GSK's crucial HIV drug will now have generic versions - including in SA

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ViiV Healthcare, a specialist HIV company majority owned by GSK, formerly GlaxoSmithKline, has signed sublicence agreements with pharma groups Aurobindo, Cipla and Viatris to manufacture generic versions of its long-acting preventative HIV drug, including in SA.

The agreement, which is signed along with the UN-backed Medicine Patents Pool (MPP), will see Aurobindo and Viatris manufacture in India, while Cipla will manufacture in India and has plans to manufacture in SA as well, ViiV said in a statement.

According to UNAIDS's latest estimates, approximately 1.5 million people acquired HIV worldwide in 2021, among whom 860 000 live in sub-Saharan Africa, with women and adolescent girls disproportionately impacted.

While oral pre-exposure prophylaxis (PrEP) options are now available in many countries, access to the drug - Cabotegravir long-acting (LA) - could significantly contribute to reducing HIV transmission by providing people a choice in their HIV-prevention options, said ViiV.

Only seven months after the first regulatory approval of Cabotegravir LA in the world by the US Food and Drug Administration (FDA), ViiV Healthcare and MPP signed a voluntary licence agreement in July 2022 for patents relating to the drug to help enable access in all least developed, low-income, lower-middle-income and sub-Saharan African countries, the statement read.

Deborah Waterhouse, CEO at ViiV Healthcare, said:

Cabotegravir LA for PrEP has the potential to change the trajectory of HIV. The signing of sublicence agreements with three generic partners is an incredibly important milestone towards enabling broad access to this medicine in countries where there is the highest burden of new HIV cases. We are committed to working together with MPP and the selected generic manufacturers at pace to help enable development, manufacturing, and supply.

Through the agreement, the selected generic manufacturers will be able to develop, manufacture, and supply generic versions in 90 countries, subject to required regulatory approvals being obtained.

Compared to oral HIV-prevention options, Cabotegravir LA for PrEP is more complex to manufacture and ViiV Healthcare is committed to supporting Aurobindo, Cipla and Viatris with technical know-how to enable development and access as soon as possible, it said.

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