Gilead Sciences has announced a significant initiative aimed at enhancing access to its innovative HIV prevention drug, lenacapavir, by offering affordable versions in 120 low- and middle-income countries. This groundbreaking medication, which requires administration as a twice-yearly injection, has demonstrated remarkable efficacy in clinical trials, leading to substantial reductions in HIV infection rates among diverse populations.
Clinical trials conducted in South Africa and Uganda have shown lenacapavir's effectiveness in preventing HIV infections among women and girls. A follow-up study involving male participants across various countries—including Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States—revealed nearly complete protection against the virus.
In a recent statement, Gilead disclosed that it has entered into non-exclusive, royalty-free licensing agreements with six pharmaceutical companies, enabling them to produce and distribute generic versions of lenacapavir. The manufacturers involved in this initiative include Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero, and Mylan, a subsidiary of Viatris.
These licensing agreements were established ahead of any global regulatory approvals, ensuring a swift rollout of generic lenacapavir for HIV prevention. Gilead plans to supply its own version of the drug to bridge the gap until the licensed manufacturers can begin production, 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 reflect Gilead’s commitment to facilitating broad and sustainable access to lenacapavir for pre-exposure prophylaxis (PrEP) globally, as part of our vision to eradicate the HIV epidemic worldwide," the company stated.
Gilead's dual strategy seeks to ensure that lenacapavir remains accessible at low costs in resource-limited settings. This approach includes establishing a robust voluntary licensing program and providing Gilead-supplied products at no profit until generic manufacturers can meet demand. The agreements also extend to lenacapavir’s use in treating patients with multi-drug resistant HIV.
Daniel O’Day, CEO of Gilead, underscored the urgency of making lenacapavir widely accessible, emphasizing, “Given the transformative potential of lenacapavir, our priority is to make it available as quickly and broadly as possible.” He added that Gilead's teams are actively working to onboard high-volume generic manufacturers, facilitating a seamless transition to the voluntary license partners once lenacapavir for PrEP receives approval.
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