On March 30, ViiV Healthcare and Medicines Patent Pool (MPP), announced sublicensing agreements with the pharma manufacturers Aurobindo, Cipla and Viatris to produce generic forms of the long-acting cabotegravir used as pre-exposure prophylaxis (PrEP) for HIV.
According to a press release, the selected pharma companies will be allowed to produce long acting cabotegravir in 90 countries. All three manufacturers will manufacture the prophylactic in India, with Cipla also considering an expansion to South Africa. MPP is a health organisation backed by the United Nations that facilitates access to drugs for low- and middle-income countries.
This announcement follows the signing of a voluntary licensing agreement for long acting cabotegravir patents between ViiV Healthcare and the MPP in July 2022, in a bid to improve PrEP access in low-income, lower-middle-income and sub-Saharan African countries. According to Deborah Waterhouse, CEO of ViiV Healthcare, these sublicense agreements will broaden access to PrEP in countries with the highest burden of HIV cases, as quoted in yesterday’s announcement. GSK owns a majority stake in ViiV Healthcare.
Marketed as Apretude, the injectable prophylactic was approved by the US Food and Drug Administration in December 2021. This was the first approval for a long-acting HIV pre-exposure prophylactic. Since then, other countries and organisations have recommended its use.
In July 2022, the World Health Organization (WHO) recommended its use for HIV prevention in its new guidelines. Australia approved it a month later. In October 2022, Zimbabwe became the first sub-Saharan African country to approve the treatment, with a further nod in South Africa in December. Participants from both countries were included in the HPTN 084 study that studied cabotegravir. In November 2020, findings from the study’s planned interim review showed that long acting cabotegravir had superior efficacy compared to the PrEP pill Truvada in cisgender women. Truvada is a combination of emtricitabine and tenofovir disoproxil fumarate.
In July 2022, ViiV Healthcare announced additional data from the same trial, which showed there were no new HIV infections were reported in subjects who were injected with the prophylactic, a year after the study was unblinded. There were 23 incident HIV infections during the trial’s blinded phase, with three reported among participants in the cabotegravir cohort.
In the US, there are three approved forms of PrEP. This includes Apretude and the two oral drugs— Descovy and Truvada. Gilead Sciences’ Descovy is a combination of emtricitabine and tenofovir alafenamide, which is a different form of tenofovir than the one included in Truvada.
According to their labels, Descovy and Truvada are to be taken once daily. On-demand PrEP dosing is not approved by the FDA. Apretude is first initiated by a single injection given for two consecutive months before moving to an every-two months schedule. MSD previously studied the nucleoside reverse transcriptase translocation inhibitor islatravir and its use as a monthly PrEP pill, which was seen as a valuable addition, but this program was discontinued in September 2022.