Gilead Signs Landmark Agreement to Expand HIV Prevention Access

By Hamu Madzedze-Online Health Journalist, Zimbabwe

Gilead Sciences a biopharmaceutical company that researches,develops and commercialises innovative medicines in various therapeutic areas such as HIV, Hepatitis,Cancer,Inflammatory and Cardiovascular diseases has signed royalty -free licensing agreements with six generic manufacturers to produce and distribute lenacapavir, a groundbreaking HIV prevention medication in 120 high-incidence resource limited countries.

In a statement PrEP4All Executive Director Jeremiah Johnson praised the power of global advocates who have built a movement around access to long-acting injectable HIV prevention options.

"We applaud global HIV advocates for advancing this conversation and securing a commitment from Gilead before lenacapavir has received any regulatory approval for a PrEP indication" said Johnson.

The Executive Director added that the commitment to making Ienacapavir available in resource limited countries demonstrates the power of advocacy and the importance of equitable access to lifesaving treatments.

However he said while this agreement is a significant step forward there is still a need for commitments from the company for a public health price for Ienacapavir in the US which is currently priced at $42,250 per year for HIV treatment which is too expensive.

"The US has been shut out of PrEP access due to Gilead's price gouging and manipulation of the entire domestic PrEP response" he added.

Gilead's pricing strategies have sparked concerns around issues of affordability and accessibility particularly for marginalised communities.

Meanwhile AVAC has welcomed Gilead Sciences announcement of granting multiple non-exclusive licences to generic manufacturers to produce Ienacapavir,their investigational twice a year injectable for PrEP while its still in clinical trials.

AVAC's Executive Director Mitchell Warren said this is a notable improvement both in timelines for licensing and in geographic coverage ,with LEN licences being granted before regulatory approval compared to the two-year-gap after approval for injectable Cabotegravir.

Warren added that expanding manufacturing across multiple regions can further enhance efforts to accelerate global access.

"The six generics LEN come from three different countries,whereas the three Cabotegravir licences were concentrated in one country"she pointed out.

The organisation's director of product introduction Wawira Nyagah called on advocates to push for equitable and speedy PrEP access including pricing transparency from Gilead and generics , accelerated investments by donors to design and implement integrated programs that offer LEN as part of choice of product and service delivery model for everyone ,everywhere based on public health imperatives and not on World Bank country classifications or geographical location.