GSK’s ViiV Healthcare unit is countering rival HIV drugmaker Gilead’s recent global access moves with its own pledge to make at least 2 million doses of its long-acting pre-exposure prophylaxis (PrEP) available for low- and middle-income countries during 2025 and 2026, tripling the company’s current yearly supply.
The move involves the company’s long-acting cabotegravir (CAB LA), a PrEP medication made from one of the active ingredients in the company’s HIV treatment Cabenuva. The drug was the first long-acting PrEP to score FDA approval back in 2021 under the brand name Apretude.
“Today’s announcement marks another important milestone in our efforts to accelerate access to the only long-acting PrEP available now -- CAB LA -- where it’s needed most,” ViiV CEO and GSK’s president of global health Deborah Waterhouse said in a company release. “We are committed to working at pace with our partners and the community -- globally, regionally, and locally -- to continue enabling sustainable access to CAB LA for PrEP as a key part of our mission to help end the HIV epidemic.”
GSK’s CAB LA strategy aims to maximize “rapid access and uptake” for populations with high unmet needs “in a sustainable way" through partnerships and other measures, according to the company.
Regulatory submissions have been prioritized in countries with the highest disease burden, GSK explained in its release. Through partners such as the United States President's Emergency Plan For AIDS Relief (PEPFAR), and The Global Fund, the GSK-manufactured product is available at a not-for-profit price in low-income and Sub-Saharan African countries.
So far, rollouts have begun in Zambia, Malawi, Zimbabwe, Eswatini and Ukraine. By the end of this year, the drug will be supplied to 14 countries through the partnerships.
Importantly, GSK inked a licensing agreement with the Medicines Patent Pool (MPP) in 2022, allowing generic versions of its long-acting PrEP. The company is “actively engaged” with generic makers to speed up the process by providing technology transfers and expertise.
Gilead, meanwhile, has licensed five of its HIV products through the MPP, including its top-selling Biktarvy. However, the company has been criticized by some access advocates for going a different route with its long-acting lenacapavir.
Even before officially entering the long-acting PrEP market, Gilead and GSK are locked in an access showdown. Last week, the Biktarvy maker tapped six generic manufacturers to make and sell its twice-yearly lenacapavir in 120 high-incidence, resource-limited countries through voluntary license agreements that cover the drug’s currently approved indication for the treatment of multi-drug-resistant HIV and its so far unapproved use as a PrEP. Gilead looks to submit bids for that indication this year.
Still, the Joint United Nations Programme on HIV/AIDS (UNAIDS) recently called out Gilead for excluding several middle-income countries from the agreements and urged the company to secure further licenses.
GSK’s long-acting option can be administered up to every two months, but the company is working on an every-four-month version and a twice-yearly option. The company has estimated that the HIV PrEP market will more than double in size to around 4 billion pounds to 5 billion pounds by 2031, with long-acting injectables taking up about 80% of the market value. As it stands, Gilead’s lenacapavir is “probably well situated” to take a significant share of the PrEP market, William Blair analysts wrote in a June note after lenacapavir as a PrEP proved an unprecedented 100% efficacy in its PURPOUSE 1 trial.