This, thanks to ViiV Healthcare, together with the Medicines Patent Pool (MPP), which has signed sub-licence agreements with Aurobindo, Cipla and Viatris (through its subsidiary Mylan).
The agreement will enable these manufacturers to produce generic versions of cabotegravir long-acting (Cab-La) for HIV pre-exposure prophylaxis (PrEP) and includes potential for large-scale manufacturing on the continent of Africa.
The accord was formed after ViiV Healthcare and MPP signed a voluntary license agreement in July 2022 for patents related to Cab-La for PrEP. This follows the world's first regulatory approval of Cab-La for PrEP by the US Food and Drug Administration (FDA) just seven months earlier.
Ninety countries stand to benefit from the deal, subject to their required regulatory approvals being obtained. To this end, Aurobindo and Viatris will manufacture Cab-La in India while Cipla will be manufacturing Cab-La in either Durban or Benoni in South Africa.
Kimberly Smith, ViiV Healthcare’s head of research and development, explained last year that the process of making a generic version of a branded medicine requires tech transfer for pharmaceutical companies to understand the manufacturing process. Regarding the timeline for availability, she stated, "Having generics ready to sell will therefore not be immediate, but could take three to five years from the time that a license has been granted until the product is market-ready."
Currently the Cab-La injection is undergoing clinical trials at the Emavundleni Prevention Research Centre run by the Desmond Tutu HIV Centre at the University of Cape Town.
It is part of HPTN 084 - a study being done to evaluate the safety and efficacy of the injectable Cab-La compared to the most commonly used oral PrEP options for HIV prevention worldwide: tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC), taken orally as a single tablet once daily by HIV-uninfected women.
Cab-La is an antiretroviral medication that works differently from a vaccine. Instead of using weakened or inactivated forms of the virus, it contains cabotegravir, which prevents the integration of HIV's DNA into host cells, stopping the virus from replicating.
Taken every two months, Cab-La is intended to be used by HIV-negative individuals who are at high risk of acquiring HIV.
While oral PrEP options are now available in many countries, access to Cab-La for PrEP could significantly contribute to reducing HIV transmission by providing people a choice in their HIV-prevention options.
Waterhouse, in reference to ViiV Healthcare's signing of sub-license agreements with its three generic partners, emphasised the potential impact of Cab-La for PrEP on the trajectory of HIV.
She stated, "The signing of these sub-license agreements 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."
According to UNAids' latest estimates, the global acquisition of HIV in 2021 reached approximately 1.5 million people, with 860,000 of those cases occurring on the African continent. The burden is particularly heavy on women and adolescent girls, who are disproportionately impacted.