GSK licenses out new HIV PrEP drug in poorer nations

GSK’s majority-owned HIV unit ViiV has agreed licensing deals with a trio of generic manufacturers to make its recently-approved long-acting drug for pre-exposure prophylaxis (PrEP) available in low-income, lower-middle-income, and sub-Saharan African countries.

The move follows an agreement with ViiV’s minority shareholders Pfizer and Shionogi, as well as the Medicines Patent Pool (MPP), to voluntarily license out rights to the long-acting, injectable formulation of cabotegravir last year, clearing the way for low-cost generics to be produced.

The decision is remarkable in that the HIV integrase inhibitor is one of ViiV’s most up-to-date products, only getting FDA approval under the Apretude brand name at the end of 2021, and has been licensed out far earlier than previous HIV medicines. The drug is the first injectable therapy for HIV PrEP, protecting against infection with just six doses a year.

GSK also said the new agreements with Aurobindo, Cipla, and Viatris could lead to large-scale manufacturing of the drug on the continent of Africa, where the burden of HIV is felt most strongly, as Cipla has plans to build a plant in South Africa. For now, all three generics companies will produce the PrEP drug at facilities in India.

The new agreement will allow the generic manufacturers to develop, manufacture, and supply generic versions of cabotegravir LA for PrEP – in 90 countries worldwide – once the relevant regulatory approvals are obtained, said GSK.

At the moment, PrEP is delivered using daily, oral pills that can pose challenges in compliance that could be addressed by the use of a long-acting injectable delivered at clinics. Use in areas like sub-Saharan Africa is low, but is likely to be cost-effective and even cost-saving if delivered at scale, according to a study published in The Lancet HIV journal last year.

According to UNAIDS’ latest estimates, approximately 1.5 million people acquired HIV worldwide in 2021, and of those 860,000 lived in sub-Saharan Africa, with women and adolescent girls making up a disproportionate share of cases.

According to ViiV’s chief executive, Deborah Waterhouse, widespread use of cabotegravir for PrEP “has the potential to change the trajectory of HIV.”

“We are committed to working together with MPP and the selected generic manufacturers at pace to help enable development, manufacturing, and supply,” she pledged.

MPP said that the licensing deals for cabotegravir LA are its first for a long-acting HIV therapy, adding that until supplies of the generic become available it will “work with partners to widen access and supply cabotegravir LA for PrEP at a non-profit price in low-income, least developed, and all sub-Saharan African countries.”

So far, cabotegravir LA has been approved in the US, Australia, Zimbabwe, South Africa, and Malawi, said GSK.

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