WHO welcomes the announcement that the Medicines Patent Pool (MPP) has signed sublicense agreements with 3 manufacturers to produce long-acting injectable cabotegravir (CAB-LA) as pre-exposure prophylaxis (PrEP). This follows the voluntary licensing agreement between ViiV Healthcare, the originator manufacturer of CAB-LA, and MPP in July 2022. These sublicenses will allow the manufacturers Aurobindo, Cipla, and Viartris (through their subsidiary Mylan) to produce generic versions of CAB-LA.
In 2022, WHO recommended that CAB-LA may be offered as an additional prevention option for people at substantial risk of HIV acquisition. Consistent with previous WHO guidelines, the CAB-LA guidelines are based on a public health approach that considers effectiveness, acceptability, feasibility and resource needs across a variety of settings. CAB-LA was shown to be safe and highly effective among cisgender women, cisgender men who have sex with men, and transgender women who have sex with men in 2 large randomized controlled trials. The WHO recommendation also considered the findings of a systematic review that suggested that CAB-LA is an acceptable HIV prevention option across different populations.
''The signing of the sublicences with 3 manufacturers has the potential to enable substantial scale-up and implementation of CAB-LA for HIV prevention in a large number of countries in the long term,'' said Dr Meg Doherty, Director of WHO's Global HIV, Hepatitis and STIs Programmes. "However, in the short to medium term, WHO encourages that the current limited product focus on CAB-LA implementation studies embedded in HIV programmes to ensure country readiness as supply increases."
Since the WHO recommendation, a significant number of implementation science studies have been planned to answer critical outstanding research and implementation question regarding CAB-LA, including how people choose and switch between PrEP products, relating HIV drug resistance, HIV testing, safety in pregnancy and breastfeeding, service delivery models, and resource requirements. It is important that these projects consider populations and geographies not included in the trials, particularly people from key populations, who, together with their sexual partners, account according to UNAIDS estimates for 70% of all new HIV infections globally, are disproportionally affected by HIV even in generalized epidemics, and often face barriers to accessing effective HIV prevention options.
WHO, as part of the Coalition to Accelerate Access to Long-Acting PrEP – convened together with the Global Fund, PEPFAR, UNAIDS, and Unitaid, with AVAC as the Secretariat – will continue to support and work with implementation projects, countries as they consider regulatory approval and national guidelines, and manufacturers. Collaboration across partners is critical to ensure that research questions can be addressed in a timely fashion and equitable access to HIV prevention options.
