Pepfar And Global Fund Target Rollout Of HIV Prevention Injectable

Some two million people may get access to lenacapavir, the twice-yearly antiretroviral injection that prevents HIV injection, within the next three years, thanks to the Global Fund and United States President’s Emergency Plan for AIDS Relief (PEPFAR).

The initiative is contingent upon regulatory approval from the US. Food and Drug Administration (FDA), national pharmaceutical regulators, and a recommendation from the World Health Organization (WHO).

It is being supported by the Children’s Investment Fund Foundation (CIFF) and the Bill & Melinda Gates Foundation (BMGF) 

At present, lenacapavir is licensed in the US and other countries as a treatment for adults with drug-resistant HIV. 

However, in two clinical trials it has shown to almost completely block HIV when used as pre-exposure prophylaxis (PrEP). Not a single one of the 2,138 women in PURPOSE 1 trial who received lenacapavir contracted HIV.

In the PURPOSE 2 trial involving men and gender-diverse people, only two of the 2,179 participants became infected during the trial – a success rate of over 99%.

In both trials, lenacapavir was tested alongside oral PrEP and found to be superior as the twice-a-year injection is much easier to adher to than taking daily pills.

“We cannot reach a sustainable HIV response without rapidly reducing the 1.3 million new HIV infections that occur worldwide every year,” said Ambassador Dr John Nkengasong, US Global AIDS Coordinator head of PEPFAR in a statement on Tuesday.

“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.”

In October the medicine’s manufacturer, Gilead, announced that it had signed non-exclusive, voluntary licensing agreements with six pharmaceutical companies to manufacture and supply generic versions of lenacapavir for 120 primarily low- and lower-middle-income countries.

“At the Global Fund, we are incredibly excited by the promise of lenacapavir and its potential to help us achieve a further significant reduction in new infections among individuals at high risk of acquiring HIV,” said Peter Sands, Executive Director of the Global Fund. 

“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.”

CIFF founder and chair Sir Chris Hohn, said that innovations like lenacapavir can profoundly impact the lives of millions.

“It will be a travesty if the communities who need it most don’t have access. That is why this collaboration is so essential to ensure that lenacapavir is available as soon as possible for those who need it the most,” said Hohn.

Image Credits: Gilead.