Gilead Sciences has announced plans to make affordable versions of its innovative HIV prevention drug, lenacapavir, accessible in 120 low- and middle-income countries.
This drug, which is administered as a twice-yearly injection, has demonstrated significant efficacy in reducing HIV infection rates among both women and men in clinical trials.
Trials conducted in South Africa and Uganda showed that lenacapavir effectively prevented HIV infections in girls and women. Further trials involving men across countries like Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the US indicated nearly complete protection.
In a statement, Gilead revealed that it has entered into non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical companies—Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero, and Mylan (a subsidiary of Viatris)—to allow them to produce and sell generic lenacapavir in these countries.
The company highlighted that these agreements were established before obtaining any global regulatory approvals to expedite the rollout of generic lenacapavir for HIV prevention.
Furthermore, Gilead will supply its own stock of the drug to bridge the gap until the licensed manufacturers become 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.
Gilead stated, “These agreements support our strategy to ensure 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.”
Gilead’s dual approach aims to provide low-cost access to lenacapavir in resource-limited countries by implementing a strong voluntary licensing program and offering Gilead-supplied products at no profit until generic manufacturers can fully meet demand. The agreements also cover lenacapavir for treating heavily treatment-experienced adults with multi-drug resistant HIV.
Gilead CEO Daniel O’Day emphasized the importance of making lenacapavir widely available, stating, “Given the transformative potential of lenacapavir, our focus is on making it available as quickly and broadly as possible.”
He added that Gilead teams are actively working to onboard high-volume generic manufacturers to ensure a swift transition to the voluntary license partners once lenacapavir for PrEP receives approval.
