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AVAC, BMGF, CIFF, MEDACCESS, UNITAID AND VIIV HEALTHCARE ANNOUNCE COLLABORATION TO CATALYSE MORE AFFORDABLE ACCESS TO LONG-ACTING CABOTEGRAVIR FOR HIV PREVENTION
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London, 28 July 2022 - At the 24th International AIDS Conference, AVAC, the Bill & Melinda Gates Foundation (BMGF), the Children's Investment Fund Foundation (CIFF), MedAccess, Unitaid, and ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced a strategic collaboration to speed equitable access to injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP). This collaboration demonstrates the commitment of global health partners and ViiV to work together to accelerate access to a new HIV prevention option as part of a comprehensive response to reduce the number of new HIV infections and advance efforts to end the HIV epidemic by 2030.
Cabotegravir long-acting (LA) is an injectable form of PrEP that is given every two months by trained healthcare workers. Cabotegravir LA for PrEP, which was approved by the U.S. Food and Drug Administration (FDA) in December 2021, is the first and only long-acting injectable PrEP option available.
Global health partners and ViiV are committed to making cabotegravir LA for PrEP more accessible in resource-limited settings in the near-term, while working in parallel to accelerate market entry of quality-assured generic products. This two-pronged strategy is fundamental to meeting current demand for the product and establishing a sustainable longer-term market.
In order to increase access to cabotegravir LA for PrEP in the near term, ViiV, AVAC, BMGF, CIFF, MedAccess, and Unitaid will:
• Hold discussions on pricing, with the aim of identifying a pathway for cabotegravir LA for PrEP to be offered to public sector purchasers at a more affordable price
• Examine the potential role of innovative financing mechanisms to deliver on this goal
• Include civil society in planning and decision-making to accelerate equitable access
• Share responses to frequently asked questions on procurement channels and requirements
• Track and share regulatory submissions and approvals across priority countries
"Stagnating rates of new HIV infections underline the importance of getting innovative prevention tools to the people who need them as quickly as possible," said Michael Anderson, CEO of MedAccess. "By combining expertise in science, innovative finance and global health, this collaboration has the potential to catalyse access to cabotegravir LA at a sustainable price. MedAccess will work urgently with all partners to find solutions that unlock access for thousands of people as quickly as possible."
Efforts to increase access to cabotegravir LA for PrEP will be especially impactful for key populations such as women and girls, who account for a disproportionate number of new HIV infections. Every week, 5,000 adolescent girls and women1 (15-24 years) contract HIV globally. For key populations, who have a 13-30 times higher risk of acquiring HIV infection2 as compared to the rest of the population, a long-acting prevention method could help overcome pill fatigue, stigma, and adherence issues3.
"Cabotegravir long-acting for PrEP has the potential to transform HIV prevention efforts by offering people an additional option for HIV prevention, but only if we can make it available with urgency, with equity and at scale. While no one method will work for all people - or for any one person all of the time - this new approach significantly reduces frequency of dosing and may be easier for some people versus taking a pill a day," said Mitchell Warren, CEO of AVAC.
Deborah Waterhouse, CEO of ViiV Healthcare said: "We are pleased to join this ambitious new collaboration as an active partner, working to find solutions to enable at-scale access to innovative HIV prevention options as quickly as possible. Together with our new voluntary licence agreement with the Medicines Patent Pool, we are making significant progress towards our common goal of expanding access to cabotegravir LA for PrEP, which we believe has the potential to be a game changer in HIV prevention and to play an important role in ending the HIV epidemic."
In response to civil society's calls to make cabotegravir LA for PrEP equitably available as soon as possible, global health partners and ViiV Healthcare are stepping up their collaboration to accelerate product access. HIV community groups, advocates and Ministries of Health are eager to add cabotegravir LA for PrEP to the HIV prevention toolkit, as choice is critical to meeting the needs of those most at risk of acquiring HIV.
"We are thrilled to join this important collaboration, which can help ensure that this transformative prevention tool is made available to those most in need as quickly as possible," said Nina Russell, Director, TB and HIV Prevention at the Bill & Melinda Gates Foundation. "It takes all of us - companies, foundations, governments, civil society and those affected by HIV - working together to overcome the market failures that keep people in resource-limited settings from benefitting from innovation."
These efforts build on the recent announcement that ViiV and the Medicines Patent Pool (MPP), which was founded by Unitaid, have agreed a voluntary license for cabotegravir LA for PrEP. This will enable generic cabotegravir LA for PrEP to come to market in the coming years and should significantly expand the reach of this important prevention tool in low- and lower middle-income, least developed, and sub-Saharan African countries.
The collaboration announced today and the voluntary license agreement between ViiV and MPP, are part of a broader package of interventions being discussed by a coalition of partners to accelerate affordable and equitable access to long-acting PrEP in low- and middle-income countries. The coalition, currently being formalized, will comprise a wide range of partners including funders, communities, civil society organizations, ministries of health, and United Nations agencies, and will be co-convened by Unitaid, the World Health Organization (WHO), the Global Fund and UNAIDS. These partners will jointly identify barriers to access for cabotegravir LA for PrEP and develop a roadmap to overcome them.
"Oral PrEP took over a decade to be accessible in low- and middle-income countries. This strategic partnership and the broader coalition being formed will ensure that we leverage lessons learned from past experiences to make this promising long-acting solution for PrEP quickly available at an affordable price for everyone who could benefit from it," said Dr Philippe Duneton, Executive Director of Unitaid.
ViiV Healthcare is also donating product to support initial implementation science projects that will provide critical information on the feasibility, acceptability, and future adoption of cabotegravir LA for PrEP into national programmes in access markets. The partners in this collaboration will ensure these projects are coordinating to address critical questions across the widest possible range of populations and geographies.
"People need more ways to protect themselves from HIV that fit with their lifestyles and environments," said Miles Kemplay, Executive Director of Sexual and Reproductive Health and Rights at CIFF."Cabotegravir promises to be one of those choices - but only if it is available at a cost that health systems can afford. We are looking forward to working with ViiV to figure out how to make cabotegravir accessible to those who need it today."
Indication and Important Safety Information for Apretude (cabotegravir extended-release injectable suspensions)
APRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
IMPORTANT SAFETY INFORMATION
See link to full press release
phttps://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/july/avac-bmgf-ciff-medaccess-unitaid-and-viiv-healthcare/
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