A co-ordinated international funding effort to provide easier access to a key drug to treat HIV was launched on Tuesday.
The initiative would enable access to the drug lenacapavir for at least 2-million HIV infected people over three years in countries supported by the US President’s Emergency Plan for Aids Relief (Pepfar) and the Global Fund to Fight Aids, Tuberculosis and Malaria (the Global Fund).
The two funds have joined forces with the Children’s Investment Fund Foundation (CIFF) and the Bill & Melinda Gates Foundation (BMGF) to rapidly provide affordable and equitable access to twice-yearly injectable lenacapavir for HIV pre-exposure prophylaxis (PrEP). Lenacapavir is produced by Gilead Sciences.
This would be contingent upon regulatory approval from the US Food and Drug Administration, relevant national pharmaceutical regulators, and a recommendation from the World Health Organisation (WHO).
SA activists have been pushing hard for lower prices for lenacapavir.
In a statement on Tuesday the Global Fund and Pepfar said Gilead Sciences’ lenacapavir was already approved in multiple countries to treat adults with multidrug-resistant HIV in combination with other antiretroviral drugs.
“Recent and highly promising clinical trial results show its potential in preventing new HIV infections as well. If rolled out at scale alongside other HIV prevention tools, including daily oral antiretroviral medications already approved for PrEP, lenacapavir has the potential to accelerate progress toward the 2030 Sustainable Development Goal 3 HIV target of ending HIV/AIDS as a public health threat, as well as ensuring a sustainable HIV response beyond 2030,” the statement said.
In October, Gilead announced that it had signed non-exclusive, royalty-free voluntary licensing with six pharmaceutical companies to manufacture and supply high-quality, low-cost versions of lenacapavir for HIV prevention, for 120 primarily low- and lower-middle-income countries.
“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,” Global Fund executive director Peter Sands said.
“As part of this co-ordinated 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.”
Health Justice Initiative founder Fatima Hassan said the announcement by the Global Fund and Pepfar raised many questions and there was a need for greater transparency.
"The entire world, especially those countries hard hit by HIV with high prevalence, need LEN-LA (lenacapavir), so this number, while it may seem large, is a drop in the ocean," she said.
What also needed to be clarified was the price at which the drug would be made available to the Global Fund and Pepfar and whether the price and other terms would be disclosed and made public.
Hassan also wanted to know whether this was a pilot programme with plans to expand it further within the next three years, or whether these supplies were all that would be available from Gilead before generic mass production was ready. Also, did the 2-million targeted people over three years mean 650,000 per year, or a gradual rise to 2-million to be treated by the end of 2027?
“These are the questions the access community are unclear about and Gilead, the Global Fund and Pepfar and others involved should share this information promptly, and make full disclosures," Hassan said.
Ambassador Dr John Nkengasong, US Global Aids co-ordinator and senior bureau official for global health security and diplomacy at the US department of state, said: “We cannot reach a sustainable HIV response without rapidly reducing the 1.3-million new HIV infections that occur worldwide every year.”
The statement said the Global Fund and Pepfar would work closely with CIFF and BMGF to support countries and communities to implement national and subnational HIV long-acting injectable PrEP programmes, alongside WHO, Unitaid, UNAids and others.
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