Gilead Sciences to Offer Affordable Versions of HIV Prevention Drug in 120 Countries

 

Gilead Sciences has announced plans to provide affordable versions of its groundbreaking HIV prevention drug, lenacapavir, in 120 low and middle-income countries. Lenacapavir, administered as a twice-yearly injection, has shown highly promising results in clinical trials, significantly reducing HIV infection rates among both women and men.

Clinical trials conducted in South Africa and Uganda revealed lenacapavir’s effectiveness in preventing HIV infections among girls and women. In a separate study involving men from various countries—including Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States—the drug demonstrated near-total protection against the virus.

In a statement, Gilead revealed it has entered into voluntary licensing agreements with six pharmaceutical manufacturers, enabling them to produce and distribute generic versions of lenacapavir without paying royalties. These manufacturers include Dr. Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero, and Mylan, a subsidiary of Viatris.

The agreements were established ahead of any global regulatory approvals, ensuring the swift introduction of the generic drug once authorized. To bridge the supply gap until licensed manufacturers become fully operational, Gilead will provide its own supply of lenacapavir, focusing on registration in 18 countries with high HIV prevalence, such as Botswana, Kenya, Nigeria, South Africa, and Uganda.

Gilead stated, “These agreements further our strategy to provide broad, sustainable access to lenacapavir for pre-exposure prophylaxis (PrEP) globally, aligning with our commitment to ending the HIV epidemic for all people, everywhere.”

The company’s two-part approach involves working with generic manufacturers to ensure low-cost access to lenacapavir in resource-limited countries, while also offering the drug at no profit until production by these partners is fully established. The agreements also include lenacapavir for treating adults with advanced HIV who are resistant to multiple drugs.

Gilead’s CEO, Daniel O’Day, highlighted the urgency of making lenacapavir widely accessible, saying, “Given lenacapavir’s transformative potential, we are focused on ensuring it becomes available as quickly and broadly as possible.” O’Day added that Gilead’s teams are collaborating with high-volume generic producers to ensure a smooth transition to the voluntary license partners once the drug is approved for PrEP.