PROGRESS CONTINUES TO ACCELERATE ACCESS TO CABOTEGRAVIR LA FOR PREP IN LOW AND MIDDLE-INCOME COUNTRIES 

ViiV Healthcare is committed to enabling access to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP).

We continue to make progress in enabling access to this innovation. Working together with GSK and our global partners, we are pleased with the progress across many areas to enable access to cabotegravir LA for PrEP in countries where the HIV burden and unmet need is greatest.

Registration

Registrations have continued with the majority of regulatory approvals received in 2023 being in low and middle-income countries. We also received European authorisation in September 2023. For more information regarding ongoing submissions around the world, please click here.

Supply

We are very proud to have delivered our first order of cabotegravir LA for PrEP to a global partner in October. Together with GSK, we continue to increase our manufacturing capacity and are committed to work towards increasing supply as further demand increases.

Pricing

Given the strong progress we have made to enable greater access to cabotegravir LA for PrEP, we no longer consider the non-profit price for this product to be confidential. To help us better support our partners and strengthen our shared commitment to enable accelerated access to this innovation, we believe this transparency is important. Aligned with our publicly available Access to Medicines policy, qualifying programmes for the non-profit price include: public or donor agency programmes in low-income countries (LICs), least-developed countries (LDCs) and sub-Saharan Africa. This progress is thanks to the commitment of our teams and global partners to our shared goal of ending the HIV/AIDS epidemic. We look forward to continuing to work closely with partners to help enable access to this new option for HIV prevention, particularly for areas where the HIV burden and unmet need is the greatest.

Voluntary licensing

Progress continues with the Medicines Patent Pool (MPP) and generic sublicensees on our voluntary licence. We have now signed Tech Support and Know-How Licence Agreements and shared technical packages with all three of the generic manufacturers. We are looking forward to working closely with MPP and these sublicensees to continue to enable development of and access to cabotegravir LA for PrEP as soon as possible.

Implementation Science

In partnership with study sponsors and global donors, ViiV is committed to supporting the implementation science studies, designed to generate evidence to inform HIV prevention policies and practices. In line with our commitment, we are supplying cabotegravir LA for PrEP to support implementation science studies currently under way and we are working closely with study sponsors to initiate the remaining studies.

Post-trial access

Facilitating post-study access to cabotegravir LA for PrEP for HPTN 083/084 clinical trial participants until there is local drug availability remains a priority and we will continue to work with global partners, who are implementing programmatic access in low and middle-income countries.

Community Stakeholder Engagement

We continue our proactive community engagement, guided by the Good Participatory Practice principles (GPP) 1 and our vision for community stakeholder engagement. This means that the voices of individuals and communities are understood and integrated into access strategies to enable personal choice and increase their HIV prevention options, regardless of income or where they live. Most recently, we contributed to the development and support of tools to help inform countries on the options to reduce HIV incidence including the principles of the CHOICE Manifesto.

Reference:

  1. Good Participatory Practice (GPP) Guidelines | AVAC

Media contacts

For our corporate press office, email: Rachel Jaikaran

OR call +44 7823 523 755

For US-specific media enquiries,email: Audrey Abernathy

OR call +1 919 605 4521

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.

If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.