The CHOICE Manifesto Welcomes Lenacapavir’s Approval
KAMPALA, 25 June 2025—The International Community of Women Living with HIV in Eastern Africa (ICWEA), together with partners under the CHOICE Manifesto, welcomes the U.S. Food and Drug Administration’s (FDA) approval of Lenacapavir (LEN) for pre-exposure prophylaxis (PrEP). This groundbreaking advancement adds a powerful, long-acting tool to the HIV prevention basket—especially for adolescent girls and young women in Eastern and Southern Africa who continue to face the highest risk of HIV infection.
The addition of Lenacapavir, a twice-yearly injectable PrEP developed by Gilead Sciences, represents a major milestone in ICWEA’s ongoing advocacy for accessible, affordable, and woman-centered HIV prevention options. This approval is a moment of hope—but most importantly it must translate into access for those most in need in our region and countries with limited resources.
The Approval of Lenacapavir Advances the Realization of the CHOICE Manifesto
In 2023, 450,000 [360,000–580,000] new HIV infections were recorded in the Eastern and Southern Africa (ESA) region (UNAIDS, 2024). In Uganda alone, 1,100 new infections occur weekly, totaling over 54,000 annually, with four in five among adolescent girls and young women (AGYW).
“When prevention options are limited, our choices are limited too. Lenacapavir brings hope, but only if it is made available, accessible, and affordable to those of us most at risk,”—HIV Prevention Champion, Uganda
This alarming trend highlights the urgent need to expand access to diverse and effective HIV prevention tools. Currently, Uganda’s prevention toolkit includes Voluntary Medical Male Circumcision, condoms, oral Pre Exposure Prophylaxis ( PrEP), and Post Exposure Prophylaxis( PEP) however their uptake their uptake remains low and has not effectively addressed the high rates of HIV infection among especially AGYW and key and vulnerable populations.
Some of the barriers to access include stigma associated with antiretroviral drugs (ARVs), lack of information, gender-based violence (GBV), insufficient service delivery diversification, poor attitudes among health workers, and low perceived risk of HIV. In addition, newer options like CAB-LA, the Dapivirine Vaginal Ring (DVR), and event-driven PrEP remain limited to demonstration studies—leaving many young women without choices that meet their needs.
ICWEA welcomes the FDA’s approval of Lenacapavir, a twice-yearly injectable PrEP option developed by Gilead Sciences. With nearly 100% protection demonstrated in the PURPOSE 1 and 2 trials, LEN represents a bold step forward—particularly for adolescent girls and young women, who remain at the epicenter of new HIV infections in sub-Saharan Africa.
Approval Alone Is Not Enough — The Fight for Access Begins Now
While this scientific breakthrough is welcome, it must be followed by action. The promise of Lenacapavir will only be fulfilled if:
- It is quickly registered and rolled out in low- and middle-income countries, especially in Africa;
- It is priced fairly, with public health systems able to afford and distribute it widely;
- Community-led organizations, especially women living with HIV, are central to rollout strategies—from demand creation to accountability;
- It is presented as part of a comprehensive prevention package, not a replacement for other methods, reinforcing the importance of choice.
ICWEA Calls for Feminist Funding and Bold Partnerships for Prevention Choice
As co-host of the Africa Women Prevention Community Accountability Board (AWPCAB) and lead of the CHOICE Manifesto, ICWEA is calling on Gilead Sciences, governments, donors, and global health actors to ensure Lenacapavir does not become another innovation accessible only to high-income countries.
Conclusion
The approval of Lenacapavir is a major stride toward achieving HIV prevention equity. But without a deliberate, well-funded, and community-led strategy for rollout, its impact will remain limited. ICWEA urges global solidarity and investment to ensure LEN reaches the last mile and leaves no woman behind.
For inquiries, please contact:
Lillian Mworeko
Executive Director, ICWEA
info@icwea.org
Website: www.icwea.org
