Geneva, Switzerland – 28 July 2022. A voluntary licensing agreement for patents relating to cabotegravir long-acting (LA), an injectable form of HIV prevention, or pre-exposure prophylaxis (PrEP), will help enable access to generic formulations of the product in least developed, low income, lower-middle income and sub-Saharan African countries[1].
PrEP is a highly effective method of HIV prevention, but until recently was only available in pill form, taken daily or, in some cases, before and after sex. Cabotegravir LA for PrEP is an important advancement as it can provide two months of continuous protection against HIV infection through a single intramuscular injection, therefore mitigating challenges related to pill burden.
Announced today by the Medicines Patent Pool (MPP), founded by Unitaid in 2010 to facilitate affordable access to quality-assured generic products, and ViiV Healthcare (ViiV), the agreement will give selected manufacturers the opportunity to develop, manufacture and supply generic versions of cabotegravir LA for PrEP in 90 countries where over 70% of all new HIV infections occurred in 2020. This announcement comes just seven months after the first regulatory approval of cabotegravir LA for PrEP in the world, and it is hoped that the agreement will contribute to enabling at-scale access to lower-cost generic supplies of the product in record time.
Each year, approximately 1.5 million people become infected with HIV worldwide, mostly among people living in low- and middle-income countries. Efforts to increase access to cabotegravir LA for PrEP will be especially impactful for groups that experience particularly high rates of infection, such as men who have sex with men, sex workers, transgender women, adolescent girls and young women.
In sub-Saharan Africa, the epicenter of the HIV epidemic, the HIV infection rate of adolescent girls aged 15-19 is six times that of their male peers.
While oral PrEP is now available in many countries, challenges with adherence and stigma have limited their impact in most populations. Access to an effective long-acting HIV prevention option could significantly contribute to the goal of ending HIV transmission and ending the epidemic by 2030.
The agreement responds to Unitaid’s March 2022 call for ViiV to develop a transparent access policy for cabotegravir LA and assure a generic pathway to broader access. This is a key milestone for a broader coalition, formally launched today, that builds on longstanding collaborative efforts to accelerate affordable and equitable access to long-acting PrEP in low- and middle-income countries. Co-convened by leading global health agencies Unitaid, the World Health Organization, the Global Fund and UNAIDS, the coalition brings together a wide range of partners and civil society actors to jointly identify and address access barriers for LA PrEP products, both from ViiV and generic manufacturers, as well as for future PrEP products in the pipeline.
To ensure this new option for PrEP can reach people in resource-limited settings as quickly as possible, Unitaid is simultaneously funding some of the first large-scale implementation of cabotegravir LA in South Africa and Brazil. The work, which began earlier this year, will answer remaining questions about optimal use and demand generation that will lay the groundwork for scaling up cabotegravir LA for PrEP in low- and middle-income countries around the world.
References:
[1] Country classifications as defined by the World Bank: https://data.worldbank.org/country
About Unitaid
Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, cheaply, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities including advanced HIV disease, cervical cancer, and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator, co-leading with Wellcome the Therapeutics Pillar and participating in the Diagnostics Pillar. Unitaid is hosted by the World Health Organization. For more information, please visit www.unitaid.org
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