Gilead Sciences has announced plans to provide affordable versions of its innovative HIV prevention drug, lenacapavir, in 120 low and middle-income countries. Administered as a twice-yearly injection, lenacapavir has demonstrated significant effectiveness in clinical trials, leading to a notable reduction in HIV infection rates among both women and men.
Trials conducted in South Africa and Uganda confirmed lenacapavir’s efficacy in preventing HIV infections among girls and women. A subsequent study involving men across multiple countries, including Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States, reported nearly complete protection.
In its announcement, Gilead revealed that it has entered into non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical companies, enabling them to produce and sell generic lenacapavir in these countries. The companies involved include Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero, and Mylan, a subsidiary of Viatris.
Gilead emphasized that these agreements were established before any global regulatory approvals to ensure the quick introduction of generic lenacapavir for HIV prevention. Additionally, Gilead will supply its own stock of the drug to cover the interim period until licensed manufacturers are operational, prioritizing registration in 18 countries with high HIV prevalence, including Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, the Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe.
“The agreements enhance Gilead’s strategy to provide broad, sustainable access to lenacapavir for pre-exposure prophylaxis (PrEP) globally, if approved, and align with our vision of ending the HIV epidemic for everyone, everywhere,” the company stated.
Gilead’s two-part strategy aims to ensure low-cost access to lenacapavir in resource-limited countries by establishing a strong voluntary licensing program and supplying Gilead-produced products at no profit until generic manufacturers can meet demand. The agreements also extend to lenacapavir for treating heavily treatment-experienced adults with multi-drug resistant HIV.
Daniel O’Day, CEO of Gilead, highlighted the urgency of making lenacapavir accessible, stating, “Given the transformative potential of lenacapavir, the focus is on making it available as quickly and broadly as possible.” He also mentioned that Gilead teams are working diligently to onboard high-volume generic manufacturers to facilitate a swift transition to voluntary license partners once lenacapavir for PrEP receives approval.