including in Latin America and Eastern Europe, with expanding HIV epidemics among key groups, such as gay and bisexual men, sex workers and people who use drugs.
What’s next: “As part of this coordinated effort, the Global Fund, PEPFAR, CIFF, and BMGF will work with Gilead and the voluntary licensing manufacturers to accelerate affordable and equitable access, so that more people can benefit from this powerful innovation from day one,” Global Fund Executive Director Peter Sands said in a statement.
