Get Guardian on GoogleThe United States Food and Drug Administration (FDA) has approved a generic version of lenacapavir, a long-acting HIV prevention injection administered twice a year, in a major development expected to improve access to affordable HIV prevention medication in 120 low- and middle-income countries.
The approval marks a significant step towards expanding access to pre-exposure prophylaxis (PrEP), a preventive medication taken by people at risk of contracting HIV before potential exposure to the virus.
The announcement was made on Monday by the manufacturer and organisations involved in accelerating the development and availability of the generic version of the drug.
Lenacapavir, which is administered through an injection every six months, is expected to be available at an annual cost of about $40 per person in the eligible countries, matching the price of existing daily oral HIV prevention pills.
However, the injectable formulation is considered more convenient because it eliminates the need for daily medication, potentially addressing adherence challenges among people who struggle to take preventive pills consistently.
The drug has also demonstrated significant effectiveness in two groundbreaking clinical studies involving people at high risk of HIV infection, nearly eliminating new infections among participants.
Speaking on the development, Carmen Pérez Casas, HIV lead at Unitaid, a global health agency that supports access to affordable healthcare innovations, said the twice-yearly injection could address one of the major challenges associated with existing HIV prevention options.
She explained that daily preventive medication offers protection only when taken consistently, noting that missed doses could leave individuals vulnerable to infection.
“People don’t always take their daily dose of medication, and if you do not take it, you cannot get protected against HIV,” Pérez Casas said.
She added that the longer interval between lenacapavir injections offered renewed hope for improving adherence and expanding HIV prevention efforts.
Health advocates believe the availability of an affordable generic version could significantly increase the number of people accessing PrEP, particularly in countries where the cost and accessibility of preventive medication remain major barriers.
Carolyn Amole, who leads the HIV programme at the Clinton Health Access Initiative (CHAI), said the development could help expand access to the medication among millions of people who need protection against HIV.
She said the availability of a high-quality generic formulation at an affordable price could support efforts to reach approximately 20 million people worldwide who need PrEP.
“With an affordable, high-quality generic medication now available, we could help to scale this to the 20 million people around the world who need PrEP,” Amole said.
She expressed optimism that expanding access to the medication could contribute to ending the HIV epidemic.
“And if we scale to those levels, we can actually begin to bring an end to the HIV epidemic,” she added.
According to the World Health Organisation (WHO), approximately 41 million people were living with HIV worldwide last year, while an estimated 570,000 people died from HIV-related causes during the same period.
The latest approval is therefore expected to strengthen global HIV prevention efforts by providing a longer-acting and more affordable alternative to daily preventive medication.
By reducing the frequency of administration and lowering costs, health advocates hope the generic version of lenacapavir will help overcome barriers to PrEP access, reduce new HIV infections and ultimately lower AIDS-related deaths.
